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نشرة الممارس الصحي نشرة معلومات المريض بالعربية نشرة معلومات المريض بالانجليزية صور الدواء بيانات الدواء
  SFDA PIL (Patient Information Leaflet (PIL) are under review by Saudi Food and Drug Authority)

Damesta contains the active substance escitalopram. Damesta belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonin-system in the brain by increasing the serotonin level. Disturbances in the serotonin-system are considered an important factor in the development of depression and related diseases.

Damesta contains escitalopram and is used to treat depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalised anxiety disorder and obsessive-compulsive disorder).

It may take a couple of weeks before you start to feel better. Continue to take Damesta, even if it takes some time before you feel any improvement in your condition.

You must talk to a doctor if you do not feel better or if you feel worse.


Do not take Damesta

  • If you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6).
  • If you take other medicines which belong to a group called MAO inhibitors, including selegiline (used in the treatment of Parkinson’s disease), moclobemide (used in the treatment of depression) and linezolid (an antibiotic).
  • If you are born with or have had an episode of abnormal heart rhythm (seen at ECG; an examination to evaluate how the heart is functioning).
  • If you take medicines for heart rhythm problems or that may affect the heart’s rhythm (see section 2 “Damesta and other medicines”).

Warnings and precautions

Talk to your doctor or pharmacist before taking Damesta. Please tell your doctor if you have any other condition or illness, as your doctor may need to take this into consideration. In particular, tell your doctor:

  • If you have epilepsy. Treatment with Damesta should be stopped if seizures occur for the first time, or if there is an increase in the seizure frequency (see also section 4 “Possible side effects”).
  • If you suffer from impaired liver or kidney function. Your doctor may need to adjust your dosage.
  • If you have diabetes. Treatment with Damesta may alter glycaemic control. Insulin and/or oral hypoglycaemic dosage may need to be adjusted.
  • If you have a decreased level of sodium in the blood.
  • If you have a tendency to easily develop bleedings or bruises.
  • If you are receiving electroconvulsive treatment.
  • If you have coronary heart disease.
  • If you suffer or have suffered from heart problems or have recently had a heart attack.
  • If you have a low resting heart-rate and/or you know that you may have salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets).
  • If you experience a fast or irregular heart beat, fainting, collapse or dizziness on standing up, which may indicate abnormal functioning of the heart rate.
  • If you have or have previously had eye problems, such as certain kinds of glaucoma (increased pressure in the eye).

Please note

Some patients with manic-depressive illness may enter into a manic phase. This is characterized by unusual and rapidly changing ideas, inappropriate happiness and excessive physical activity. If you experience this, contact your doctor.

Symptoms such as restlessness or difficulty in sitting or standing still can also occur during the first weeks of the treatment. Tell your doctor immediately if you experience these symptoms.

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.

You may be more likely to think like this:

  • If you have previously had thoughts about killing or harming yourself.
  • If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Children and adolescents under 18 years of age

Damesta should normally not be used for children and adolescents under 18 years. Also, you should know that patients under 18 have an increased risk of side effects such as suicide attempts, suicidal thoughts and hostility (predominately aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe Damesta for patients under 18 because he/she decides that this is in their best interest. If your doctor has prescribed Damesta for a patient under 18 and you want to discuss this, please go back to your doctor. You should inform your doctor if any symptoms listed above develop or worsen when patients under 18 are taking Damesta. Also, the long term safety effects of Damesta, concerning growth, maturation, cognitive and behavioral development in this group, have not yet been demonstrated. 

Damesta and other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tell your doctor if you are taking any of the following medicines:

  • “Non-selective monoamine oxidase inhibitors (MAOIs)”, containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active ingredients. If you have taken any of these medicines you will need to wait 14 days before you start taking Damesta. After stopping Damesta you must allow 7 days before taking any of these medicines.
  • “Reversible, selective MAO-A inhibitors”, containing moclobemide (used to treat depression).
  • “Irreversible MAO-B inhibitors”, containing selegiline (used to treat Parkinson’s disease). These increase the risk of side effects.
  • The antibiotic linezolid.
  • Lithium (used in the treatment of manic-depressive disorder) and tryptophan.
  • Imipramine and desipramine (both used to treat depression).
  • Sumatriptan and similar medicines (used to treat migraine) and tramadol (used against severe pain). These increase the risk of side effects.
  • Cimetidine, lansoprazole and omeprazole (used to treat stomach ulcers), fluvoxamine (antidepressant) and ticlopidine (used to reduce the risk of stroke). These may cause increased blood levels of escitalopram.
  • St. John's wort (hypericum perforatum) - a herbal remedy used for depression.
  • Acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory drugs (medicines used for pain relief or to thin the blood, so called anti-coagulant). These may increase bleeding-tendency.
  • Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, so called anti-coagulant). Your doctor will probably check the coagulation time of your blood when starting and discontinuing Damesta in order to verify that your dose of anti-coagulant is still adequate.
  • Mefloquine (used to treat Malaria), bupropion (used to treat depression) and tramadol (used to treat severe pain) due to a possible risk of a lowered threshold for seizures.
  • Neuroleptics (medicines to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to a possible risk of a lowered threshold for seizures.
  • Flecainide, propafenone, and metoprolol (used in cardiovascular diseases) clomipramine, and nortriptyline (antidepressants) and risperidone, thioridazine, and haloperidol (antipsychotics). The dosage of Damesta may need to be adjusted.
  • Medicines that decrease blood levels of potassium or magnesium, as these conditions increase the risk of life-threatening heart rhythm disorders.

Do not take Damesta if you take medicines for heart rhythm problems or medicines that may affect the heart’s rhythm, such as Class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarial treatment particularly halofantrine), certain antihistamines (e.g. astemizole, mizolastine). If you have any further questions about this you should speak to your doctor.

Damesta with food, drink and alcohol

Damesta can be taken with or without food (see section 3 “How to take Damesta”).

As with many medicines, combining Damesta with alcohol is not advisable, although Damesta is not expected to interact with alcohol.

Pregnancy, breast-feeding and fertility

Inform your doctor if you are pregnant or planning to become pregnant. Do not take Damesta if you are pregnant or breast-feeding, unless you and your doctor have discussed the risks and benefits involved.

If you take Damesta during the last 3 months of your pregnancy you should be aware that the following effects may be seen in your newborn baby: trouble with breathing, bluish skin, fits, body temperature changes, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, vivid reflexes, tremor, jitteriness, irritability, lethargy, constant crying, sleepiness and sleeping difficulties. If your newborn baby has any of these symptoms, please contact your doctor immediately.

Make sure your midwife and/or doctor know you are on Damesta. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Damesta may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately.

If used during pregnancy Damesta should never be stopped abruptly.

It is expected that Damesta will be excreted into breast milk.

Citalopram, a medicine like escitalopram, has been shown to reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but impact on human fertility has not been observed as yet.

Driving and using machines

You are advised not to drive a car or operate machinery until you know how Damesta affects you.


Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Adults

Depression

The normally recommended dose of Damesta is 10 mg taken as one daily dose. The dose may be increased by your doctor to a maximum of 20 mg per day.

Panic disorder

The starting dose of Damesta is 5 mg as one daily dose for the first week before increasing the dose to 10 mg per day. The dose may be further increased by your doctor to a maximum of 20 mg per day.

Social anxiety disorder

The normally recommended dose of Damesta is 10 mg taken as one daily dose. Your doctor can either decrease your dose to 5 mg per day or increase the dose to a maximum of 20 mg per day, depending on how you respond to the medicine.

Generalised anxiety disorder

The normally recommended dose of Damesta is 10 mg taken as one daily dose. The dose may be increased by your doctor to a maximum of 20 mg per day.

Obsessive-compulsive disorder

The normally recommended dose of Damesta is 10 mg taken as one daily dose. The dose may be increased by your doctor to a maximum of 20 mg per day.

Elderly patients (above 65 years of age)

The recommended starting dose of Damesta is 5 mg taken as one daily dose. The dose may be increased by your doctor to 10 mg per day.

Children and adolescents (below 18 years of age)

Damesta should not normally be given to children and adolescents. For further information please see section 2 “What you need to know before you take Damesta”.

You can take Damesta with or without food. Swallow the tablet with some water. Do not chew them, as the taste is bitter.

Duration of treatment

It may take a couple of weeks before you start to feel better. Continue to take Damesta even if it takes some time before you feel any improvement in your condition.

Do not change the dose of your medicine without talking to your doctor first.

Continue to take Damesta for as long as your doctor recommends. If you stop your treatment too soon, your symptoms may return. It is recommended that treatment should be continued for at least 6 months after you feel well again.

If you take more Damesta than you should

If you take more than the prescribed dose of Damesta, contact your doctor or nearest hospital emergency department immediately. Do this even if there are no signs of discomfort. Some of the signs of an overdose could be dizziness, tremor, agitation, convulsion, coma, nausea, vomiting, change in heart rhythm, decreased blood pressure and change in body fluid/salt balance. Take the Damesta box/container with you when you go to the doctor or hospital.

If you forget to take Damesta

Do not take a double dose to make up for forgotten doses. If you do forget to take a dose, and you remember before you go to bed, take it straight away. Carry on as usual the next day. If you only remember during the night, or the next day, leave out the missed dose and carry on as usual.

If you stop taking Damesta

Do not stop taking Damesta until your doctor tells you to do so. When you have completed your course of treatment, it is generally advised that the dose of Damesta is gradually reduced over a number of weeks.

