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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)

SILAFIL contains the active substance Sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE 5) inhibitors. It works by helping to relax the blood vessels in your penis, allowing blood to flow into your penis when you get sexually excited. SILAFIL will only help you to get an erection if you are sexually stimulated.

SILAFIL is a treatment for adult men with erectile dysfunction, sometimes known as impotence. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity.


-If you are allergic to Sildenafil or any other ingredients of this medicine (listed in section 6).

-If you are taking medicines called nitrates, as the combination may lead to a dangerous fall in your blood pressure. Tell your doctor if you are taking any of these medicines which are often given for relief of angina pectoris (or "chest pain"). If you are not certain, ask your doctor or pharmacist.

-If you are using any of the medicines known as nitric oxide donors such as amyl nitrite ("poppers"), as the combination may also lead to a dangerous fall in your blood pressure. - -If you have a severe heart or liver problem.

-If you have recently had a stroke or a heart attack, or if you have low blood pressure.

-If you have certain rare inherited eye diseases (such as retinitis pigmentosa).

-If you have ever had loss of vision due to non-arteritic anterior ischaemic optic neuropathy (NAION).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking SILAFIL

-    If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), multiple myeloma (cancer of bone marrow).

-    If you have a deformity of your penis or Peyronie's Disease.

-If you have problems with your heart. Your doctor should carefully check whether your heart can take the additional strain of having sex.

-If you currently have a stomach ulcer, or a bleeding problems (such as haemophilia).

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

You should not use SILAFIL with any other oral or local treatments for erectile dysfunction.

You should not use SILAFIL with treatments for pulmonary arterial hypertension (PAH) containing Sildenafil or any other PDE5 inhibitors.

You should not take SILAFIL if you do not have erectile dysfunction.

You should not take SILAFIL if you are a woman.

Special considerations for patients with kidney or liver problems you should tell your doctor if you have kidney or liver problems. Your doctor may decide on a lower dose for you.

Children and adolescents

SILAFIL should not be given to individuals under the age of 18.

Other medicines and SILAFIL

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

SILAFIL tablets may interfere with some medicines, especially those used to treat chest pain. In the event of a medical emergency, you should tell your doctor, pharmacist or nurse that you have taken SILAFIL and when you did. Do not take SILAFIL with other medicines unless your doctor tells you that you can. You should not take SILAFIL if you are taking medicines called nitrates as the combination of these medicines may lead to a dangerous fall in your blood pressure. Always tell your doctor, pharmacist or nurse if you are taking any of these medicines that are often used for the relief of angina pectoris (or "chest pain"). You should not take SILAFIL if you are using any of the medicines known as nitric oxide donors such as amyl nitrite ("poppers") as the combination may also lead to a dangerous fall in your blood pressure.

If you are taking medicines known as protease inhibitors, such as for the treatment of HIV, your doctor may start you on the lowest dose (25 mg) of SILAFIL.

Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate enlargement may experience dizziness or light-headedness which may be caused by low blood pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms when taking SILAFIL with alpha-blockers. This is most likely to happen within 4 hours after taking SILAFIL. To reduce the chance that these symptoms might happen, you should be on a regular daily dose of your alpha-blocker before you start SILAFIL. Your doctor may start you on a lower dose (25 mg) of SILAFIL.

SILAFIL with food and drink and alcohol

SILAFIL can be taken with or without food. However, you may find that SILAFIL takes longer to start working if you take it with a heavy meal.

Drinking alcohol can temporarily impair your ability to get an erection. To get the maximum benefit from your medicine, you are advised not to drink excessive amounts of alcohol before taking SILAFIL.

Pregnancy, breast-feeding and fertility

SILAFIL is not indicated for use by women.

Driving and using machines

SILAFIL can cause dizziness and can affect vision. You should be aware of how you react to SILAFIL before you drive or use machinery.

SILAFIL contains lactose

If you have been told by your doctor that you have intolerance to some sugars, such as lactose, contact your doctor before taking SILAFIL.


Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended starting dose is 50 mg.

You should not take SILAFIL more than once a day.

You should take SILAFIL about one hour before you plan to have sex. Swallow the tablet whole with a glass of water.

If you feel that the effect of SILAFIL is too strong or too weak, talk to your doctor or pharmacist.

SILAFIL will only help you to get an erection if you are sexually stimulated. The amount of time SILAFIL takes to work varies from person to person, but it normally takes between half an hour and one hour. You may find that SILAFIL takes longer to work if you take it with a heavy meal.

If SILAFIL does not help you to get an erection or if your erection does not last long enough for you to complete sexual intercourse you should tell your doctor.

If you take more SILAFIL than you should:

You may experience an increase in side effects and their severity. Doses above 100 mg do not increase the efficacy.

You should not take more tablets than your doctor tells you to.

Contact your doctor if you take more tablets than you should.

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


Like all medicines, this medicine can cause side effects although not everybody gets them. The side effects reported in association with the use of SILAFIL are usually mild to moderate and of a short duration.

If you experience any of the following serious side effects stop taking SILAFIL and seek medical help immediately:

-An allergic reaction (this occurs rarely)

Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.

-Chest pains (this occurs uncommonly)

If this occurs during or after intercourse -Get in a semi-sitting position and try to relax.

-Do not use nitrates to treat your chest pain.

-Prolonged and sometimes painful erections (frequency unknown). If you have an erection which lasts for more than 4 hours, you should contact a doctor immediately.

-A sudden decrease or loss of vision (frequency unknown). -Serious skin reactions (frequency unknown).

Symptoms may include severe peeling and swelling of the skin, blistering of the mouth, genitals and around the eyes, fever. -Seizures or fits (frequency unknown).

Other side effects:

Very common (may affect more than 1 in 10 people) is headache.

