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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)

Acetab belongs to the group of medicines called Angiotensin Converting Enzyme (ACE) Inhibitors. ACE inhibitors work by helping to widen your blood vessels, which then make it easier for your heart to pump blood through them.

 

§ Acetab is used to treat high blood pressure and certain heart conditions. If high blood pressure is left uncontrolled it can increase the risk of heart disease or stroke. Acetab works by lowering your blood pressure which reduces this risk.

§ Acetab can also help people whose heart no longer pumps blood as well as it once did. This condition is known as heart failure.

§ Acetab may also be used to treat patients who recently suffered a heart attack. A heart attack happens once one of the major blood vessels supplying blood to the heart muscle becomes blocked. This means that the heart does not receive the oxygen it needs and the heart muscle becomes damaged.

§ In addition, Acetab can be used for the treatment of kidney disease in patients with diabetes.


Do not take Acetab Tablets:

 

§ If you are allergic (hypersensitive) to captopril, any of the other ingredients in these tablets or other ACE inhibitors (see Section 6 and end of Section 2).

§ If you have ever had a reaction which included swelling of the hands, lips face or tongue where the cause was unknown.

§ If you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren

§ If you are more than 3 months pregnant. (It is also better to avoid Acetab tablets in early pregnancy – see pregnancy section.)

 

Do not take Acetab tablets if any of the above apply to you. If you are not sure, talk to your doctor before taking Acetab tablets.

 

Warnings and precautions

 

Talk to your doctor, pharmacist or nurse before using Acetab tablets:

 

§ If you suffer from kidney disease.

§ If you suffer from liver disease.

§ If you are undergoing dialysis.

§ If you have suffered from heart disease, in particular problems with the valves of the heart.

§ If you are receiving immuno-suppressant therapy.

§ If you have recently suffered from excessive diarrhoea or vomiting.

§ If you have diabetes.

§ If you suffer from any collagen vascular diseases such as rheumatoid arthritis, systemic lupus erythematosus or scleroderma.

§ If you experience more infections such as sore throat or fever which can be due to changes in your blood cells and can be monitored by a blood test carried out by your doctor.

§ If you are going to have dental surgery or major surgery involving anesthetic.

§ If you are going to have desensitization treatment, e.g. for an allergic reaction to wasp or bee stings.

§ If you are about to have treatment for the removal of cholesterol from your blood by a machine, (called LDL apheresis).

§ You must tell your doctor if you think you are (or might become) pregnant. Acetab tablet is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant it may cause serious harm to your baby if used at that stage (see pregnancy section).

§ Some Afro-Caribbean patients may require higher doses of Captopril to obtain an adequate reduction in blood pressure.

 

§ if you are taking any of the following medicines used to treat high blood pressure:

 

- an angiotensin II receptor blocker (ARBs) (also known as sartans - for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems.

- aliskiren Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also information under the heading “Do not take Acetab Tablets”

 

Other medicines and Acetab Tablets:

 

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

 

Your doctor may need to change your dose and/or to take other precautions:

 

If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not take Acetab Tablets” and “Warnings and precautions”.

 

It is especially important to tell your doctor if you are taking any of the following:

 

§ Diuretics (water tablets).

§ Potassium supplements or salt substitutes containing potassium (e.g. triamterene, amiloride and spironolactone).

§ Medicines that cause dilation of the blood vessels (e.g. minoxidil, and clonidine).

§ Medicines to treat mental problems including manic depression or depression (e.g. lithium and amitriptyline).

§ Immuno-suppressants (e.g. azathioprine and cyclophosphamide).

§ Medicines to treat gout (e.g. allopurinol and probenecid).

§ Medicines to treat irregular heartbeats (e.g. procainamide).

§ Non-steroidal anti-inflammatory painkiller (NSAIDS) (e.g. indometacin, and ibuprofen).

§ Medicines to treat diabetes (e.g. oral antidiabetics and insulin).

§ Medicines to treat high blood pressure (e.g. beta-blockers such as propranolol, atenolol or calcium channel blockers such as amlodipine and nifedipine).

§ Any medicine that may be used during and after a heart attack.

 

Taking with Food or Drinks:

 

Acetab Tablets can be taken with or without food.

 

Moderate amounts of alcohol will not affect Acetab, however, you should check with your doctor first to see if drinking is advisable for you.

 

Pregnancy and breast feeding:

 

Pregnancy:

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Acetab tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Acetab.

 

Acetab tablet is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

 

Breast-feeding:

 

Tell your doctor if you are breast-feeding or about to start breast-feeding. Breast-feeding newborn babies (first few weeks after birth), and especially premature babies, is not recommended whilst taking Acetab. In the case of an older baby your doctor should advise you on the benefits and risks of taking Acetab whilst breast-feeding, compared with other treatments. Ask your doctor or pharmacist for advice before taking any medicine.

