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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)

Gapentin belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long lasting pain caused by damage to the nerves).

The active substance in Gapentin is gabapentin.

Gapentin is used to treat:

·         Various forms of epilepsy (seizures that are initially limited to certain parts of the brain, whether the seizure spreads to other parts of the brain or not). The doctor treating you or your child 6 years of age and older will prescribe Gapentin to help treat epilepsy when the current treatment is not fully controlling the condition. You or your child 6 years of age and older should take Gapentin in addition to the current treatment unless told otherwise. Gapentin can also be used on its own to treat adults and children over 12 years of age.

·         Peripheral neuropathic pain (long lasting pain caused by damage to the nerves). A variety of different diseases can cause peripheral neuropathic pain (primarily occurring in the legs and/or arms), such as diabetes or shingles. Pain sensations may be described as hot, burning, throbbing, shooting, stabbing, sharp, cramping, aching, tingling, numbness, pins and needles etc.


Do not take Gapentin

·         If you are allergic (hypersensitive) to gabapentin or any of the other ingredients, of this medicine (listed in section 6).

Warnings and Precautions

Talk to your doctor or pharmacist before taking Gapentin:

·         If you suffer from kidney problems your doctor may prescribe a different dosing schedule

·         If you are on haemodialysis (to remove waste products because of kidney failure), tell your doctor if you develop muscle pain and/or weakness

·         If you develop signs such as persistent stomach pain, feeling sick and being sick contact your doctor immediately as these may be symptoms of acute pancreatitis (an inflamed pancreas) .

·         if you have nervous system disorders, respiratory disorders, or you are more than 65 years old, your doctor may prescribe you a different dosing regimen

Cases of abuse and dependence have been reported for gabapentin from the post-marketing experience. Talk to your doctor if you have a history of abuse or dependence.

 

A small number of people being treated with antiepileptics such as gabapentin have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

 

Respiratory Depression :

Gabapentin has been associated with serious, life-threatening, and fatal respiratory depression. The risk may be increased with the concomitant use of opioids and other central nervous system (CNS) depressants, and with conditions such as chronic obstructive pulmonary disease

 

Important information about potentially serious reactions

A small number of people taking Gapentin get an allergic reaction or potentially serious skin reaction, which may develop into more serious problems if they are not treated. You need to know the symptoms to look out for while you are taking Gapentin.

 

Read the description of these symptoms in section 4 of this leaflet under ‘Contact your doctor immediately if you experience any of the following symptoms after taking this medicine as they can be serious’

 

Muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown which can be life-threatening and lead to kidney problems. You may also experience discoloration of your urine, and a change in blood test results (notably blood creatine phosphokinase increased). If you experience any of these signs or symptoms, please contact your doctor immediately.

 

Other medicines and Gapentin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor (or pharmacist) if you are taking or have been recently taking any medicines for convulsions, sleeping disorders, depression, anxiety, or any other neurological or psychiatric problems.

 

Medicines containing opioids such as morphine

If you are taking any medicines containing morphine, please tell your doctor or pharmacist as morphine may increase the effect of Gapentin.

Cases of respiratory depression and/or sedation associated with gabapentin and opioid use have been reported.

Patients who require concomitant treatment with opioids should be carefully observed for signs of CNS depression, such as somnolence, sedation and respiratory depression and the dose of gabapentin or opioid should be reduced appropriately

 

CNS depressants

serious breathing problems may occur with Gapentin when co-administered with CNS depressants such as benzodiazepine. Therefore, monitor for symptoms of respiratory depression and sedation in patients who require concomitant treatment with CNS depressants.

 

Antacids for indigestion

If Gapentin and antacids containing aluminium and magnesium are taken at the same time, absorption of Gapentin from the stomach may be reduced. It is therefore recommended that Gapentin is taken at the earliest two hours after taking an antacid.

 
  

 

Gapentin:

-       is not expected to interact with other antiepileptic drugs or the oral contraceptive pill.

-       may interfere with some laboratory tests, if you require a urine test tell your doctor or hospital what you are taking.

 

Gapentin with food, drink and alcohol

Gapentin can be taken with or without food.

 

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Gapentin should not be taken during pregnancy, unless you are told otherwise by your doctor. Effective contraception must be used by women of child-bearing potential.

There have been no studies specifically looking at the use of gabapentin in pregnant women, but other medications used to treat seizures have reported an increased risk of harm to the developing baby, particularly when more than one seizure medication is taken at the same time. Therefore, whenever possible, you should try to take only one seizure medication during pregnancy and only under the advice of your doctor.

Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking Gapentin. Do not suddenly discontinue taking this medicine as this may lead to a breakthrough seizure, which could have serious consequences for you and your baby.

 

Breast-feeding

Gabapentin, the active substance of Gapentin, is passed on through human milk. Because the effect on the baby is unknown, it is not recommended to breast-feed while using Gapentin.

 

Fertility

There is no effect on fertility in animal studies.

 

Driving and using machines

Gapentin may produce dizziness, drowsiness and tiredness. You should not drive, operate complex machinery or take part in other potentially hazardous activities until you know whether this medication affects your ability to perform these activities.

 


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

Your doctor will determine what dose is appropriate for you.

 

Epilepsy, the recommended dose is

Adults and adolescents:

Take the number of capsules or as instructed. Your doctor will usually build up your dose gradually. The starting dose will generally be between 300 mg and 900 mg each day. Thereafter, the dose may be increased as instructed by your doctor, up to a maximum of 3600 mg each day and your doctor will tell you to take this in 3 separate doses, i.e. once in the morning, once in the afternoon and once in the evening.

 

Children aged 6 years and above:

The dose to be given to your child will be decided by your doctor as it is calculated against your child’s weight. The treatment is started with a low initial dose which is gradually increased over a period of approximately 3 days. The usual dose to control epilepsy is 25-35 mg per kg of body weight per day. It is usually given in 3 separate doses, by taking the capsule(s) each day, usually once in the morning, once in the afternoon and once in the evening.

Gapentin is not recommended for use in children below 6 years of age.

 

Peripheral Neuropathic Pain, the recommended dose is

Adults:

Take the number of capsules or as instructed by your doctor. Your doctor will usually build up your dose gradually. The starting dose will generally be between 300 mg and 900 mg each day. Thereafter, the dose may be increased as instructed by your doctor, up to a maximum of 3600 mg each day and your doctor will tell you to take this in 3 separate doses, i.e. once in the morning, once in the afternoon and once in the evening.

 

If you have kidney problems or are receiving haemodialysis

Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your kidneys or are undergoing haemodialysis.

 

If you are an elderly patient (over 65 years of age)

you should take the normal dose of Gapentin unless you have problems with your kidneys. Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your kidneys.

If you have the impression that the effect of Gapentin is too strong or too weak, talk to your doctor or pharmacist as soon as possible.

 

Method of administration

Gapentin is for oral use. Always swallow the capsules with plenty of water.

Continue taking Gapentin until your doctor tells you to stop.

 

If you take more Gapentin than you should

Higher than recommended doses may result in an increase in side effects including loss of consciousness, dizziness, double vision, slurred speech, drowsiness and diarrhoea. Call your doctor or go to the nearest hospital emergency unit immediately if you take more Gapentin than your doctor prescribed. Take along any capsules that you have not taken, together with the container and the label so that the hospital can easily tell what medicine you have taken.

 

If you forget to take Gapentin

If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. Do not take a double dose to make up for a forgotten dose.

 

If you stop taking Gapentin

Do not stop taking Gapentin unless your doctor tells you to. If your treatment is stopped it should be done gradually over a minimum of 1 week. If you stop taking Gapentin suddenly or before your doctor tells you, there is an increased risk of seizures.