When you stop taking Damesta, especially if it is abruptly, you may feel discontinuation symptoms. These are common when treatment with Damesta is stopped. The risk is higher, when Damesta has been used for a long time or in high doses or when the dose is reduced too quickly. Most people find that the symptoms are mild and go away on their own within two weeks. However, in some patients they may be severe in intensity or they may be prolonged (2-3 months or more). If you get severe discontinuation symptoms when you stop taking Damesta, please contact your doctor. He or she may ask you to start taking your tablets again and come off them more slowly.

Discontinuation symptoms include: Feeling dizzy (unsteady or off-balance), feelings like pins and needles, burning sensations and (less commonly) electric shock sensations, including in the head, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling anxious, headaches, feeling sick (nausea), sweating (including night sweats), feeling restless or agitated, tremor (shakiness), feeling confused or disorientated, feeling emotional or irritable, diarrhoea (loose stools), visual disturbances, fluttering or pounding heartbeat (palpitations).

If you have any further questions on the use of this product, ask your doctor or pharmacist.


Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects usually disappear after a few weeks of treatment. Please be aware that many of the effects may also be symptoms of your illness and therefore will improve when you start to get better.

If you experience any of the following symptoms you should contact your doctor or go to the hospital straight away:

Uncommon (may affect up to 1 in 100 people):

  • Unusual bleeds, including gastrointestinal bleeds

Rare (may affect up to 1 in 1000 people):

  • Swelling of skin, tongue, lips, or face, or have difficulties breathing or swallowing (allergic reaction).
  • High fever, agitation, confusion, trembling and abrupt contractions of muscles these may be signs of a rare condition called serotonin syndrome.

Not known (frequency cannot be estimated from the available data):

  • Difficulties urinating
  • Seizures (fits), see also section 2 “Warnings and precautions”
  • Yellowing of the skin and the white in the eyes are signs of liver function impairment/hepatitis
  • Fast, irregular heart beat, fainting which could be symptoms of a life-threatening condition known as torsade de pointes
  • Thoughts of harming or killing yourself, see also section 2 "Warnings and precautions"

In addition to the above the following side effects have been reported:

Very common (may affect more than 1 in 10 people):

  • Feeling sick (nausea)
  • Headache

Common (may affect up to 1 in 10 people):

  • Blocked or runny nose (sinusitis)
  • Decreased or increased appetite
  • Anxiety, restlessness, abnormal dreams, difficulties falling asleep, feeling sleepy, dizziness, yawning, tremors, prickling of the skin
  • Diarrhoea, constipation, vomiting, dry mouth
  • Increased sweating
  • Pain in muscle and joints (arthralgia and myalgia)
  • Sexual disturbances (delayed ejaculation, problems with erection, decreased sexual drive and women may experience difficulties achieving orgasm)
  • Fatigue, fever
  • Increased weight

Uncommon (may affect up to 1 in 100 people):

  • Nettle rash (urticaria), rash, itching (pruritus)
  • Grinding one’s teeth, agitation, nervousness, panic attack, confusion
  • Disturbed sleep, taste disturbance, fainting (syncope)
  • Enlarged pupils (mydriasis), visual disturbance, ringing in the ears (tinnitus)
  • Loss of hair
  • Excessive menstrual bleeding
  • Irregular menstrual period
  • Decreased weight
  • Fast heart beat
  • Swelling of the arms or legs
  • Nosebleeds

Rare (may affect up to 1 in 1000 people):

  • Aggression, depersonalisation, hallucination
  • Slow heart beat

Not known (frequency cannot be estimated from the available data):

  • Decreased levels of sodium in the blood (the symptoms are feeling: sick and unwell with weak muscles; or confused)
  • Dizziness when you stand up due to low blood pressure (orthostatic hypotension)
  • Abnormal liver function test (increased amounts of liver enzymes in the blood)
  • Movement disorders (involuntary movements of the muscles)
  • Painful erections (priapism)
  • Signs of increased bleeding e.g. from skin and mucous membranes (ecchymosis)
  • Sudden swelling of skin or mucosa (angioedemas)
  • Increase in the amount of urine excreted (inappropriate ADH secretion)
  • Flow of milk in men and in women that are not nursing
  • Mania
  • An increased risk of bone fractures has been observed in patients taking this type of medicine
  • Alteration of the heart rhythm (called “prolongation of QT interval”, seen on ECG, measuring electrical activity of the heart).

In addition, a number of side effects are known to occur with drugs that work in a similar way to escitalopram (the active ingredient of Damesta). These are:

  • Motor restlessness (akathisia)

Loss of appetite


Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Store below 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help to protect the environment.


What Damesta contains

The active substance is escitalopram. Each Damesta tablet contains 10 mg or 20 mg escitalopram (as oxalate).

The other ingredients are:

Purified Talc, Silicified microcrystalline cellulose, Croscarmellose sodium type A, Magnesium stearate, Polysorbate, Titanium dioxide, Polyethylene glycol, and Hydroxypropyl methylcellulose


Damesta 10 mg film-coated tablet is: A white to off-white, round, biconvex film-coated tablet engraved with “T4” on one side and plain surface on the other side Damesta 20 mg film-coated tablet is: A white to off-white, round, biconvex film-coated tablet engraved with “T5” on one side and plain surface on the other side Each unit carton of Damesta 10mg contains 30 film-coated tablets in 2 blister strips. Each unit carton of Damesta 20mg contains 30 film-coated tablets in 3 blister strips.

Dammam Pharma

Saudi Arabia

Address: 1st industrial city, unit No.1, PO.BOX: 7137, Dammam 32234-4384

Phone: +966138216444

Email: regulatory-affairs@dammampharma.sa


September 2020
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

يحتوي دامستا على إسيتالوبرام كمادة فعالة. ينتمي دامستا إلى مجموعة من مضادات الاكتئاب تسمى مثبطات استرداد أو استرجاع السيروتونين الانتقائية (اس اس اراي). هذه الأدوية تعمل على نظام السيروتونين في الدماغ عن طريق زيادة مستوى السيروتونين. تعتبر الاضطرابات في نظام السيروتونين عاملا مهما في تطور الاكتئاب والأمراض ذات الصلة.

يحتوي دامستا على إسيتالوبرام، ويستخدم لعلاج الاكتئاب (نوبات الاكتئاب الكبرى) واضطرابات القلق (مثل اضطراب الهلع مع أو بدون الخوف من الأماكن المكشوفة، واضطراب القلق الاجتماعي، واضطراب القلق العام واضطراب الوسواس القهري).

قد يستغرق بضعة أسابيع قبل أن تبدأ في الشعور بتحسن. استمر في تناول دامستا، حتى لو استغرق ذلك بعض الوقت قبل أن تشعر بأي تحسن في حالتك.

يجب عليك التحدث الى الطبيب إذا كنت لا تشعر بتحسن أو إذا كنت تشعر أن حالتك قد ساءت.

 

لا تتناول دامستا فى الحالات التالية:

 

• إذا كان لديك حساسية من إسيتالوبرام أو أي من المكونات الأخرى من هذا الدواء (المذكورة في الفقرة 6).

• إذا كنت تتناول أدوية أخرى التي تنتمي إلى مجموعة تسمى مثبطات MAO، بما في ذلك سيليجيلين (المستخدم في علاج مرض الشلل الرعاش)، موكلوبميد (المستخدم في علاج الاكتئاب) ولينزوليد (مضاد حيوي).

• إذا ولدت مع أو حدث لك عدم انتظام فى ضربات القلب (ينظر في رسم القلب الكهربائى؛ وهو فحص لتقييم الكيفية التي يعمل بها القلب).

• إذا كنت تتناول أدوية للمشاكل فى ضربات القلب أو التي قد تؤثر على ضربات القلب (انظر الفقرة 2 " دامستا و الأدوية الأخرى").

 

التحذيرات والاحتياطات

 

تحدث مع طبيبك أو الصيدلي قبل تناول دامستا. يرجى إخبار الطبيب إذا كان لديك أي شرط أو مرض آخر، و قد يحتاج الطبيب إلى أخذ هذا بعين الاعتبار. على وجه الخصوص، أخبر طبيبك:

• إذا كان لديك مرض الصرع. يجب إيقاف العلاج مع دامستا في حالة حدوث نوبات لأول مرة، أو إذا كان هناك زيادة في وتيرة النوبات (انظر أيضا فقرة 4 "الأعراض الجانبية المحتملة").

• إذا كنت تعاني من خلل فى وظائف الكبد أو الكلى. قد يحتاج طبيبك إلى تعديل الجرعة.

• إذا كان لديك مرض السكري. قد يغير العلاج مع دامستا السيطرة على السكر. قد تحتاج جرعة الأنسولين و / أو أدوية نقص سكر الدم عن طريق الفم إلى تعديل.

• إذا كان لديك انخفاض فى مستوى الصوديوم في الدم.

• إذا كان لديك ميل لحدوث النزيف أو الكدمات بسهولة.

• إذا كنت تتلقى العلاج بالصدمات الكهربائية.

• إذا كان لديك مرض فى شريان القلب التاجي.

• إذا كنت تعاني أو عانيت من مشاكل في القلب أو مررت مؤخرا بأزمة قلبية.

• إذا كان لديك معدل ضربات القلب منخفض و / أو إذا حدث لك نضوب الملح نتيجة الإسهال الحاد والقيء لفترات طويلة (أن تكون مريضا) أو استخدام مدرات البول (أقراص الماء).