 

Driving or operating machinery:

 

Acetab can affect your ability to drive, usually when you first start taking your medicine or if your doctor changes your dose. If you do feel light-headed or dizzy when taking Acetab tablets, you should not drive or use machinery.

 

Important information about some of the ingredients in Acetab

 

These tablets contain Lactose. If you have been told by your doctor that if you have an intolerance to some sugars, contact your doctor before taking this medicine.


Always take Acetab Tablets as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure. The usual dose is as follows:

 

For the treatment of high blood pressure:

 

The usual starting dose is 12.5 – 25 mg twice a day. Your doctor may gradually increase this dose to 100 – 150 mg a day. You may also need to be given other medicines to lower your blood pressure. Older patients and those with kidney problems may be given a lower starting dose.

 

In heart failure:

 

The usual starting dose is 6.25 – 12.5 mg two or three times a day. Your doctor may gradually increase this dose to a maximum of 150 mg a day.

 

After a heart attack:

 

The usual starting dose is 6.25 mg, which will then be increased by your doctor to a maximum of 150 mg a day.

 

For the treatment of diabetic patients with kidney disease:  

 

The usual dose is 75 – 100 mg a day.

 

For children

 

The starting dose is 0.3 mg/kg bodyweight, which may be increased gradually by the doctor.

 

For children with kidney problems, premature babies and newborn babies and infants:

 

The starting dose should be 0.15 mg/kg bodyweight.

 

Elderly patients (over 65 years):

 

Your doctor may start you on a lower dose. If you have a kidney disorder your doctor will increase the dose gradually until your blood pressure is adequately controlled. The dosage may then be adjusted by your doctor to suit individual requirements.

 

Doctors sometimes prescribe different doses to the above and if this applies to you, you should discuss it with your doctor. The tablet can be broken in half for a 12.5 mg dose or quarters for 6.25 mg dose Sometimes patients may feel dizzy after taking the first one or two doses of Acetab. If this happens to you, lie down until these symptoms disappear.

 

You should try to take Acetab at about the same time each morning. It can be taken before, during or after meals.

 

Even if you feel well continue to take Acetab until your doctor tells you otherwise.

 

 

If you take more Acetab Tablet than you should:

 

If you or anyone else takes too many tablets you should go to your nearest hospital emergency department or tell your doctor immediately. Take the carton and any remaining tablets you have with you.

 

If you forget to take Acetab Tablet:

 

If you miss a dose do not worry. Just carry on taking your normal dose when the next one is due. Do not take a double dose to make up for the one you missed

 

If you stop taking Acetab Tablets

 

Do not stop taking this medicine without telling your doctor first. If you have any further questions on the use of this product, ask your doctor or pharmacist.


Like all medicines, Acetab Tablet can cause side effects, although not everybody gets them.

 

Important side effects to look out for:

 

If you experience any of the following reactions stop taking Acetab and contact your doctor immediately:

 

§ Swelling of the hands, face, lips or tongue.

§ Difficulty in breathing.

§ A sudden, unexpected rash or burning, red or peeling skin.

§ Sore throat or fever.

§ Severe dizziness or fainting.

§ Severe stomach pain.

§ Unusually fast or irregular heartbeat.

§ Yellowing of the skin and/or eyes (jaundice).

 

Common side effects (affecting between 1 in 10 and 1 in 100 people):

 

Dizziness, Dry mouth, Itching, Sleep problems, Rashes, Diarrhoea or constipation, Hair loss, Dry, irritating cough, Changes in the way things taste, Upset stomach, sickness, abdominal pain, Shortness of breath.

 

Uncommon side effects (affecting between 1 in 100 and 1 in 1000 people):

 

Fast, irregular, louder heartbeat, Tiredness, Chest pain, generally feeling unwell, Low blood pressure, looking pale, Reduced blood flow to the hands and feet, Swelling of the eyes and lips (angioedema)(e.g. Raynaud syndrome), Flushing.

 

Rare side effects (affecting between 1 in 1000 and 1 in 10,000 people):

 

Loss of appetite, Mouth ulcers, Drowsiness, Kidney disorders or failure, Headache, Changes in frequency of passing urine, Pins and needles, numbness or tingling.

