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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)

CIALIS contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

 

CIALIS 5 mg is used to treat adult men with:

-             erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. CIALIS has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity. 
Following sexual stimulation CIALIS 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. CIALIS will not help you if you do not have erectile dysfunction. It is important to note that CIALIS for the treatment of erectile dysfunction 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.
 

-             urinary symptoms associated with a common condition called benign prostatic hyperplasia.  This is when the prostate gland gets bigger with age. Symptoms include difficulty in starting to pass water, a feeling of not completely emptying the bladder and a more frequent need to pass water even at night. CIALIS improves blood flow to, and relaxes the muscles of, the prostate and bladder which may reduce symptoms of benign prostatic hyperplasia. CIALIS has been shown to improve these urinary symptoms as early as 1-2 weeks after starting treatment.


Do not take CIALIS 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”). CIALIS 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 CIALIS, 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 CIALIS.

 

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.

 

Since benign prostatic hyperplasia and prostate cancer may have the same symptoms, your doctor will check you for prostate cancer before starting treatment with CIALIS for benign prostatic hyperplasia. CIALIS does not treat prostate cancer.

 

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 CIALIS 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 CIALIS 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 CIALIS and contact your doctor immediately.

 

CIALIS is not intended for use by women. 

 

Children and adolescents

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

 

Other medicines and CIALIS

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

 

Do not take CIALIS if you are already taking nitrates.

 

Some medicines may be affected by CIALIS or they may affect how well CIALIS 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.

 

CIALIS with drink and alcohol

Information on the effect of alcohol is in section 3. Grapefruit juice may affect how well CIALIS 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 CIALIS in clinical studies have reported dizziness. Check carefully how you react to the tablets before driving or using machines.

 

CIALIS contains lactose:

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

 

CIALIS contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium‑free’

 


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

 

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

 

Drinking alcohol may temporarily lower your blood pressure. If you have taken or are planning to take CIALIS, avoid excessive drinking (blood alcohol level of 0.08% or greater), since this may increase the risk of dizziness when standing up.

 

For the treatment of erectile dysfunction

The recommended dose is one 5 mg tablet taken once a day at approximately the same time of the day. Your doctor may adjust the dose to 2.5 mg based on your response to CIALIS. This will be given as a 2.5mg tablet.

Do not take CIALIS more than once a day.

 

When taken once a day CIALIS allows you to obtain an erection, when sexually stimulated, at any time point during the 24 hours of the day. Once a day dosing of CIALIS may be useful to men who anticipate having sexual activity two or more times per week.

It is important to note that CIALIS 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.

 

For the treatment benign prostatic hyperplasia

The dose is one 5 mg tablet taken once a day at approximately the same time of the day.
If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet taken once a day.

Do not take CIALIS more than once a day.

 

If you take more CIALIS than you should

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

 

If you forget to take CIALIS

Take your dose as soon as you remember but do not take a double dose to make up for a forgotten tablet. You should not take CIALIS more than once a day.

 

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).

-             priapism, a prolonged and possibly painful erection after taking CIALIS (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, prolonged erection, 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 CIALIS. 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 CIALIS 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 CIALIS. Diarrhoea has been reported more frequently in men over 65 years of age taking CIALIS.

 

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 via the national reporting system listed in section 6. 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.

 

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 that month.

 

Store in the original package in order to protect from moisture. Do not store above 25°C.

 

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 tadalafil. Each tablet contains 5 mg of tadalafil.

-        The other ingredients are:
Tablet core: lactose monohydrate (see end of section 2), croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium laurilsulfate, magnesium stearate, see section 2 “CIALIS contains lactose”.

Film-coat: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), talc.

 


CIALIS 5 mg is a light yellow film-coated tablet in the shape of an almond and has "C 5" marked on one side. CIALIS 5 mg is available in blister packs containing 14 or 28 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

AJA Pharmaceutical Industries Company, Ltd.
Hail Industrial City MODON, Street No 32
PO Box 6979, Hail 55414
Kingdom of Saudi Arabia

Manufacturer: Lilly del Caribe, Inc.12.6 KM 65th Infantry Road (PR01). Carolina, Puerto Rico 00985

Packaging and release site: Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.

