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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)

Tadalafil Tablets is a treatment for adult men with erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tadalafil Tablets has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity.

Tadalafil Tablets contains the active substance Tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation Tadalafil Tablets works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is improved erectile function. Tadalafil Tablets will not help you if you do not have erectile dysfunction.

It is important to note that Tadalafil Tablets, does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

 


Do not take Tadalafil Tablets If you:

·     are allergic to Tadalafil or any of the other ingredients of this medicine (listed in section 6).

·     are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”). Tadalafil Tablets has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure tell your doctor.

·     have serious heart disease or recently had a heart attack within the last 90 days.

·     recently had a stroke within the last 6 months.

·     have low blood pressure or uncontrolled high blood pressure.

·     ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.

·     are taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as Tadalafil Tablets, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Warnings and precautions

Talk to your doctor before taking Tadalafil Tablets.

Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra strain on your heart. If you have a heart problem you should tell your doctor.

Before taking the tablets, tell your doctor if you have:

·     sickle cell anaemia (an abnormality of red blood cells).

·     multiple myeloma (cancer of the bone marrow).

·     leukaemia (cancer of the blood cells).

·     any deformation of your penis.

·     a serious liver problem.

·     a severe kidney problem.

It is not known if Tadalafil Tablets is effective in patients who have had:

·     pelvic surgery.

·     removal of all or part of the prostate gland in which nerves of the prostate are cut (radical non-nerve- sparing prostatectomy).

 

If you experience sudden decrease or loss of vision, stop taking Tadalafil Tablets and contact your doctor immediately.

Decreased or sudden hearing loss has been noted in some patients taking Tadalafil. Although it is not known if the event is directly related to Tadalafil, if you experience decreased or sudden hearing loss, stop taking Tadalafil and contact your doctor immediately

Tadalafil Tablets is not intended for use by women.

Children and adolescents

Tadalafil Tablets is not intended for use by children and adolescents under the age of 18.

Other medicines and Tadalafil Tablets

Tell your doctor if you are taking, have recently taken or might take any other medicines Do not take Tadalafil Tablets if you are already taking nitrates.

Some medicines may be affected by Tadalafil Tablets or they may affect how well Tadalafil Tablets will work. Tell your doctor or pharmacist if you are already taking:

·     an alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).

·     other medicines to treat high blood pressure.

·     riociguat.

·     a 5- alpha reductase inhibitor (used to treat benign prostatic hyperplasia).

·     medicines such as ketoconazole tablets (to treat fungal infections) and protease inhibitors for treatment of AIDS or HIV infection.

·     phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines).

·     rifampicin, erythromycin , clarithromycin or itraconazole.

·     other treatments for erectile dysfunction.

Tadalafil Tablets with drink and alcohol

Information on the effect of alcohol is in section 3. Grapefruit juice may affect how well Tadalafil Tablets will work and should be taken with caution. Talk to your doctor for further information.

Fertility

When dogs were treated there was reduced sperm development in the testes. A reduction in sperm was seen in some men. These effects are unlikely to lead to a lack of fertility.

Driving and using machines

 

Some men taking Tadalafil Tablets in clinical studies have reported dizziness. Check carefully how you react to the tablets before driving or using machines.

Tadalafil Tablets contains lactose:

If you have an intolerance to some sugars, contact your doctor before taking this medicine.


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

Tadalafil Tablets tablets are for oral use in men only. Swallow the tablet whole with some water. The tablets can be taken with or without food.

The recommended starting dose is one 10 mg tablet before sexual activity. However, you have been given the dose of one 20mg tablet as your doctor has decided that the recommended dose of 10mg is too weak.

You may take a Tadalafil Tablets tablet at least 30 minutes before sexual activity. Tadalafil Tablets may still be effective up to 36 hours after taking the tablet.

Do not take Tadalafil Tablets more than once a day. Tadalafil Tablets 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.

It is important to note that Tadalafil Tablets does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Drinking alcohol may affect your ability to get an erection and may temporarily lower your blood pressure. If you have taken or are planning to take Tadalafil Tablets, avoid excessive drinking (blood alcohol level of

0.08 % or greater), since this may increase the risk of dizziness when standing up.

If you take more Tadalafil Tablets than you should

Contact your doctor. You may experience side effects described in section 4.

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. These effects are normally mild to moderate in nature.

If you experience any of the following side effects stop using the medicine and seek medical help immediately:

·     allergic reactions including rashes (frequency uncommon).

·     chest pain - do not use nitrates but seek immediate medical assistance (frequency uncommon).

 

·     prolonged and possibly painful erection after taking Tadalafil Tablets (frequency rare). If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.

·     sudden loss of vision (frequency rare). Other side effects have been reported:

Common (seen in 1 to 10 in every 100 patients)

·     headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion, and indigestion.

Uncommon (seen in 1 to 10 in every 1,000 patients)

·     dizziness, stomach ache, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty in breathing, presence of blood in urine, pounding heartbeat sensation, a fast heart rate, high blood pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, feet or ankles and feeling tired.

Rare (seen in 1 to 10 in every 10,000 patients)

·     fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red welts on the surface of the skin), penile bleeding, presence of blood in semen and increased sweating.

Heart attack and stroke have also been reported rarely in men taking Tadalafil Tablets. Most of these men had known heart problems before taking this medicine

Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported. Some additional rare side effects have been reported in men taking Tadalafil Tablets that were not seen in clinical trials. These include:

·     migraine, swelling of the face, serious allergic reaction which causes swelling of the face or throat, serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina and sudden cardiac death.

The side effect dizziness has been reported more frequently in men over 75 years of age taking Tadalafil Tablets. Diarrhoea has been reported more frequently in men over 65 years of age taking Tadalafil Tablets.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

 • Saudi Arabia:

 

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

 

 

 

 

 

 

 

o Other GCC States:

         Please contact the relevant competent authority.


·     Store below 30°C.

·     Store in the original package in order to protect from moisture.

·     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 pack after EXP. The expiry date refers to the last day of the month.

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


What Tadalafil Tablets USP 20mg contains

The active substance is Tadalafil USP.

Each film coated tablet contains Tadalafil USP 20 mg.

The other ingredients are: Lactose monohydrate, Copovidone, Colloidal silicon dioxide, Polyoxyl 40 hydrogenated castor oil, Microcrystalline cellulose, Croscarmellose sodium, Magnesium Stearate.

Film coating composition: HPMC 2910/Hypromellose, Lactose monohydrate, Titanium dioxide Triacetin, Talc.


What Tadalafil Tablets USP 20mg looks like? White colour, capsule shaped, biconvex, film-coated tablets, debossed with 'T15' on one side and ‘H’ on the other side. How supplied:   Tadalafil Tablets Tablets are supplied in Blister pack. Tadalafil Tablets USP 20 - Box of 10 blister tablets (1x10’s). Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

 

Saudi Amarox Industrial Company

 

Aljameah Street, Malaz quarter, Riyadh 11441

 


October, 2018
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

يستخدم تاديل أقراص كعلاج للرجال البالغين والذين يعانون من ضعف الانتصاب . ويحدث ذلك عندما يعجز الرجل عن جعل – أو الإبقاء على القضيب صلبا ومنتصبا بما يلائم الممارسة الجنسية . وقد أظهر تناول أقراص تاديل تحسن كبير في القدرة الجنسية وذلك بالحصول على قضيب منتصب وصلب بالقدر الملائم للنشاط الجنسي .