 

 

 

Very rare side effects (affecting less than 1 in 10,000 people):

 

Impaired liver function and raised liver enzymes, Liver damage, inflammation of the liver or jaundice, Confusion, depression, fainting, Stomach ulcers, Mini-stroke, Muscle pain, Blurred vision, Joint pain, Heart problems including heart attack, and chest infections, wheezing or difficulty breathing, Inflammation of the pancreas, Rashes or skin reactions, Runny nose, Swelling of breast tissue in men, Swollen tongue, Fever, Impotence, Sensitivity of the skin to light, Stevens-Johnson syndrome(a serious illness with blistering of the skin, mouth, eyes and genitals), Changes in levels of chemicals in the blood or lymphatic systems (e.g. potassium, sugars).

 

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist immediately.


Keep in a safe place, out of the reach and sight of children.

§ Store below 30° C.

§ Do not take Acetab Tablets after the expiry date printed on the packaging. The expiry date refers to the last day of the month.

 

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


What Acetab Tablet contains?

 

The active substance is Captopril .

 

Each Acetab 25 tablet contains: 25 mg captopril.

 

Each Acetab 50 tablet contains: 50 mg captopril.

 

The excipients are:

 

Lactose monohydrate, Pregelatinized starch, Microcrystalline cellulose & Stearic acid.


What Acetab Tablet looks like and what are the contents of the pack?   Acetab 25 mg form: White to off-white round tablet with two break lines on one side and KS27 engraved on the other side which may have a characteristic, sulfide-like odour. Acetab 50 mg form: White to off white round tablet with break line on one side and KS 52 engraved on the other side which may have characteristic, sulfide-like odour. Acetab 25 & Acetab 50 tablets are available in packs of 30 tablets

 

 

Kuwait Saudi Pharmaceutical Industries Company

Tel: +965 24745012/3/4

Fax: +965 24745361, P. O. Box: 5512, postal code: 13056 Safat, Kuwait

Website: www.kspico.com


This leaflet was revised in December 2019
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

ينتمي الأسیتاب إلى المجموعة الدوائية المعروفة باسم: مثبطات الإنزيم المحول للأنجیوتنسین. و هذه المجموعة تعمل على توسيع الأوعية الدموية، مما يجعل عملية ضخ القلب للدم خلال تلك الأوعية أسهل.

§   تستخدم أقراص أسیتاب لعلاج ارتفاع ضغط الدم وبعض حالات القلب. إذا لم يتم التحكم بضغط الدم المرتفع فإن ذلك قد يزيد من خطر حدوث أمراض القلب و السكتة الدماغية. يعمل الأسیتاب عن طريق تخفيض ضغط الدم لديك مما يقلل خطر الإصابة تلك.

§   قد يساعد الأسیتاب المرضى الذين لم يعد قلبهم يضخ الدم كما كان في الماضي و تعرف هذه الحالة بالفشل القلبي.

§   قد يستخدم الأسیتاب لعلاج المرضى الذين يعانون مؤخراً من نوبة قلبية. تحدث النوبة القلبية عندما ينغلق أحد الأوعية الدموية الكبيرة المغذية لعضلة القلب. هذا يعني أن القلب لا يتلقى ما يحتاجه من الأكسجين و تلف عضلة القلب.

بالإضافة إلى ذلك، قد يستخدم الأسیتاب لعلاج اعتلال الكلى لدى مرضى السكري.

لا تتناول أقراص أسیتاب:

§   إذا كنت لديك حساسية (مفرطة) تجاه الكابتوبریل أو أيًا من المكونات الأخرى لهذه الأقراص أو تجاه الأدوية المثبطة لإنزيم المحول للأنجیوتنسین الأخرى (أنظر الجزء ٦ وآخر الجزء ۲)

§   إذا كنت قد عانيت سابقًا من ردود أفعال تشمل تورم في اليدين، الشفاه، الوجه أو اللسان، و كان السبب غير معلوم.

§   إذا كنت مريضًا بالسكري أو باعتلال وظائف الكلى و كنت تخضع للعلاج بخافض لضغط الدم يحتوي على ألیسكیرین.

§   إذا كنتِ حاملًا في أكثر من ثلاثة أشهر (يفضل تجنب أقراص أسیتاب في مراحل الحمل الأولى - انظري الجزء الخاص بالحمل).

لا تتناول أقراص أسیتاب إذا انطبق عليك أيًا مما ذكر أعلاه. إذا كنت غير متأكدًا، استشر طبيبك قبل تناول اٌقراص أسیتاب.

التحذيرات و الاحتياطات

أخبر طبيبك، الصيدلي أو الممرضة قبل تناول أقراص أسیتاب:

§   إذا كنت تعاني من اعتلال كلوى.

§   إذا كنت تعاني من اعتلال كبدي.

§   إذا كنت تخضع للديلزة (الغسيل الكلوي).

§   إذا كنت تعاني من اعتلال في القلب، خاصة اعتلال صمامات القلب.