• إذا كنت تعاني من سرعة أو عدم انتظام ضربات القلب، والاغماء، وانهيار أو الدوخة عند الوقوف، مما قد يشير إلى عمل غير طبيعي في معدل ضربات القلب.

• إذا كان لديك أو عانيت في السابق من مشاكل في العين، مثل أنواع معينة من الجلوكوما (ارتفاع الضغط في العين).

 

يرجى ملاحظة

 

قد يدخل بعض المرضى الذين يعانون من مرض الهوس الاكتئابي في مرحلة الهوس. يتميز هذا بالأفكار الغير عادية وسرعة التغير، والسعادة غير لائقة والنشاط البدني المفرط. إذا واجهت هذه، اتصل بطبيبك.

قد تحدث أعراض مثل الأرق أو صعوبة في الجلوس أو الوقوف أيضا خلال الأسابيع الأولى من العلاج. أخبر طبيبك فورا إذا واجهت هذه الأعراض.

 

التفكير في الانتحار وتفاقم الاكتئاب أو اضطرابات القلق

 

إذا كنت مكتئبا و / أو كان لديك اضطرابات القلق يمكن أن يحدث في بعض الأحيان أفكار إيذاء أو قتل نفسك. يمكن أن تزداد عند بداية العلاج لأول مرة بمضادات الاكتئاب، لأن هذه الأدوية قد تستغرق وقتا طويلا للعمل، وعادة حوالي أسبوعين لكن في بعض الأحيان قد تحتاج لفترة أطول.

 

قد تكون أكثر عرضة لهذا التفكير:

 

• إذا كان لديك تاريخ من الأفكار حول قتل أو إيذاء نفسك.

• إذا كنت من الشباب البالغين. وقد أظهرت المعلومات المستقاة من التجارب السريرية زيادة خطر السلوك الانتحاري لدى البالغين الذين تقل أعمارهم عن 25 عاما الذين يعانون من حالات نفسية والذين عولجوا بمضاد للاكتئاب.

 

إذا كان لديك أفكار إيذاء أو قتل نفسك في أي وقت، اتصل بطبيبك أو اذهب إلى المستشفى على الفور.

 

قد تجد أنه من المفيد إخبار قريب أو صديق حميم أنك مكتئبا أو لديك اضطراب القلق، وتطلب منهم أن يقرأ هذه النشرة. قد تسألهم اذا كانوا يعتقدون أن الاكتئاب أو القلق يزداد سوءا، أو إذا كانوا قلقين بشأن التغيرات في سلوكك.

 

الأطفال والمراهقين تحت سن 18 سنة من العمر

 

لا ينبغي استخدام دامستا للأطفال والمراهقين دون سن 18 عاما. أيضا، يجب أن نعرف أن المرضى الذين تقل أعمارهم عن 18 عرضة لخطر متزايد من الأعراض الجانبية مثل محاولات الانتحار، والأفكار الانتحارية والعداء (العدوان الغالب، وسلوك المعارضة والغضب) عندما تتناول هذه الفئة من الأدوية. على الرغم من هذا، فإن طبيبك قد يصف دامستا للمرضى دون سن 18 عاما لأنه / أنها قررت أن هذا فيه مصلحتهم. إذا وصف طبيبك دامستا للمريض تحت 18 سنة، وترغب في مناقشة هذا الموضوع، يرجى الرجوع إلى الطبيب. يجب إبلاغ الطبيب إذا كان أي من الأعراض المذكورة أعلاه حدثت أو ازدادت سوءا عند المرضى الذين تقل أعمارهم عن 18 سنة عندما يتناولون دامستا. أيضا، لم يتم حتى الآن اثبات آثار السلامة على المدى الطويل لـ دامستا بشأن النمو والنضج والتطور المعرفي والسلوكي في هذه الفئة العمرية.

 

دامستا و الأدوية الأخرى

أخبر طبيبك أو الصيدلي إذا كنت تأخذ، قد اتخذت مؤخرا أو قد تأخذ أي أدوية أخرى.

أخبر طبيبك إذا كنت تأخذ أي من الأدوية التالية:

• "مثبطات أحادى أمين الأوكسيديز (MAOIs)"، التي تحتوي على فينيلزين، إيبرونيازيد، إيزوكربوكسازيد، نيالاميد، وترانيلسيبرومين كمواد فعالة. إذا كنت قد اتخذت أي من هذه الأدوية سوف تحتاج إلى الانتظار 14 يوما قبل البدء بتناول دامستا. بعد وقف دامستا يجب السماح 7 أيام قبل اتخاذ أي من هذه الأدوية.

• " مثبطات عكسية، انتقائية لـ MAO-A "، التي تحتوي على موكلوبميد (التي تستخدم لعلاج الاكتئاب).

• "مثبطات MAO-B غير عكسى"، تحتوي على سيليجيلين (التي تستخدم لعلاج مرض الشلل الرعاش). هذه تزيد من خطر الأعراض الجانبية.

• لينزوليد المضاد الحيوي.

• ليثيوم (المستخدم في علاج اضطراب الهوس الاكتئابي)، والتربتوفان.

• إميبرامين وديسيبرامين (كلاهما يستخدم لعلاج الاكتئاب).

• سوماتريبتان والأدوية المماثلة (التي تستخدم لعلاج الصداع النصفي) وترامادول (يستخدم لعلاج الآلام الحادة). هذه تزيد من خطر الأعراض الجانبية.

• سيميتيدين، لانزوبرازول وأوميبرازول (التي تستخدم لعلاج قرحة المعدة)، فلوفوكسامين (اكتئاب) وتيكلوبيدين (التي تستخدم للحد من خطر السكتة الدماغية). قد تسبب هذه زيادة مستويات الدم من إسيتالوبرام.

• نبتة سانت جون (هيبركم بيرفوراتوم) - علاج بالاعشاب يستخدم لعلاج الاكتئاب.

• حمض أسيتيل سالسيليك (الاسبرين) والعقاقير المضادة للالتهاب غير الستيرويدية (الأدوية المستخدمة لتخفيف الألم أو تزيد سيولة الدم، ما يسمى مضادات تجلط الدم). هذه قد تزيد من الميل للنزيف.

• وارفارين، ديبيريدامول، وفينوبروكومون (الأدوية المستخدمة لزيادة سيولة الدم ، ما يسمى مضادات تجلط الدم). من المحتمل أن يتحقق الطبيب من وقت تخثر الدم عند البدء والتوقف عن تناول دامستا من أجل التحقق من أن جرعة مضاد تجلط الدم كافية.

• ميفلوكين (التي تستخدم لعلاج الملاريا)، بوبروبيون (التي تستخدم لعلاج الاكتئاب) وترامادول (التي تستخدم لعلاج الألم الحاد) وذلك بسبب احتمال وجود خطر خفض حد النوبات.

• نيورولوبتك (الأدوية لعلاج الفصام والذهان) ومضادات الاكتئاب (مضادات الاكتئاب ثلاثية الحلقات وإس إس آرآي) نظرا لاحتمال وجود خطر خفض حد النوبات.

• فليكاينايد، بروبافينون، وميتوبرولول (التي تستخدم في أمراض القلب والأوعية الدموية) كلوميبرامين، ونورتريبتيلين (مضادات الاكتئاب) وريسبيريدون، ثيوريدازين، وهالوبيريدول (مضاد الذهان). قد تحتاج الى تعديل جرعة دامستا.

• الأدوية التي تقلل مستويات البوتاسيوم أو المغنيسيوم فى الدم ، حيث تزيد هذه الظروف من خطر اضطرابات ضربات القلب التى تهدد الحياة.

لا تأخذ دامستا إذا كنت تأخذ أدوية للمشاكل فى ضربات القلب أو الأدوية التي يمكن ان تؤثر على ضربات القلب، مثل مضادات عدم انتظام ضربات القلب من فئة IA وIII ، مضادات الذهان (مثل مشتقات الفينوثيازين، بيموزيد، هالوبيريدول)، مضادات الاكتئاب ثلاثية الحلقات، وبعض العوامل المضادة للجراثيم (على سبيل المثال سبارفلوكساسين، موكسيفلوكساسين، الاريثروميسين IV، بنتاميدين، المضادة للملاريا العلاج لا سيما هالوفانترين)، مضادات الهيستامين (على سبيل المثال استيميزول، ميزولاستين). إذا كان لديك أي أسئلة أخرى حول هذا يجب عليك التحدث مع طبيبك.

 

تناول دامستا مع الطعام والشراب والكحول

 

يمكن تناول دامستا مع أو بدون الطعام (انظر الفقرة 3 " كيفية تناول أقراص دامستا").

كما هو الحال مع العديد من الأدوية، ليس من المستحسن الجمع بين دامستا مع الكحول ، على الرغم من أنه ليس من المتوقع تفاعل دامستا مع الكحول.

 

الحمل، الرضاعة الطبيعية والخصوبة

 

إبلغى طبيبك إذا كنتى حاملا أو تخططين لتصبحى حاملا. لا تتناولى دامستا إذا كنتى حاملا أو ترضعين طفلك رضاعة طبيعية، إلا إذا ناقشتى مع طبيبك المخاطر والمنافع المعنية.

إذا تناولتى دامستا خلال آخر 3 أشهر من الحمل يجب أن تعلمى بأن التأثيرات التالية يمكن أن تحدث للمولود الجديد: مشاكل مع التنفس، و ازرقاق الجلد، تشنجات، تغييرات فى درجة حرارة الجسم، وصعوبات في التغذية، والتقيؤ، وانخفاض نسبة السكر في الدم، تصلب العضلات أو المرنة، وردود فعل قوية، ورعاش، والعصبيه، والتهيج، والخمول، والبكاء المستمر، والنعاس وصعوبات النوم. إذا حدث لطفلك حديث الولادة أي من هذه الأعراض، يرجى الاتصال بالطبيب على الفور.