يحتوي تاديل أقراص على تادالافيل (مادة فعالة) وينتمي إلى مجموعة من الأدوية تسمى مثبطات إنزيم فوسفوداي إستريز نوع 5 . وتعمل أقراص تاديل بعد الإستثارة الجنسية على إرتخاء الأوعية الدموية الموجودة في القضيب ، بما يسمح بتدفق الدم إلى القضيب . ونتيجة لهذ تتحسن وظيفة الانتصاب . ولن تساعدك أقراص تاديل إذا لم يكن لديك ضعف بالانتصاب .

من المهم أن نلاحظ أن تاديل أقراص ، لايعمل إذا لم تكن هناك إستثارة جنسية . ولذا ستكون أنت وشريكك بحاجة إلى الإنشغال بالمداعبة قبل الجماع ، تماما كما تفعل إن لم تكن تتناول دواء لعلاج ضعف الانتصاب .

لا تقم باستعمال تاديل أقراص  :

·       إذا كنت تعاني من حساسية (حساسية مفرطة) لتادالافيل أو إلى أي من المكونات الأخرى من تاديل أقراص المذكورة في الفقرة 6  .

·       إذا كنت تتناول أي شكل من أشكال النترات العضوية أو على شكل أكسيد النيتريك مثل نتريت الأميل . وهي مجموعة من الأدوية تسمى ("النترات") وتستخدم في علاج الذبحة الصدرية ("ألم في الصدر") . حيث أظهر تاديل أقراص زيادة في تآثير هذه الأدوية . إذاكنت تتناول أي شكل من أشكال النترات أو غير متأكد أخبر طبيبك .

·       إذا كنت تعاني من أمراض خطيرة بالقلب أو أصيبت مؤخرا بأزمة قلبية خلال 90 يوما الماضية .

·       إذا أصيبت مؤخرا بسكتة دماغية خلال الأشهرالستة الأخيرة .

·       إذا كنت تعاني من انخفاض ضغط الدم أو ارتفاع في ضغط الدم بشكل غيرالمنضبط .

·       إذا كنت تعاني في أي وقت مضى من فقدان الرؤية بسبب الاعتلال العصبي غير ناتج عن إلتهاب شرياني (نيون) ، وهي حالة يتم وصفها بأنها "السكتة الدماغية للعين" .

·       إذا كنت تتناول أدوية الريوسيغوات . ويستخدم هذا الدواء لعلاج ارتفاع ضغط الدم في الشريان الرئوي (أي ارتفاع لضغط الدم في الرئتين) وارتفاع ضغط الدم الرئوي المزمن (أي ارتفاع ضغط الدم في الرئتين والذي قد يتضاعف إلى جلطات بالدم) . وقد ثبت أن المثبطات من نوع PDE5 ، مثل أقراص تادالافيل ، تزيد من تأثيرات هذا الدواء الخافضة للضغط . إذا كنت تتناول ريوسيغوات أو غير متأكد أخبر طبيبك .

 التحذيرات والاحتياطات

تحدث مع الطبيب المعالج قبل تناول تاديل أقراص خاصة إذا كنت تعاني من:

يجب العلم بأن النشاط الجنسي يحمل مخاطر محتملة للمرضى الذين يعانون من أمراض بالقلب لأنه يضع أعباء إضافية على قلبك . إذا كان لديك مشكلة في القلب يجب أن تخبر طبيبك .

قبل تناول تاديل أقراص ، أخبر طبيبك إذا كان لديك:

·       إذا كنت تعاني من فقر الدم المنجلي (شذوذ في خلايا الدم الحمراء) .

·       إذا كنت تعاني من المايلوما المتعددة (سرطان في نخاع العظام) .

·       إذا كنت تعاني من سرطان الدم (سرطان خلايا الدم) .

·       إذا كنت تعاني من أي تشوه في القضيب .

·       إذا كنت تعاني من مشكلة خطيرة في الكبد .

·       إذا كنت تعاني  من مشكلة شديدة في الكلى .

ومن غير المعروف ما إذا كان تناول تاديل أقراص فعال في المرضى الذين لديهم:

·       جراحة بالحوض .

·       استئصال جزئي أو كلي لغدة البروستاتا التي يتم فيها قطع أعصاب البروستاتا (استئصال البروستاتا الجذري غير العصبي) .

إذا كنت تعاني من انخفاض مفاجئ أو فقدان الرؤية ، يجب التوقف عن تناول تاديل أقراص والاتصال بطبيبك على الفور . تاديل أقراص ليست مخصصة للاستخدام من قبل النساء .

الأطفال والمراهقين

تاديل أقراص غير مخصصة للاستخدام بالنسبة للأطفال والمراهقين دون سن 18 عاما .

تناول أدوية أخرى مع تاديل أقراص :        

أخبر طبيبك أو الصيدلي إذا كنت تتناول ، أو تناولت مؤخرا أو قد تتناول أي أدوية أخرى.

لا تتناول تاديل أقراص إذا كنت تتناول الأدوية المحتوية على النترات .

قد يتغير تأثير بعض الأدوية بتناول تاديل أقراص أو قد يتغير تأثير وفعالية تاديل أقراص بتناول الأدوية الأخرى . أخبر طبيبك أو الصيدلي إذا كنت تتناول الأدوية التالية :

·       حاصرات ألفا (يستخدم لعلاج ارتفاع ضغط الدم أو الأعراض البولية المرتبطة بتضخم البروستاتا الحميد) .

·       أدوية أخرى لعلاج ارتفاع ضغط الدم .

·       أدوية الريوسيغوات .

·       الادوية المثبطة لإنزيمات الألفا - 5 ريداكتيز (يستخدم لعلاج تضخم البروستات الحميد) .

·       أدوية مثل أقراص كيتوكونازول (لعلاج الالتهابات الفطرية) ومثبطات الأنزيم البروتيني لعلاج الإيدز أو عدوى فيروس نقص المناعة البشري .

·       الفينوباربيتال ، الفينيتوين والكاربامازيبين (الأدوية المضادة للتشنجات) .

·       ريفامبيسين ، الاريثروميسين ، كلاريثروميسين أو إتراكونازول .

·       علاجات أخرى لضعف الانتصاب .

تناول تاديل أقراص مع المشروبات والكحوليات:

ترد معلومات عن تأثير الكحول تم ذكرها في القسم 3 . عصير الجريب فروت قد يؤثر على كيفية عمل تاديل أقراص بشكل جيد لذا يجب تتناوله بحذر . تحدث مع طبيبك للحصول على مزيد من المعلومات .

الخصوبة

عندما تم تجربة العلاج على الكلاب كان هناك انخفاض في إنتاج الحيوانات المنوية من الخصيتين . وقد لوحظ انخفاض في عدد الحيوانات المنوية في بعض الرجال . ومن غير المحتمل أن تؤدي هذه الآثار إلى نقص الخصوبة .

القيادة واستخدام الآلات

أثبتت الدراسات السريرية على أقراص تاديل أن بعض الرجال الذين يتناولون تاديل قد يعانون من الدوخة . تحقق بعناية من كيفية تفاعلك مع الأقراص قبل القيادة أو استخدام الآلات .