 


March 2021 Version: 8
  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 سيالس على المادة الفعالة تادالافيل التي تنتمي إلى مجموعة من الأدوية تسمى مثبطات إنزيم الفوسفودياستيراز من النوع الخامس.

 

يستخدم سيالس 5 ملجم لعلاج الرجال البالغين المصابين بـ:

-             ضعف الانتصاب يحدث ذلك عندما لا يستطيع الرجل الحصول على قضيب منتصب مناسب لممارسة العلاقة الجنسية، أو الاحتفاظ به في وضع الانتصاب. أظهر سيالس تحسينًا ملحوظًا في القدرة على الحصول على قضيب قوي منتصب مناسب لممارسة العلاقة الجنسية.

بعد الإثارة الجنسية يعمل سيالس عن طريق مساعدة الأوعية الدموية في القضيب على الاسترخاء، مما يسمح بتدفق الدم إلى القضيب. وينتج عن ذلك تحسين وظيفة الانتصاب. لن يساعدك سيالس إذا لم تكن مصابًا بضعف الانتصاب. من المهم ملاحظة أن سيالس لا يعالج ضعف الانتصاب إذا لم تكن هناك إثارة جنسية. يتطلب الأمر أن تقوم مع شريكتك بمداعبة ما قبل الجماع، بالشكل الذي كنت ستقوم به لو لم تكن تتناول دواء لعلاج ضعف الانتصاب.
 

-             الأعراض البولية المصاحبة لحالة شائعة تسمى تضخم البروستاتا الحميد. تحدث هذه الحالة عندما تتضخم غدة البروستاتا مع تقدم العمر. تتضمن الأعراض صعوبة البدء في التبول، والشعور بعدم إفراغ المثانة بالكامل، والحاجة للتبول بشكل أكثر تكرارًا حتى أثناء الليل. يحسن سيالس من تدفق الدم إلى عضلات البروستاتا والمثانة ويعمل على استرخائها، مما قد يقلل من أعراض تضخم البروستاتا الحميد. أدى سيالس لتحسين هذه الأعراض البولية بعد بدء العلاج بفترة قصيرة تتراوح بين أسبوع إلى أسبوعين.

لا تتناول سيالس في الحالات التالية:

 

-             إذا كنت تعاني من حساسية لتادالافيل أو أي من المكونات الأخرى في الدواء (مدرجة في القسم 6).

-             إذا كنت تتناول أي شكل من أشكال النترات العضوية أو مانحات أكسيد النيتريك مثل نتريت الأميل. هذه مجموعة من الأدوية تسمى ("النترات") وتستخدم لعلاج الذبحة الصدرية ("ألم الصدر"). أظهر سيالس زيادة في تأثيرات هذه الأدوية. أخبر طبيبك إذا كنت تتناول أي شكل من النترات أو كنت غير متأكد.

-             إذا كنت مصابًا بمرض في القلب أو أصبت مؤخرًا بنوبة قلبية خلال الـ 90 يومًا الأخيرة.

-             إذا أصبت مؤخرًا بسكتة خلال الـ 6 أشهر الأخيرة.

-             إذا كنت تعاني من انخفاض ضغط الدم أو ارتفاع ضغط الدم غير المتحكَّم فيه.

إذا عانيت في أي وقت سابق من فقد الإبصار بسبب اعتلال العصب البصري الاقفاري الأمامي اللاشرياني (NAION)، وهي حالة يتم وصفها بأنها "سكتة العين".