Common (may affect up to 1 in 10 people): facial flushing, indigestion, effects on vision (including colour tinge to vision, light sensitivity, blurred vision or reduced sharpness of vision) stuffy nose and dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, bleeding at the back of the eye, bloodshot eyes/red eyes, eye irritation, eye pain, double vision, abnormal sensation in the eye, watery eyes, pounding heartbeat, rapid heartbeat, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, nausea, dry mouth, penile bleeding, presence of blood in semen and/or urine, chest pain and feeling tired.

Rare (may affect up to 1 in 1,000 people): high blood pressure, low blood pressure, fainting, stroke, heart attack, irregular heartbeat, nosebleed and sudden decrease or loss of hearing. Not known (frequency cannot be estimated from the available data):

Additional side effects reported from post-marketing experience:

Unstable angina (a heart condition), sudden death, temporary decreased blood flow to parts of the brain.

Most, but not all, of the men who experienced these side effects had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to SILAFIL.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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.


Keep this medicine out of the sight and reach of children. Store below 30°C.

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

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

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.


-The active substance is Sildenafil. Each tablet contains 50 mg of Sildenafil (as the citrate salt).

-The other ingredients are:

microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate, colloidal anhydrous silica & Opadry blue.


SILAFIL film-coated tablets are blue, with a rounded-diamond shape. PVC/Aluminium foil blisters in cartons of 4 tablets.

SAJA Pharmaceuticals

Saudi Arabian Japanese pharmaceutical company limited Jeddah - Saudi Arabia


June/2014
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

يحتوي سيلافيل على المادة الفعالة سيلدينافيل التي تنتمي إلى فئة أدوية، تُسمى مثبطات ثنائي إستراز الفوسفات من النوع ٥. وهو يعمل من خلال مساعدة الأوعية الدموية الموجودة في العضو الذكري على الاسترخاء، مما يسمح بتدفق الدم إليه عند الآثار ة الجنسية. يساعدك سيلافيل في الحصول على انتصاب فقط عند إثارتك جنسياً. يعد سيلافيل علاجاً للرجال البالغين الذين يعانون من اضطرابات الانتصاب،

والتي تعرف في بعض الحيان بالعنانة. وهذه حالة تحدث عندما لا يستطيع الرجل الحصول أو الحفاظ على عضو ذكري منتصب وصلب بشكل مناسب لممارسة النشاط الجنسي.

لا تتناول سيلافيل في الحالات الآتية

- إذا كنت تعاني من حساسية لسيلدينافيل أو لاي من المواد الأخرى في هذا الدواء (مذكورة في قسم٦).

- إذا كنت تتناول أدوية تسمى النترات، ذلك لأن الجمع بينها وبين هذا العقار قد يؤدي إلى انخفاض خطير في ضغط الدم. أخبر طبيبك إذا كنت تتناول أيا من الأدوية التي يتم وصفها عادة لتخفيف الذبحة الصدرية (أو "ألم الصدر"). إذا لم تكن متأكدا فاستشر الطبيب أو الصيدلي الخاص بك.

- إذا كنت تستخدم أي من الأدوية التي تسمى مانحات أكسيد النتريك مثل نترات الأميل ("بوبرز")، ذلك لأن الجمع بينها وبين هذا العقار قد يؤدي إلى انخفاض خطير في ضغط الدم.

- إذا كنت تعاني من مشكلة شديدة بالقلب أو الكبد.

- إذا كنت قد عانيت مؤخرا من سكتة دماغية أو نوبة قلبية، أو إذا كنت تعاني من انخفاض ضغط الدم.

- إذا كنت تعاني من بعض الامراض الوراثية النادرة بالعين (مثل التهاب الشبكية الصباغي).

- إذا كنت قد عانيت من فقدان الرؤية بسبب اعتلال العصب البصري اللاقفاري الامامي اللا شرياني.

تحذيرات واحتياطات

تحدث إلى طبيبك أو الصيدلي أو الممرض(ة) قبل تناول سيلافيل:

- إذا كنت تعاني من فقر الدم المنجلي (اضطراب في خلايا الدم الحمراء)، ابيضاض الدم (سرطان خلايا الدم)، ورم نقوي متعدد (سرطان النخاع العظمي).

- إذا كنت تعاني من تشوه في العضو الذكري أو داء بيروني.

- إذا كنت تعاني من مشاكل بالقلب. يجب أن يتأكد طبيبك بعناية مما إذا كان قلبك يمكنه تحمل الإجهاد الإضافي الناجم عن مارسة الجماع أم لا.

- إذا كنت تعاني حاليا من قرحة بالمعدة، أو مشاكل نزفية (مثل مرض الهيموفيليا).

- إذا كنت تعاني من ضعف أو فقدان مفاجئ للرؤية، فتوقف عن تناول سيلافيل واتصل بطبيبك فورا.

لا يجب أن تستخدم سيلافيل مع أية علاجات موضعية أو فموية أخرى تستخدم لعلاج اضطرابات الانتصاب.

لا يجب أن تستخدم سيلافيل مع علاجات ارتفاع ضغط دم الشرايين الرئوية التي تحتوي على سيلدينافيل أو أحد مثبطات ثنائي إستراز الفوسفات من النوع ٥ الأخرى.

لا يجب أن تتناول سيلافيل إذا لم تكن تعاني من اضطرابات بالانتصاب.

إذا كنت سيدة، فيجب ألا تتناولين سيلافيل.

اعتبارات خاصة للمرضى المصابين بمشاكل في الكبد أو الكلي

يجب أن تخبر طبيبك إذا كانت لديك مشاكل في الكلى أو الكبد. فقد يحدد لك طبيبك جرعة أقل.

الأطفال والمراهقون

لا يجب إعطاء سيلافيل لأشخاص ممن تقل أعمارهم عن 18 عاما.

تناول سيلافيل مع الأدوية الأخرى

يُرجى إبلاغ الطبيب أو الصيدلي الخاص بك إذا كنت تتناول أو تناولت مؤخرا أو قد تتناول أية أدوية أخرى.