 

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


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

Contact your doctor immediately if you experience any of the following symptoms after taking this medicine as they can be serious:

·         Severe skin reactions that require immediate attention, swelling of the lips and face, skin rash and redness, and/or hair loss (these may be symptoms of a serious allergic reaction)

·         Persistent stomach pain, feeling sick and being sick as these may be symptoms of acute pancreatitis (an inflamed pancreas)

·         breathing problems, which if severe you may need emergency and intensive care to continue breathing normally

·         Gapentin may cause a serious or life-threatening allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells. You may or may not have rash when you get this type of reaction. It may cause you to be hospitalized or to stop Gapentin. Call your doctor right away if you have any of the following symptoms:

o   Skin rash

o   Hives

o   Fever

o   Swollen glands that do not go away

o   Swelling of your lip and tongue

o   Yellowing of your skin or of the whites of the eyes

o   Unusual bruising or bleeding

o   Severe fatigue or weakness

o   Unexpected muscle pain

o   Frequent infections

 

These symptoms may be the first signs of a serious reaction. A doctor should examine you to decide if you should continue taking Gapentin.

·         If you are on haemodialysis, tell your doctor if you develop muscle pain and/or weakness.

 

Other side effects include:

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

·         Viral infection

·         Feeling drowsy, dizziness, lack of coordination

·         Feeling tired, fever

 

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

·         Pneumonia, respiratory infections, urinary tract infection, inflammation of the ear or other infections

·         Low white blood cell counts

·         Anorexia, increased appetite

·         Anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty with thinking

·         Convulsions, jerky movements, difficulty with speaking, loss of memory, tremor, difficulty sleeping, headache, sensitive skin, decreased sensation (numbness), difficulty with coordination, unusual eye movement, increased, decreased or absent reflexes

·         Blurred vision, double vision

·         Vertigo

·         High blood pressure, flushing or dilation of blood vessels

·         Difficulty breathing, bronchitis, sore throat, cough, dry nose

·         Vomiting (being sick), nausea (feeling sick), problems with teeth, inflamed gums, diarrhoea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence

·         Facial swelling, bruises, rash, itch, acne

·         Joint pain, muscle pain, back pain, twitching

·         Difficulties with erection (impotence)

·         Swelling in the legs and arms, difficulty with walking, weakness, pain, feeling unwell, flu-like symptoms

·         Decrease in white blood cells, increase in weight

·         Accidental injury, fracture, abrasion

 

Additionally in clinical studies in children, aggressive behaviour and jerky movements were reported commonly.

 

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

·         Agitation (a state of chronic restlessness and unintentional and purposeless motions)

·         Allergic reaction such as hives

·         Decreased movement

·         Racing heartbeat

·         Swelling that may involve the face, trunk and limbs

·         Abnormal blood test results suggesting problems with the liver

·         Mental impairment

·         Fall

·         Increase in blood glucose levels (most often observed in patients with diabetes)

 

Rare (may affect up to 1 in 1,000 people):

·         Decrease in blood glucose levels (most often observed in patients with diabetes)

·         Loss of consciousness

·         Trouble breathing, shallow breaths (respiratory depression).

 

After marketing Gapentin the following side effects have been reported:

·         Decreased platelets (blood clotting cells)

·         Hallucinations

·         Problems with abnormal movements such as writhing, jerking movements and stiffness

·         Ringing in the ears

·         A group of side effects that could include swollen lymph nodes (isolated small raised lumps under the skin), fever, rash, and inflammation of liver occurring together

·         Yellowing of the skin and eyes (jaundice), inflammation of the liver

·         Acute kidney failure, incontinence

·         Increased breast tissue, breast enlargement

·         Adverse events following the abrupt discontinuation of gabapentin (anxiety, difficulty sleeping, feeling sick, pain, sweating), chest pain

·         Breakdown of muscle fibers (rhabdomyolysis)

·         Change in blood test results (creatine phosphokinase increased)

·         Problems with sexual functioning including inability to achieve a sexual climax, delayed ejaculation

·         Low blood sodium level

·         Anaphylaxis (serious, potentially life threatening allergic reaction including difficulty breathing, swelling of the lips, throat, and tongue, and hypotension requiring emergency treatment)


-        Keep out of the reach and sight of children.

-        Store below 30 °C.

-        Store in the original package in order to protect from light and moisture.

-        Do not use Gapentin after the expiry date which is stated on the package.

-        Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.


Capsules:

Each capsule contains Gabapentin (USP) 100 mg, 300 mg or 400 mg.

Other ingredients: Mannitol and Magnesium Stearate.


Gapentin 100 mg: off white opaque hard gelatin capsule with printing on head MC83 containing white powder. Gapentin 300 mg: yellow opaque hard gelatin capsule with printing on head MC81 containing white powder. Gapentin 400 mg: orange opaque hard gelatin capsule with printing on head MC82 containing white powder. PRESENTATION: Capsules: Packs contain (50) capsules of GAPENTIN 100 mg, 300 mg or 400 mg. Each pack contains 5 blisters (PVD/PVDC/Alu) each blisters contains 10 capsules.

Medical and Cosmetic Products Company Ltd. (Riyadh Pharma)

P.O. Box 442, Riyadh 11411

Fax: +966 11 265 0505

Email: contact@riyadhpharma.com

For any information about this medicinal product, please contact the local representative of marketing authorization holder:

Saudi Arabia

Marketing department

Riyadh

Tel: +966 11 265 0111

Email: marketing@riyadhpharma.com


11/2020
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

جابنتين ينتمي إلى مجموعة من الأدوية المستخدمة في علاج الصرع وآلام الأعصاب الطرفية (الآلام طويلة الأمد الناجمة عن الأضرار التي لحقت بالأعصاب).

المادة الفعالة في جابنتين هي جابابنتين.

يستخدم جابنتين لعلاج:

·         أشكال مختلفة من الصرع (نوبات الصرع التي تقتصر في البداية على أجزاء معينة من الدماغ ، سواء تنتشر النوبات لأجزاء أخرى من الدماغ أم لا). الطبيب المعالج لك أو لطفلك البالغ 6 سنوات من العمر وكبار السن سيصف جابنتين للمساعدة في علاج الصرع عندما يكون العلاج الحالي لا يسيطر بالكامل على حالتك. يجب عليك أنت أو طفلك البالغ 6 سنوات من العمر وما فوق تناول جابنتين بالإضافة إلى العلاج الحالي ما لم يخبرك الطبيب خلاف ذلك. جابنتين يمكن أيضا أن يستخدم وحده لعلاج البالغين والأطفال فوق 12 سنة من العمر.

·         آلام اعتلال الأعصاب الطرفية (الآلام طويلة الأمد الناجمة عن الأضرار التي لحقت بالأعصاب). مجموعة متنوعة من الأمراض المختلفة يمكن أن تسبب ألم الاعتلال العصبي الطرفية (يحدث في المقام الأول في الساقين و / أو الأذرع)، مثل مرض السكري أو القوباء. ويمكن وصف مشاعر الألم بوصفها ساخنة، وحرقان، والخفقان، أو كإطلاق النار، والطعن، الحادة، والتشنج، ألم، وخز أو تنميل، والوخز بدبابيس وإبر الخ.

لا تتناول جابنتين

·        إذا كنت تعاني من حساسية (فرط حساسية) لجابابنتين أو أي من المكونات الأخرى من هذا الدواء (المدرجة في القسم 6).

التحذيرات والاحتياطات

تحدث إلى طبيبك أو الصيدلاني قبل تناول جابنتين:

·        إذا كنت تعاني من مشاكل في الكلى قد يصف الطبيب جدول جرعات مختلف

·        إذا كنت على الغسيل الكلوي (لإزالة الفضلات بسبب الفشل الكلوي)، أخبر طبيبك إذا ظهرت آلام في العضلات و/أو ضعف بها

·        إذا أصبت بعلامات مثل ألم في المعدة مستمر، والشعور بالإعياء والإعياء فعلاً اتصل بطبيبك فورا لأن هذه قد تكون أعراض التهاب البنكرياس الحاد (التهاب البنكرياس)

·        إذا كنت تعاني من اضطرابات في الجهاز العصبي أو اضطرابات تنفسية أو إذا كان عمرك يزيد عن 65 عامًا، فقد يصف لك الطبيب نظامًا مختلفًا للجرعات

وقد تم الإبلاغ عن حالات سوء استخدام وتعود على الدواء لجابابنتين من دراسة ما بعد التسويق. تحدث إلى طبيبك إذا كان لديك تاريخ من سوء الاستخدام أو اعتيادية الدواء.