-             إذا كنت تستخدم  riociguat. يستخدم هذا الدواء لعلاج ارتفاع ضغط الدم الشرياني الرئوي (أي ارتفاع ضغط الدم في الرئتين)، الانسداد التجلطي المزمن وارتفاع ضغط الدم الرئوي (أي ارتفاع ضغط الدم في الرئتين الثانوية لتجلط الدم). وقد ثبت أن مثبطات PDE5، مثل سيالس، تزيد من مفعول هذا الدواء المخفِّض للضغط. إذا كنت تأخذ riociguat أو غير متأكد أخبر طبيبك.

 

التحذيرات والاحتياطات

تحدث مع طبيبك قبل تناول سيالس.

 

يجب عليك إدراك أن العلاقة الجنسية قد تمثل خطرًا على المرضى المصابين بمرض في القلب، لأنها تمثل إجهادًا إضافيًا على القلب. يجب عليك إبلاغ طبيبك إذا كنت تعاني من مشكلة في القلب.

 

بما أن تضخم البروستاتا الحميد وسرطان البروستاتا قد يسببان نفس الأعراض، فسوف يفحصك طبيبك للتأكد من عدم إصابتك بسرطان البروستاتا قبل بدء علاج تضخم البروستاتا الحميد بسيالس. سيالس لا يعالج سرطان البروستاتا.

 

قبل تناول الأقراص، أخبر طبيبك إذا كنت تعاني من:

-             أنيميا الخلايا المنجلية (شذوذ خلايا الدم الحمراء).

-             ورم نقوي متعدد (الميلوما المتعددة أو سرطان نخاع العظام).

-             ابيضاض الدم (لوكيميا أو سرطان خلايا الدم).

-             أي تشوه في القضيب.

-             مشكلة خطيرة في الكبد.

-             مشكلة خطيرة في الكلى.

 

من غير المعروف ما إذا كان سيالس فعالا لدى المرضى الذين خضعوا لـ:

-             جراحة في الحوض.

-             استئصال جزء من غدة البروستاتا و الذي يتم فيه قطع أعصاب البروستات (الاستئصال الجذري للبروستاتا مع عدم الحفاظ على الأعصاب التي تتحكم في الانتصاب).

 

إذا أصبت بنقص مفاجئ في حدة الإبصار أو بفقد الإبصار، أوقف تناول سيالس واتصل بطبيبك على الفور.

لقد لوحظ انخفاض أو فقدان السمع المفاجئ لدى بعض المرضى الذين يتناولون تادالافيل. على الرغم من أنه ليس من المعروف ما إذا كان الحدث يرتبط مباشرة بتادالافيل، إذا تعرضت لانخفاض أو فقدان مفاجئ للسمع، توقف عن تناول سياليس واتصل بطبيبك على الفور.

 

سيالس غير مخصص للاستخدام لدى النساء. 

 

الأطفال والمراهقون

سيالس غير مخصص للاستخدام لدى الأطفال والمراهقين تحت سن 18 عامًا.

 

الأدوية الأخرى وسيالس

أخبر طبيبك إذا كنت تتناول في الوقت الحالي، أو تناولت مؤخرًا، أو تخطط لتناول أي أدوية أخرى.

 

لا تتناول سيالس إذا كنت تتناول في الوقت الحالي أحد أدوية النترات.

 

بعض الأدوية يمكن أن تتأثر بسيالس، أو قد تؤثر على فعالية سيالس. أخبر طبيبك أو الصيدلي إذا كنت تتناول في الوقت الحالي:

 

-             حاصرات (مثبطات) مستقبلات ألفا (يستخدم لعلاج ارتفاع ضغط الدم أو الأعراض البولية المصاحبة لتضخم البروستاتا الحميد).

-             بعض الأدوية التي تستخدم لعلاج ارتفاع ضغط الدم.

-             riociguat

-             أحد مثبطات إنزيم 5-ألفا ريدكتاز (تستخدم لعلاج تضخم البروستاتا الحميد).

-             أدوية مثل أقراص الكيتوكونازول (لعلاج العدوى الفطرية)، ومثبطات إنزيم البروتياز التي تستخدم لعلاج الإيدز أو عدوى فيروس نقص المناعة البشرية (HIV).