§   إذا كنت تخضع لعلاج مثبط للمناعة.

§   إذا كنت قد عانيت مؤخراً من إسهال مفرط أو قيء.

§   إذا كنت مريضًا بالسكري

§   إذا كنت تعاني من أيٍ من أمراض الكولاجين الوعائية مثل التهاب المفاصل الروماتويدي، الذئبة الحمامية الجهازية أو تصلب الجلد.

§   إذا تعرضت لأكثر من عدوى مثل التهاب الحلق أو الحمى والتي قد تنتج عن تغيرات في خلايا الدم و يمكن مراقبتها بإجراء فحوصات للدم و التي تنفذ من قبل الطبيب.

§   إذا كنت على وشك إجراء جراحة بالأسنان أو عملية جراحية كبرى تتطلب التخدير.

§   إذا كنت على وشك تناول علاج مزيل للحساسية (على سبيل المثال الحساسية الناتجة عن لسعة الدبور أو النحلة).

§   إذا كنت على وشك الخضوع لعلاج يزيل الكوليسترول من الدم بواسطة جهاز يسمى (فصل لیبوبروتین منخفض الكثافة).

§   إذا كنتِ تعتقدين أنكِ حاملًا (أو قد تصبحين حاملًا)، يجب عليكِ إخبار الطبيب. لا ينصح بتناول أقراص أسیتاب في مراحل الحمل الأولى، كما أنه يمنع تناوله بعد الثلاثة أشهر الأولى من الحمل، وذلك لأنه قد يسبب ضررًا خطيرًا على الجنين إذا تم استخدامه في تلك الفترة (أنظري الجزء الخاص بالحمل).

§   قد يحتاج بعض المرضى المنحدرين من منطقة البحر الكاريبي إلى جرعة مرتفعة من أسیتاب للحصول على التأثير الكافي الخافض لضغط الدم.

§   إذا كنت تتناول أي من الأدوية التالية التي تستخدم لعلاج ارتفاع ضغط الدم:

-    حاصرات مستقبلات الأنجیوتنسین II )تعرف أيضًا بالسارتانز-  على سبيل المثال فالسارتان، تیلمیسارتان، إربیسارتان)،  و خاصةً إذا كنت تعاني من مشاكل في الكلى متعلقة بالسكري.

-    ألیسكیرین، قد يفحص طبيبك وظائف الكلى، ضغط الدم، و مستويات الكهارل (مثل البوتاسيوم) في الدم على فترات منتظمة. انظر أيضًا المعلومات المدرجة تحت عنوان "لا تتناول أقراص أسیتاب".

 

تناول أدوية أخرى مع أقراص أسیتاب

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

 

قد يقوم طبيبك بتغيير الجرعة و / أو أخذ بعض الاحتياطات:

إذا كنت تتناول حاصرات مستقبلات الأنجیوتنسین II أو ألیسكیرین (انظر أيضًا المعلومات المدرجة تحت عنوان "لا تتناول

أقراص أسیتاب" و "التحذيرات و الاحتياطات").

 

على وجه الخصوص، أخبر طبيبك أو الصيدلي إذا كنت تتناول أي من الأدوية التالية:

§   مدرات البول (أقراص الماء).

§   مكملات البوتاسيوم أو بدائل الملح التي تحتوي على البوتاسيوم (مثل تریامتیرین، أمیلورید و سبیرونولاكتون).

§   الأدوية التي تسبب تمدد الأوعية الدموية (مثل مینوكسیدیل و كلونیدین).

§   الأدوية التي تستخدم لعلاج المشاكل الذهنية بما في ذلك الهوس الاكتئابي و الاكتئاب (مثل الليثيوم و أمیتریبتیلین).

§   مثبطات المناعة (مثل: أزاثیوبرین و سیكلوفوسفامید).

§   الأدوية المستخدمة لعلاج النقرس (مثل ألوبیورینول و بروبینسید).

§   الأدوية المستخدمة لعلاج اضطراب ضربات القلب (مثل بروكینامید).

§   مسكنات الألم ومضادات الالتهاب غير الإستيرويدية (مثل: إندومیتاسین، أیبوبروفین).

§   الأدوية المستخدمة لعلاج السكري (مثل مضادات السكري الفموية و الأنسولين).

§   الأدوية المستخدمة لعلاج ارتفاع ضغط الدم (مثل حاصرات مستقبلات بيتا مثل بروبرانولول و أتینولول، أو حاصرات قنوات الكالسيوم مثل أملودیبین، و نیفیدیبین).

§   أي دواء يمكن استخدامه أثناء و بعد حدوث أزمة قلبية.

 

تناول أقراص أسیتاب مع الطعام أو الشراب:

يمكن تناول أسیتاب مع أو بدون الطعام.