هناك عدد قليل من الناس يعالجون بمضادات الصرع مثل جابابنتين كان لهم أفكار إيذاء أو قتل أنفسهم. إذا كان لديك في أي وقت هذه الأفكار، اتصل بطبيبك على الفور.

 

ضيق التنفس :

ارتبط جابابنتين بضيق تنفسي خطير ومهدّد للحياة ومميت. يمكن زيادة الخطر مع الاستخدام المتزامن للمواد الأفيونية وغيرها من مثبطات الجهاز العصبي المركزي (CNS) ، ومع حالات مثل مرض الانسداد الرئوي المزمن.

معلومات هامة حول ردود فعل قد تكون خطيرة

هناك عدد قليل من الأشخاص الذين يتناولون جابنتين يحدث لهم رد فعل تحسسي أو ردة فعل بالبشرة قد تكون خطيرة، والذي قد يتطور إلى مشاكل أكثر خطورة إذا لم يتم علاجها. أنت بحاجة إلى معرفة هذه الأعراض لتحذر منها أثناء تناول جابنتين.

 

إقرأ وصف هذه الأعراض في القسم 4 من هذه النشرة تحت عنوان "اتصل بطبيبك على الفور إذا كنت تواجه أي من الأعراض التالية بعد تناول هذا الدواء لأنها يمكن أن تكون خطيرة"

ضعف عضلات، ايلام أو الألم وبشكل خاص، إذا كان في الوقت نفسه، كنت تشعر بتوعك أو لديك ارتفاع في درجة الحرارة قد ينجم ذلك عن طريق انهيار العضلات غير الطبيعي الذي يمكن أن يكون مهدداً للحياة، وتؤدي إلى مشاكل في الكلى. أيضا قد تواجه تلون البول، وتغير في نتائج فحص الدم (لا سيما زيادة فسفوكيناز الكرياتين في الدم). إذا واجهت أي من هذه العلامات أو الأعراض، يرجى الاتصال بالطبيب على الفور.

 

الأدوية الأخرى وجابنتين

أخبر طبيبك أو الصيدلي إذا كنت تتناول، قد تناولت مؤخرا أو قد تتناول أي أدوية أخرى. على وجه الخصوص ، أخبر طبيبك (أو الصيدلي) إذا كنت تتناول أو تناولت في الآونة الأخيرة  أي أدوية للتشنجات أو اضطرابات النوم أو الاكتئاب أو القلق أو أي شيء لعلاج مشاكل عصبية أو نفسية.

 

الأدوية التي تحتوي على أفيونات مثل المورفين

إذا كنت تتناول أي أدوية تحتوي على المورفين، يرجى إخبار الطبيب أو الصيدلي حيث أن المورفين قد يزيد من تأثير جابنتين.

تم الإبلاغ عن حالات ضيق و / أو التخدير التنفسي المرتبط باستخدام جابابنتين واستخدام المواد الأفيونية

يجب ملاحظة المرضى الذين يحتاجون إلى العلاج المتزامن  بالمواد الأفيونية بعناية عند ظهورعلامات تثبيط الجهاز العصبي المركزي ، مثل النعاس والتخدير و ضيق التنفس ويجب تقليل جرعة جابابنتين أو الأفيون بشكل مناسب.

 

مثبطات الجهاز العصبي المركزي

قد تحدث مشاكل خطيرة في التنفس عند تناول جابنتين مع مثبطات الجهاز العصبي المركزي مثل البنزوديازيبين. لذلك ، راقب أعراض ضيق التنفس والخدر في المرضى الذين يحتاجون إلى علاج متزامن بمثبطات الجهاز العصبي المركزي.

 

مضادات الحموضة لعسر الهضم

إذا ما تناولت جابنتين مع مضادات الحموضة التي تحتوي على الألمنيوم والمغنيسيوم في نفس الوقت، ربما يتم تخفيض امتصاص جابنتين من المعدة. ولذلك فمن المستحسن أن تتناول جابنتين أبكر بساعتين عند تناول مضاد للحموضة.

جابنتين:

- ليس من المتوقع أن يتفاعل مع العقاقير المضادة للصرع الأخرى، أو حبوب منع الحمل عن طريق الفم.

- قد يتعارض مع بعض الفحوصات المخبرية، إذا كنت تحتاج إلى اختبار البول أخبر طبيبك أو المستشفى بما تتناوله.

جابنتين مع الطعام والشراب والكحول

يمكن تناول جابنتين مع او بدون الطعام.

الحمل والرضاعة الطبيعية

إذا كنتي حاملا أو ترضعين الرضاعة الطبيعية، تعتقدين أنك قد تكوني حاملا أو تخططين لإنجاب طفل، اسألي طبيبك أو الصيدلي للحصول على المشورة قبل تناول هذا الدواء.

الحمل

لا ينبغي أن تتناولي جابنتين أثناء الحمل، إلا إذا قيل لك خلاف ذلك من قبل الطبيب. يجب استخدام موانع حمل فعالة من قبل النساء في ظل وجود إمكانية الحمل.

لم تكن هناك دراسات تبحث على وجه التحديد في استخدام جابابنتين في النساء الحوامل، ولكن قد ذكرت الأدوية الأخرى المستخدمة لعلاج النوبات زيادة خطر وقوع ضرر نمو الجنين، لا سيما عندما يستخدم أكثرمن دواء للنوبات في نفس الوقت. لذلك، كلما كان ذلك ممكنا، يجب أن تحاولي أن تتناولي دواء واحد فقط أثناء الحمل وفقط تحت مشورة الطبيب.

اتصلي بطبيبك على الفور إذا أصبحتي حاملا، تعتقدين أنك قد تكوني حاملا أو تخططين لتصبحي حاملا وقت تناول جابنتين. لا تتوقفي فجأة عن تناول هذا الدواء لأن هذا قد يؤدي إلى نوبات تشنج مفاجئة، والتي يمكن أن يكون لها عواقب وخيمة لكِ ولطفلك.

 

الرضاعة الطبيعية

جابابنتين، المادة الفعالة في جابنتين، تفرز عن طريق لبن الأم. ولأن تأثيرها على الطفل غير معروف، فمن غير المستحسن أن يرضع الطفل رضاعة طبيعية  أثناء استخدام جابنتين.

 

الخصوبة

لا يوجد أي تأثير على الخصوبة في الدراسات على الحيوانات.

 

القيادة واستخدام الآلات

جابنتين قد يؤدي إلى الدوخة والنعاس والتعب. يجب ألا تقود، أو تشغل الآلات المعقدة أو المشاركة في أنشطة أخرى يحتمل أن تكون خطرة حتى تعرف ما إذا كان هذا الدواء يؤثر على قدرتك على أداء هذه الأنشطة.

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

طبيبك سوف يحدد ما هي الجرعة المناسبة لك.

الصرع، والجرعة الموصى بها هي

البالغين والمراهقين:

تناول عدد الكبسولات وفقا للتعليمات. سيقوم الطبيب عادة بزيادة الجرعة تدريجيا. فإن جرعة البداية تكون عادة ما بين 300 ملجم و 900 ملجم كل يوم. بعد ذلك، يمكن زيادة الجرعة حسب تعليمات الطبيب، وتصل إلى حد أقصى قدره 3600 ملجم كل يوم وطبيبك سوف يخبرك أن تتناول هذه في 3 جرعات منفصلة، أي مرة واحدة في الصباح، ومرة واحدة في فترة ما بعد الظهر مع مرة واحدة مساءً.

 

الأطفال الذين تتراوح أعمارهم بين 6 سنوات فما فوق:

ستتقرر الجرعة التي ستعطى لطفلك من قبل الطبيب حيث يتم احتسابها على حسب وزن طفلك. يتم بدء العلاج مع جرعة منخفضة أولية والتي تزداد تدريجيا على مدى فترة حوالي 3 أيام. الجرعة المعتادة للسيطرة على الصرع هي 25-35 ملجم لكل كيلوجرام من وزن الجسم يوميا. وعادة ما تعطى في 3 جرعات منفصلة، من خلال تناول الكبسولات في كل يوم، عادة مرة واحدة في الصباح، ومرة واحدة في فترة ما بعد الظهر ومرة في المساء.