قد يتداخل سيلافيل أقراص مع بعض الأدوية، خاصة تلك الأدوية التي تستخدم في علاج ألم الصدر. في حالات الطوارئ الطبية، يجب أن تخبر طبيبك أو الصيدلي أو الممرض(ة) بأنك تناولت سيلافيل وبالموعد الذي تناولته فيه. لا تتناول سيلافيل مع أدوية أخرى ما لم يخبرك طبيبك بأنه يمكنك ذلك.

لا يجب أن تتناول سيلافيل إذا كنت تتناول أدوية تسمى بالنترات لأن الجمع بينها وبين هذا العقار قد يؤدي إلى انخفاض خطير في ضغط الدم. أخبر طبيبك أو الصيدلي أو الممرض(ة) دائما إذا كنت تتناول أيا من الأدوية التي يتم استخدامها عادة لتخفيف الذبحة الصدرية (أو "ألم الصدر").

لا يجب أن تتناول سيلافيل إذا كنت تستخدم أيا من الأدوية التي تسمى مانحات أكسيد النتريك مثل نترات الأميل ("بوبرز") لأن الجمع بينها وبين هذا العقار قد يؤدي إلى انخفاض خطير في ضغط الدم.

إذا كنت تتناول أدوية تسمى مثبطات إنزيم البروتياز، مثل الأدوية التي تُستخدم لعلاج فيروس نقص المناعة البشري (الإيدز)، فقد يجعلك طبيبك تبدأ بأقل جرعة (25 ملج) من سيلافيل.

قد يعاني بعض المرضى الذين يتناولون علاج حاصر لمستقبلات ألفا لعلاج ارتفاع ضغط الدم أو تضخم البروستاتا من دوخة أو دوار قد يكونا ناجمين عن انخفاض ضغط الدم عند الجلوس أو الوقوف بسرعة. عانى بعض المرضى من هذه الإعراض عند تناول سيلافيل مع حاصرات مستقبلات ألفا. من الوارد جداً أن يحدث ذلك في خلال ٤ ساعات بعد تناول سيلافيل. لتقليل احتمالية حدوث هذه الإعراض، يجب أن تتناول جرعة يومية منتظمة من حاصرات مستقبلات ألفا قبل البدء في تناول سيلافيل. قد يجعلك طبيبك تبدأ بأقل جرعة (25 ملج) من سيلافيل.

تناول سيلافيل مع الأطعمة والمشروبات والكحوليات

يكن تناول سيلافيل مع الطعام أو بدونه. ومع ذلك، قد تلاحظ أن سيلافيل يستغرق وقتا أطول ليبدأ مفعوله في حالة تناوله مع وجبة دسمة.

يمكن لتناول الكحوليات أن يؤدي إلى قصور مؤقت في قدرتك على الوصول إلى الانتصاب. للحصول على الفائدة القصوى من الدواء، يوصى بعدم الإفراط في تناول الكحوليات قبل تناول سيلافيل.

الحمل والرضاعة الطبيعية والخصوبة

لا يشار باستخدام سيلافيل من قبل النساء.

القيادة واستخدام الآلات.

يمكن أن يؤدي تناول سيلافيل إلى حدوث دوخة ويمكن أن يؤثر على الرؤية. يجب أن تكون على دراية بالكيفية التي يؤثر بها سيلافيل عليك قبل أن تمارس القيادة أو تستخدم الآلات.

يحتوي سيلافيل على لاكتوز

إذا كان طبيبك قد أخبرك بأنك لا تتحمل بعض أنواع السكريات، مثل لاكتوز، فاتصل به قبل تناول سيلافيل.

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تناول دائما هذا الدواء بالضبط كما أخبرك الطبيب أو الصيدلي الخاص بك.

يرجى مراجعة الطبيب أو الصيدلي إذا لم تكن متأكدا من كيفية التناول.

جرعة البدء الموصى بها هي 50 ملج.

لا يجب أن تتناول سيلافيل أكثر من مرة واحدة في اليوم.

يجب أن تتناول سيلافيل قبل شروعك في ممارسة الجماع بساعة واحدة تقريباً.

ابتلع الأقراص كاملة مع كوب من الماء.

إذا شعرت أن تأثير سيلافيل أقوى من اللازم أو أقل من اللازم، فاتصل بطبيبك أو بالصيدلي.

يساعدك سيلافيل في الحصول على انتصاب فقط عند إثارتك جنسيا.

يختلف الوقت اللازم ليظهر تأثير سيلافيل من شخص لأخر، ولكنه يتراوح عادة بين نصف ساعة وساعة. قد تلاحظ أن سيلافيل يستغرق وقتا أطول ليبدأ مفعوله في حالة تناوله مع وجبة دسمة.

إذا لم يساعدك سيلافيل في الحصول على انتصاب أو إذا كان الانتصاب لا يستمر لوقت طويل بما يكفي لإكمال عملية الجماع فيجب إبلاغ طبيبك.

إذا تناولت كمية من سيلافيل أكثر ما يجب:

قد تعاني من زيادة في الآثار  الجانبية وشدتها. لا تزيد الجرعات الأكبر من 100ملج من فعالية الدواء.

يجب عليك ألا تتناول كمية من الأقراص أكثر من التي وصفها لك طبيبك.

اتصل بطبيبك إذا تناولت كمية من الأقراص أكثر ما يجب.

إذا كانت لديك أية أسئلة إضافية حول استخدام هذا الدواء، فاستشر طبيبك أو الصيدلي أو الممرض(ة)

مثله مثل كافة الأدوية، قد يسبب هذا الدواء آثارا جانبية، على الرغم من عدم حدوثها لدى الجميع. تعد الآثار  الجانبية الناجمة عن استخدام سيلافيل والتي تم الإبلاغ عنها خفيفة إلى متوسطة عادة وتستمر لفترة قصيرة.

إذا كنت تعاني من أي من الآثار  الجانبية الخطيرة التالية فتوقف عن تناول سيلافيل وأسعى في الحصول على مساعدة طبية على الفور:

- تفاعل حساسية (نادرا ًما يحدث ذلك)

تتضمن الإعراض أزيز مفاجئ بالصدر، صعوبة في التنفس أو دوخة، تورم الجفون أو الوجه أو الشفتين أو الحلق.