لا يؤثر تناول كميات معتدلة من الكحوليات على أقراص أسیتاب، و مع ذلك، يجب عليك مراجعة طبيبك أولًا لمعرفة إذا

كان ينصح بتناول الكحوليات أم لا.

 

الحمل و الرضاعة:

الحمل

يجب عليكِ إخبار الطبيب إذا كنتِ تعتقدين أنكِ (أو قد تصبحين) حاملًا. من الطبيعي أن ينصحك طبيبك بالتوقف عن تناول أقراص أسیتاب قبل أن تصبحي حاملًا أو فور علمك بأنكِ حاملًا و سوف ينصحك بتناول دواء آخر بدلًا من أقراص

أسیتاب.

لا ينصح بتناول أقراص أسیتاب في مراحل الحمل الأولى، كما أنه يمنع تناوله بعد الثلاثة أشهر الأولى من الحمل، وذلك

لأنه قد يسبب ضررًا خطيرًا على الجنين إذا تم استخدامه في تلك الفترة بعد الشهر الثالث من الحمل.

 

الرضاعة

أخبري طبيبك إذا كنتِ أمًا مرضعة أو على وشك أن ترضعين. لا ينصح بإرضاع الأطفال حديثي الولادة (في الأسابيع الأولى بعد الولادة)، و خاصة الأطفال الخدج أثناء تناول أقراص أسیتاب. في حالات الأطفال الأكبر سنًا، يجب أن يخبرك طبيبك عن فوائد و مخاطر تناول أقراص أسیتاب أثناء الرضاعة الطبيعية، مقارنة مع الأدوية الأخرى. استشر طبيبك أو الصيدلي قبل تناول أي دواء.

 

القيادة و استخدام الآلات

قد تؤثر أقراص أسیتاب على قدرتك على القيادة ، و يحدث ذلك عادةً عند بدء تناول الدواء أو إذا قام طبيبك بتغيير الجرعة.

إذا كنت تشعر بالدوار أو الدوخة عند تناول أقراص أسیتاب، يجب عليك تجنب القيادة أو استخدام الآلات.

 

معلومات مهمة حول بعض مكونات أقراص الأسیتاب

تحتوي أقراص أسیتاب على اللاكتوز. إذا أخبرك طبيبك أن لديك عدم تحمل لبعض السكريات، استشر طبيبك قبل تناول

هذا الدواء.

https://localhost:44358/Dashboard

تناول أقراص أسیتاب دائمًا حسب وصفة طبيبك. يجب عليك التحقق مع طبيبك أو مع الصيدلي إذا لم تكن واثقًا. الجرعة

المعتادة كالتالي:

 

لعلاج ارتفاع ضغط الدم: الجرعة الابتدائية المعتادة هي ١۲,٥ – ۲٥ ملجم مرتين يوميًا. و ربما يزيد طبيبك الجرعة تدريجيًا حتى تصل إلى ١۰۰ – ١٥۰ ملجم يوميًا. قد تحتاج أيضًا أن تتناول أدوية أخرى حتى تقلل من ضغط الدم لديك.

في حالة المرضى كبار السن و الذين يعانون مشاكل في الكلى يمكن إعطائهم جرعة ابتدائية أقل.

 

في حالة فشل القلب: الجرعة الابتدائية المعتادة هي ٦,۲٥ – ١۲,٥ ملجم مرتين أو ثلاث مرات في اليوم. قد يزيد طبيبك هذه الجرعة تدريجيًا إلى حد أقصاه ۱٥۰ ملجم يوميًا.

 

بعد حدوث نوبة قلبية: الجرعة الابتدائية المعتادة هي ٦,۲٥ ملجم، و التي سوف يزيدها طبيبك إلى حد أقصاه ۱٥۰ ملجم

يوميًا.

 

لعلاج مرضى السكري الذين يعانون من مرض في الكلى: الجرعة المعتادة هي ۷٥ –  ١۰۰ ملجم يوميًا.

 

الأطفال الجرعة الابتدائية هي ۰,۳ ملجم/كجم من وزن الجسم، والتي من الممكن زيادتها تدريجيًا بواسطة الطبيب المعالج.

 

الأطفال الذين يعانون مشاكل في الكلى، و الأطفال الخدج، و حديثي الولادة و الرضع: الجرعة الابتدائية يجب أن تكون ۰,۱٥ ملجم/كجم من وزن الجسم.

 

كبار السن (فوق ٦٥ عام): في البداية قد يقرر لك الطبيب جرعة أقل. إذا كنت لديك اعتلال كلوي سوف يقوم طبيبك بزيادة الجرعة تدريجيًا حتى يتم التحكم بضغط الدم بدقة. قد يقوم طبيبك بتعديل الجرعة لتتناسب مع احتياجاتك الفردية.