-             فينوباربيتال، و الفينيتوين، والكاربامازيبين (أدوية مضادة للتشنجات).

-             ريفامبيسين، إريثرومايسين، كلاريثرومايسين، إتراكونازول.

-             علاجات ضعف الانتصاب الأخرى.

 

سيالس مع المشروبات والكحول

تم إدراج المعلومات الخاصة بتأثير الكحول في القسم 3. قد يؤثر عصير الجريب فروت على فعالية سيالس ويجب تناوله بحذر. تحدث إلى طبيبك للحصول على مزيد من المعلومات.

 

الخصوبة

عند علاج الكلاب بسيالس حدث نقص في تطور الحيوانات المنوية في الخصيتين. وقد لوحظ حدوث نقص في الحيوانات المنوية لدى بعض الرجال. ومن غير المرجح أن تؤدي هذه التأثيرات إلى نقص الخصوبة.

 

القيادة واستخدام الآلات

أبلغ بعض الرجال الذين يتناولون سيالس في التجارب السريرية عن حدوث حالات دوار. تحقق بعناية من استجابتك للأقراص قبل أن تقوم بالقيادة أو استخدام الآلات.

 

يحتوي سيالس على اللاكتوز:

إذا أخبرك طبيبك بأنك تعاني من عدم تحمل بعض أنواع السكر، اتصل بطبيبك قبل تناول هذا الدواء.

 

يحتوي سيالس على الصوديوم

يحتوي هذا الدواء على أقل من 1 مليمول من الصوديوم 23) ملجم( في كل قرص، ما يعني أنه في الأساس “خال من الصوديوم.”

https://localhost:44358/Dashboard

استخدم هذا الدواء دائمًا بالشكل الذي حدده طبيبك. إذا لم تكن متأكدًا، تحقق من طبيبك أو الصيدلي.

 

أقراص سيالس مخصصة للتناول عن طريق الفم لدى الرجال فقط. ابتلع القرص كاملاً مع بعض الماء. يمكن تناول الأقراص مع الطعام أو بدونه.

 

قد يؤدي تناول الكحول إلى انخفاض ضغط الدم بشكل مؤقت. إذا تناولت سيالس أو كنت تخطط لتناوله، تجنب الإفراط في تناول الكحول (مستوى الكحول في الدم 0.08% أو أكثر)، حيث قد يسبب ذلك زيادة خطر الدوار عند الوقوف.

 

لعلاج ضعف الانتصاب

الجرعة الموصى بها هي قرص 5 ملجم مرة واحدة يوميًا في نفس الوقت تقريبًا كل يوم. قد يقوم طبيبك بتعديل الجرعة إلى 2.5 ملجم بناءً على استجابتك لسيالس. يتم تعاطي هذه الجرعة كقرص 2.5 ملجم.

لا تتناول سيالس أكثر من مرة واحدة يوميًا.

 

عند تناول سيالس مرة واحدة يوميًا، فإنه يسمح لك بالحصول على الانتصاب عند الإثارة الجنسية في أي وقت خلال الـ 24 ساعة في اليوم. قد يكون تناول سيالس مرة واحدة يوميًا مفيدًا للرجال الذين يتوقعون القيام بالعلاقة الجنسية مرتين أو أكثر في الأسبوع.

من المهم ملاحظة أن سيالس لا يعمل في حالة عدم وجود إثارة جنسية. يتطلب الأمر أن تقوم مع شريكتك بمداعبة ما قبل الجماع، بالشكل الذي كنت ستقوم به لو لم تكن تتناول دواء لعلاج ضعف الانتصاب.

 

قد يؤثر تناول الكحول على قدرتك على الحصول على الانتصاب.

 

لعلاج تضخم البروستاتا الحميد

الجرعة هي قرص 5 ملجم  مرة واحدة يوميًا في نفس الوقت تقريبًا كل يوم.
إذا كنت مصابًا بتضخم البروستاتا الحميد وضعف الانتصاب، فإن الجرعة هي قرص 5 ملجم مرة واحدة يوميًا.