- ألم في الصدر (غير شائع الحدوث)

إذا حدث ذلك أثناء الجماع أو بعده

- اتخذ وضع نصف جلسة وحاول أن تسترخي.

- لا تستخدم النترات لعلاج ألم الصدر.

- انتصاب يستمر لفترات طويلة ويكون مؤلما في بعض الحيان (معدل التكرار غير معروف). إذا استمر الانتصاب لاكثر من ٤ ساعات، فيجب أن تتصل بالطبيب فورا.

- قصور أو فقدان مفاجئ للرؤية (معدل التكرار غير معروف).

- تفاعلت جلدية خطيرة (معدل التكرار غير معروف).

قد تتضمن الأعراض تقشر الجلد وتورمه بشدة، ظهور نفطات على الفم والأعضاء التناسلية وحول العين، حمى.

- نوبات تشنج أو صرع (معدل التكرار غير معروف).

آثار جانبية أخرى:

شائعة جدا (قد تؤثر على أكثر من ١ من كل 10 أشخاص).

شائعة (قد تؤثر على ما يصل إلى شخص واحد من كل 10 أشخاص): احمرار الوجه، عسر الهضم، تأثيرات على الرؤية (با في ذلك تلون الرؤية، حساسية للضوء، عدم وضوح الرؤية أو انخفاض حدة الإبصار)، انسداد الأنف ودوخة.

غير شائعة (قد تؤثر على ما يصل إلى شخص واحد من كل 100 شخص):

قيء، طفح جلدي، نزيف بمؤخرة العين، تجمع الدم بالعينين/احمرار العينين، تهيج العين، ألم في العين، ازدواج الرؤية، إحساس غير طبيعي في العين، إدماع العينين، ضربات قلب قوية، تسارع ضربات القلب، ألم عضلي، شعور بالنعاس،

انخفاض حاسة اللمس، دوار، طنين في الاذنين، غثيان، جفاف الفم، نزيف من القضيب، وجود دم في السائل المنوى و/أو البول، ألم في الصدر وشعور بالتعب.

نادرة (قد تؤثر على ما يصل إلى شخص واحد من كل 1000 شخص): ارتفاع ضغط الدم، انخفاض ضغط الدم، إغماء، سكتة دماغية، نوبة قلبية، عدم انتظام ضربات القلب، نزيف الأنف وانخفاض أو فقدان مفاجئ في حاسة السمع.

غير معروفة (لا يمكن تقدير معدل التكرار من واقع البيانات المتاحة):

الآثار  الجانبية الإضافية التي تم الإبلاغ عنها من خلال خبرة ما بعد التسويق:

ذبحة صدرية غير مستقرة (حالة قلبية)، موت مفاجئ، انخفاض مؤقت في تدفق الدم إلى أجزاء الخ.

كان معظم، وليس جميع الرجال الذين عانوا من هذه الآثار  الجانبية يعانون من مشاكل بالقلب قبل تناول هذا الدواء. لا يمكن معرفة ما إذا كانت هذه الأعراض مرتبطة بشكل مباشر بسيلافيل أم لا.

الإبلاغ عن الآثار  الجانبية

إذا أصبت بأية آثار جانبية، فتحدث إلى طبيبك أو الصيدلي أو الممرض(ة).

ويشمل ذلك أية آثار جانبية محتملة غير مدرجة في هذه النشرة. يكنك أيضا أن تبلغ عن الآثار  الجانبية بشكل مباشر (انظر التفاصيل الواردة أدناه).

من خلال إبلاغك عن الآثار الجانبية، يمكنك المساعدة في توفير معلومات إضافية حول أمان استخدام هذا الدواء.

يحفظ هذا الدواء بعيدا عن رؤية ومتناول الطفال.

يُحفظ في درجة حرارة أقل من 30 درجة مئوية.

لا تستعمل هذا الدواء بعد تاريخ انتهاء الصالحية المدون على العبوة والشريط بعد كلمة "EXP". يشير تاريخ انتهاء الصالحية إلى اليوم الأخير من الشهر.

يجب حفظ الدواء في العبوة الأصلية لحمايته من الرطوبة.

لا تتخلص من الأدوية عن طريق إلقائها في مياه الصرف أو مع المخلفات المنزلية.

استشر الصيدلي الخاص بك عن كيفية التخلص من الأدوية التي لم تعد تستخدمها. ستساعد هذه الإجراءات في الحفاظ على البيئة.

- المادة الفعالة هي سيلدينافيل. يحتوي كل قرص على 50 ملج سيلدينافيل (في هيئة ملح سيترات).

- المكونات الأخرى هي:

سليلوز دقيق التبلور، فوسفات هيدروجين الكالسيوم (لا مائي)، كروسكارميلوز الصوديوم، ستيرات الماغنسيوم، سيليكا غروية لا مائية

وأوبادري أزرق.

أقراص سيلافيل هي أقراص مغلفة ذات لون أزرق، وشكل ماسة دائرية. يتوفر في أشرطة من ألومينيوم/بولي فينيل الكلوريد في عبوات بها ٤ أقراص.

مصنع ساجا للصناعات الدوائية

الشركة العربية السعودية اليابانية للمنتجات الصيدلانية المحدودة

جدة – المملكة العربية السعودية

يونيو / 2014
 Read this leaflet carefully before you start using this product as it contains important information for you

SILAFIL 50 mg film-coated tablets

Each tablet contains sildenafil citrate equivalent to 50 mg of sildenafil. Excipient with known effect: Each tablet contains 6.0 mg magnesium stearate For the full list of excipients, see section 6.1.

Film-coated tablet. 50 mg: Blue rounded diamond-shaped tablets, marked “Silafil”.

SILAFIL is indicated in adult men with erectile dysfunction, which is the inability to achieve or
maintain a penile erection sufficient for satisfactory sexual performance.
In order for SILAFIL to be effective, sexual stimulation is required.
 