قد يصف الأطباء أحيانًا جرعات مختلفة عما سبق وإذا انطبق ذلك عليك لابد وأن تناقش ذلك مع طبيبك المعالج. يمكن كسر القرص إلى نصفين للحصول على جرعة ۱۲,٥ ملجم أو إلى أرباع للحصول على جرعة ٦٫۲٥ ملجم.

قد يشعر المرضى أحيانًا بالدوار بعد تناول الجرعة الأولى أو الثانية من أسیتاب. فلو حدث ذلك لك استلق حتى تختفي تلك

الأعراض.

عليك أن تحاول أن تتناول أسیتاب في نفس الوقت كل صباح. تستطيع تناوله قبل، أو خلال، أو بعد الطعام.

إذا شعرت أنك أصبحت بحالة جيدة استمر في تناول أسیتاب إلا إذا أخبرك الطبيب بخلاف ذلك.

 

إذا تناولت أقراص أسیتاب أكثر من الكمية الموصى بها:

إذا تناولت أنت أو أي شخص آخر الكثير من الأقراص يجب عليك أن تذهب إلى أقرب قسم طوارئ في المستشفى أو تخبر طبيبك حالًا. خذ معك العلبة الفارغة وأي أقراص متبقية.

 

إذا نسيت تناول جرعة أسیتاب:

لا تقلق إذا نسيت الجرعة. فقط استمر في تناول جرعتك الاعتيادية عندما يحين موعد تناولها. لا تأخذ جرعة مضاعفة لتعويض الجرعة التي نسيت تناولها.

 

إذا توقفت عن تناول أقراص الأسیتاب

لا تتوقف عن تناول هذا الدواء دون إبلاغ طبيبك أولاً. إذا كان لديك أي أسئلة أخرى عن استخدام هذا الدواء، اسأل طبيبك أو الصيدلي.

كما في جميع الأدوية، قد يسبب أسیتاب تأثيرات جانبية و مع ذلك قد لا تحدث مع كل الأشخاص.

 

الآثار الجانبية المهم النظر إليها:

إذا عانيت أي من ردود الأفعال التالية توقف عن تناول أسیتاب و اتصل بطبيبك على الفور:

§   تورم في اليدين و الوجه و الشفاه أو اللسان.

§   صعوبة في التنفس.

§   حكة مفاجئة و غير متوقعة أو حرق، أو احمرار أو تقشير في الجلد.

§   التهاب الحلق أو حمى.

§   دوار شديد أو إغماء.

§   آلام شديدة بالمعدة.

§   سرعة غير معتادة أو عدم انتظام في ضربات القلب.

§   اصفرار في الجلد و/أو العين (اليرقان).

 

أعراض جانبية مألوفة (تؤثر على ما بين ۱ ضمن ۱۰ و ۱ ضمن ۱۰۰ شخص): دوار، و جفاف في الحلق، حكة، مشاكل في النوم، طفح جلدي، إسهال، أو إمساك، سقوط الشعر، سعال جاف و متهيج، تغير في طريقة تذوق الأشياء، اضطراب في المعدة، الشعور بالإعياء، ألم في البطن، ضيق في التنفس.

 

أعراض جانبية غير مألوفة (تؤثر على ما بين ۱ ضمن ۱۰۰ و ۱ ضمن ۱۰۰۰ شخص): ضربات قلب غير منظمة سريعة و عالية الصوت، و تعب، ألم في الصدر، و الشعور بالإعياء بصفة عامة، و انخفاض في ضغط الدم، شحوب، انخفاض في تدفق الدم لليدين و القدمين، و تورم في العينين و الشفتين (وذمة وعائیة) (مثل متلازمة رینود)، و احمرار في الوجه.

 

أعراض جانبية نادرة (تؤثر على ما بين ۱ ضمن ۱۰۰۰ و ۱ ضمن ۱۰,۰۰۰ شخص): فقدان الشهية، و تقرحات الفم، و شعور بالنعاس، و اضطرابات أو فشل في الكلى، و صداع، و تغيرات في تواتر التبول، و الشعور بالوخز، و الخدر أو التنميل.