 

لا ينصح جابنتين للاستخدام في الأطفال أقل من 6 سنوات من العمر.

 

آلام الأعصاب الطرفية، الجرعة الموصى بها هي

الكبار:

تناول عدد الكبسولات وفقا لتعليمات الطبيب. سيقوم الطبيب عادة بزيادة الجرعة تدريجيا. فإن جرعة البداية تكون عادة ما بين 300 ملجم و900 ملجم كل يوم. بعد ذلك، يمكن زيادة الجرعة حسب تعليمات الطبيب، وتصل إلى حد أقصى قدره 3600 ملجم كل يوم وطبيبك سوف يخبرك أن تتناول هذه في 3 جرعات منفصلة، أي مرة واحدة في الصباح، ومرة واحدة في فترة ما بعد الظهر مع مرة واحدة في مساء.

 

إذا كان لديك مشاكل في الكلى أو تقوم بالغسيل الكلوي

طبيبك قد يصف جدول علاج مختلف و / أو الجرعة إذا كان لديك مشاكل في الكليتين أو تخضع للغسيل الكلوي.

 

إذا كنت مريض مسن (أكثر من 65 سنة من العمر)، يجب أن تتناول الجرعة العادية من جابنتين إلا إذا كان لديك مشاكل في الكليتين. طبيبك قد يصف جدول جرعات مختلف و / أو تعديل الجرعة إذا كان لديك مشاكل في الكليتين.

إذا كان لديك الانطباع بأن تأثير جابنتين قوي جدا أو ضعيف للغاية، تحدث إلى طبيبك أو الصيدلي في أقرب وقت ممكن.

 

طريقة التناول

جابنتين للاستخدام عن طريق الفم. ابتلع دائما الكبسولات مع الكثير من الماء.

استمر في تناول جابنتين حتى يطلب منك الطبيب أن تتوقف.

 

إذا تتناولت جابنتين أكثر مما يجب

جرعات أكثر من الموصى بها قد يؤدي إلى زيادة في الآثار الجانبية بما في ذلك فقدان الوعي، والدوخة، ازدواج الرؤية وثقل اللسان والنعاس والإسهال. اتصل بطبيبك أو اذهب إلى أقرب وحدة طوارئ في المستشفى على الفور إذا تناولت جابنتين أكثر مما وصفه الطبيب. خذ معك أي من الكبسولات التي لم تتناول، جنبا إلى جنب مع العبوة والملصق بحيث يمكن للمستشفى ان تعلم بسهولة ما الدواء الذي قد تناولته.

 

إذا نسيت أن تتناول جابنتين

إذا كنت قد نسيت أن تتناول جرعة، تناولها حالما تتذكر إلا إذا قد حان الوقت لتناول الجرعة التالية. لا تتناول جرعة مضاعفة لتعويض الجرعة المنسية.

 

إذا توقفت عن تناول جابنتين

لا تتوقف عن تناول جابنتين إلا إذا طلب منك الطبيب ذلك. إذا تقرر إيقاف العلاج ينبغي أن يتم ذلك تدريجيا على مدى ما لا يقل عن اسبوع واحد. إذا توقفت عن تناول جابنتين فجأة أو قبل أن يطلب منك الطبيب، هناك خطر متزايد من النوبات.

 

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

مثل جميع الأدوية، يمكن لهذا الدواء أن يسبب آثارا جانبية، على الرغم من أن ليس كل شخص يحصل له.

اتصل بطبيبك على الفور إذا كنت تواجه أي من الأعراض التالية بعد تناول هذا الدواء لأنها يمكن أن تكون خطيرة:

·         ردود فعل الجلد الشديدة التي تتطلب اهتماما فوريا، تورم في الشفتين والوجه، والطفح الجلدي والاحمرار، و / أو فقدان الشعر (وهذه قد تكون أعراض رد فعل حساسيه خطير)

·         ألم في المعدة متواصل، والشعور بالإعياء أوالإعياء فعلاً حيث أن هذه قد تكون أعراض التهاب البنكرياس الحاد (التهاب البنكرياس)

·         مشاكل في التنفس، والتي إذا كنت شديدة قد تحتاج إلى رعاية الطوارئ والعناية المركزة لمواصلة التنفس بشكل طبيعي

·         قد يسبب جابنتين حساسية خطيرة أو مهددة للحياة التي قد تؤثر على بشرتك أو أجزاء أخرى من الجسم مثل الكبد أو خلايا الدم. قد يكون أو لا يكون هناك طفح جلدي عند حدوث هذا النوع من ردود الفعل. قد يؤدي ذلك الى دخول المستشفى أو إلى وقف جابنتين. اتصل بطبيبك على الفور إذا كان لديك أي من الأعراض التالية:

o       طفح جلدي

o       الشرى

o       حمى

o       تورم بالغدد لا تبرأ

o       تورم باللسان والشفايف

o       اصفرار الجلد أو البياض بالعينين

o       كدمات أو نزيف غير طبيعي

o       تعب شديد أو ضعف

o       آلام بالعضلات غير متوقعة

o       عدوى متكررة

قد تكون هذه الأعراض العلامات الأولى إلى رد فعل شديد. يجب على الطبيب أن يفحصك ليقرر ما إذا كان يجب الاستمرار في تناول جابنتين.

·         إذا كنت تخضع لغسيل الكلى، أخبر طبيبك إذا ظهرت آلام في العضلات و / أو ضعف.

وتشمل الآثار الجانبية الأخرى:

 

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

·         عدوى فيروسية

·         الشعور بالنعاس، والدوخة، وانعدام التنسيق

·         الشعور بالتعب والحمى

 

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

·         الالتهاب الرئوي والتهابات الجهاز التنفسي، التهاب المسالك البولية، التهاب الأذن أو التهابات أخرى

·         انخفاض عدد خلايا الدم البيضاء

·         فقدان الشهية، أو زيادة الشهية

·         الغضب تجاه الآخرين، والارتباك، تغيرات في المزاج، والاكتئاب، والقلق، والعصبية، صعوبة في التفكير

·         التشنجات وحركات متشنجة، صعوبة في الكلام، وفقدان الذاكرة، ورعاش، وصعوبة النوم، والصداع، وحساسية الجلد، تناقص الإحساس (التنميل)، صعوبة في تنسيق الحركات، وحركة بالعين غير عادية، زيادة / نقصان/ أو غياب ردود الفعل

·         عدم وضوح الرؤية، الرؤية المزدوجة

·         الدوار

·         ارتفاع ضغط الدم، احمرار الجلد أو تمدد الأوعية الدموية

·         صعوبة في التنفس والتهاب الشعب الهوائية، والتهاب الحلق، والسعال، وجفاف الأنف

·         التقيؤ (الإعياء)، الغثيان (الشعور بالإعياء)، ومشاكل في الأسنان واللثة الملتهبة، والإسهال، وآلام في المعدة، وعسر الهضم، والإمساك، وجفاف الفم أو الحلق، وانتفاخ البطن

·         تورم الوجه وكدمات، وطفح جلدي، حكة، حب الشباب

·         آلام المفاصل، وآلام في العضلات، وآلام الظهر، والوخز

·         صعوبة في الانتصاب (الضعف الجنسي)

·         تورم في الساقين والذراعين، وصعوبة في المشي، والضعف، الألم، والشعور بتوعك، وأعراض تشبه الانفلونزا

·         نقص في خلايا الدم البيضاء، وزيادة في الوزن

·         الإصابات العرضية، كسور، والكشط

بالإضافة إلى ذلك في الدراسات السريرية لدى الأطفال، شاع الإبلاغ عن سلوك عدواني وحركات متشنجة.

 

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

·         الهياج (حالة من التململ المزمن والحركات غير المقصودة والعديمة الغرض)

·         رد فعل حساسية مثل الشرى

·         تناقص الحركة

·         تسارع ضربات القلب

·         تورم الذي قد يتضمن الوجه والجذع والأطراف

·         نتائج فحص الدم غير العادية التي تنم عن مشاكل في الكبد

·         ضعف عقلي

·         السقوط

·         زيادة مستويات الجلوكوز في الدم (غالبًا ما تلاحظ في مرضى السكري)

 

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

·         انخفاض مستويات الجلوكوز في الدم (غالباً ما يلاحظ في مرضى السكري)

·         فقدان الوعي

·         صعوبة التنفس والتنفس الضحل (ضيق التنفس)  .