Posology
Use in adults
The recommended dose is 50 mg taken as needed approximately one hour before sexual activity.
Based on efficacy and tolerability, the dose may be increased to 100 mg or decreased to 25 mg.
The maximum recommended dose is 100 mg. The maximum recommended dosing frequency is
once per day. If SILAFIL is taken with food, the onset of activity may be delayed compared to
the fasted state (see section 5.2).
Special populations
Elderly patients
Dosage adjustments are not required in elderly patients (≥ 65 years old).
Patients with renal impairment
The dosing recommendations described in “Use in adults” apply to patients with mild to
moderate renal impairment (creatinine clearance = 30-80 mL/min).
Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine
clearance < 30 mL/min) a 25 mg dose should be considered. Based on efficacy and tolerability,
the dose may be increased step-wise to 50mg up to 100 mg as necessary.
Patients with hepatic impairment
Since sildenafil clearance is reduced in patients with hepatic impairment (e.g. cirrhosis) a 25 mg
dose should be considered. Based on efficacy and tolerability, the dose may be increased stepwise to 50 mg up to 100 mg as necessary.
Paediatric population
SILAFIL is not indicated for individuals below 18 years of age.
Use in patients taking other medicinal products
With the exception of ritonavir for which co-administration with sildenafil is not advised (see
Section 4.4) a starting dose of 25mg should be considered in patients receiving concomitant
treatment with CYP3A4 inhibitors (see section 4.5).
In order to minimise the potential of developing postural hypotension in patients receiving alphablocker treatment patients should be stabilised on alpha-blocker therapy prior to initiating
sildenafil treatment. In addition, initiation of sildenafil at a dose of 25mg should be considered
(see sections 4.4 and 4.5).
Method of administration
For oral use.
 


Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Consistent with its known effects on the nitric oxide/cyclic guanosine monophosphate (cGMP) pathway (see section 5.1), sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors (such as amyl nitrite) or nitrates in any form is therefore contraindicated. Agents for the treatment of erectile dysfunction, including sildenafil, should not be used in men for whom sexual activity is inadvisable (e.g. patients with severe cardiovascular disorders such as unstable angina or severe cardiac failure). SILAFIL is contraindicated in patients who have loss of vision in one eye because of nonarteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4). The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: severe hepatic impairment, hypotension (blood pressure < 90/50mmHg), recent history of stroke or myocardial infarction and known hereditary degenerative retinal disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).

A medical history and physical examination should be undertaken to diagnose erectile
dysfunction and determine potential underlying causes, before pharmacological treatment is
considered.
Cardiovascular risk factors
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. Sildenafil has vasodilator properties, resulting in mild and transient decreases in
blood pressure (see section 5.1). Prior to prescribing sildenafil, physicians should carefully
consider whether their patients with certain underlying conditions could be adversely affected by
such vasodilatory effects, especially in combination with sexual activity. Patients with increased
susceptibility to vasodilators include those with left ventricular outflow obstruction (e.g., aortic
stenosis, hypertrophic obstructive cardiomyopathy), or those with the rare syndrome of multiple
system atrophy manifesting as severely impaired autonomic control of blood pressure.
SILAFIL potentiates the hypotensive effect of nitrates (see section 4.3).
Serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac
death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack,
hypertension and hypotension have been reported post-marketing in temporal association with
the use of SILAFIL. Most, but not all, of these patients had pre-existing cardiovascular risk
factors. Many events were reported to occur during or shortly after sexual intercourse and a few
were reported to occur shortly after the use of SILAFIL without sexual activity. It is not possible
to determine whether these events are related directly to these factors or to other factors.
Priapism
Agents for the treatment of erectile dysfunction, including sildenafil, 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).
Prolonged erections and priapism have been reported with sildenafil in post-marketing
experience. In the event of an erection that persists for longer than 4 hours, the patient should
seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage
and permanent loss of potency could result.
Concomitant use with other PDE5 inhibitors or other treatments for erectile dysfunction
The safety and efficacy of combinations of sildenafil with other PDE5 inhibitors, or other
pulmonary arterial hypertension (PAH) treatments containing sildenafil (REVATIO), or other
treatments for erectile dysfunction have not been studied. Therefore the use of such combinations
is not recommended.
Effects on vision
Cases of visual defects have been reported spontaneously in connection with the intake of
sildenafil and other PDE5 inhibitors (see section 4.8). Cases of non-arteritic anterior ischaemic
optic neuropathy, a rare condition, have been reported spontaneously and in an observational
study in connection with the intake of sildenafil and other PDE5 inhibitors (see section 4.8).
Patients should be advised that in the event of any sudden visual defect, they should stop taking
SILAFIL and consult a physician immediately (see section 4.3).
Concomitant use with ritonavir
Co-administration of sildenafil with ritonavir is not advised (see section 4.5).
Concomitant use with alpha-blockers
Caution is advised when sildenafil is administered to patients taking an alpha-blocker, as the coadministration may lead to symptomatic hypotension in a few susceptible individuals (see
section 4.5). This is most likely to occur within 4 hours post sildenafil dosing. In order to
minimise the potential for developing postural hypotension, patients should be hemodynamically
stable on alpha-blocker therapy prior to initiating sildenafil treatment. Initiation of sildenafil at a
dose of 25 mg should be considered (see section 4.2). In addition, physicians should advise
patients what to do in the event of postural hypotensive symptoms.
Effect on bleeding
Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of
sodium nitroprusside in vitro. There is no safety information on the administration of sildenafil
to patients with bleeding disorders or active peptic ulceration. Therefore sildenafil should be
administered to these patients only after careful benefit-risk assessment.
The film coating of the tablet contains lactose. SILAFIL should not be administered to men with
rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose
malabsorption.
Women
SILAFIL is not indicated for use by women.
 