 

أعراض جانبية نادرة جدا (تؤثر على أقل من ۱ ضمن ۱۰,۰۰۰ شخص): اختلال وظائف الكبد و زيادة في إنزيمات الكبد، تلف الكبد، و التهاب الكبد أو اليرقان، و التشوش، و الاكتئاب، و الإغماء، و قرحة المعدة، و سكتة دماغية بسيطة، آلام في

العضلات، عدم وضوح الرؤية، و آلام في المفاصل، و مشاكل في القلب بما في ذلك النوبات القلبية، و عدوى الصدر، و الصفير أو صعوبة في التنفس، و التهاب البنكرياس، و الطفح الجلدي أو حساسية الجلد، و سيلان الأنف، و تورم أنسجة

الثدي لدى الرجال، و تورم اللسان، و الحمى، العجز الجنسي، و حساسية الجلد للضوء، و متلازمة ستیفنز جونسون (مرض

خطير يحدث فيه تقرحات في الجلد و الفم و العينين و الأعضاء التناسلية)، و تغيرات في مستويات المواد الكيميائية في الدم

أو النظام اللمفاوي (مثل البوتاسيوم و السكريات).

يرجى إخبار الطبيب أو الصيدلي إذا أصبحت إحدى تلك الآثار الجانبية خطيرة أو إذا لاحظت حدوث آثار جانبية غير مذكورة في هذه النشرة.

§   أحفظ الدواء في مكان أمن بعيدًا عن متناول و نظر الأطفال.

§   يحفظ في درجة حرارة أقل من ۳۰ درجة مئوية.

§   لا تأخذ الأسیتاب بعد تاريخ انتهاء الصلاحية المطبوع على العبوة. تاريخ الانتهاء يشير إلى اليوم الأخير من الشهر.

يجب أن لا يتم التخلص من الأدوية عن طريق مياه الصرف الصحي أو النفايات المنزلية. اسأل الصيدلي عن كيفية التخلص من الأدوية التي لم تعد مطلوبة. وسوف تساعد هذه التدابير على حماية البيئة.

مما تتكون أقراص أسیتاب

المادة النشطة هي كابتوبریل.

يحتوي كل قرص أسیتاب ۲٥ على: ۲٥ ملجم كابتوبریل.

يحتوي كل قرص أسیتاب ٥۰ على: ٥۰ ملجم كابتوبریل.

 

السواغ:

لاكتوز أحادي الماء، نشا ، میكروكریستالین سیلیولوز، و حمض ستیاریك.

 

ما هو الشكل الصيدلي لقرص الأسیتاب و ما هي محتويات العبوة

قرص أسیتاب ۲٥ ملجم: هو قرص مستدير أبيض إلى شبيه بالأبيض به خطين فاصلين على أحد الأوجه و محفور على الوجه الآخر (KS27) و له رائحة كبريتية مميزة.

قرص أسیتاب ٥۰ ملجم: هو قرص مستدير أبيض إلى شبيه بالأبيض به خط فاصل على أحد الأوجه و محفور على الوجه الآخر (KS52) و له رائحة كبريتية مميزة.

الشركة المصنعة والمفوضة بالتسويق

الشركة الكويتية السعودية للصناعات الدوائيه

ص ب: 5512 ،الرمز البريدي: 13056 الصفاة، الكويت

هاتف: 96524745013-96524745014+

فاكس: 96524745361+

الموقع الالكتروني: www.kspico.com

تم تحديث النشرة بتاريخ ديسمبر ۲۰۱۹
 Read this leaflet carefully before you start using this product as it contains important information for you

Acetab tablets 25 mg Acetab tablets 50 mg

Each Acetab 25 tablet contains: 25mg captopril Each Acetab 50 tablet contains: 50mg captopril (For full list of excipients , see section 6.1 )

Acetab 25 mg tablet is white to off-white round tablet with two break lines on one side and KS27 engraved on the other side which may have a characteristic, sulfide-like odour. Acetab 50 mg tablet is white to off-white round tablet with break lines on one side and KS52 engraved on the other side which may have a characteristic, sulfide-like odour.

Hypertension:The management of mild to moderate hypertension. In severe hypertension it should be used where standard therapy is ineffective or inappropriate.

Congestive heart failure: Acetab is indicated for the treatment of congestive heart failure. The drug should be used together with diuretics and, when appropriate, digitalis and beta-blockers.

In patients on doses of over 100 mg daily plus or minus a diuretic, in those with severe renal impairment or those with severe congestive heart failure use of Acetab should be under specialist supervision.

Myocardial Infarction:

- Short-term (4 weeks) treatment: Acetab is indicated in any clinically stable patient within the first 24 hours of an infarction.

- long-term prevention of symptomatic heart failure: Acetab is indicated in clinically stable patients with asymptomatic left ventricular dysfunction (ejection fraction ≤ 40%) following myocardial infarction to improve survival, delay the onset of symptomatic heart failure, reduce hospitalisations for heart failure and reduce recurrent myocardial infarction and coronary revascularisation procedures.

Before starting therapy, cardiac function should be determined by radionuclide ventriculography or echocardiography.