 تحتوي أقراص تاديل على اللاكتوز

إذا أخبرك الطبيب من قبل أن لديك مخاطر من تناول السكريات ، اتصل بالطبيب قبل تناول هذا الدواء.

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دائما تناول تاديل أقراص كما وصف لك طبيبك.   يجب استشارة الطبيب أو الصيدلي إذا كنت غير متأكد  .

تاديل أقراص هي للاستخدام عن طريق الفم للرجال فقط . يجب ابتلاع القرص كاملا مع بعض الماء . يمكن أن يتم تناول الأقراص مع أو بدون الطعام .

الجرعة الموصى بها هي قرص 10 ملغم قبل النشاط الجنسي . ومع ذلك ، قد يقرر الطبيب جرعة من قرص واحد 20 ملغم  إذا ثبت أن جرعة 10 ملغم ضعيفة جدا .

يجب تناول تاديل أقراص قبل النشاط الجنسي  ب 30 دقيقة على الأقل .

قد يستمر تأثير تاديل أقراص بشكل  فعال حتى 36 ساعة بعد تتناول الأقراص .

لا تتناول تاديل أقراص أكثر من مرة في اليوم . تاديل أقراص 10 ملغم و 20 ملغم مخصص للاستخدام قبل النشاط الجنسي المتوقع ولا ينصح بالاستخدام اليومي المستمر .

من المهم أن نلاحظ أن تاديل أقراص لا يعمل إذا لم يكن هناك التحفيز الجنسي . لذا ينبغي أن تبدأ أنت وشريكتك  في الإنشغال بالمداعبة ، تماما كما لو كنت لا تتناول دواء لعلاج ضعف الانتصاب .

قد يؤثر شرب الكحول على قدرتك على الحصول على الانتصاب وقد يقلل ضغط الدم بشكل مؤقت . إذا كنت قد تناولت أو تخطط لتناول تاديل أقراص ، يجب تجنب الإفراط في شرب الكحول (مستوى الكحول في الدم من  0.08 % أو أكثر) ، لأن هذا قد يزيد من خطر الدوخة أثناء الوقوف .

الجرعة الزائدة من تاديل أقراص :

إذا تناولت أقراص تاديل أكثر من الجرعة التي أوصى بها الطبيب . فقد تصبح عرضة للآثار الجانبية المحتمله والمذكوره في القسم 4 .

إذا كان لديك أي أسئلة أخرى عن استخدام هذا المنتج ، إستشر الطبيب أو الصيدلي .

مثل جميع الأدوية ، من الممكن أن يسبب تاديل أقراص بعض الآثار الجانبية ، على الرغم من أنها لا تؤثر في الجميع . وعادة ما تكون هذه الآثار خفيفة إلى معتدلة في الطبيعة .

إذا كنت تعاني من أي من الآثار الجانبية التالية ، يجب التوقف عن تناول الدواء وطلب المساعدة الطبية على الفور :

·       الحساسية بما في ذلك الطفح الجلدي (المعدل: غير طبيعي) .

·       ألم في الصدر - لا تتناول النترات ويجب أن تسعى للحصول على مساعدة طبية فورية (المعدل: غير شائع) .

·       الانتصاب لفترة طويلة وربما مؤلمة بعد تناول تاديل أقراص (المعدل: نادر) . إذا كان لديك مثل هذا الانتصاب ، الذي يستمر بشكل مستمر لأكثر من 4 ساعات يجب عليك الاتصال بالطبيب على الفور .

·       فقدان مفاجئ للرؤية (المعدل: نادر) .

وقد تم الإبلاغ عن آثار جانبية أخرى :

أعراض جانبية شائعة (قد تصيب 1 إلى 10 أشخاص من أصل 100 شخص) .

·     صداع ، آلام في الظهر ، آلام في العضلات ، ألم في الذراعين والساقين ، احمرار الوجه ، احتقان الأنف ، وعسر الهضم . صعوبة النوم .

أعراض جانبية غير شائعة (قد تصيب 1 إلى 10 أشخاص من أصل 1000 شخص) .

·    الدوخة وآلام المعدة والشعور بالمرض والإعياء (القيء) والارتجاع وعدم وضوح الرؤية وألم العين وصعوبة في التنفس وظهور الدم في البول والشعور بضربات القلب وسرعة في معدل ضربات القلب وارتفاع ضغط الدم وانخفاض ضغط الدم ، نزيف بالأنف ، رنين في الأذنين ، تورم في اليدين والقدمين أو الكاحلين والشعور بالتعب . زيادة في مستويات السكر في الدم .

 أعراض جانبية نادرة (قد تصيب 1 إلى 10 أشخاص من أصل 10000 شخص) .

·    الإغماء ، تشنجات ، وفقدان الذاكرة ، وتورم الجفون ، واحمرار العين ، والانخفاض المفاجئ أو فقدان السمع ، والطفح الجلدي (حكة حمراء على سطح الجلد) ، ونزيف بالقضيب ، ووجود الدم في السائل المنوي ، وزيادة التعرق .

كما تم الإبلاغ عن نوبات قلبية والسكتة الدماغية بمعدل نادرا في الرجال الذين يتناولون تاديل أقراص . وكان معظم هؤلاء الرجال يعانون من مشاكل في القلب قبل تناول هذا الدواء .

ونادرا ما تم الإبلاغ عن نقص جزئي أو مؤقت أو دائم أو فقدان الرؤية في واحدة أو كلتا العينين .

وقد تم الإبلاغ عن بعض الآثار الإضافية الجانبية النادرة في الرجال الذين يتناولون تاديل أقراص التي لم ينظر إليها في التجارب السريرية . وتشمل هذه:

·    الصداع النصفي ، تورم في الوجه ، رد فعل تحسسي خطير يسبب تورم في الوجه أو الحلق ، الطفح الجلدي الخطير ، بعض الاضطرابات التي تؤثر على تدفق الدم إلى العينين ، عدم انتظام ضربات القلب ، الذبحة الصدرية والموت القلبي المفاجئ .

وقد تم الإبلاغ عن حالات دوخة بمعدل أكثر في الرجال أكثر من 75 عاما من العمر والذين تناولوا تاديل أقراص . وقد تم الإبلاغ عن الإسهال بمعدل أكثر في الرجال الذين تزيد أعمارهم عن 65 عاما الذين يتناولون تاديل أقراص .

الإبلاغ عن الآثار الجانبية:

إذا زادت حدة أي من هذه الأعراض الجانبية ، أو لاحظت ظهور أعراض جانبية غير ما تم ذكره في هذه النشرة ، يرجى إبلاغ الطبيب المعالج أو الصيدلي . وهذا يشمل أي آثار جانبية محتملة غير مدرجة في هذه النشرة . يمكنك أيضا الإبلاغ عن الآثار الجانبية مباشرة (انظر التفاصيل أدناه) . بالإبلاغ عن الآثار الجانبية يمكنك المساعدة في توفير مزيد من المعلومات حول أمان هذا الدواء .