 

بعد تسويق جابنتين الآثار الجانبية التالية تم الإبلاغ عنها:

·         تناقص الصفائح الدموية (خلايا تخثر الدم)

·         الهلوسة

·         مشاكل مع حركات غير طبيعية مثل التلوي، ارتعاشات وتصلب

·         رنين في الأذنين

·         مجموعة من الآثار الجانبية التي يمكن أن تشمل تورم الغدد اللمفاوية (كتل صغيرة مرتفعة تحت الجلد)، والحمى والطفح الجلدي، والتهاب الكبد تحدث معا

·         اصفرار الجلد والعينين (اليرقان)، والتهاب الكبد

·         الفشل الكلوي الحاد، وسلس البول

·         زيادة أنسجة الثدي، تضخم الثدى

·         أحداث سلبية بعد التوقف المفاجئ للجابابنتين (القلق، وصعوبة في النوم، والشعور بالمرض، والألم، والتعرق)، ألم في الصدر

·         انهيار الألياف العضلية (انحلال الربيدات)

·         تغيير في نتائج اختبار الدم (زيادة الكرياتين فسفوكيناز)

·         مشاكل الأداء الجنسي بما في ذلك عدم القدرة على تحقيق الذروة الجنسية، وتأخر القذف

·         انخفاض مستوى الصوديوم في الدم

·         الحساسية المفرطة (أعراض حساسية خطيرة ، يحتمل أن تهدد الحياة بما في ذلك صعوبة التنفس ، وتورم في الشفتين ، والحنجرة ، واللسان ، وانخفاض ضغط الدم يتطلب علاج الطوارئ)

 

إذا أصبح أي من الآثار الجانبية خطيراً، أو إذا لاحظت أي آثار جانبية غير المذكورة في النشرة، يرجى إخبار الطبيب أو الصيدلي.

-        يحفظ بعيداً عن متناول ومرأى الأطفال.

-        يحفظ في درجة حرارة اقل من 30 درجة مئوية.

-        يحفظ في العبوة الأصلية من أجل حمايته من الضوء أو الرطوبة

-        لا تستخدم جابنتين بعد تاريخ انتهاء الصلاحية المطبوع على العبوة.

-        لا ينبغي التخلص من الأدوية في مياه الصرف الصحي أو عن طريق النفايات المنزلية. اسأل الصيدلي حول كيفية التخلص من الأدوية التي لم تعد مطلوبة. ومن شأن هذه التدابير أن تساعد على حماية البيئة.

على ماذا تحتوي كبسولات جابنتين؟

تحتوي كل كبسولة على جابابنتين (دستور الأدوية الأمريكي) ١٠٠ملجم، ٣۰۰ملجم أو ٤٠٠ملجم.

المواد الإضافية: مانيتول ومغنيسيوم ستيريت.

 

جابنتين 100 ملجم: كبسولات لونها ابيض داكن غير شفافة مطبوع على رأسها MC83 تحتوي على بودرة بيضاء

جابنتين 300 ملجم: كبسولات صفراء غير شفافة مطبوع على رأسها MC81 تحتوي على بودرة بيضاء

جابنتين 400 ملجم: كبسولات برتقالية غير شفافة مطبوع على رأسها MC82 تحتوي على بودرة بيضاء

 

الشكل الصيدلاني:

كبسولات: عبوات تحتوي على (٥۰) كبسولة من جابنتين ١٠٠ملجم، ٣۰۰ملجم أو ٤٠٠ملجم. كل عبوة تحتوي على 5 شرائط (PVD/PVDC/Alu) كل شريط يحتوي على 10 كبسولات.

شركة المنتجات الطبية والتجميلية المحدودة ( الرياض فارما)

ص.ب. 442 الرياض 11411

فاكس: 966112650505+

البريد الإلكتروني: contact@riyadhpharma.com

لأية معلومات عن هذا المنتج الطبي، يرجى الاتصال على  صاحب الترخيص والتسويق:

المملكة العربية السعودية

قسم التسويق

الرياض

تلفون: 966112650111+

البريد الإلكتروني: marketing@riyadhpharma.com

11/2020
 Read this leaflet carefully before you start using this product as it contains important information for you

Gabapentin 100 mg Capsules Gabapentin 300 mg Capsules Gabapentin 400 mg Capsules

Each capsule, hard contains 100, 300 or 400 mg of gabapentin. For a full list of excipients, see section 6.1

Hard gelatin capsule Gabapentin 100 mg Capsules :Hard gelatin capsules with off white opaque body and off white opaque head with printing MC83 on head , containing white powder. Gabapentin 300 mg Capsules :Hard gelatin capsules with yellow opaque body and yellow opaque head with printing MC81 on head , containing white powder. Gabapentin 400 mg Capsules : Hard gelatin capsules with orange opaque body and orange opaque head with printing MC82 on head , containing white powder.

Epilepsy

Gapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children aged 6 years and above (see section 5.1).

Gapentin is indicated as monotherapy in the treatment of partial seizures with and without secondary generalization in adults and adolescents aged 12 years and above.

 

Treatment of peripheral neuropathic pain

Gapentin is indicated for the treatment of peripheral neuropathic pain such as painful diabetic neuropathy and post-herpetic neuralgia in adults.


Posology

For all indications a titration scheme for the initiation of therapy is described in Table 1, which is recommended for adults and adolescents aged 12 years and above. Dosing instructions for children under 12 years of age are provided under a separate sub-heading later in this section.

 

Table 1

DOSING CHART – INITIAL TITRATION

Day 1

Day 2

Day 3

300 mg once a day

300 mg two times a day

300 mg three times a day

 

Discontinuation of gabapentin

In accordance with current clinical practice, if gabapentin has to be discontinued it is recommended this should be done gradually over a minimum of 1 week independent of the indication.

Epilepsy

Epilepsy typically requires long-term therapy. Dosage is determined by the treating physician according to individual tolerance and efficacy.

Adults and adolescents:

In clinical trials, the effective dosing range was 900 to 3600 mg/day. Therapy may be initiated by titrating the dose as described in Table 1 or by administering 300 mg three times a day (TID) on Day 1. Thereafter, based on individual patient response and tolerability, the dose can be further increased in 300 mg/day increments every 2-3 days up to a maximum dose of 3600 mg/day. Slower titration of gabapentin dosage may be appropriate for individual patients. The minimum time to reach a dose of 1800 mg/day is one week, to reach 2400 mg/day is a total of 2 weeks, and to reach 3600 mg/day is a total of 3 weeks. Dosages up to 4800 mg/day have been well tolerated in long-term open-label clinical studies. The total daily dose should be divided in three single doses, the maximum time interval between the doses should not exceed 12 hours to prevent breakthrough convulsions.

Children aged 6 years and above:

The starting dose should range from 10 to 15 mg/kg/day and the effective dose is reached by upward titration over a period of approximately three days. The effective dose of gabapentin in children aged 6 years and older is 25 to 35 mg/kg/day. Dosages up to 50 mg/kg/day have been well tolerated in a long-term clinical study. The total daily dose should be divided in three single doses, the maximum time interval between doses should not exceed 12 hours.

It is not necessary to monitor gabapentin plasma concentrations to optimize gabapentin therapy. Further, gabapentin may be used in combination with other antiepileptic medicinal products without concern for alteration of the plasma concentrations of gabapentin or serum concentrations of other antiepileptic medicinal products.

Peripheral neuropathic pain

Adults

The therapy may be initiated by titrating the dose as described in Table 1. Alternatively, the starting dose is 900 mg/day given as three equally divided doses. Thereafter, based on individual patient response and tolerability, the dose can be further increased in 300 mg/day increments every 2-3 days up to a maximum dose of 3600 mg/day. Slower titration of gabapentin dosage may be appropriate for individual patients. The minimum time to reach a dose of 1800 mg/day is one week, to reach 2400 mg/day is a total of 2 weeks, and to reach 3600 mg/day is a total of 3 weeks.