 

تأكدى  أن تعلم قابلتك و / أو الطبيب انكى تتناولين دامستا. عندما يؤخذ خلال فترة الحمل، وخصوصا في آخر 3 أشهر من الحمل، تزيد بعض الأدوية مثل دامستا من خطر حدوث حالة خطيرة في الأطفال، تدعى ارتفاع ضغط الدم الرئوي المستمر لحديثي الولادة (PPHN)، مما يجعل الطفل يتنفس بشكل أسرع ويظهر مزرق. عادة ما تبدأ هذه الأعراض خلال ال 24 ساعة الأولى بعد ولادة الطفل. إذا حدث هذا لطفلك يجب عليكى الاتصال بقابلتك و / أو بالطبيب على الفور.

 

إذا استخدمت أثناء الحمل دامستا لا ينبغي أبدا أن توقف فجأة.

ومن المتوقع أن يفرز دامستا في حليب الأم.

سيتالوبرام، وهو دواء مثل إسيتالوبرام، وقد ظهر أنه يحد من نوعية الحيوانات المنوية في الدراسات الحيوانية. من الناحية النظرية، وهذا قد يؤثر على الخصوبة، ولكن لم يلاحظ تأثير على الخصوبة البشرية حتى الآن.

 

القيادة واستخدام آلات

 

ينصح بعدم قيادة السيارة أو تشغيل الآلات حتى تعرف كيف يؤثر دامستا عليك.

 

https://localhost:44358/Dashboard

تناول دائما هذا الدواء تماما كما أخبرك طبيبك. استشر طبيبك أو الصيدلي إذا لم تكن متأكدا.

 

البالغين

الاكتئاب

الجرعة الموصى بها عادة من دامستا هي 10 ملجم تؤخذ بجرعة واحدة يوميا. ويمكن زيادة الجرعة من قبل الطبيب بحد أقصى 20 ملجم يوميا.

اضطراب الهلع

الجرعة المبدئية من دامستا هي 5 ملجم كجرعة واحدة يوميا في الأسبوع الأول قبل زيادة الجرعة إلى 10 ملجم يوميا. ويمكن زيادة الجرعة كذلك من قبل الطبيب بحد أقصى 20 ملجم يوميا.

اضطراب القلق الاجتماعي

الجرعة الموصى بها عادة من دامستا هي 10 ملجم تؤخذ بجرعة واحدة يوميا. يمكن أن ينقص طبيبك الجرعة إلى 5 ملجم يوميا أو زيادة الجرعة بحد أقصى 20 ملجم في اليوم الواحد، وهذا يتوقف على كيفية الاستجابة للدواء.

اضطراب القلق العام

الجرعة الموصى بها عادة من دامستا هي 10 ملجم تؤخذ بجرعة واحدة يوميا. ويمكن زيادة الجرعة من قبل الطبيب بحد أقصى 20 ملجم يوميا.

الوسواس القهري

الجرعة الموصى بها عادة من دامستا هي 10 ملجم تؤخذ بجرعة واحدة يوميا. ويمكن زيادة الجرعة من قبل الطبيب بحد أقصى 20 ملجم يوميا.

 

المرضى كبار السن (فوق 65 سنة من العمر)

الجرعة المنصوح بها من دامستا هي 5 ملجم تؤخذ بجرعة واحدة يوميا. ويمكن زيادة الجرعة من قبل الطبيب إلى 10 ملجم يوميا.

 

الأطفال والمراهقين (أقل من 18 سنة من العمر)

لا ينبغي عادة أن يعطى دامستا للأطفال والمراهقين. لمزيد من المعلومات يرجى الاطلاع على قسم 2 "ما تحتاج إلى معرفته قبل اتخاذ دامستا".

يمكنك أن تتناول دامستا مع أو بدون طعام. إبتلع قرص مع بعض الماء. لا تمضغه لأن طعمه مر.

 

مدة العلاج

قد يستغرق بضعة أسابيع قبل أن تبدأ في الشعور بتحسن. استمر في تناول دامستا حتى لو استغرق ذلك بعض الوقت قبل أن تشعر بأي تحسن في حالتك.

لا تغير جرعة الدواء دون التحدث مع طبيبك أولا.

استمر في تناول دامستا لطالما يوصي الطبيب. إذا توقفت عن العلاج بشكل مبكر جدا، قد ترجع الأعراض الخاصة بك. فمن المستحسن أن يستمر العلاج لمدة 6 أشهر على الأقل بعد أن تشعر بصحة جيدة ثانية.

 

إذا كنت تتناول دامستا أكثر مما يجب

إذا كنت تتناول أكثر من الجرعة الموصوفة من دامستا، اتصل بطبيبك أو أقرب قسم الطوارئ في المستشفى على الفور. قم بذلك حتى لو لم تكن هناك علامات الانزعاج. بعض من علامات الجرعة الزائدة يمكن أن تكون الدوخة، والرعاش، والإثارة، التشنج والغيبوبة والغثيان والقيء، والتغير في ضربات القلب، وانخفاض ضغط الدم، وتغير في توازن الجسم السوائل / الملح. خذ عبوة / حاوية دامستا معك عند الذهاب إلى الطبيب أو المستشفى.

 

إذا كنت قد نسيت أن تتناول دامستا

لا تأخذ جرعة مضاعفة لتعويض الجرعات المنسية. إذا كنت قد نسيت تناول جرعة، وتذكرت قبل أن تذهب إلى السرير، تناولها على الفور. و استمر كالمعتاد في اليوم التالي. لو تذكرت فقط أثناء الليل، أو في اليوم التالي اترك الجرعة المنسية و استمر كالمعتاد.

 

إذا توقفت عن تناول دامستا

لا تتوقف عن تناول دامستا حتى يقول لك الطبيب أن تفعل ذلك. عندما كنت قد أكملت مدة العلاج، وينصح عموما أن يتم خفض جرعة دامستا تدريجيا على مدى عدة أسابيع.

عند التوقف عن تناول دامستا، لا سيما إذا كان فجأة، قد تشعر بأعراض التوقف. وهي شائعة عندما يتم إيقاف العلاج مع دامستا. ترتفع مخاطر، عندما يتم استخدام دامستا لفترة طويلة أو بجرعات عالية أو عندما يتم تقليل الجرعة بسرعة كبيرة جدا. معظم الناس يجدون أن الأعراض خفيفة وتزول من تلقاء نفسها في غضون أسبوعين. ومع ذلك، في بعض المرضى قد تكون شديدة في الحدة أو قد تكون لفترات طويلة (2-3 أشهر أو أكثر). اذا كان لديك أعراض التوقف حادة عند التوقف عن تناول دامستا، يرجى الاتصال بالطبيب. ويجوز له / لها أن يطلب منك للبدء في تناول الأقراص مرة أخرى، وإيقافها ببطء أكثر.

 

وتشمل أعراض التوقف: الشعور بالدوار (متقلب أو في حالة عدم توازن)، و الشعور مثل الدبابيس والإبر، والإحساس بالحرق و(أقل شيوعا) الأحساس بالصدمة الكهربائية، بما في ذلك في الرأس، واضطرابات النوم (أحلام اليقظة والكوابيس، وعدم القدرة على النوم)، والشعور بالقلق، والصداع، والشعور بالمرض (الغثيان)، والتعرق (بما في ذلك تعرق ليلي)، والشعور بالقلق أو الهياج، والرعاش (الاهتزاز)، والشعور بالارتباك أو الضلال، والشعور العاطفي أو الانفعال، والإسهال (براز رخو)، اضطرابات بصرية، ترفرف أو قصف ضربات القلب (خفقان).

إذا كان لديك أي أسئلة أخرى عن استخدام هذا المنتج، اسأل طبيبك أو الصيدلي.

 

مثل جميع الأدوية، قد يسبب هذا الدواء أعراض جانبية، وإن لم تكن تحدث لكل من يتناول هذا الدواء.

عادة ما تختفي الأعراض الجانبية بعد بضعة أسابيع من العلاج. يرجى أن تكون على علم بأن العديد من هذه الأعراض قد تكون أعراض مرضك أيضا، وبالتالي سوف تتحسن عند بدء شعورك بالتحسن.

إذا كنت تواجه أي من الأعراض التالية يجب عليك الاتصال بطبيبك أو اذهب إلى المستشفى على الفور:

غير شائعة (قد تؤثر على ما يصل إلى 1 في 100 شخص):

• نزيف غير عادي، بما في ذلك نزيف الجهاز الهضمي

نادرة (قد تؤثر على ما يصل إلى 1 في 1000 شخص):

• تورم الجلد، اللسان، الشفاه، أو الوجه، أو صعوبات في التنفس أو البلع (رد الفعل التحسسي).

• ارتفاع درجة الحرارة، والإثارة، والارتباك، وارتعاش الانقباضات المفاجئة للعضلات هذه قد تكون دلائل على وجود حالة نادرة تسمى متلازمة سيروتونين.

غير معروفة (لا يمكن تقدير تردد من البيانات المتاحة):

• صعوبات التبول

• المضبوطات (نوبات)، وانظر أيضا قسم 2 "تحذيرات واحتياطات"

• اصفرار الجلد وبياض في عيون دلائل على ضعف وظيفة الكبد / التهاب الكبد.