للإبلاغ عن الأعراض الجانبية

-        المركز الوطني للتيقظ والسلامة الدوائية

o     فاكس 7662-205-1-966+

o     الاتصال على المركز الوطني للتيقظ والسلامة الدوائية +966-11-2038222 ، تحويلة: 2317-2356-2353-2354-2334-2340

o     الهاتف المجاني: 8002490000

o     البريد الإلكتروني : npc .drug@sfda .gov .sa

o     الموقع الإلكتروني: www .sfda .gov .sa/npc

 

دول مجلس التعاون الخليجي الأخرى:

   يرجى الاتصال بالسلطة الصحية المختصة .

·         يجب حفظ الأقراص في درجة حرارة أقل من 30 ° مئوية .

·         يجب حفظ الأقراص في عبوتها الأصلية بعيدا عن الرطوبة .

·         يحفظ بعيدا عن متناول أيدي الأطفال أو على مرأى منهم .

·         لا تستخدم تاديل أقراص بعد تاريخ انتهاء الصلاحية الموجود على العبوة . تاريخ انتهاء الصلاحية يشير إلى اليوم الأخير من ذلك الشهر .

·         لا ينبغي التخلص من الأدوية عن طريق مياه الصرف الصحي أو النفايات المنزلية . استشرالصيدلي في كيفية التخلص من الأدوية التي لم تعد مطلوبة . حيث أنه من شأن هذه التدابيرالمساعدة على حماية البيئة .

ما الذي يحتوي عليه تاديل أقراص :

المادة الفعالة هي تادالافيل المتوافق مع دستور الأدوية الأمريكي .

يحتوي كل قرص مغطى بطبقة رقيقة على20 ملغم تادالافيل المتوافق مع دستور الأدوية الأمريكي .

الصواغات الأخرى هي: اللاكتوز أحادي الهدرجه ، ﺍﻟﺒﻭﻟﻲ ﻓﻴﻨﻴل ﺒﻴﺭﻭﻟﻴﺩﻭﻥ ، ثاني أكسيد السيليكون الغروي ، بولي أوكسي 40 زيت الخروع المهدرج ، السيلولوز دقيق التبلور ، كروسكارملوز الصوديوم ، ستيرات المغنيسيوم .

الصواغات الأخرى لطبقة الكسوة : هيدروكسي بروبيل ميثيل السيليلوز 2910 / هايبروميلوز، اللاكتوز أحادي الهدرجه ، ثاني أكسيد التيتانيوم ، ترياسيتين ، التلك .   

 ما هو شكل تاديل أقراص ومحتويات العلبة ؟

تاديل أقراص 20 ملغم

أقراص مغطاه بطبقة رقيقة على شكل كبسولات محدبة الوجهين ذات اللون الأبيض ومحفور عليها  " 15T " على جانب واحد و " H " من الجانب الآخر.

يتوافر تاديل أقراص في:

يتوافر تاديل أقراص على شكل علبة

تاديل أقراص 20 ملغم – علبة تحتوي على شريط به 10 أقراص .

قد لا تتوافر كافة العبوات في السوق

اسم وعنوان مالك رخصة التسويق والمصنع

     المصنع: ھتیرو لاب المحدودة - الھند

 صاحب حق التسويق:

شركة أماروكس السعودية للصناعة

شارع الجامعة – الملز - الرياض

المملكة العربية السعودية .   

 هاتف : 0096611477221 

 

نوفمبر /2017
 Read this leaflet carefully before you start using this product as it contains important information for you

Tadalafil Tablets USP 2.5mg, 5mg and 20mg

Tadalafil Tablets USP 2.5mg: Each film coated tablet contains Tadalafil USP 2.5mg. Tadalafil Tablets USP 5mg: Each film coated tablet contains Tadalafil USP 5mg. Tadalafil Tablets USP 20mg: Each film coated tablet contains Tadalafil USP 20mg.

Tadalafil Tablets USP 2.5mg: Blue colour, round shaped, biconvex, film coated tablets debossed with 'T18' on one side and 'H' on the other side Tadalafil Tablets USP 5mg: White colour, round shaped, biconvex, film coated tablets debossed with 'T17' on one side and 'H' on the other side. Tadalafil Tablets USP 20mg: White colour, capsule shaped, biconvex, film coated tablets debossed with 'T15' on one side and 'H' on the other side

Treatment of erectile dysfunction in adult males.

In order for tadalafil to be effective for the treatment of erectile dysfunction, sexual stimulation is required.

5 mg only: Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males.

Tadalafil Tablets is not indicated for use by women.


Posology

Erectile dysfunction in adult Men

In general, the recommended dose is 10 mg taken prior to anticipated sexual activity and with or without food. In those patients in whom tadalafil 10 mg does not produce an adequate effect, 20 mg might be tried. It may be taken at least 30 minutes prior to sexual activity.

The maximum dose frequency is once per day.

Tadalafil 10 and 20 mg is intended for use prior to anticipated sexual activity and it is not recommended for continuous daily use.

In patients who anticipate a frequent use of Tadalafil Tablets (i.e., at least twice weekly) a once daily regimen with the lowest doses of Tadalafil Tablets  might be considered suitable, based on patient choice and the physician's judgement. 

In these patients, the recommended dose is 5mg taken once a day at approximately the same time of day. The dose may be decreased to 2.5mg once a day based on individual tolerability.

 The appropriateness of continued use of the daily regimen should be reassessed periodically.

Benign prostatic hyperplasia in adult men (tadalafil 5 mg only)

The recommended dose is 5 mg, taken at approximately the same time every day with or without food. For adult men being treated for both benign prostatic hyperplasia and erectile dysfunction the recommended dose is also 5 mg taken at approximately the same time every day. Patients who are unable to tolerate tadalafil 5 mg for the treatment of benign prostatic hyperplasia should consider an alternative therapy as the efficacy of tadalafil 2.5 mg for the treatment of benign prostatic hyperplasia has not been demonstrated.

Special Populations

Elderly Men

Dose adjustments are not required in elderly patients.

 

Men with Renal Impairment

Dose adjustments are not required in patients with mild to moderate renal impairment. For patients with severe renal impairment, 10 mg is the maximum recommended dose.

Once-a-day dosing of 2.5 or 5 mg tadalafil both for the treatment of erectile dysfunction or benign prostatic hyperplasia is not recommended in patients with severe renal impairment. 

Men with Hepatic Impairment

For the treatment of erectile dysfunction using on-demand Tadalafil Tablets  the recommended dose of Tadalafil Tablets  is 10 mg taken prior to anticipated sexual activity and with or without food. There is limited clinical data on the safety of Tadalafil Tablets in patients with severe hepatic impairment (Child-Pugh class C); if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. There are no available data about the administration of doses higher than 10mg of tadalafil to patients with hepatic impairment. Once-a-day dosing both for the treatment of erectile dysfunction and benign prostatic hyperplasia has not been evaluated in patients with hepatic impairment; therefore, if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. Men with Diabetes

Dose adjustments are not required in diabetic patients.

Paediatric population

There is no relevant use of Tadalafil Tablets in the paediatric population with regard to the treatment of erectile dysfunction. Method of administration:

Tadalafil Tablets  is available as 2.5, 5, 10, and 20 mg film-coated tablets for oral use.


Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates. This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway. Therefore, administration of Tadalafil Tablets to patients who are using any form of organic nitrate is contraindicated. Tadalafil Tablets must not be used in men with cardiac disease for whom sexual activity is inadvisable. Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease. The following groups of patients with cardiovascular disease were not included in clinical trials and the use of tadalafil is therefore contraindicated: - patients with myocardial infarction within the last 90 days, - patients with unstable angina or angina occurring during sexual intercourse, - patients with New York Heart Association Class 2 or greater heart failure in the last 6 months, -patients with uncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertension, - patients with a stroke within the last 6 months. Tadalafil Tablets is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure. The co-administration of PDE5 inhibitors, including tadalafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension.

Before treatment with Tadalafil Tablets   

 

A medical history and physical examination should be undertaken to diagnose erectile dysfunction or benign prostatic hyperplasia and determine potential underlying causes, before pharmacological treatment is considered.

Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Tadalafil has vasodilator properties, resulting in mild and transient decreases in blood pressure and as such potentiates the hypotensive effect of nitrates.

The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following an appropriate medical assessment. It is not known if Tadalafil Tablets is effective in patients who have undergone pelvic surgery or radical non-nerve-sparing prostatectomy.

Tadalafil 5mg - Prior to initiating treatment with tadalafil for benign prostatic hyperplasia patients should be examined to rule out the presence of carcinoma of the prostate and carefully assessed for cardiovascular conditions. Cardiovascular

 

Serious cardiovascular events, including myocardial infarction, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischaemic attacks, chest pain, palpitations and tachycardia, have been reported either post marketing and/or in clinical trials. Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors. However, it is not possible to definitively determine whether these events are related directly to these risk factors, to Tadalafil Tablets to sexual activity, or to a combination of these or other factors. 

Tadalafil 2.5 mg and 5 mg - In patients receiving concomitant antihypertensive medicinal products, tadalafil may induce a blood pressure decrease. When initiating daily treatment with tadalafil, appropriate clinical considerations should be given to a possible dose adjustment of the antihypertensive therapy.

In patients who are taking alpha1 blockers, concomitant administration of Tadalafil Tablets may lead to symptomatic hypotension in some patients. The combination of tadalafil and doxazosin is not recommended.

Vision 

Visual defects and cases of NAION have been reported in connection with the intake of Tadalafil Tablets  and other PDE5 inhibitors. The patient should be advised that in case of sudden visual defect, he should stop taking Tadalafil Tablets and consult a physician immediately.

Renal and hepatic impairment (tadalafil 2.5 mg and 5 mg)

Due to increased Tadalafil exposure (AUC), limited clinical experience and the lack of ability to influence clearance by dialysis, once-a-day dosing of Tadalafil Tablets is not recommended in patients with severe renal impairment.

There is limited clinical data on the safety of single-dose administration of Tadalafil Tablets in patients with severe hepatic insufficiency (Child-Pugh Class C). Once-a-day administration has not been evaluated in patients with hepatic insufficiency. If Tadalafil Tablets is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.

Hepatic impairment (tadalafil 10 mg and 20 mg)

 

There is limited clinical data on the safety of single-dose administration of Tadalafil Tablets in patients with severe hepatic insufficiency (Child-Pugh Class C). If Tadalafil Tablets is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.

Priapism and anatomical deformation of the penis

Patients who experience erections lasting 4 hours or more should be instructed to seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.

Tadalafil Tablets should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease) or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).

Use with CYP3A4 inhibitors

Caution should be exercised when prescribing Tadalafil Tablets to patients using potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin), as increased tadalafil exposure (AUC) has been observed if the medicinal products are combined 

Tadalafil Tablets  and other treatments for erectile dysfunction

The safety and efficacy of combinations of Tadalafil Tablets and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied. The patients should be informed not to take Tadalafil Tablets in such combinations.

Lactose

Tadalafil Tablets contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.


Interaction studies were conducted with 10 mg and/or 20 mg tadalafil, as indicated below. With regard to those interaction studies where only the 10 mg tadalafil dose was used, clinically relevant interactions at higher doses cannot be completely ruled out.

Effects of Other Substances on Tadalafil

Cytochrome P450 inhibitors

Tadalafil is principally metabolised by CYP3A4. A selective inhibitor of CYP3A4, ketoconazole (200 mg daily), increased tadalafil (10 mg) exposure (AUC) 2-fold and Cmax by 15%, relative to the AUC and Cmax values for tadalafil alone. Ketoconazole (400 mg daily) increased tadalafil (20 mg) exposure (AUC) 4-fold and Cmax by 22%. Ritonavir, a protease inhibitor (200 mg twice daily), which is an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP2D6, increased tadalafil (20 mg) exposure (AUC) 2-fold with no change in Cmax. Although specific interactions have not been studied, other protease inhibitors, such as saquinavir, and other CYP3A4 inhibitors, such as erythromycin, clarithromycin, itraconazole, and grapefruit juice, should be coadministered with caution, as they would be expected to increaseplasma concentrations of tadalafil. Consequently, the incidence of the adverse reactions listed might be increased. Transporters

The role of transporters (for example, p-glycoprotein) in the disposition of tadalafil is not known.

Therefore, there is the potential of drug interactions mediated by inhibition of transporters. Cytochrome P450 inducers

A CYP3A4 inducer, rifampicin, reduced tadalafil AUC by 88%, relative to the AUC values for tadalafil alone (10 mg). This reduced exposure can be anticipated to decrease the efficacy of tadalafil; the magnitude of decreased efficacy is unknown. Other inducers of CYP3A4, such as phenobarbital, phenytoin, and carbamazepine, may also decrease plasma concentrations of tadalafil.

Effects of Tadalafil on Other Medicinal Products Nitrates

In clinical studies, tadalafil (5, 10 and 20 mg) was shown to augment the hypotensive effects of nitrates. Therefore, administration of Tadalafil Tablets to patients who are using any form of organic nitrate is contraindicated.

Based on the results of a clinical study in which 150 subjects receiving daily doses of tadalafil 20 mg for 7 days and 0.4 mg sublingual nitroglycerin at various times, this interaction lasted for more than 24 hours and was no longer detectable when 48 hours had elapsed after the last tadalafil dose. Thus, in a patient prescribed any dose of Tadalafil Tablets  (2.5 mg- 20 mg), where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should have elapsed after the last dose of Tadalafil Tablets  before nitrate administration is considered. In such circumstances, nitrates should only be administered under close medical supervision with appropriate haemodynamic monitoring. Anti-hypertensives (including calcium channel blockers)

The co-administration of doxazosin (4 and 8 mg daily) and tadalafil (5 mg daily dose and 20 mg as a single dose) increases the blood pressure-lowering effect of this alpha-blocker in a significant manner. This effect lasts at least twelve hours and may be symptomatic, including syncope. Therefore, this combination is not recommended.

In interaction studies performed in a limited number of healthy volunteers, these effects were not reported with alfuzosin or tamsulosin. However, caution should be exercised when using tadalafil in patients treated with any alpha-blockers, and notably in the elderly. Treatments should be initiated at minimal dosage and progressively adjusted.