In the treatment of peripheral neuropathic pain such as painful diabetic neuropathy and post-herpetic neuralgia, efficacy and safety have not been examined in clinical studies for treatment periods longer than 5 months. If a patient requires dosing longer than 5 months for the treatment of peripheral neuropathic pain, the treating physician should assess the patient's clinical status and determine the need for additional therapy.

Instruction for all areas of indication

In patients with poor general health, i.e., low body weight, after organ transplantation etc., the dose should be titrated more slowly, either by using smaller dosage strengths or longer intervals between dosage increases.

Use in elderly patients (over 65 years of age)

Elderly patients may require dosage adjustment because of declining renal function with age (see Table 2). Somnolence, peripheral oedema and asthenia may be more frequent in elderly patients.

Use in patients with renal impairment

Dosage adjustment is recommended in patients with compromised renal function as described in Table 2 and/or those undergoing haemodialysis. Gabapentin 100 mg capsules can be used to follow dosing recommendations for patients with renal insufficiency.

Table 2

DOSAGE OF GABAPENTIN IN ADULTS BASED ON RENAL FUNCTION

Creatinine Clearance (mL/min)

Total Daily Dosea (mg/day)

≥80

900-3600

50-79

600-1800

30-49

300-900

15-29

150b-600

<15c

150b-300

Total daily dose should be administered as three divided doses. Reduced dosages are for patients with renal impairment (creatinine clearance < 79 mL/min).

b The 150 mg daily dose to be administered as 300 mg every other day.

For patients with creatinine clearance <15 mL/min, the daily dose should be reduced in proportion to creatinine clearance (e.g., patients with a creatinine clearance of 7.5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive).

Use in patients undergoing haemodialysis

For anuric patients undergoing haemodialysis who have never received gabapentin, a loading dose of 300 to 400 mg, then 200 to 300 mg of gabapentin following each 4 hours of haemodialysis, is recommended. On dialysis-free days, there should be no treatment with gabapentin.

For renally impaired patients undergoing haemodialysis, the maintenance dose of gabapentin should be based on the dosing recommendations found in Table 2. In addition to the maintenance dose, an additional 200 to 300 mg dose following each 4-hour haemodialysis treatment is recommended.

Method of administration

For oral use.

Gabapentin can be given with or without food and should be swallowed whole with sufficient fluid-intake (e.g. a glass of water).


Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Drug Rash with Eosinophilia and Systemic Symptoms (DRESS)

Severe, life-threatening, systemic hypersensitivity reactions such as Drug rash with eosinophilia and systemic symptoms (DRESS) have been reported in patients taking antiepileptic drugs including gabapentin (see section 4.8).

It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. Gabapentin should be discontinued if an alternative etiology for the signs or symptoms cannot be established.

 

Anaphylaxis

Gabapentin can cause anaphylaxis. Signs and symptoms in reported cases have included difficulty breathing, swelling of the lips, throat, and tongue, and hypotension requiring emergency treatment. Patients should be instructed to discontinue gabapentin and seek immediate medical care should they experience signs or symptoms of anaphylaxis (see section 4.8).

 

Suicidal ideation and behaviour

Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications. A meta-analysis of randomised placebo controlled trials of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for gabapentin.

Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.

Acute pancreatitis

If a patient develops acute pancreatitis under treatment with gabapentin, discontinuation of gabapentin should be considered (see section 4.8).

 

Seizures

Although there is no evidence of rebound seizures with gabapentin, abrupt withdrawal of anticonvulsants in epileptic patients may precipitate status epilepticus (see section 4.2).

As with other antiepileptic medicinal products, some patients may experience an increase in seizure frequency or the onset of new types of seizures with gabapentin.

As with other anti-epileptics, attempts to withdraw concomitant anti-epileptics in treatment refractive patients on more than one anti-epileptic, in order to reach gabapentin monotherapy have a low success rate.

Gabapentin is not considered effective against primary generalized seizures such as absences and may aggravate these seizures in some patients. Therefore, gabapentin should be used with caution in patients with mixed seizures including absences.

Gabapentin treatment has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall). There have also been post-marketing reports of confusion, loss of consciousness and mental impairment. Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medication.

 

Concomitant use with opioids

Patients who require concomitant treatment with opioids should be carefully observed for signs of central nervous system (CNS) depression, such as somnolence, sedation and respiratory depression. Patients who use gabapentin and morphine concomitantly may experience increases in gabapentin concentrations. The dose of gabapentin or opioids should be reduced appropriately (see section 4.5).

 

Respiratory depression

Gabapentin has been associated with serious, life-threatening, and fatal respiratory depression. The risk may be increased with the concomitant use of opioids and other central nervous system (CNS) depressants, and with conditions such as chronic obstructive pulmonary disease. The elderly are also at higher risk. Health care providers should start gabapentinoids at the lowest dose and monitor patients for symptoms of respiratory depression and sedation when co-prescribing gabapentinoids with an opioid or other CNS depressants (eg, benzodiazepines). Patients with underlying respiratory disease and elderly patients are also at increased risk and should be managed similarly.

 

Elderly (over 65 years of age)

No systematic studies in patients 65 years or older have been conducted with gabapentin. In one double blind study in patients with neuropathic pain, somnolence, peripheral oedema and asthenia occurred in a somewhat higher percentage in patients aged 65 years or above, than in younger patients. Apart from these findings, clinical investigations in this age group do not indicate an adverse event profile different from that observed in younger patients.

 

Paediatric population

The effects of long-term (greater than 36 weeks) gabapentin therapy on learning, intelligence, and development in children and adolescents have not been adequately studied. The benefits of prolonged therapy must therefore be weighed against the potential risks of such therapy.

 

Abuse and dependence

Cases of abuse and dependence have been reported in the post-marketing database. Carefully evaluate patients for a history of drug abuse and observe them for possible signs of gabapentin abuse e.g. drug-seeking behaviour, dose escalation, development of tolerance.

 

Laboratory tests

False positive readings may be obtained in the semi-quantitative determination of total urine protein by dipstick tests. It is therefore recommended to verify such a positive dipstick test result by methods based on a different analytical principle such as the Biuret method, turbidimetric or dye-binding methods, or to use these alternative methods from the beginning.

Gapentin hard capsules contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.


There are spontaneous and literature case reports of respiratory depression and/or sedation associated with gabapentin and opioid use. In some of these reports, the authors considered this a particular concern with the combination of gabapentin and opioids, especially in elderly patients.

 

In a study involving healthy volunteers (N=12), when a 60 mg controlled-release morphine capsule was administered 2 hours prior to a 600 mg gabapentin capsule, mean gabapentin AUC increased by 44% compared to gabapentin administered without morphine. Therefore, patients who require concomitant treatment with opioids should be carefully observed for signs of CNS depression, such as somnolence, sedation and respiratory depression and the dose of gabapentin or opioid should be reduced appropriately.

 

Furthermore, serious breathing problems may occur with gabapentin when co-administered with CNS depressants such as benzodiazepine. Therefore, monitor for symptoms of respiratory depression and sedation in patients who require concomitant treatment with CNS depressants.

 

Gabapentin steady-state pharmacokinetics are similar for healthy subjects and patients with epilepsy receiving these antiepileptic agents.

 

Co-administration of gabapentin with oral contraceptives containing norethindrone and/or ethinyl estradiol, does not influence the steady-state pharmacokinetics of either component.

 

Co-administration of gabapentin with antacids containing aluminium and magnesium, reduces gabapentin bioavailability up to 24%. It is recommended that gabapentin be taken at the earliest two hours following antacid administration.

 

Renal excretion of gabapentin is unaltered by probenecid.

 

A slight decrease in renal excretion of gabapentin that is observed when it is coadministered with cimetidine is not expected to be of clinical importance


Pregnancy

Risk related to epilepsy and antiepileptic medicinal products in general

The risk of birth defects is increased by a factor of 2 – 3 in the offspring of mothers treated with an antiepileptic medicinal product. Most frequently reported are cleft lip, cardiovascular malformations and neural tube defects. Multiple antiepileptic drug therapy may be associated with a higher risk of congenital malformations than monotherapy, therefore it is important that monotherapy is practised whenever possible. Specialist advice should be given to women who are likely to become pregnant or who are of childbearing potential and the need for antiepileptic treatment should be reviewed when a woman is planning to become pregnant. No sudden discontinuation of antiepileptic therapy should be undertaken as this may lead to breakthrough seizures, which could have serious consequences for both mother and child. Developmental delay in children of mothers with epilepsy has been observed rarely. It is not possible to differentiate if the developmental delay is caused by genetic, social factors, maternal epilepsy or the antiepileptic therapy.