لا تتناول سيالس أكثر من مرة واحدة يوميًا.

 

في حالة تناول سيالس بجرعة أكبر من الجرعة المقررة

اتصل بطبيبك. قد تصاب بالآثار الجانبية التي تم وصفها في القسم 4.

 

في حالة نسيان تناول سيالس

تناول جرعتك بمجرد تذكرها ولكن لا تتناول جرعة مزدوجة لتعويض الجرعة الفائتة. ينبغي عدم تناول سيالس أكثر من مرة واحدة يوميًا.

 

إذا كانت لديك أية استفسارات أخرى بخصوص استخدام هذا الدواء، اسأل طبيبك أو الصيدلي.

على غرار جميع الأدوية، قد يسبب هذا الدواء آثارًا جانبية على الرغم من أنها لا تحدث لجميع الأشخاص. عادة ما تكون هذه الآثار ذات طبيعة خفيفة إلى معتدلة.

 

إذا أصبت بأي من الآثار الجانبية التالية، أوقف تناول الدواء واطلب المساعدة الطبية على الفور:

-        تفاعلات حساسية تتضمن الطفح (غير شائعة).

-        ألم في الصدر- لا تستخدم النترات واطلب المساعدة الطبية على الفور (غير شائع).

-        انتصاب مطول، انتصاب لفترة طويلة قد يكون مؤلمًا بعد تناول سيالس (نادر) .إذا عانيت من هذا النوع من الانتصاب، والذي يستمر لفترة تزيد عن 4 ساعات، يجب عليك الاتصال بالطبيب على الفور.

-        الفقدان المفاجئ للإبصار (نادر).

 

الآثار الجانبية الاخرى التي تم الإبلاغ عنها:

 

شائعة (تصيب شخص واحد من كل 100 شخص)

-        صداع، ألم في الظهر، ألم في العضلات، ألم في الذراعين والساقين، احمرار الوجه، احتقان الأنف وسوء الهضم.

 

غير شائعة (تصيب من شخص إلى 10 أشخاص من كل 1000 شخص)

-        دوار، ألم في المعدة، الشعور بالمرض، المرض (القيء)، ارتداد، تغيم الرؤية، ألم في العين، صعوبة التنفس، -وجود دم في- البول، انتصاب مطوّل للقضيب، بدق في ضربات القلب، زيادة سرعة ضربات القلب، ارتفاع ضغط الدم، انخفاض ضغط الدم، نزف الأنف، طنين في الأذنين، تورم في اليدين والقدمين والكاحلين والشعور بالتعب.

 

نادرة (تصيب من شخص إلى 10 أشخاص من كل 10000 شخص)

-        ضعف، تشنجات وفقد الذاكرة، تورم جفن العين، احمرار العينين، نقص السمع أو فقد السمع المفاجئ، والشرى (خطوط حمراء ملتهبة تثير الحكة على سطح الجلد)، نزيف القضيب، وجود الدم في السائل المنوي وزيادة التعرق.

 

كما تم الإبلاغ بشكل نادر عن حدوث نوبة قلبية وسكتة دماغية لدى الرجال الذين يتناولون سيالس. معظم هؤلاء الرجال مصابون بمشاكل في القلب قبل تناول هذا الدواء.

 

تم الإبلاغ بشكل نادر عن نقص جزئي أو مؤقت أو دائم في الإبصار أو فقد الإبصار في إحدى العينين أو كلتاهما.

 

تم الإبلاغ عن بعض الآثار الجانبية الأخرى النادرة لدى الرجال الذين يتناولون سيالس، والتي لم تحدث في التجارب السريرية. وتتضمن هذه الآثار الجانبية:

-        الصداع النصفي، تورم الوجه، تفاعل حساسية شديد يسبب تورم الوجه أو الحلق، طفح جلدي خطير، بعض الاضطرابات التي تؤثر على تدفق الدم إلى العينين، عدم انتظام ضربات القلب، الذبحة وتوقف القلب المفاجئ.