Effects of other medicinal products on sildenafil
In vitro studies
Sildenafil metabolism is principally mediated by the cytochrome P450 (CYP) isoforms 3A4
(major route) and 2C9 (minor route). Therefore, inhibitors of these isoenzymes may reduce
sildenafil clearance and inducers of these isoenzymes may increase sildenafil clearance.
In vivo studies
Population pharmacokinetic analysis of clinical trial data indicated a reduction in sildenafil
clearance when co-administered with CYP3A4 inhibitors (such as ketoconazole, erythromycin,
cimetidine). Although no increased incidence of adverse events was observed in these patients,
when sildenafil is administered concomitantly with CYP3A4 inhibitors, a starting dose of 25 mg
should be considered.
Co-administration of the HIV protease inhibitor ritonavir, which is a highly potent P450
inhibitor, at steady state (500 mg twice daily) with sildenafil (100 mg single dose) resulted in a
300% (4-fold) increase in sildenafil Cmax and a 1,000% (11-fold) increase in sildenafil plasma
AUC. At 24 hours, the plasma levels of sildenafil were still approximately 200ng/mL, compared
to approximately 5ng/mL when sildenafil was administered alone. This is consistent with
ritonavir's marked effects on a broad range of P450 substrates. Sildenafil had no effect on
ritonavir pharmacokinetics. Based on these pharmacokinetic results co-administration of
sildenafil with ritonavir is not advised (see section 4.4) and in any event the maximum dose of
sildenafil should under no circumstances exceed 25 mg within 48 hours.
Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state
(1200 mg three times a day) with sildenafil (100 mg single dose) resulted in a 140% increase in
sildenafil Cmax and a 210% increase in sildenafil AUC. Sildenafil had no effect on saquinavir
pharmacokinetics (see section 4.2). Stronger CYP3A4 inhibitors such as ketoconazole and
itraconazole would be expected to have greater effects.
When a single 100 mg dose of sildenafil was administered with erythromycin, a moderate
CYP3A4 inhibitor, at steady state (500 mg twice daily for 5 days), there was a 182% increase in
sildenafil systemic exposure (AUC). In normal healthy male volunteers, there was no evidence
of an effect of azithromycin (500 mg daily for 3 days) on the AUC, Cmax, tmax, elimination rate
constant, or subsequent half-life of sildenafil or its principal circulating metabolite. Cimetidine
(800 mg), a cytochrome P450 inhibitor and non-specific CYP3A4 inhibitor, caused a 56%
increase in plasma sildenafil concentrations when co-administered with sildenafil (50 mg) to
healthy volunteers.
Grapefruit juice is a weak inhibitor of CYP3A4 gut wall metabolism and may give rise to modest
increases in plasma levels of sildenafil.
Single doses of antacid (magnesium hydroxide/aluminium hydroxide) did not affect the
bioavailability of sildenafil.
Although specific interaction studies were not conducted for all medicinal products, population
pharmacokinetic analysis showed no effect of concomitant treatment on sildenafil
pharmacokinetics when grouped as CYP2C9 inhibitors (such as tolbutamide, warfarin,
phenytoin), CYP2D6 inhibitors (such as selective serotonin reuptake inhibitors, tricyclic
antidepressants), thiazide and related diuretics, loop and potassium sparing diuretics, angiotensin
converting enzyme inhibitors, calcium channel blockers, beta-adrenoreceptor antagonists or
inducers of CYP450 metabolism (such as rifampicin, barbiturates). In a study of healthy male
volunteers, co-administration of the endothelin antagonist, bosentan, (an inducer of CYP3A4
[moderate], CYP2C9 and possibly of CYP2C19) at steady state (125 mg twice a day) with
sildenafil at steady state (80 mg three times a day) resulted in 62.6% and 55.4% decrease in
sildenafil AUC and Cmax, respectively. Therefore, concomitant administration of strong CYP3A4
inducers, such as rifampin, is expected to cause greater decreases in plasma concentrations of
sildenafil.
Nicorandil is a hybrid of potassium channel activator and nitrate. Due to the nitrate component it
has the potential to result in a serious interaction with sildenafil.
Effects of sildenafil on other medicinal products
In vitro studies
Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and
3A4 (IC50 >150 μM). Given sildenafil peak plasma concentrations of approximately 1 μM after
recommended doses, it is unlikely that SILAFIL will alter the clearance of substrates of these
isoenzymes.
There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors
such as theophylline or dipyridamole.
In vivo studies
Consistent with its known effects on the nitric oxide/cGMP pathway (see section 5.1), sildenafil
was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric
oxide donors or nitrates in any form is therefore contraindicated (see section 4.3).
Concomitant administration of sildenafil to patients taking alpha-blocker therapy may lead to
symptomatic hypotension in a few susceptible individuals. This is most likely to occur within 4
hours post sildenafil dosing (see sections 4.2 and 4.4). In three specific drug-drug interaction
studies, the alpha-blocker doxazosin (4 mg and 8 mg) and sildenafil (25 mg, 50 mg, or 100 mg)
were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized
on doxazosin therapy. In these study populations, mean additional reductions of supine blood
pressure of 7/7 mmHg, 9/5 mmHg, and 8/4 mmHg, and mean additional reductions of standing
blood pressure of 6/6 mmHg, 11/4 mmHg, and 4/5 mmHg, respectively, were observed. When
sildenafil and doxazosin were administered simultaneously to patients stabilized on doxazosin
therapy, there were infrequent reports of patients who experienced symptomatic postural
hypotension. These reports included dizziness and light-headedness, but not syncope.
No significant interactions were shown when sildenafil (50 mg) was co-administered with
tolbutamide (250 mg) or warfarin (40 mg), both of which are metabolised by CYP2C9.
Sildenafil (50 mg) did not potentiate the increase in bleeding time caused by acetyl salicylic acid
(150 mg).
Sildenafil (50 mg) did not potentiate the hypotensive effects of alcohol in healthy volunteers with
mean maximum blood alcohol levels of 80 mg/dl.
Pooling of the following classes of antihypertensive medication; diuretics, beta-blockers, ACE
inhibitors, angiotensin II antagonists, antihypertensive medicinal products (vasodilator and
centrally-acting), adrenergic neurone blockers, calcium channel blockers and alpha-adrenoceptor
blockers, showed no difference in the side effect profile in patients taking sildenafil compared to
placebo treatment. In a specific interaction study, where sildenafil (100 mg) was co-administered
with amlodipine in hypertensive patients, there was an additional reduction on supine systolic
blood pressure of 8 mmHg. The corresponding additional reduction in supine diastolic blood
pressure was 7 mmHg. These additional blood pressure reductions were of a similar magnitude
to those seen when sildenafil was administered alone to healthy volunteers (see section 5.1).
 