 

Risk related to gabapentin

Gabapentin crosses the human placenta.

There are no adequate data from the use of gabapentin in pregnant women.

Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Gabapentin should not be used during pregnancy unless the potential benefit to the mother clearly outweighs the potential risk to the foetus.

No definite conclusion can be made as to whether gabapentin is associated with an increased risk of congenital malformations when taken during pregnancy, because of epilepsy itself and the presence of concomitant antiepileptic medicinal products during each reported pregnancy.

 

Breast-feeding

Gabapentin is excreted in human milk. Because the effect on the breast-fed infant is unknown, caution should be exercised when gabapentin is administered to a breast-feeding mother. Gabapentin should be used in breast-feeding mothers only if the benefits clearly outweigh the risks.

 

Fertility

There is no effect on fertility in animal studies (see section 5.3).


Gabapentin may have minor or moderate influence on the ability to drive and use machines. Gabapentin acts on the central nervous system and may cause drowsiness, dizziness or other related symptoms. Even, if they were only of mild or moderate degree, these undesirable effects could be potentially dangerous in patients driving or operating machinery. This is especially true at the beginning of the treatment and after increase in dose


The adverse reactions observed during clinical studies conducted in epilepsy (adjunctive and monotherapy) and neuropathic pain have been provided in a single list below by class and frequency: 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). Where an adverse reaction was seen at different frequencies in clinical studies, it was assigned to the highest frequency reported.

Additional reactions reported from post-marketing experience are included as frequency Not known (cannot be estimated from the available data) in italics in the list below.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Body System

Adverse drug reactions

Infections and infestations

Very Common

viral infection

Common

pneumonia, respiratory infection, urinary tract infection, infection, otitis media

Blood and the lymphatic system disorders

Common

leucopenia

Not known

thrombocytopenia

Immune system disorders

Uncommon

allergic reactions (e.g. urticaria)

Not known

hypersensitivity syndrome, a systemic reaction with a variable presentation that can include fever, rash, hepatitis, lymphadenopathy, eosinophilia, and sometimes other signs and symptoms

Metabolism and Nutrition Disorders

Common

anorexia, increased appetite

Uncommon

hyperglycemia (most often observed in patients with diabetes)

Rare

hypoglycaemia (most often observed in patients with diabetes)

Not known

hyponatraemia

Psychiatric disorders

Common

hostility, confusion and emotional lability, depression, anxiety, nervousness, thinking abnormal

 

agitation

Not known

hallucinations

Nervous system disorders

Very Common

somnolence, dizziness, ataxia

Common

convulsions, hyperkinesias, dysarthria, amnesia, tremor, insomnia, headache, sensations such as paresthesia, hypaesthesia, coordination abnormal, nystagmus, increased, decreased, or absent reflexes

Uncommon

hypokinesia, mental impairment

Rare

loss of consciousness

Not known

other movement disorders (e.g. choreoathetosis, dyskinesia, dystonia)

Eye disorders

Common

visual disturbances such as amblyopia, diplopia

Ear and Labyrinth disorders

Common

vertigo

Not known

tinnitus

Cardiac disorders

Uncommon

palpitations

Vascular disorders

Common

hypertension, vasodilatation

Respiratory, thoracic and mediastinal disorders

Common

dyspnoea, bronchitis, pharyngitis, cough, rhinitis

Rare

Respiratory depression

Gastrointestinal disorders

Common

vomiting, nausea, dental abnormalities, gingivitis, diarrhoea, abdominal pain, dyspepsia, constipation, dry mouth or throat, flatulence

Not known

pancreatitis

Hepatobiliary disorders

Not known

hepatitis, jaundice

Skin and subcutaneous tissue disorders

Common

facial oedema, purpura most often described as bruises resulting from physical trauma, rash, pruritus, acne

Not known

Stevens-Johnson syndrome, angioedema, erythema multiforme, alopecia, drug rash with eosinophilia and systemic symptoms (see section 4.4)

Musculoskeletal and connective tissue disorders

Common

arthralgia, myalgia, back pain, twitching

Not known

rhabdomyolysis, myoclonus

Renal and urinary disorder

Not known

acute renal failure, incontinence

Reproductive system and breast disorders

Common

impotence

Not known

breast hypertrophy, gynaecomastia, sexual dysfunction (including changes in libido, ejaculation disorders and anorgasmia)

General disorders and administration site conditions

Very Common

fatigue, fever

Common

peripheral oedema, abnormal gait, asthenia, pain, malaise, flu syndrome

Uncommon

generalized oedema

Not known

withdrawal reactions (mostly anxiety, insomnia, nausea, pains, sweating), chest pain. Sudden unexplained deaths have been reported where a causal relationship to treatment with gabapentin has not been established.

Investigations

Common

WBC (white blood cell count) decreased, weight gain

Uncommon

elevated liver function tests SGOT (AST), SGPT (ALT) and bilirubin

Not known

blood creatine phosphokinase increased

Injury and poisoning

Common

accidental injury, fracture, abrasion

Uncommon

fall

Under treatment with gabapentin cases of acute pancreatitis were reported. Causality with gabapentin is unclear (see section 4.4).

In patients on haemodialysis due to end-stage renal failure, myopathy with elevated creatine kinase levels has been reported.

Respiratory tract infections, otitis media, convulsions and bronchitis were reported only in clinical studies in children. Additionally, in clinical studies in children, aggressive behaviour and hyperkinesias were reported commonly.

 

Please report adverse drug events to :

The National Pharmacovigilance Center (NPC):

Fax: +966-11-205-7662

SFDA Call Center: 19999

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

Website: https://ade.sfda.gov.sa


Acute, life-threatening toxicity has not been observed with gabapentin overdoses of up to 49 g. Symptoms of the overdoses included dizziness, double vision, slurred speech, drowsiness, loss of consciousness, lethargy and mild diarrhoea. All patients recovered fully with supportive care. Reduced absorption of gabapentin at higher doses may limit drug absorption at the time of overdosing and, hence, minimise toxicity from overdoses.

Overdoses of gabapentin, particularly in combination with other CNS depressant medications, may result in coma.

Although gabapentin can be removed by haemodialysis, based on prior experience it is not usually required. However, in patients with severe renal impairment, haemodialysis may be indicated.

An oral lethal dose of gabapentin was not identified in mice and rats given doses as high as 8000 mg/kg. Signs of acute toxicity in animals included ataxia, laboured breathing, ptosis, hypoactivity, or excitation.


Pharmacotherapeutic groups: Antiepileptics, Other antiepileptics ATC code: N03AX12

Mechanism of action

Gabapentin readily enters the brain and prevents seizures in a number of animal models of epilepsy. Gabapentin does not possess affinity for either GABAA or GABAB receptor nor does it alter the metabolism of GABA. It does not bind to other neurotransmitter receptors of the brain and does not interact with sodium channels. Gabapentin binds with high affinity to the α2δ (alpha-2-delta) subunit of voltage-gated calcium channels and it is proposed that binding to the α2δ subunit may be involved in gabapentin's anti-seizure effects in animals. Broad panel screening does not suggest any other drug target other than α2δ.

Evidence from several pre-clinical models inform that the pharmacological activity of gabapentin may be mediated via binding to α2δ through a reduction in release of excitatory neurotransmitters in regions of the central nervous system. Such activity may underlie gabapentin's anti-seizure activity. The relevance of these actions of gabapentin to the anticonvulsant effects in humans remains to be established.

Gabapentin also displays efficacy in several pre-clinical animal pain models. Specific binding of gabapentin to the α2δ subunit is proposed to result in several different actions that may be responsible for analgesic activity in animal models. The analgesic activities of gabapentin may occur in the spinal cord as well as at higher brain centers through interactions with descending pain inhibitory pathways. The relevance of these pre-clinical properties to clinical action in humans is unknown.