 

تم الإبلاغ عن الأثر الجانبي الدوار بشكل أكثر تكرارًا لدى المرضى الذين تتجاوز أعمارهم 75 عامًا ويتناولون سيالس. وقد تم الإبلاغ عن الإسهال بشكل أكثر تكرارا لدى الرجال الذين تزيد أعمارهم عن 65 عاما من العمر.

 

الإبلاغ عن الآثار الجانبية

إذا شعرت بأيّ آثار جانبية، تحدّث مع طبيبك أو الصيدلي. ويشمل هذا أيّ آثار جانبية محتملة غير مدرجة في هذه النشرة. یمکنك أیضا الإبلاغ عن الآثار الجانبیة مباشرة من خلال نظام الإبلاغ الوطني المدرج في القسم 6. من خلال الإبلاغ عن الآثار الجانبیة یمکنك المساعدة في توفیر المزید من المعلومات حول سلامة ھذا الدواء. 

يحفظ هذا الدواء بعيدًا عن نظر ومتناول الأطفال.

لا تستخدم هذا الدواء بعد تاريخ انتهاء الصلاحية المدون على العبوة والشريط بعد الرمز "EXP". يشير تاريخ انتهاء الصلاحية إلى آخر يوم من ذلك الشهر.

يحفظ الدواء في عبوته الأصلية من أجل حمايته من الرطوبة. لا يحفظ في درجة حرارة أكثر من  25درجة مئوية.

لا تتخلص من الأدوية في مياه الصرف الصحي أو النفايات المنزلية. اسأل الصيدلي عن طريقة التخلص من الأدوية التي لم تعد في حاجة لاستخدامها. تساعد هذه الإجراءات على حماية البيئة.

-        المادة الفعالة هي تادالافيل. يحتوي كل قرص على 5 ملجم من تادالافيل.

-        المكونات الأخرى هي:
قلب القرص:  لاكتوز أحادي الهيدرات (انظر نهاية القسم 2)، كروسكارميلوز الصوديوم، هيدروكسي بروبيل سليلوز، سليلوز دقيق التبلور، صوديوم لوريل سلفات، ستيرات الماغنسيوم، انظر الفقرة” 2 يحتوي سيالس على اللاكتوز”.
غلاف القرص: لاكتوز أحادي الهيدرات، هيبوميلوز، ثلاثي الأستين، ثاني أكسيد التيتانيوم (E171)، أكسيد الحديد الأصفر (E172)، الطلق.

 

سيالس 5 ملجم هو قرص مغلف ذو لون أصفر فاتح على شكل حبة اللوز، ومطبوع على أحد جانبيه علامة ""C 5.

سيالس 5 ملجم متوفر في عبوات بها شرائط تحتوي على 14 قرصًا أو 28 قرصًا.

 

قد لا تكون جميع أحجام العبوات مطروحة في الأسواق.

صاحب رخصة التسويق :

شركة أجا للصناعات الدوائية المحدودة

المدينة الصناعية مدن بحائل، شارع رقم 32

ص.ب. 6979، حائل 55414

المملكة العربية  السعودية

 

المصنّع :ليلي دل كريبي٬ 12.6 Inc. كلم٬ طريق  65إنفنتري(PR01) . كرولينا،  00985بويرتوريكو .

 

 موقع التغليف والفسح: ليلي إس ايه (Lilly S.A.)، 30 أفادا دي لا انداستريا، 28108 ألكوبنداس، مدريد، إسبانيا.

مارس 2021 النسخة: 8
 Read this leaflet carefully before you start using this product as it contains important information for you

CIALIS 5 mg film-coated tablets

Each tablet contains 5 mg tadalafil. Excipient(s) with known effect: Each coated tablet contains 121 mg lactose (as monohydrate). For the full list of excipients, see section 6.1.

Film-coated tablet (tablet). Light yellow and almond shaped tablets, marked "C 5" on one 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.

 

Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males.