• سرعة، عدم انتظام ضربات القلب، والاغماء التي يمكن أن تكون أعراض حالة تهدد حياتهم تعرف باسم تورساد دى بوانت.

• أفكار إيذاء أو قتل نفسك، انظر أيضا القسم 2 "تحذيرات واحتياطات".

بالإضافة إلى ما سبق تم الإبلاغ عن الأعراض الجانبية التالية:

شائعة جدا (قد تؤثر على أكثر من 1 في 10 شخص):

• الشعور بالغثيان (الغثيان)

• الصداع

شائعة (قد يؤثر على ما يصل إلى 1 في 10 شخص):

• غلق أو سيلان الأنف (التهاب الجيوب الأنفية)

• انخفاض أو زيادة الشهية

• القلق، والأرق، والأحلام الغير طبيعية، وصعوبات في النوم، والشعور بالنعاس، والدوخة، والتثاؤب، والهزات، قشعريرة في الجلد

• الإسهال والإمساك والتقيؤ وجفاف الفم

• زيادة التعرق

• ألم في العضلات والمفاصل (ألم مفصلي وألم عضلي)

• الاضطرابات الجنسية (تأخير القذف، ومشاكل في الانتصاب، و انخفاض الدافع الجنسي و قد تواجه النساء صعوبات فى الوصول إلى هزة الجماع)

• التعب، الحمى

• زيادة الوزن

غير شائعة (قد يؤثر على ما يصل إلى 1 في 100 شخص):

• الطفح الجلدي (الشرى)، والطفح الجلدي، والحكة (حكة)

• طحن أسنان المرء، والإثارة، والعصبية، ونوبات الهلع والارتباك

• اضطراب النوم، اضطراب الذوق، الإغماء (الغشيان)

• توسيع حدقة العين (توسيع حدقة العين)، اضطرابات بصرية، طنين في الأذنين (الطنين)

• فقدان الشعر

• نزيف الحيض المفرط

• عدم انتظام فترة الحيض

• انخفاض الوزن

• سرعة فى ضربات القلب

• تورم في الذراعين أو الساقين

• نزيف الأنف

نادرة (قد يؤثر على ما يصل إلى 1 في 1000 شخص):

• العدوان، انفصال من الشخصية، هلوسة

• بطئ ضربات القلب

غير معروف (لا يمكن تقدير تردد من البيانات المتاحة):

• انخفاض مستويات الصوديوم في الدم (الأعراض هى: الشعور بالمرض ولست على ما يرام مع ضعف العضلات، أو الارتباك)

• الدوخة عند الوقوف بسبب انخفاض ضغط الدم (انخفاض ضغط الدم الانتصابي)

• نتائج غير طبيعية فى اختبار وظائف الكبد (زيادة كميات من أنزيمات الكبد في الدم)

• اضطرابات الحركة (حركات لا إرادية للعضلات)

• انتصاب مؤلم (الانتصاب المستمر)

• علامات زيادة النزيف مثلا من الجلد والأغشية المخاطية (كدمة)

• تورم مفاجئ من الجلد أو الغشاء المخاطي (angioedemas)

• زيادة في كمية البول تفرز (غير مناسب إفراز ADH)

• تدفق الحليب عند الرجال وعند النساء الغير مرضعات

• هوس

• لوحظ زيادة خطر كسور العظام في المرضى الذين يتناولون هذا النوع من الدواء

• تغيير في ضربات القلب (وتسمى "إطالة فترة QT"، وينظر في تخطيط القلب، قياس النشاط الكهربائي للقلب).

بالإضافة إلى ذلك، ومن المعروف أن عددا من الأعراض الجانبية تحدث مع الأدوية التي تعمل بطريقة مماثلة لإسيتالوبرام (المادة الفعالة في دامستا). وهذه هي:

• التململ الحركى (تعذر الجلوس)

• فقدان الشهية

يحفظ الدواء بعيدا عن متناول ونظر الأطفال.

لا تستعمل هذا الدواء بعد انتهاء تاريخ الصلاحية المدون على العبوة بعد كلمة EXP. وتاريخ الإنتهاء يشير إلى أخر يوم فى الشهر المذكور.

يحفظ في درجة حرارة أقل من 30 درجة مئوية.

يجب عدم التخلص من الأدوية في مياه المجاري أو قمامة المنزل. اسأل الصيدلي كيف تتخلص من الأدوية التي لم تعد بحاجتها. لأن هذه الاعتبارات ستعمل على حماية البيئة.

 

علام يحتوى دامستا

المادة الفعالة هي إسيتالوبرام. يحتوي كل قرص مغلف بطبقة رقيقة من دامستا على 10 ملجم أو 20 ملجم إسيتالوبرام (كما أكسالات).

المكونات الأخرى هي:

تنقيته التلك، سيليسيفايد السليلوز ميكروكريستالين، كروزكارميللوز نوع الصوديوم A، ستيرات المغنيسيوم، بوليسوربات، ثاني أكسيد التيتانيوم، البولي ايثيلين جلايكول، وهيدروكسي ميثيل.

 

قرص دامستا 10 ملجم مغلف بطبقة رقيقة: هو قرص أبيض إلى مائل للبياض، مستدير، محدب الوجهين مغلف بطبقة رقيقة محفورة مع "4T" على جانب واحد وسطح عادي على الجانب الآخر

قرص دامستا 20 ملجم مغلف بطبقة رقيقة: هو قرص أبيض إلى مائل للبياض، مستدير، محدب الوجهين مغلف بطبقة رقيقة محفورة مع "5T" على جانب واحد وسطح عادي على الجانب الآخر

تحتوي كل عبوة من دامستا 10 ملجم على 30 قرص مغلف بطبقة رقيقة في شريطين.

تحتوي كل عبوة من دامستا 20 ملجم على 30 قرص مغلف بطبقة رقيقة في ثلاثة شرائط.

 

الدمام فارما

العنوان: المدينة الصناعية الأولى , وحدة رقم 1 , صندوق بريد: 7137 , الدمام 32234 – 4384

تليفون: 966138216444+

البريد الإلكتروني: regulatory-affairs@dammampharma.sa

 

سبتمبر 2020
 Read this leaflet carefully before you start using this product as it contains important information for you

DAMESTA® 10 mg film-coated tablets DAMESTA® 20 mg film-coated tablets

Damesta 10 mg: Each tablet contains 10 mg escitalopram (as oxalate) Damesta 20 mg: Each tablet contains 20 mg escitalopram (as oxalate) For the full list of excipients, see section 6.1.

Damesta 10 mg film-coated tablet is: A white to off-white, round, biconvex film-coated tablet engraved with “T4” on one side and plain surface on the other side Damesta 20 mg film-coated tablet is: A white to off-white, round, biconvex film-coated tablet engraved with “T5” on one side and plain surface on the other side

Treatment of major depressive episodes.

Treatment of panic disorder with or without agoraphobia.

Treatment of social anxiety disorder (social phobia).

Treatment of generalised anxiety disorder.

Treatment of obsessive-compulsive disorder.


Safety of daily doses above 20 mg has not been demonstrated.

Damesta is administered as a single daily dose and may be taken with or without food.

Major depressive episodes

Usual dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily.

Usually 2-4 weeks are necessary to obtain antidepressant response. After the symptoms resolve, treatment for at least 6 months is required for consolidation of the response.

Panic disorder with or without agoraphobia

An initial dose of 5 mg is recommended for the first week before increasing the dose to 10 mg daily. The dose may be further increased, up to a maximum of 20 mg daily, dependent on individual patient response.

Maximum effectiveness is reached after about 3 months. The treatment lasts several months.

Social anxiety disorder

Usual dosage is 10 mg once daily. Usually 2-4 weeks are necessary to obtain symptom relief. The dose may subsequently, depending on individual patient response, be decreased to 5 mg or increased to a maximum of 20 mg daily.

Social anxiety disorder is a disease with a chronic course, and treatment for 12 weeks is recommended to consolidate response. Long-term treatment of responders has been studied for 6 months and can be considered on an individual basis to prevent relapse; treatment benefits should be re-evaluated at regular intervals.

Social anxiety disorder is a well-defined diagnostic terminology of a specific disorder, which should not be confounded with excessive shyness. Pharmacotherapy is only indicated if the disorder interferes significantly with professional and social activities.

The place of this treatment compared to cognitive behavioural therapy has not been assessed. Pharmacotherapy is part of an overall therapeutic strategy.

Generalised anxiety disorder

Initial dosage is 10 mg once daily. Depending on the individual patient response, the dose may be increased to a maximum of 20 mg daily.

Long-term treatment of responders has been studied for at least 6 months in patients receiving 20 mg daily. Treatment benefits and dose should be re-evaluated at regular intervals (see Section 5.1).

Obsessive-compulsive disorder

Initial dosage is 10 mg once daily. Depending on the individual patient response, the dose may be increased to a maximum of 20 mg daily.

As OCD is a chronic disease, patients should be treated for a sufficient period to ensure that they are symptom free.

Treatment benefits and dose should be re-evaluated at regular intervals (see section 5.1).

Elderly patients (> 65 years of age)

Initial dosage is 5 mg once daily. Depending on individual patient response the dose may be increased to 10 mg daily (see section 5.2).

The efficacy of Damesta in social anxiety disorder has not been studied in elderly patients.

Children and adolescents (<18 years)

Damesta should not be used in the treatment of children and adolescents under the age of 18 years (see section 4.4).