 

Clinical efficacy and safety

A clinical trial of adjunctive treatment of partial seizures in paediatric subjects ranging in age from 3 to 12 years, showed a numerical but not statistically significant difference in the 50% responder rate in favour of the gabapentin group compared to placebo. Additional post-hoc analyses of the responder rates by age did not reveal a statistically significant effect of age, either as a continuous or dichotomous variable (age groups 3-5 and 6-12 years). The data from this additional post-hoc analysis are summarised in the table below:

Response (≥ 50% Improved) by Treatment and Age MITT* Population

Age Category

Placebo

Gabapentin

P-Value

< 6 Years Old

4/21 (19.0%)

4/17 (23.5%)

0.7362

6 to 12 Years Old

17/99 (17.2%)

20/96 (20.8%)

0.5144

*The modified intent to treat population was defined as all patients randomised to study medication who also had evaluable seizure diaries available for 28 days during both the baseline and double-blind phases.


Absorption

Following oral administration, peak plasma gabapentin concentrations are observed within 2 to 3 hours. Gabapentin bioavailability (fraction of dose absorbed) tends to decrease with increasing dose. Absolute bioavailability of a 300 mg capsule is approximately 60%. Food, including a high-fat diet, has no clinically significant effect on gabapentin pharmacokinetics.

Gabapentin pharmacokinetics are not affected by repeated administration. Although plasma gabapentin concentrations were generally between 2 μg/mL and 20 μg/mL in clinical studies, such concentrations were not predictive of safety or efficacy. Pharmacokinetic parameters are given in Table 3.

Table 3

Summary of gabapentin mean (%CV) steady-state pharmacokinetic parameters following every eight hours administration

Pharmacokinetic parameter

300 mg

(N = 7)

400 mg

(N = 14)

800 mg

(N=14)

 

Mean

%CV

Mean

%CV

Mean

%CV

Cmax (μg/mL)

4.02

(24)

5.74

(38)

8.71

(29)

tmax (hr)

2.7

(18)

2.1

(54)

1.6

(76)

T1/2 (hr)

5.2

(12)

10.8

(89)

10.6

(41)

AUC (0-8) μg•hr/mL)

24.8

(24)

34.5

(34)

51.4

(27)

Ae% (%)

NA

NA

47.2

(25)

34.4

(37)

Cmax = Maximum steady state plasma concentration

tmax = Time for Cmax

T1/2 = Elimination half-life

AUC(0-8) = Steady state area under plasma concentration-time curve from time 0 to 8 hours postdose

Ae% = Percent of dose excreted unchanged into the urine from time 0 to 8 hours postdose

NA = Not available

Distribution

Gabapentin is not bound to plasma proteins and has a volume of distribution equal to 57.7 litres. In patients with epilepsy, gabapentin concentrations in cerebrospinal fluid (CSF) are approximately 20% of corresponding steady-state trough plasma concentrations. Gabapentin is present in the breast milk of breast-feeding women.

Biotransformation

There is no evidence of gabapentin metabolism in humans. Gabapentin does not induce hepatic mixed function oxidase enzymes responsible for drug metabolism.

Elimination

Gabapentin is eliminated unchanged solely by renal excretion. The elimination half-life of gabapentin is independent of dose and averages 5 to 7 hours.

In elderly patients, and in patients with impaired renal function, gabapentin plasma clearance is reduced. Gabapentin elimination-rate constant, plasma clearance, and renal clearance are directly proportional to creatinine clearance.

Gabapentin is removed from plasma by haemodialysis. Dosage adjustment in patients with compromised renal function or undergoing haemodialysis is recommended (see section 4.2).

Gabapentin pharmacokinetics in children were determined in 50 healthy subjects between the ages of 1 month and 12 years. In general, plasma gabapentin concentrations in children > 5 years of age are similar to those in adults when dosed on a mg/kg basis.

In a pharmacokinetic study in 24 healthy paediatric subjects aged between 1 month and 48 months, an approximately 30% lower exposure (AUC), lower Cmax and higher clearance per body weight have been observed in comparison to available reported data in children older than 5 years.

Linearity/Non-linearity

Gabapentin bioavailability (fraction of dose absorbed) decreases with increasing dose which imparts non-linearity to pharmacokinetic parameters which include the bioavailability parameter (F) e.g. Ae%, CL/F, Vd/F. Elimination pharmacokinetics (pharmacokinetic parameters which do not include F such as CLr and T1/2), are best described by linear pharmacokinetics. Steady state plasma gabapentin concentrations are predictable from single-dose data.


Carcinogenesis

Gabapentin was given in the diet to mice at 200, 600, and 2000 mg/kg/day and to rats at 250, 1000, and 2000 mg/kg/day for two years. A statistically significant increase in the incidence of pancreatic acinar cell tumours was found only in male rats at the highest dose. Peak plasma drug concentrations in rats at 2000 mg/kg/day are 10 times higher than plasma concentrations in humans given 3600 mg/day. The pancreatic acinar cell tumours in male rats are low-grade malignancies, did not affect survival, did not metastasise or invade surrounding tissue, and were similar to those seen in concurrent controls. The relevance of these pancreatic acinar cell tumours in male rats to carcinogenic risk in humans is unclear.

Mutagenesis

Gabapentin demonstrated no genotoxic potential. It was not mutagenic in vitro in standard assays using bacterial or mammalian cells. Gabapentin did not induce structural chromosome aberrations in mammalian cells in vitro or in vivo, and did not induce micronucleus formation in the bone marrow of hamsters.

Impairment of Fertility

No adverse effects on fertility or reproduction were observed in rats at doses up to 2000 mg/kg (approximately five times the maximum daily human dose on a mg/m2 of body surface area basis).

Teratogenesis

Gabapentin did not increase the incidence of malformations, compared to controls, in the offspring of mice, rats, or rabbits at doses up to 50, 30 and 25 times respectively, the daily human dose of 3600 mg, (four, five or eight times, respectively, the human daily dose on a mg/m2 basis).

Gabapentin induced delayed ossification in the skull, vertebrae, forelimbs, and hindlimbs in rodents, indicative of fetal growth retardation. These effects occurred when pregnant mice received oral doses of 1000 or 3000 mg/kg/day during organogenesis and in rats given 500, 1000, or 2000 mg/kg prior to and during mating and throughout gestation. These doses are approximately 1 to 5 times the human dose of 3600 mg on a mg/m2 basis.

No effects were observed in pregnant mice given 500 mg/kg/day (approximately 1/2 of the daily human dose on a mg/m2basis).

An increased incidence of hydroureter and/or hydronephrosis was observed in rats given 2000 mg/kg/day in a fertility and general reproduction study, 1500 mg/kg/day in a teratology study, and 500, 1000, and 2000 mg/kg/day in a perinatal and postnatal study. The significance of these findings is unknown, but they have been associated with delayed development. These doses are also approximately 1 to 5 times the human dose of 3600 mg on a mg/m2 basis.

In a teratology study in rabbits, an increased incidence of post-implantation fetal loss, occurred in doses given 60, 300, and 1500 mg/kg/day during organogenesis. These doses are approximately 1/4 to 8 times the daily human dose of 3600 mg on a mg/m2 basis. The margins of safety are insufficient to rule out the risk of these effects in humans.


Gabapentin (active)

Mannitol Spray Dried 

Magnesium Stearate

Capsule shell


Not applicable.


2 years

Store below 30°C.

Blisters: Store in the original package in order to protect from light and moisture.


Transparent PVC/PVDC/Alu blister

Pack sizes:

5 Blisters ,10 capsules per blister.


No special requirements


Marketing Authorisation Holder and Manufacturer Medical and Cosmetic Products Company Ltd. (Riyadh Pharma) P.O.Box 442, Riyadh 11411 Fax: +966 11 265 0505 Email: contact@riyadhpharma.com For any information about this medicinal product, please contact the local representative of marketing authorisation holder: Saudi Arabia Marketing department Riyadh Tel: +966 11 265 0111 Email: marketing@riyadhpharma.com

5/2020
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