In clinical pharmacology studies, the potential for tadalafil to augment the hypotensive effects of antihypertensive medicinal products was examined. Major classes of antihypertensive medicinal products were studied, including calcium-channel blockers (amlodipine), angiotensin converting enzyme (ACE) inhibitors (enalapril), beta-adrenergic receptor blockers (metoprolol), thiazide diuretics (bendrofluazide), and angiotensin II receptor blockers (various types and doses, alone or in combination with thiazides, calcium-channel blockers, beta-blockers, and/or alphablockers).Tadalafil (10 mg, except for studies with angiotensin II receptor blockers and amlodipine in which a 20 mg dose was applied) had no clinically significant interaction with any of these classes. In another clinical pharmacology study, tadalafil (20 mg) was studied in combination with up to 4 classes of antihypertensives. In subjects taking multiple antihypertensives, the ambulatory-blood-pressure changes appeared to relate to the degree of blood pressure control. In this regard, study subjects whose blood pressure was well controlled, the reduction was minimal and similar to that seen in healthy subjects. In study subjects whose blood pressure was not controlled, the reduction was greater, although this reduction was not associated with hypotensive symptoms in the majority of subjects. In patients receiving concomitant antihypertensive medicinal products, tadalafil 20 mg may induce a blood pressure decrease, which (with the exception of alpha-blockers - see above) is, in general, minor and not likely to be clinically relevant. Analysis of Phase 3 clinical trial data showed no difference in adverse events in patients taking tadalafil with or without antihypertensive medicinal products. However, appropriate clinical advice should be given to patients regarding a possible decrease in blood pressure when they are treated with antihypertensive.

Riociguat

Preclinical studies showed an additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat. In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5 inhibitors. There was no evidence of favourable clinical effect of the combination in the population studied. Concomitant use of riociguat with PDE5 inhibitors, including tadalafil, is contraindicated.

5- alpha reductase inhibitors

In a clinical trial that compared tadalafil 5 mg coadministered with Finasteride 5 mg to placebo plus finasteride 5 mg in the relief of BPH symptoms, no new adverse reactions were identified. However, as a formal drug-drug interaction study evaluating the effects of tadalafil and 5-alpha reductase inhibitors (5-ARIs) has not been performed, caution should be exercised when tadalafil is co-administered with 5-ARIs. CYP1A2 substrates (e.g. theophylline)

When tadalafil 10 mg was administered with theophylline (a non-selective phosphodiesterase inhibitor) in a clinical pharmacology study, there was no pharmacokinetic interaction. The only pharmacodynamic effect was a small (3.5bpm) increase in heart rate. Although this effect is minor and was of no clinical significance in this study, it should be considered when coadministering these medicinal products. Ethinylestradiol and terbutaline

Tadalafil has been demonstrated to produce an increase in the oral bioavailability of ethinylestradiol; a similar increase may be expected with oral administration of terbutaline, although the clinical consequence of this is uncertain.

Alcohol

Alcohol concentrations (mean maximum blood concentration 0.08%) were not affected by coadministration with tadalafil (10 mg or 20 mg). In addition, no changes in tadalafil concentrations were seen 3 hours after coadministration with alcohol. Alcohol was administered in a manner to maximise the rate of alcohol absorption (overnight fast with no food until 2 hours after alcohol). Tadalafil (20 mg) did not augment the mean blood pressure decrease produced by alcohol (0.7 g/kg or approximately 180 ml of 40% alcohol [vodka] in an 80 kg male) but, in some subjects, postural dizziness and orthostatic hypotension were observed. When tadalafil was administered with lower doses of alcohol (0.6 g/kg), hypotension was not observed and dizziness occurred with similar frequency to alcohol alone. The effect of alcohol on cognitive function was not augmented by tadalafil (10 mg).

Cytochrome P450 metabolised medicinal products

Tadalafil is not expected to cause clinically significant inhibition or induction of the clearance of medicinal products metabolised by CYP450 isoforms. Studies have confirmed that tadalafil does not inhibit or induce CYP450 isoforms, including CYP3A4, CYP1A2, CYP2D6, CYP2E1,

CYP2C9 and CYP2C19. 

CYP2C9 substrates (e.g. R-warfarin)

Tadalafil (10 mg and 20 mg) had no clinically significant effect on exposure (AUC) to Swarfarin or R-warfarin (CYP2C9 substrate), nor did tadalafil affect changes in prothrombin time induced by warfarin. Aspirin

Tadalafil (10 mg and 20 mg) did not potentiate the increase in bleeding time caused by acetylsalicylic acid.

Antidiabetic medicinal products

Specific interaction studies with antidiabetic medicinal products were not conducted.

 


Tadalafil Tablets is not indicated for use by women.

Pregnancy

There are limited data from the use of tadalafil in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. As a precautionary measure, it is preferable to avoid the use of Tadalafil Tablets during pregnancy.

Breastfeeding

Available pharmacodynamic/toxicological data in animals have shown excretion of tadalafil in milk. A risk to the suckling child cannot be excluded. Tadalafil Tablets should not be used during breast feeding.

Fertility

Effects were seen in dogs that might indicate impairment of fertility. Two subsequent clinical studies suggest that this effect is unlikely in humans, although a decrease in sperm concentration was seen in some men.


Tadalafil Tablets has negligible influence on the ability to drive or use machines. Although the frequency of reports of dizziness in placebo and Tadalafil arms in clinical trials was similar, patients should be aware of how they react to Tadalafil Tablets before driving or using machines.


Summary of the safety profile

The most commonly reported adverse reactions in patients taking Tadalafil Tablets for the treatment of erectile dysfunction or benign prostatic hyperplasia were headache, dyspepsia, back pain and myalgia, in which the incidences increase with increasing dose of Tadalafil Tablets  The adverse reactions reported were transient, and generally mild or moderate. The majority of headaches reported with Tadalafil Tablets once-a-day dosing are experienced within the first 10 to 30 days of starting treatment.

Tabulated summary of adverse reactions

The table below lists the adverse reactions observed from spontaneous reporting and in placebocontrolled clinical trials (comprising a total of 8022 patients on Tadalafil Tablets  and 4422 patients on placebo) for on-demand and once-a-day treatment of erectile dysfunction and the once-a-day treatment of benign prostatic hyperplasia.

Frequency convention: 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) and Not known (cannot be estimated from the available data).

Very common 

Common 

Uncommon 

Rare 

Immune system disorders  

 

 

Hypersensitivity reactions

 Angioedema2 

Nervous system disorders  

 Headache  Dizziness  Stroke1 (including

haemorrhagic events), Syncope, Transient ischaemic attacks1, Migraine2, Seizures2,

Transient amnesia 

Eye disorders  

 

 

Blurred vision, Sensations described as eye pain 

Visual field defect,

Swelling of eyelids,

Conjunctival hyperaemia, Non-arteritic anterior ischaemic optic neuropathy (NAION)2, Retinal vascular occlusion2 

Ear and labyrinth disorders 

 

 

Tinnitus 

Sudden hearing loss 

Cardiac disorders1 

 

 

Tachycardia, Palpitations 

Myocardial infarction,

Unstable angina pectoris2,

Ventricular arrhythmia2 

Vascular disorders 

 

Flushing 

Hypotension3,

Hypertension 

 

Respiratory, thoracic and mediastinal disorders 

 

 

Nasal congestion 

Dyspnoea, Epistaxis 

 

Gastrointestinal disorders  

 

 

Dyspepsia 

Abdominal pain,

Vomiting, Nausea, Gastro-oesophageal

reflux 

 

Skin and subcutaneous tissue disorders 

 

 

 

Rash 

Urticaria, StevensJohnson syndrome2,

Exfoliative dermatitis2,

Hyperhydrosis (sweating)

Musculoskeletal, connective tissue and bone disorders  

 

 

Back pain, Myalgia, Pain in extremity 

 

 

Renal and urinary disorders 

 

 

 

Haematuria 

 

Reproductive system and breast disorders  

 

 

 

Prolonged erections 

Priapism, Penile haemorrhage, Haematospermia 

General disorders and administration site conditions 

 

 

 

Chest pain1, Peripheral oedema, Fatigue 

Facial oedema2, Sudden cardiac death1,2 

(1)  Most of the patients had pre-existing cardiovascular risk factors.