Reduced renal function

Dosage adjustment is not necessary in patients with mild or moderate renal impairment. Caution is advised in patients with severely reduced renal function (CLCR less than 30 ml/min.) (see section 5.2).

Reduced hepatic function

An initial dose of 5 mg daily for the first two weeks of treatment is recommended in patients with mild or moderate hepatic impairment. Depending on individual patient response, the dose may be increased to 10 mg daily. Caution and extra careful dose titration is advised in patients with severely reduced hepatic function (see section 5.2).

Poor metabolisers of CYP2C19

For patients who are known to be poor metabolisers with respect to CYP2C19, an initial dose of 5 mg daily during the first two weeks of treatment is recommended. Depending on individual patient response, the dose may be increased to 10 mg daily (see section 5.2).

Discontinuation symptoms seen when stopping treatment

Abrupt discontinuation should be avoided. When stopping treatment with escitalopram the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of discontinuation symptoms (see sections 4.4 and 4.8). If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.


Hypersensitivity to the active substance or to any of the excipients, listed in section 6.1. Concomitant treatment with non-selective, irreversible monoamine oxidase inhibitors (MAO-inhibitors) is contraindicated due to the risk of serotonin syndrome with agitation, tremor, hyperthermia etc. (see section 4.5). The combination of escitalopram with reversible MAO-A inhibitors (e.g. moclobemide) or the reversible non-selective MAO-inhibitor linezolid is contraindicated due to the risk of onset of a serotonin syndrome (see section 4.5). Escitalopram is contraindicated in patients with known QT interval prolongation or congenital long QT syndrome. Escitalopram is contraindicated together with medicinal products that are known to prolong the QT interval (see section 4.5).

The following special warnings and precautions apply to the therapeutic class of SSRIs (Selective Serotonin Re-uptake Inhibitors).

Use in children and adolescents under 18 years of age

Damesta should not be used in the treatment of children and adolescents under the age of 18 years. Suicide related behaviours (suicide attempt and suicidal thoughts), and hostility (predominately aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo. If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms. In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.

Paradoxical anxiety

Some patients with panic disorder may experience increased anxiety symptoms at the beginning of treatment with antidepressants. This paradoxical reaction usually subsides within two weeks during continued treatment. A low starting dose is advised to reduce the likelihood of an anxiogenic effect (see section 4.2).

Seizures

Escitalopram should be discontinued if a patient develops seizures for the first time, or if there is an increase in seizure frequency (in patients with a previous diagnosis of epilepsy). SSRIs should be avoided in patients with unstable epilepsy, and patients with controlled epilepsy should be closely monitored.

Mania

SSRIs should be used with caution in patients with a history of mania/hypomania. SSRIs should be discontinued in any patient entering a manic phase.

Diabetes

In patients with diabetes, treatment with an SSRI may alter glycaemic control (hypoglycaemia or hyperglycaemia). Insulin and/or oral hypoglycaemic dosage may need to be adjusted.

Suicide/suicidal thoughts or clinical worsening

Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery.

Other psychiatric conditions for which Damesta is prescribed can also be associated with an increased risk of suicide-related events. In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.

Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment, are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. A meta analysis of placebo controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old. Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes.

Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.

Akathisia/psychomotor restlessness

The use of SSRIs/SNRIs has been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still. This is most likely to occur within the first few weeks of treatment. In patients who develop these symptoms, increasing the dose may be detrimental.

Hyponatraemia

Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion (SIADH), has been reported rarely with the use of SSRIs and generally resolves on discontinuation of therapy. Caution should be exercised in patients at risk, such as the elderly, or patients with cirrhosis, or if used in combination with other medications which may cause hyponatraemia.

Haemorrhage

There have been reports of cutaneous bleeding abnormalities, such as ecchymoses and purpura, with SSRIs. Caution is advised in patients taking SSRIs, particularly in concomitant use with oral anticoagulants, with medicinal products known to affect platelet function (e.g. atypical antipsychotics and phenothiazines, most tricyclic antidepressants, acetylsalicylic acid and non-steroidal anti-inflammatory medicinal products (NSAIDs), ticlopidine and dipyridamole) and in patients with known bleeding tendencies.

ECT (electroconvulsive therapy)

There is limited clinical experience of concurrent administration of SSRIs and ECT, therefore caution is advisable.

Serotonin syndrome

Caution is advisable if escitalopram is used concomitantly with medicinal products with serotonergic effects such as sumatriptan or other triptans, tramadol and tryptophan.

In rare cases, serotonin syndrome has been reported in patients using SSRIs concomitantly with serotonergic medicinal products. A combination of symptoms, such as agitation, tremor, myoclonus and hyperthermia may indicate the development of this condition. If this occurs treatment with the SSRI and the serotonergic medicinal product should be discontinued immediately and symptomatic treatment initiated.

St. John's wort

Concomitant use of SSRIs and herbal remedies containing St. John's wort (Hypericum perforatum) may result in an increased incidence of adverse reactions (see section 4.5).

Discontinuation symptoms seen when stopping treatment

Discontinuation symptoms when stopping treatment are common, particularly if discontinuation is abrupt (see section 4.8). In clinical trials adverse events seen on treatment discontinuation occurred in approximately 25% of patients treated with escitalopram and 15% of patients taking placebo.

The risk of discontinuation symptoms may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction. Dizziness, sensory disturbances (including paraesthesia and electric shock sensations), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor, confusion, sweating, headache, diarrhoea, palpitations, emotional instability, irritability, and visual disturbances are the most commonly reported reactions. Generally these symptoms are mild to moderate, however, in some patients they may be severe in intensity.

They usually occur within the first few days of discontinuing treatment, but there have been very rare reports of such symptoms in patients who have inadvertently missed a dose.

Generally these symptoms are self-limiting and usually resolve within 2 weeks, though in some individuals they may be prolonged (2-3 months or more). It is therefore advised that escitalopram should be gradually tapered when discontinuing treatment over a period of several weeks or months, according to the patient's needs (see “Discontinuation symptoms seen when stopping treatment”, section 4.2).

Coronary heart disease

Due to limited clinical experience, caution is advised in patients with coronary heart disease (see section 5.3).

QT interval prolongation

Escitalopram has been found to cause a dose-dependent prolongation of the QT interval. Cases of QT interval prolongation and ventricular arrhythmia including torsade de pointes have been reported during the post-marketing period, predominantly in patients of female gender, with hypokalaemia, or with pre-existing QT interval prolongation or other cardiac diseases (see sections 4.3, 4.5, 4.8, 4.9 and 5.1).

Caution is advised in patients with significant bradycardia; or in patients with recent acute myocardial infarction or uncompensated heart failure.

Electrolyte disturbances such as hypokalaemia and hypomagnesaemia increase the risk for malignant arrhythmias and should be corrected before treatment with escitalopram is started.

If patients with stable cardiac disease are treated, an ECG review should be considered before treatment is started.

If signs of cardiac arrhythmia occur during treatment with escitalopram, the treatment should be withdrawn and an ECG should be performed.

Angle-Closure Glaucoma

SSRIs including escitalopram may have an effect on pupil size resulting in mydriasis. This mydriatic effect has the potential to narrow the eye angle resulting in increased intraocular pressure and angle-closure glaucoma, especially in patients pre-disposed. Escitalopram should therefore be used with caution in patients with angle-closure glaucoma or history of glaucoma


Contraindicated combinations:

Irreversible non-selective MAOIs

Cases of serious reactions have been reported in patients receiving an SSRI in combination with a non-selective, irreversible monoamine oxidase inhibitor (MAOI), and in patients who have recently discontinued SSRI treatment and have been started on such MAOI treatment (see section 4.3). In some cases, the patient developed serotonin syndrome (see section 4.8).

Escitalopram is contraindicated in combination with non-selective, irreversible MAOIs. Escitalopram may be started 14 days after discontinuing treatment with an irreversible MAOI. At least 7 days should elapse after discontinuing escitalopram treatment, before starting a non-selective, irreversible MAOI.

Reversible, selective MAO-A inhibitor (moclobemide)

Due to the risk of serotonin syndrome, the combination of escitalopram with a MAO-A inhibitor such as moclobemide is contraindicated (see section 4.3). If the combination proves necessary, it should be started at the minimum recommended dosage and clinical monitoring should be reinforced.

Reversible, non-selective MAO-inhibitor (linezolid)

The antibiotic linezolid is a reversible non-selective MAO-inhibitor and should not be given to patients treated with escitalopram. If the combination proves necessary, it should be given with minimum dosages and under close clinical monitoring (see section 4.3).

Irreversible, selective MAO-B inhibitor (selegiline)

In combination with selegiline (irreversible MAO-B inhibitor), caution is required due to the risk of developing serotonin syndrome. Selegiline doses up to 10 mg/day have been safely co-administered with racemic citalopram.

QT interval prolongation

Pharmacokinetic and pharmacodynamic studies of escitalopram combined with other medicinal products that prolong the QT interval have not been performed. An additive effect of escitalopram and these medicinal products cannot be excluded. Therefore, co-administration of escitalopram with medicinal products that prolong the QT interval, such as Class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarial treatment particularly halofantrine), certain antihistamines (e.g. astemizole, mizolastine), is contraindicated.

Combinations requiring precautions for use:

Serotonergic medicinal products

Co-administration with serotonergic medicinal products (e.g. tramadol, sumatriptan and other triptans) may lead to serotonin syndrome.