 

CIALIS 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 CIALIS (i.e., at least twice weekly) a once daily regimen with the lowest doses of CIALIS might be considered suitable, based on patient choice and the physician’s judgement.

 

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

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 2.5mg 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 for on-demand treatment.

 

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. (see sections 4. 4 and 5.2).

 

Men with hepatic impairment

For the treatment of erectile dysfunction using on-demand CIALIS the recommended dose of CIALIS is 10 mg taken prior to anticipated sexual activity and with or without food. There is limited clinical data on the safety of CIALIS 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 10 mg of tadalafil to patients with hepatic impairment.

 

Once-a-day dosing of CIALIS 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. (see sections 4.4 and 5.2).

 

Men with diabetes

Dose adjustments are not required in diabetic patients.

 

Paediatric population

There is no relevant use of CIALIS in the paediatric population with regard to the treatment of erectile dysfunction.

 

Method of administration

CIALIS 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 CIALIS to patients who are using any form of organic nitrate is contraindicated. (see section 4.5). CIALIS, 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. CIALIS 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 (see section 4.4). 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 (see section 4.5).

Before treatment with CIALIS

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 (see section 5.1) and as such potentiates the hypotensive effect of nitrates (see section 4.3).

 

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 (see section 4.3).

 

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 CIALIS is effective in patients who have undergone pelvic surgery or radical non-nerve-sparing prostatectomy.

 

Cardiovascular

Serious cardiovascular events, including myocardial infarction, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischemic 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 CIALIS, to sexual activity, or to a combination of these or other factors.

 

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 CIALIS may lead to symptomatic hypotension in some patients (see section 4.5). 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 CIALIS and other PDE5 inhibitors. Analyses of observational data suggest an increased risk of acute NAION in men with erectile dysfunction following exposure to tadalafil or other PDE5 inhibitors. As this may be relevant for all patients exposed to tadalafil, the patient should be advised that in case of sudden visual defect, he should stop taking CIALIS and consult a physician immediately (see section 4.3).

 

Decreased or sudden hearing loss

Cases of sudden hearing loss have been reported after the use of tadalafil. Although other risk factors were present in some cases (such as age, diabetes, hypertension and previous hearing loss history) patients should be advised to stop taking tadalafil and seek prompt medical attention in the event of sudden decrease or loss of hearing.

 

Renal and hepatic impairment

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

 

There is limited clinical data on the safety of single-dose administration of CIALIS in patients with severe hepatic insufficiency (Child-Pugh Class C). Once-a-day administration either for the treatment of erectile dysfunction or benign prostatic hyperplasia has not been evaluated in patients with hepatic insufficiency. If CIALIS 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.

 

CIALIS, 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 CIALIS 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 (see section 4.5).

 

CIALIS and other treatments for erectile dysfunction

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

 

Lactose

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

 

Sodium

 

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium‑free’.


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 co-administered with caution as they would be expected to increase plasma concentrations of tadalafil (see section 4.4).

Consequently the incidence of the adverse reactions listed in section 4.8 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 CIALIS to patients who are using any form of organic nitrate is contraindicated (see section 4.3). 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 CIALIS (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 CIALIS 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 (see section 4.4).

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 alpha-blockers). 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 medicinal products.

 

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 (see section 4.3). 

 

 

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 (3.5 bpm) increase in heart rate. Although this effect is minor and was of no clinical significance in this study, it should be considered when co-administering 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 co-administration with tadalafil (10 mg or 20 mg). In addition, no changes in tadalafil concentrations were seen 3 hours after co-administration 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 S-warfarin 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 acetyl salicylic acid.

 

Antidiabetic medicinal products

Specific interaction studies with antidiabetic medicinal products were not conducted.


CIALIS 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 (see section 5.3). As a precautionary measure, it is preferable to avoid the use of CIALIS 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. CIALIS 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 (see sections 5.1 and 5.3).


CIALIS 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 CIALIS, before driving or using machines.