(2)  Postmarketing surveillance reported adverse reactions not observed in placebo-controlled clinical trials.

(3)  More commonly reported when tadalafil is given to patients who are already taking antihypertensive medicinal products.

 

Description of selected adverse reactions

A slightly higher incidence of ECG abnormalities, primarily sinus bradycardia, has been reported in patients treated with tadalafil once a day as compared with placebo. Most of these ECG abnormalities were not associated with adverse reactions.

Other special populations

Data in patients over 65 years of age receiving tadalafil in clinical trials, either for the treatment of erectile dysfunction or the treatment of benign prostatic hyperplasia, are limited. In clinical trials with tadalafil taken on demand for the treatment of erectile dysfunction, diarrhoea was reported more frequently in patients over 65 years of age. In clinical trials with tadalafil 5 mg taken once a day for the treatment of benign prostatic hyperplasia, dizziness and diarrhoea Were reported more frequently in patients over 75 years of age.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions in the below mentioned. 

Saudi Arabia:

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

 o Other GCC States:

Please contact the relevant competent authority


Single doses of up to 500 mg have been given to healthy subjects, and multiple daily doses up to 100 mg have been given to patients. Adverse events were similar to those seen at lower doses.

In cases of overdose, standard supportive measures should be adopted, as required.

Haemodialysis contributes negligibly to tadalafil elimination.


Pharmacotherapeutic group: Urologicals, Drugs used in erectile dysfunction. ATC code: 

G04BE08.

 

Mechanism of action

 

Tadalafil is a selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). When sexual stimulation causes the local release of nitric oxide, inhibition of PDE5 by tadalafil produces increased levels of cGMP in the corpus cavernosum. This results in smooth muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection. Tadalafil has no effect in the treatment of erectile dysfunction in the absence of sexual stimulation.

Tadalafil 5 mg - The effect of PDE5 inhibition on cGMP concentration in the corpus cavernosum is also observed in the smooth muscle of the prostate, the bladder and their vascular supply. The resulting vascular relaxation increases blood perfusion which may be the mechanism by which symptoms of benign prostatic hyperplasia are reduced. These vascular effects may be complemented by inhibition of bladder afferent nerve activity and smooth muscle relaxation of the prostate and bladder.

Pharmacodynamic effects

Studies in vitro have shown that tadalafil is a selective inhibitor of PDE5. PDE5 is an enzyme found in corpus cavernosum smooth muscle, vascular and visceral smooth muscle, skeletal muscle, platelets, kidney, lung, and cerebellum. The effect of tadalafil is more potent on PDE5 than on other phosphodiesterases. Tadalafil is >10,000-fold more potent for PDE5 than for PDE1, PDE2, and PDE4 enzymes which are found in the heart, brain, blood vessels, liver, and other organs. Tadalafil is >10,000-fold more potent for PDE5 than for PDE3, an enzyme found in the heart and blood vessels. This selectivity for PDE5 over PDE3 is important because PDE3 is an enzyme involved in cardiac contractility. Additionally, tadalafil is approximately 700-fold more potent for PDE5 than for PDE6, an enzyme which is found in the retina and is responsible for phototransduction. Tadalafil is also >10,000-fold more potent for PDE5 than for PDE7 through PDE10.

Clinical efficacy and safety

Tadalafil administered to healthy subjects produced no significant difference compared to placebo in supine systolic and diastolic blood pressure (mean maximal decrease of 1.6/0.8mmHg, respectively), in standing systolic and diastolic blood pressure (mean maximal decrease of 0.2/4.6mmHg, respectively), and no significant change in heart rate.

In a study to assess the effects of tadalafil on vision, no impairment of colour discrimination (blue/green) was detected using the Farnsworth-Munsell 100-hue test. This finding is consistent with the low affinity of tadalafil for PDE6 compared to PDE5. Across all clinical studies, reports of changes in colour vision were rare (<0.1%).

Three studies were conducted in men to assess the potential effect on spermatogenesis of Tadalafil Tablets 10mg (one 6-month study) and 20mg (one 6-month and one 9-month study) administered daily. In two of these studies decreases were observed in sperm count and concentration related to tadalafil treatment of unlikely clinical relevance. These effects were not associated with changes in other parameters, such as motility, morphology, and FSH.

Erectile dysfunction

Three clinical studies were conducted in 1054 patients in an at-home setting to define the period of responsiveness to Tadalafil tablets on demand. Tadalafil demonstrated statistically significant improvement in erectile function and the ability to have successful sexual intercourse up to 36 hours following dosing, as well as patients' ability to attain and maintain erections for successful intercourse compared to placebo as early as 16 minutes following dosing.

In a 12-week study performed in 186 patients (142 tadalafil, 44 placebo) with erectile dysfunction secondary to spinal cord injury, tadalafil significantly improved the erectile function leading to a mean per-subject proportion of successful attempts in patients treated with tadalafil 10 or 20 mg (flexible-dose, on demand) of 48% as compared to 17% with placebo.

Tadalafil at doses of 2 to 100mg has been evaluated in 16 clinical studies involving 3250 patients, including patients with erectile dysfunction of various severities (mild, moderate, severe), etiologies, ages (range 21-86 years), and ethnicities. Most patients reported erectile dysfunction of at least 1 year in duration. In the primary efficacy studies of general populations, 81% of patients reported that Tadalafil Tablets l improved their erections as compared to 35% with placebo. Also, patients with erectile dysfunction in all severity categories reported improved erections whilst taking Tadalafil Tablets .(86%, 83%, and 72% for mild, moderate, and severe, respectively, as compared to 45%, 42%, and 19% with placebo). In the primary efficacy studies, 75% of intercourse attempts were successful in Tadalafil Tablets -treated patients as compared to 32% with placebo.

For once-a-day evaluation of tadalafil at doses of 2.5, 5, and 10 mg 3 clinical studies were initially conducted involving 853 patients of various ages (range 21-82 years) and ethnicities, with erectile dysfunction of various severities (mild, moderate, severe) and etiologies. In the two primary efficacy studies of general populations, the mean per-subject

proportion of successful intercourse attempts were 57 and 67% on  Tadalafil Tablets 5mg, 50% on Tadalafil Tablets 2.5mg as compared to 31 and 37% with placebo. In the study in patients with erectile dysfunction secondary to diabetes, the mean per subject proportion of successful attempts were 41 and 46% on Tadalafil Tablets 5mg and 2.5mg, respectively, as compared to 28% with placebo. Most patients in these three studies were responders to previous on-demand treatment with PDE5

Inhibitors. In a subsequent study, 217 patients who were treatment-naive to PDE5 inhibitors were randomised to Tadalafil Tablets 5mg once a day vs. placebo. The mean per-subject proportion of successful sexual intercourse attempts was 68% for Tadalafil Tablets patients compared to 52% for patients on placebo.