SILAFIL is not indicated for use by women.
There are no adequate and well-controlled studies in pregnant or breast-feeding women.
No relevant adverse effects were found in reproduction studies in rats and rabbits following oral
administration of sildenafil.
There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil
in healthy volunteers (see section 5.1).
 


No studies on the effects on the ability to drive and use machines have been performed.
As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be
aware of how they react to SILAFIL, before driving or operating machinery.
 


Summary of the safety profile
The safety profile of SILAFIL is based on 8691 patients who received the recommended dosing
regimen in 67 placebo-controlled clinical studies. The most commonly reported adverse
reactions in clinical studies among sildenafil treated patients were headache, flushing, dyspepsia,
visual disorders, nasal congestion, dizziness and visual colour distortion.
Adverse reactions from post-marketing surveillance has been gathered covering an estimated
period >9 years. Because not all adverse reactions are reported to the Marketing Authorisation
Holder and included in the safety database, the frequencies of these reactions cannot be reliably
determined.
Tabulated list of adverse reactions
In the table below all medically important adverse reactions, which occurred in clinical trials at
an incidence greater than placebo are listed by system organ 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).
In addition, the frequency of medically important adverse reactions reported from post-marketing
experience is included as not known.
Within each frequency grouping, undesirable effects are presented in order of decreasing
seriousness.


In single dose volunteer studies of doses up to 800 mg, adverse reactions were similar to those
seen at lower doses, but the incidence rates and severities were increased. Doses of 200 mg did
not result in increased efficacy but the incidence of adverse reactions (headache, flushing,
dizziness, dyspepsia, nasal congestion, altered vision) was increased.
In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis
is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not
eliminated in the urine.
 


Pharmacotherapeutic group: Urologicals; Drugs used in erectile dysfunction. ATC Code: G04B
E03.
Mechanism of action
Sildenafil is an oral therapy for erectile dysfunction. In the natural setting, i.e. with sexual
stimulation, it restores impaired erectile function by increasing blood flow to the penis.
The physiological mechanism responsible for erection of the penis involves the release of nitric
oxide (NO) in the corpus cavernosum during sexual stimulation. Nitric oxide then activates the
enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate
(cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of
blood.
Sildenafil is a potent and selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5)
in the corpus cavernosum, where PDE5 is responsible for degradation of cGMP. Sildenafil has a
peripheral site of action on erections. Sildenafil has no direct relaxant effect on isolated human
corpus cavernosum but potently enhances the relaxant effect of NO on this tissue. When the
NO/cGMP pathway is activated, as occurs with sexual stimulation, inhibition of PDE5 by
sildenafil results in increased corpus cavernosum levels of cGMP. Therefore sexual stimulation
is required in order for sildenafil to produce its intended beneficial pharmacological effects.
Pharmacodynamic effects
Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the
erection process. Its effect is more potent on PDE5 than on other known phosphodiesterases.
There is a 10-fold selectivity over PDE6 which is involved in the phototransduction pathway in
the retina. At maximum recommended doses, there is an 80-fold selectivity over PDE1, and over
700-fold over PDE 2, 3, 4, 7, 8, 9, 10 and 11. In particular, sildenafil has greater than 4,000-fold
selectivity for PDE5 over PDE3, the cAMP-specific phosphodiesterase isoform involved in the
control of cardiac contractility.
Clinical efficacy and safety
Two clinical studies were specifically designed to assess the time window after dosing during
which sildenafil could produce an erection in response to sexual stimulation. In a penile
plethysmography (RigiScan) study of fasted patients, the median time to onset for those who
obtained erections of 60% rigidity (sufficient for sexual intercourse) was 25 minutes (range 12-
37 minutes) on sildenafil. In a separate RigiScan study, sildenafil was still able to produce an
erection in response to sexual stimulation 4-5 hours post-dose.
Sildenafil causes mild and transient decreases in blood pressure which, in the majority of cases,
do not translate into clinical effects. The mean maximum decreases in supine systolic blood
pressure following 100 mg oral dosing of sildenafil was 8.4 mmHg. The corresponding change in
supine diastolic blood pressure was 5.5 mmHg. These decreases in blood pressure are consistent
with the vasodilatory effects of sildenafil, probably due to increased cGMP levels in vascular
smooth muscle. Single oral doses of sildenafil up to 100 mg in healthy volunteers produced no
clinically relevant effects on ECG.
In a study of the hemodynamic effects of a single oral 100 mg dose of sildenafil in 14 patients
with severe coronary artery disease (CAD) (>70% stenosis of at least one coronary artery), the
mean resting systolic and diastolic blood pressures decreased by 7% and 6% respectively
compared to baseline. Mean pulmonary systolic blood pressure decreased by 9%. Sildenafil
showed no effect on cardiac output, and did not impair blood flow through the stenosed coronary
arteries.
A double-blind, placebo-controlled exercise stress trial evaluated 144 patients with erectile
dysfunction and chronic stable angina who regularly received anti-anginal medicinal products
(except nitrates). The results demonstrated no clinically relevant differences between sildenafil
and placebo in time to limiting angina.
Mild and transient differences in colour discrimination (blue/green) were detected in some
subjects using the Farnsworth-Munsell 100 hue test at 1 hour following a 100 mg dose, with no
effects evident after 2 hours post-dose. The postulated mechanism for this change in colour
discrimination is related to inhibition of PDE6, which is involved in the phototransduction
cascade of the retina. Sildenafil has no effect on visual acuity or contrast sensitivity. In a small
size placebo-controlled study of patients with documented early age-related macular
degeneration (n=9), sildenafil (single dose, 100 mg) demonstrated no significant changes in the
visual tests conducted (visual acuity, Amsler grid, colour discrimination simulated traffic light,
Humphrey perimeter and photostress).
There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil
in healthy volunteers (see section 4.6).
Further information on clinical trials
In clinical trials sildenafil was administered to more than 8000 patients aged 19-87. The
following patient groups were represented: elderly (19.9%), patients with hypertension (30.9%),
diabetes mellitus (20.3%), ischaemic heart disease (5.8%), hyperlipidaemia (19.8%), spinal cord
injury (0.6%), depression (5.2%), transurethral resection of the prostate (3.7%), radical
prostatectomy (3.3%). The following groups were not well represented or excluded from clinical
trials: patients with pelvic surgery, patients post-radiotherapy, patients with severe renal or
hepatic impairment and patients with certain cardiovascular conditions (see section 4.3).
In fixed dose studies, the proportions of patients reporting that treatment improved their erections
were 62% (25 mg), 74% (50 mg) and 82% (100 mg) compared to 25% on placebo. In controlled
clinical trials, the discontinuation rate due to sildenafil was low and similar to placebo.
Across all trials, the proportion of patients reporting improvement on sildenafil were as follows:
psychogenic erectile dysfunction (84%), mixed erectile dysfunction (77%), organic erectile
dysfunction (68%), elderly (67%), diabetes mellitus (59%), ischaemic heart disease (69%),
hypertension (68%), TURP (61%), radical prostatectomy (43%), spinal cord injury (83%),
depression (75%). The safety and efficacy of sildenafil was maintained in long term studies.
Paediatric population
The European Medicines Agency has waived the obligation to submit the results of studies with
SILAFIL in all subsets of the paediatric population for the treatment of erectile dysfunction. See
section 4.2 for information on paediatric use.
 