Summary of the safety profile

 

The most commonly reported adverse reactions in patients taking CIALIS 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 CIALIS.  The adverse reactions reported were transient, and generally mild or moderate. The majority of headaches reported with CIALIS 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 placebo-controlled clinical trials (comprising a total of 8022 patients on CIALIS 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 (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1,000) and 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 ischemic 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, Stevens-Johnson 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 (see section 4.4).

(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 5mg 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 via the national reporting system listed below.

 

To report any side effect(s):

 

-                 The National Pharmacovigilance centre (NPC):

o Fax: +966-11-205-7662

o SFDA Call center: 19999

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

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

 


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.

 

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 1.6/0.8 mm Hg, respectively), in standing systolic and diastolic blood pressure (mean maximal decrease of 0.2/4.6 mm Hg, 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 CIALIS
10 mg (one 6-month study) and 20 mg (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

For CIALIS on demand, three clinical studies were conducted in 1054 patients in an at-home setting to define the period of responsiveness. 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.

 

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 CIALIS 5 mg, 50 % on CIALIS 2.5 mg 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 CIALIS 5 mg and 2.5 mg, 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-naïve to PDE5 inhibitors were randomized to CIALIS 5 mg once a day vs. placebo.  The mean per-subject proportion of successful sexual intercourse attempts was 68 % for CIALIS patients compared to 52 % for patients on placebo.

 

Benign prostatic hyperplasia

CIALIS 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 CIALIS 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 CIALIS 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 prostatic hyperplasia 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 CIALIS 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 CIALIS 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 CIALIS 5mg.

 

 

Paediatric population

A single study has been performed in paediatric patients with Duchenne Muscular Dystrophy (DMD) in which no evidence of efficacy was seen. The randomised, double‑blind, placebo‑controlled, parallel, 3‑arm study of tadalafil was conducted in 331 boys aged 7‑14 years with DMD receiving concurrent corticosteroid therapy. The study included a 48‑week double-blind period where patients were randomised to tadalafil 0.3 mg/kg, tadalafil 0.6 mg/kg, or placebo daily. Tadalafil did not show efficacy in slowing the decline in ambulation as measured by the primary 6 minute walk distance (6MWD) endpoint: least squares (LS) mean change in 6MWD at 48 weeks was ‑51.0 meters (m) in the placebo group, compared with ‑64.7 m in the tadalafil 0.3 mg/kg group (p = 0.307) and ‑59.1 m in the tadalafil 0.6 mg/kg group (p = 0.538). In addition, there was no evidence of efficacy from any of the secondary analyses performed in this study. The overall safety results from this study were generally consistent with the known safety profile of tadalafil and with adverse events (AEs) expected in a paediatric DMD population receiving corticosteroids.

 

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. See section 4.2 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 CIALIS 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 20 mg), 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 CIALIS in patients with severe hepatic insufficiency (Child-Pugh Class C). There are no available data about the administration of once-a-day dosing of tadalafil to patients with hepatic impairment. If CIALIS is prescribed once-a-day, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.

 

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, embryotoxicity or foetotoxicity in rats or mice that received up to 1000 mg/kg/day tadalafil. In a rat prenatal and postnatal development study, the no observed effect dose was 30 mg/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 3.7 – 18.6] 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. See also section 5.1.


Tablet core:

lactose monohydrate,

croscarmellose sodium,

hydroxypropylcellulose,

microcrystalline cellulose,

sodium laurilsulfate,

magnesium stearate.

 

Film-coat:

lactose monohydrate,

hypromellose,

triacetin,

titanium dioxide (E171),

iron oxide yellow (E172),

talc.


Not applicable.


3 years.

Store in the original package in order to protect from moisture. Do not store above 25°C.


Aluminium/PVC/PE/PCTFE blisters in cartons of 14, 28 or 84 film-coated tablets.

 

Not all packs sizes may be marketed.


Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


AJA Pharmaceutical Industries Company, Ltd. Hail Industrial City MODON, Street No 32 PO Box 6979, Hail 55414 Kingdom of Saudi Arabia

04 August 2022
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