Medicinal products lowering the seizure threshold

SSRIs can lower the seizure threshold. Caution is advised when concomitantly using other medicinal products capable of lowering the seizure threshold (e.g antidepressants (tricyclics, SSRIs), neuroleptics (phenothiazines, thioxanthenes and butyrophenones), mefloquin, bupropion and tramadol).

Lithium, tryptophan

There have been reports of enhanced effects when SSRIs have been given together with lithium or tryptophan, therefore concomitant use of SSRIs with these medicinal products should be undertaken with caution.

St. John's wort

Concomitant use of SSRIs and herbal remedies containing St. John´s wort (Hypericum perforatum) may result in an increased incidence of adverse reactions (see section 4.4).

Haemorrhage

Altered anti-coagulant effects may occur when escitalopram is combined with oral anticoagulants. Patients receiving oral anticoagulant therapy should receive careful coagulation monitoring when escitalopram is started or stopped (see section 4.4). Concomitant use of non-steriodal anti-inflammatory drugs (NSAIDs) may increase bleeding-tendency (see section 4.4).

Alcohol

No pharmacodynamic or pharmacokinetic interactions are expected between escitalopram and alcohol. However, as with other psychotropic medicinal products, the combination with alcohol is not advisable.

Medicinal products inducing hypokalaemia/hypomagnesaemia

Caution is warranted for concomitant use of hypokalaemia/hypomagnesaemia inducing medicinal products as these conditions increase the risk of malignant arrhythmias (see section 4.4).

 

Pharmacokinetic interactions

 

Influence of other medicinal products on the pharmacokinetics of escitalopram

The metabolism of escitalopram is mainly mediated by CYP2C19. CYP3A4 and CYP2D6 may also contribute to the metabolism although to a smaller extent. The metabolism of the major metabolite S-DCT (demethylated escitalopram) seems to be partly catalysed by CYP2D6.

Co-administration of escitalopram with omeprazole 30 mg once daily (a CYP2C19 inhibitor) resulted in moderate (approximately 50%) increase in the plasma concentrations of escitalopram.

Co-administration of escitalopram with cimetidine 400 mg twice daily (moderately potent general enzyme-inhibitor) resulted in a moderate (approximately 70%) increase in the plasma concentrations of escitalopram. Caution is advised when administering escitalopram in combination with cimetidine. Dose adjustment may be warranted.

Thus, caution should be exercised when used concomitantly with CYP2C19 inhibitors (e.g. omeprazole, esomeprazole, fluvoxamine, lansoprazole, ticlopidine) or cimetidine. A reduction in the dose of escitalopram may be necessary based on monitoring of side-effects during concomitant treatment.

Effect of escitalopram on the pharmacokinetics of other medicinal products

Escitalopram is an inhibitor of the enzyme CYP2D6. Caution is recommended when escitalopram is co-administered with medicinal products that are mainly metabolised by this enzyme, and that have a narrow therapeutic index, e.g. flecainide, propafenone and metoprolol (when used in cardiac failure), or some CNS acting medicinal products that are mainly metabolised by CYP2D6, e.g. antidepressants such as desipramine, clomipramine and nortriptyline or antipsychotics like risperidone, thioridazine and haloperidol. Dosage adjustment may be warranted.

Co-administration with desipramine or metoprolol resulted in both cases in a twofold increase in the plasma levels of these two CYP2D6 substrates.

In vitro studies have demonstrated that escitalopram may also cause weak inhibition of CYP2C19. Caution is recommended with concomitant use of medicinal products that are metabolised by CYP2C19.

 


Pregnancy

For escitalopram only limited clinical data are available regarding exposed pregnancies.

Animal studies have shown reproductive toxicity (see section 5.3). Damesta should not be used during pregnancy unless clearly necessary and only after careful consideration of the risk/benefit.

Neonates should be observed if maternal use of Damesta continues into the later stages of pregnancy, particularly in the third trimester. Abrupt discontinuation should be avoided during pregnancy.

The following symptoms may occur in the neonate after maternal SSRI/SNRI use in later stages of pregnancy: respiratory distress, cyanosis, apnoea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycaemia, hypertonia, hypotonia, hyperreflexia, tremor, jitteriness, irritability, lethargy, constant crying, somnolence and difficulty sleeping. These symptoms could be due to either serotonergic effects or discontinuation symptoms. In a majority of instances the complications begin immediately or soon (<24 hours) after delivery.

Epidemiological data have suggested that the use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). The observed risk was approximately 5 cases per 1000 pregnancies. In the general population 1 to 2 cases of PPHN per 1000 pregnancies occur.

Breast-feeding

It is expected that escitalopram will be excreted into human milk.

Consequently, breast-feeding is not recommended during treatment.

Fertility

Animal data have shown that citalopram may affect sperm quality (see section 5.3). Human case reports with some SSRIs have shown that an effect on sperm quality is reversible. Impact on human fertility has not been observed so far.


Although escitalopram has been shown not to affect intellectual function or psychomotor performance, any psychoactive medicinal product may impair judgement or skills. Patients should be cautioned about the potential risk of an influence on their ability to drive a car and operate machinery.


Adverse reactions are most frequent during the first or second week of treatment and usually decrease in intensity and frequency with continued treatment.

Tabulated list of adverse reactions

Adverse reactions known for SSRIs and also reported for escitalopram in either placebo-controlled clinical studies or as spontaneous post-marketing events are listed below by system organ class and frequency.

Frequencies are taken from clinical studies; they are not placebo-corrected. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data).

System organ class

Frequency

Undesirable Effect

Blood and lymphatic system disorders

Not known

Thrombocytopenia

Immune system disorders

Rare

Anaphylactic reaction

Endocrine disorders

Not known

Inappropriate ADH secretion

Metabolism and nutrition disorders

Common

Decreased appetite, increased appetite, weight increased

Uncommon

Weight decreased

Not known

Hyponatraemia, anorexia1

Psychiatric disorders

Common

Anxiety, restlessness, abnormal dreams

libido decreased

Female: anorgasmia

Uncommon

Bruxism, agitation, nervousness, panic attack, confusional state

Rare

Aggression, depersonalisation, hallucination

Not known

Mania, suicidal ideation, suicidal behaviour2

Nervous system disorders

Very common

Headache

Common

Insomnia, somnolence, dizziness, paraesthesia, tremor

Uncommon

Taste disturbance, sleep disorder, syncope

Rare

Serotonin syndrome

Not known

Dyskinesia, movement disorder, convulsion, psychomotor restlessness/akathisia1

Eye disorders

Uncommon

Mydriasis, visual disturbance

Ear and labyrinth disorders

Uncommon

Tinnitus

Cardiac disorders

Uncommon

Tachycardia

Rare

Bradycardia

Not known

Electrocardiogram QT prolonged Ventricular arrhythmia including torsade de pointes

Vascular disorders

Not known

Orthostatic hypotension

Respiratory, thoracic and mediastinal disorders

Common

Sinusitis, yawning

Uncommon

Epistaxis

Gastrointestinal disorders

Very common

Nausea

Common

Diarrhoea, constipation, vomiting, dry mouth

Uncommon

Gastrointestinal haemorrhages (including rectal haemorrhage)

Hepatobiliary disorders

Not known

Hepatitis, liver function test abnormal

Skin and subcutaneous tissue disorders

Common

Sweating increased

Uncommon

Urticaria, alopecia, rash, pruritus

Not known

Ecchymosis, angioedemas

Musculoskeletal and connective tissue disorders

Common

Arthralgia, myalgia

Renal and urinary disorders

Not known

Urinary retention

Reproductive system and breast disorders

Common

Male: ejaculation disorder, impotence

Uncommon

Female: metrorrhagia, menorrhagia

Not known

Galactorrhoea

Male: priapism

General disorders and administration site conditions

Common

Fatigue, pyrexia

Uncommon

Oedema

1 These events have been reported for the therapeutic class of SSRIs.

2 Cases of suicidal ideation and suicidal behaviours have been reported during escitalopram therapy or early after treatment discontinuation (see section 4.4).

QT interval prolongation

Cases of QT interval prolongation and ventricular arrhythmia including torsade de pointes have been reported during the post-marketing period, predominantly in patients of female gender, with hypokalaemia, or with pre-existing QT interval prolongation or other cardiac diseases (see sections 4.3, 4.4, 4.5, 4.9 and 5.1).

Class effects

Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. The mechanism leading to this risk is unknown.

Discontinuation symptoms seen when stopping treatment

Discontinuation of SSRIs/SNRIs (particularly when abrupt) commonly leads to discontinuation symptoms. Dizziness, sensory disturbances (including paraesthesia and electric shock sensations), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor, confusion, sweating, headache, diarrhoea, palpitations, emotional instability, irritability, and visual disturbances are the most commonly reported reactions. Generally these events are mild to moderate and are self-limiting, however, in some patients they may be severe and/or prolonged. It is therefore advised that when escitalopram treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see section 4.2 and 4.4).

 
 

 

To report any side effect(s):

 The National Pharmacovigilance and Drug Safety Centre (NPC)

o Fax: +966-11-205-7662

o Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.

o Toll free phone: 8002490000

o E-mail: npc.drug@sfda.gov.sa

o Website: www.sfda.gov.sa/npc

 

 

 

 

 

 

 

 

 

 

 

 


Toxicity

Clinical data on escitalopram overdose are limited and many cases involve concomitant overdoses of other drugs. In the majority of cases mild or no symptoms have been reported. Fatal cases of escitalopram overdose have rarely been reported with escitalopram alone; the majority of cases have involved overdose with concomitant medications. Doses between 400 and 800 mg of escitalopram alone have been taken without any severe symptoms.