Absorption
Sildenafil is rapidly absorbed. Maximum observed plasma concentrations are reached within 30
to 120 minutes (median 60 minutes) of oral dosing in the fasted state. The mean absolute oral
bioavailability is 41% (range 25-63%). After oral dosing of sildenafil AUC and Cmax increase in
proportion with dose over the recommended dose range (25-100 mg).
When sildenafil is taken with food, the rate of absorption is reduced with a mean delay in tmax of
60 minutes and a mean reduction in Cmax of 29%.
Distribution
The mean steady state volume of distribution (Vd) for sildenafil is 105 l, indicating distribution
into the tissues. After a single oral dose of 100 mg, the mean maximum total plasma
concentration of sildenafil is approximately 440 ng/mL (CV 40%). Since sildenafil (and its major
circulating N-desmethyl metabolite) is 96% bound to plasma proteins, this results in the mean
maximum free plasma concentration for sildenafil of 18 ng/mL (38 nM). Protein binding is
independent of total drug concentrations.
In healthy volunteers receiving sildenafil (100 mg single dose), less than 0.0002% (average 188
ng) of the administered dose was present in ejaculate 90 minutes after dosing.
Biotransformation
Sildenafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route)
hepatic microsomal isoenzymes. The major circulating metabolite results from N-demethylation
of sildenafil. This metabolite has a phosphodiesterase selectivity profile similar to sildenafil and
an in vitro potency for PDE5 approximately 50% that of the parent drug. Plasma concentrations
of this metabolite are approximately 40% of those seen for sildenafil. The N-desmethyl
metabolite is further metabolised, with a terminal half life of approximately 4 h.
Elimination
The total body clearance of sildenafil is 41 L/h with a resultant terminal phase half life of 3-5 h.
After either oral or intravenous administration, sildenafil is excreted as metabolites
predominantly in the faeces (approximately 80% of administered oral dose) and to a lesser extent
in the urine (approximately 13% of administered oral dose).
Pharmacokinetics in special patient groups
Elderly
Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in
approximately 90% higher plasma concentrations of sildenafil and the active N-desmethyl
metabolite compared to those seen in healthy younger volunteers (18-45 years). Due to agedifferences in plasma protein binding, the corresponding increase in free sildenafil plasma
concentration was approximately 40%.
Renal insufficiency
In volunteers with mild to moderate renal impairment (creatinine clearance = 30-80 mL/min), the
pharmacokinetics of sildenafil were not altered after receiving a 50 mg single oral dose. The
mean AUC and Cmax of the N-desmethyl metabolite increased 126% and 73% respectively,
compared to age-matched volunteers with no renal impairment. However, due to high intersubject variability, these differences were not statistically significant. In volunteers with severe
renal impairment (creatinine clearance < 30 mL/min), sildenafil clearance was reduced, resulting
in mean increases in AUC and Cmax of 100% and 88% respectively compared to age-matched
volunteers with no renal impairment. In addition, N-desmethyl metabolite AUC and Cmax values
were significantly increased 79% and 200% respectively.
Hepatic insufficiency
In volunteers with mild to moderate hepatic cirrhosis (Child-Pugh A and B) sildenafil clearance
was reduced, resulting in increases in AUC (84%) and Cmax (47%) compared to age-matched
volunteers with no hepatic impairment. The pharmacokinetics of sildenafil in patients with
severely impaired hepatic function has not been studied.
 


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


Microcrystalline cellulose
Calcium hydrogen phosphate (anhydrous)
Croscarmellose sodium
Magnesium stearate
Colloidal anhydrous silica
Opadry Blue
 


Not applicable.
 


4 years

Store below 30°C.
Store in the original package in order to protect from moisture.
 


PVC/Aluminum blisters in cartons of 4 tablets.
 


No special requirements.
 


SAJA Pharmaceuticals Saudi Arabian Japanese pharmaceutical company limited Jeddah – Saudi Arabia

06/2015
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