Benign prostatic hyperplasia

Tadalafil Tablets was studied in 4 clinical studies of 12 weeks duration enrolling over 1500 patients with signs and symptoms of benign prostatic hyperplasia. The improvement in the total international prostate symptom score with Tadalafil Tablets 5mg in the four studies were -4.8, 5.6, -6.1 and -6.3 compared to -2.2, -3.6, -3.8 and -4.2 with placebo. The improvements in total international prostate symptom score occurred as early as 1 week. In one of the studies, which also included

tamsulosin 0.4 mg as an active comparator, the improvement in total international prostate symptom score with Tadalafil Tablets 5mg, tamsulosin and placebo were -6.3, -5.7 and -4.2 respectively.

One of these studies assessed improvements in erectile dysfunction and signs and symptoms of benign prostatichyperplasia in patients with both conditions. The improvements in the erectile function domain of the international index of erectile function and the total international prostate symptom score in this study were 6.5 and -6.1 with Tadalafil Tablets 5 mg compared to 1.8 and 3.8 with placebo, respectively. The mean per-subject proportion of successful sexual intercourse attempts was 71.9% with Tadalafil Tablets 5 mg compared to 48.3% with placebo.

The maintenance of the effect was evaluated in an open-label extension to one of the studies, which showed that the improvement in total international prostate symptom score seen at 12 weeks was maintained for up to 1 additional year of treatment with Tadalafil Tablets 5mg.

Paediatric population

The European Medicines Agency has waived the obligation to submit the results of studies in all subsets of the paediatric population in the treatment of the erectile dysfunction for information on paediatric use.


Absorption

Tadalafil is readily absorbed after oral administration and the mean maximum observed plasma concentration (Cmax) is achieved at a median time of 2 hours after dosing. Absolute bioavailability of tadalafil following oral dosing has not been determined.

The rate and extent of absorption of Tadalafil are not influenced by food, thus Tadalafil Tablets may be taken with or without food. The time of dosing (morning versus evening) had no clinically relevant effects on the rate and extent of absorption.

Distribution

The mean volume of distribution is approximately 63 l, indicating that tadalafil is distributed into tissues. At therapeutic concentrations, 94% of tadalafil in plasma is bound to proteins. Protein binding is not affected by impaired renal function.

Less than 0.0005% of the administered dose appeared in the semen of healthy subjects.

Biotransformation

Tadalafil is predominantly metabolised by the cytochrome P450 (CYP) 3A4 isoform. The major circulating metabolite is the methylcatechol glucuronide. This metabolite is at least 13,000-fold less potent than tadalafil for PDE5.Consequently, it is not expected to be clinically active at observed metabolite concentrations.

Elimination

The mean oral clearance for tadalafil is 2.5 l/h and the mean half-life is 17.5 hours in healthy subjects. Tadalafil is excreted predominantly as inactive metabolites, mainly in the faeces (approximately 61% of the dose) and to a lesser extent in the urine (approximately 36% of the dose).

Linearity/Non-Linearity

Tadalafil pharmacokinetics in healthy subjects are linear with respect to time and dose. Over a dose range of 2.5 to 20 mg, exposure (AUC) increases proportionally with dose. Steady-state plasma concentrations are attained within 5 days of once daily dosing.

Pharmacokinetics determined with a population approach in patients with erectile dysfunction are similar to pharmacokinetics in subjects without erectile dysfunction.

Special Populations

Elderly

Healthy elderly subjects (65 years or over) had a lower oral clearance of tadalafil, resulting in 25% higher exposure (AUC) relative to healthy subjects aged 19 to 45 years. This effect of age is not clinically significant and does not warrant a dose adjustment.

Renal Insufficiency

In clinical pharmacology studies using single dose tadalafil (5 to 20mg), tadalafil exposure (AUC) approximately doubled in subjects with mild (creatinine clearance 51 to 80 ml/min) or moderate (creatinine clearance 31 to 50 ml/min) renal impairment and in subjects with end-stage renal disease on dialysis. In haemodialysis patients, Cmax was 41% higher than that observed in healthy subjects. Haemodialysis contributes negligibly to tadalafil elimination.

Hepatic Insufficiency

Tadalafil exposure (AUC) in subjects with mild and moderate hepatic impairment (Child-Pugh class A and B) is comparable to exposure in healthy subjects when a dose of 10 mg is administered. There is limited clinical data on the safety of Tadalafil Tablets in patients with severe hepatic insufficiency (Child-Pugh class C). If Tadalafil Tablets is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. There are no available data about the administration of once-a-day dosing of tadalafil to patients with hepatic impairment. If Tadalafil Tablets is prescribed once-a-day, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. There are no available data about the administration of doses higher than 10 mg of tadalafil to patients with hepatic impairment.

Patients with Diabetes

Tadalafil exposure (AUC) in patients with diabetes was approximately 19% lower than the AUC value for healthy subjects. This difference in exposure does not warrant a dose adjustment.

 


Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction.

There was no evidence of teratogenicity, embryo toxicity, or fetotoxicity in rats or mice that received up to 1000mg/kg/day tadalafil. In a rat prenatal and postnatal development study, the no observed effect dose was 30mg/kg/day. In the pregnant rat the AUC for calculated free drug at this dose was approximately 18-times the human AUC at a 20 mg dose.

There was no impairment of fertility in male and female rats. In dogs given tadalafil daily for 6 to 12 months at doses of 25 mg/kg/day (resulting in at least a 3-fold greater exposure [range 3.718.6] than seen in humans given a single 20 mg dose) and above, there was regression of the seminiferous tubular epithelium that resulted in a decrease in spermatogenesis in some dogs. 


Lactose monohydrate (Pharmatose 200M), Copovidone (Plasdone S630), Colloidal silicon dioxide ( Aerosil 200), Polyoxyl 40 hydrogenated castor oil ( Kolliphor RH 40), Lactose monohydrate ( Super Tab 11SD), Microcrystalline cellulose (Avicel PH 102), Croscarmellose sodium (Ac-di-sol), Magnesium Stearate (Ligamed MF-2-V), Purified Water.

 

Coating Materials used in the composition: Opadry II White 32K580001, Opadry II Blue 32K505046

 

Opadry II White 32K580001- Film coating composition: HPMC 2910/Hypromellose, Lactose monohydrate, Titanium Dioxide, Triacetin, Talc.

Opadry II Blue 32K505046 - Film coating composition: HPMC 2910/Hypromellose, Lactose monohydrate, Titanium Dioxide, Fd&C Blue #2/Indigo Carmine Aluminium Lake  Triacetin, Talc.


NA


2 Years

Store below 30ºC.


Clear PVC/PE/Aclar


NA


Saudi Hetero Lab Ltd. Aljameah Street, Malaz quarter, Riyadh 11441 Saudi Arabia Tel: +966 11 477 2215 Manufacture: Hetero Lab Limited Unit V, Hyderabad, India

03/07/2019.
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