Symptoms

Symptoms seen in reported overdose of escitalopram include symptoms mainly related to the central nervous system (ranging from dizziness, tremor, and agitation to rare cases of serotonin syndromeconvulsion, and coma), the gastrointestinal system (nausea/vomiting), and the cardiovascular system (hypotensiontachycardia, QT interval prolongation, and arrhythmia) and electrolyte/fluid balance conditions (hypokalaemia, hyponatraemia).

Management

There is no specific antidote. Establish and maintain an airway, ensure adequate oxygenation and respiratory function. Gastric lavage and the use of activated charcoal should be considered. Gastric lavage should be carried out as soon as possible after oral ingestion. Cardiac and vital signs monitoring are recommended along with general symptomatic supportive measures.

ECG monitoring is advised in case of overdose in patients with congestive heart failure/bradyarrhythmias, in patients using concomitant medications that prolong the QT interval, or in patients with altered metabolism, e.g. liver impairment.

 


Pharmacotherapeutic group: antidepressants, selective serotonin reuptake inhibitors

ATC-code: N 06 AB 10

Mechanism of action

Escitalopram is a selective inhibitor of serotonin (5-HT) re-uptake with high affinity for the primary binding site. It also binds to an allosteric site on the serotonin transporter, with a 1000 fold lower affinity.

Escitalopram has no or low affinity for a number of receptors including 5-HT1A, 5-HT2, DA D1 and D2 receptors, α1-, α2-, β-adrenoceptors, histamine H1, muscarine cholinergic, benzodiazepine, and opioid receptors.

The inhibition of 5-HT re-uptake is the only likely mechanism of action explaining the pharmacological and clinical effects of escitalopram.

Pharmacodynamic effects

In a double-blind, placebo-controlled ECG study in healthy subjects, the change from baseline in QTc (Fridericia-correction) was 4.3 ms (90% CI: 2.2, 6.4) at the 10 mg/day dose and 10.7 ms (90% CI: 8.6, 12.8) at the supratherapeutic dose 30 mg/day (see sections 4.3, 4.4, 4.5, 4.8 and 4.9).

Clinical efficacy

Major depressive episodes

Escitalopram has been found to be effective in the acute treatment of major depressive episodes in three out of four double-blind, placebo controlled short-term (8-week) studies. In a long-term relapse prevention study, 274 patients who had responded during an initial 8-week open label treatment phase with escitalopram 10 or 20 mg/day, were randomised to continuation with escitalopram at the same dose, or to placebo, for up to 36 weeks. In this study, patients receiving continued escitalopram experienced a significantly longer time to relapse over the subsequent 36 weeks compared to those receiving placebo.

Social anxiety disorder

Escitalopram was effective in both three short-term (12- week) studies and in responders in a 6-month relapse prevention study in social anxiety disorder. In a 24-week dose-finding study, efficacy of 5, 10 and 20 mg escitalopram has been demonstrated.

Generalised anxiety disorder

Escitalopram in doses of 10 and 20 mg/day was effective in four out of four placebo-controlled studies.

In pooled data from three studies with similar design comprising 421 escitalopram-treated patients and 419 placebo-treated patients there were 47.5% and 28.9% responders respectively and 37.1% and 20.8% remitters. Sustained effect was seen from week 1.

Maintenance of efficacy of escitalopram 20mg/day was demonstrated in a 24 to 76 week, randomised, maintenance of efficacy study in 373 patients who had responded during the initial 12-week open-label treatment.

Obsessive-compulsive disorder

In a randomised, double-blind, clinical study, 20 mg/day escitalopram separated from placebo on the Y-BOCS total score after 12 weeks. After 24 weeks, both 10 and 20 mg/day escitalopram were superior as compared to placebo.

Prevention of relapse was demonstrated for 10 and 20 mg/day escitalopram in patients who responded to escitalopram in a 16-week open-label period and who entered a 24-week, randomised, double-blind, placebo controlled period.

 


Absorption

Absorption is almost complete and independent of food intake. (Mean time to maximum concentration (mean Tmax) is 4 hours after multiple dosing).

As with racemic citalopram, the absolute bioavailability of escitalopram is expected to be about 80%.

Distribution

The apparent volume of distribution (Vd,β/F) after oral administration is about 12 to 26 L/kg. The plasma protein binding is below 80% for escitalopram and its main metabolites.

Biotransformation

Escitalopram is metabolised in the liver to the demethylated and didemethylated metabolites. Both of these are pharmacologically active. Alternatively, the nitrogen may be oxidised to form the N-oxide metabolite. Both parent substance and metabolites are partly excreted as glucuronides. After multiple dosing the mean concentrations of the demethyl and didemethyl metabolites are usually 28-31% and <5%, respectively, of the escitalopram concentration. Biotransformation of escitalopram to the demethylated metabolite is mediated primarily by CYP2C19. Some contribution by the enzymes CYP3A4 and CYP2D6 is possible.

Elimination

The elimination half-life (t½β) after multiple dosing is about 30 hours and the oral plasma clearance (Cloral) is about 0.6 L/min. The major metabolites have a significantly longer half-life. Escitalopram and major metabolites are assumed to be eliminated by both the hepatic (metabolic) and the renal routes, with the major part of the dose excreted as metabolites in the urine.

Linearity

There is linear pharmacokinetics. Steady-state plasma levels are achieved in about 1 week. Average steady-state concentrations of 50 nmol/L (range 20 to 125 nmol/L) are achieved at a daily dose of 10 mg.

Elderly patients (> 65 years)

Escitalopram appears to be eliminated more slowly in elderly patients compared to younger patients. Systemic exposure (AUC) is about 50 % higher in elderly compared to young healthy volunteers (see section 4.2).

Reduced hepatic function

In patients with mild or moderate hepatic impairment (Child-Pugh Criteria A and B), the half-life of escitalopram was about twice as long and the exposure was about 60% higher than in subjects with normal liver function (see section 4.2).

Reduced renal function

With racemic citalopram, a longer half-life and a minor increase in exposure have been observed in patients with reduced kidney function (CLcr 10-53 ml/min). Plasma concentrations of the metabolites have not been studied, but they may be elevated (see section 4.2).

Polymorphism

It has been observed that poor metabolisers with respect to CYP2C19 have twice as high a plasma concentration of escitalopram as extensive metabolisers. No significant change in exposure was observed in poor metabolisers with respect to CYP2D6 (see section 4.2).


No complete conventional battery of preclinical studies was performed with escitalopram since the bridging toxicokinetic and toxicological studies conducted in rats with escitalopram and citalopram showed a similar profile. Therefore, all the citalopram information can be extrapolated to escitalopram.

In comparative toxicological studies in rats, escitalopram and citalopram caused cardiac toxicity, including congestive heart failure, after treatment for some weeks, when using dosages that caused general toxicity. The cardiotoxicity seemed to correlate with peak plasma concentrations rather than to systemic exposures (AUC). Peak plasma concentrations at no-effect-level were in excess (8-fold) of those achieved in clinical use, while AUC for escitalopram was only 3- to 4-fold higher than the exposure achieved in clinical use. For citalopram AUC values for the S-enantiomer were 6- to 7-fold higher than exposure achieved in clinical use. The findings are probably related to an exaggerated influence on biogenic amines i.e. secondary to the primary pharmacological effects, resulting in haemodynamic effects (reduction in coronary flow) and ischaemia. However, the exact mechanism of cardiotoxicity in rats is not clear. Clinical experience with citalopram, and the clinical trial experience with escitalopram, do not indicate that these findings have a clinical correlate.

Increased content of phospholipids has been observed in some tissues e.g. lung, epididymides and liver after treatment for longer periods with escitalopram and citalopram in rats. Findings in the epididymides and liver were seen at exposures similar to that in man. The effect is reversible after treatment cessation. Accumulation of phospholipids (phospholipidosis) in animals has been observed in connection with many cationic amphiphilic medicines. It is not known if this phenomenon has any significant relevance for man.

In the developmental toxicity study in the rat embryotoxic effects (reduced foetal weight and reversible delay of ossification) were observed at exposures in terms of AUC in excess of the exposure achieved during clinical use. No increased frequency of malformations was noted. A pre- and postnatal study showed reduced survival during the lactation period at exposures in terms of AUC in excess of the exposure achieved during clinical use.

Animal data have shown that citalopram induces a reduction of fertility index and pregnancy index, reduction in implantation number and abnormal sperm at exposure well in excess of human exposure. No animal data related to this aspect are available for escitalopram.


·         Purified Talc

·         Silicified microcrystalline cellulose

·         Croscarmellose sodium type A

·         Magnesium stearate

·         Polysorbate

·         Titanium dioxide

·         Polyethylene glycol

·         Hydroxypropyl methylcellulose


Not applicable.


2 years.

Store below 30°C.

This medicinal product does not require any special storage conditions.


·         White opaque PVC/PE/PVDC reel blister.

·          Hard tempered aluminium foil lid.

·         Each unit carton of Damesta 10mg contains 30 film-coated tablets in 2 blister strips.

·         Each unit carton of Damesta 20mg contains 30 film-coated tablets in 3 blister strips.


No special requirements.


Dammam Pharma Saudi Arabia Address: 1st industrial city, unit No.1, PO.BOX: 7137, Dammam 32234-4384 Phone: +966138216444 Email: regulatory-affairs@dammampharma.sa

September 2020
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