Type I Diabetic nephropathy: Acetab is indicated in insulin dependent diabetics for the treatment of macroproteinuric diabetic nephropathy (microalbuminuria greater than 30 mg/day) (see section 5.1). Acetab may prevent the progression of the renal disease and reduce associated clinical events e.g. dialysis, renal transplantation and death.

Acetab can be used alone or in combination with other antihypertensive agents (see sections 4.3, 4.4, 4.5 and 5.1).


Dose should be individualised according to patient's profile (see 4.4) and blood pressure response. The recommended maximum daily dose is 150mg.

Acetab may be taken before, during and after meals.

Hypertension: the recommended starting dose is 25-50mg daily in two divided doses. The dose may be increased incrementally, with intervals of at least 2 weeks, to 100-150mg/day in two divided doses as needed to reach target blood pressure. Acetab may be used alone or with other antihypertensive agents, especially thiazide diuretics. A once-daily dosing regimen may be appropriate when concomitant antihypertensive medication such as thiazide diuretics is added.

In patients with a strongly active renin-angiotensin-aldosterone system (hypovolaemia, renovascular hypertension, and cardiac decompensation) it is preferable to commence with a single dose of 6.25mg or 12.5mg. The inauguration of this treatment should preferably take place under close medical supervision. These doses will then be administered at a rate of two per day. The dosage can be gradually increased to 50mg per day in one or two doses and if necessary to 100mg per day in one or two doses.

Congestive Heart failure: treatment with Acetab for heart failure should be initiated under close medical supervision. The usual starting dose is 6.25mg - 12.5mg BID or TID. Titration to the maintenance dose (75 - 150mg per day) should be carried out based on patient's response, clinical status and tolerability, up to a maximum of 150mg per day in divided doses. The dose should be increased incrementally, with intervals of at least 2 weeks to evaluate patient's response.

 Myocardial infarction:

- Short-term treatment: Acetab treatment should begin in hospital as soon as possible following the appearance of the signs and/or symptoms in patients with stable haemodynamics. A 6.25mg test dose should be administered, with a 12.5mg dose being administered 2 hours afterwards and a 25mg dose 12 hours later. From the following day, captopril should be administered in a 100mg/day dose, in two daily administrations, for 4 weeks, if warranted by the absence of adverse haemodynamic reactions. At the end of the 4 weeks of treatment, the patient's state should be reassessed before a decision is taken concerning treatment for the post-myocardial infarction stage.

- chronic treatment: if captopril treatment has not begun during the first 24 hours of the acute myocardial infarction stage, it is suggested that treatment be instigated between the 3rd and 16th day post-infarction once the necessary treatment conditions have been attained (stable haemodynamics and management of any residual ischaemia). Treatment should be started in hospital under strict surveillance (particularly of blood pressure) until the 75mg dose is reached. The initial dose must be low (see 4.4), particularly if the patient exhibits normal or low blood pressure at the initiation of therapy. Treatment should be initiated with a dose of 6.25mg followed by 12.5mg 3 times daily for 2 days and then 25mg 3 times daily if warranted by the absence of adverse haemodynamic reactions. The recommended dose for effective cardioprotection during long-term treatment is 75 to 150mg daily in two or three doses. In cases of symptomatic hypotension, as in heart failure, the dosage of diuretics and/or other concomitant vasodilators may be reduced in order to attain the steady state dose of captopril. Where necessary, the dose of captopril should be adjusted in accordance with the patient's clinical reactions. Captopril may be used in combination with other treatments for myocardial infarction such as thrombolytic agents, beta-blockers and acetylsalicylic acid.

Type I Diabetic nephropathy: in patients with type I diabetic nephropathy, the recommended daily dose of captopril is 75-100mg in divided doses. If additional lowering of blood pressure is desired, additional antihypertensive medications may be added.

Renal impairment: since captopril is excreted primarily via the kidneys, dosage should be reduced or the dosage interval should be increased in patients with impaired renal function. When concomitant diuretic therapy is required, a loop diuretic (e.g. furosemide), rather than a thiazide diuretic, is preferred in patients with severe renal impairment.

In patients with impaired renal function, the following daily dose may be recommended to avoid accumulation of captopril.

Creatinine clearance

(ml/min/1.73 m²)

Daily starting dose

(mg)

Daily maximum dose

(mg)

>40

25-50

150

21-40

25

100

10-20

12.5

75

<10

6.25

37.5

Elderly patients: as with other antihypertensive agents, consideration should be given to initiating therapy with a lower starting dose (6.25mg BID) in elderly patients who may have reduced renal function and other organ dysfunctions.

Dosage should be titrated against the blood pressure response and kept as low as possible to achieve adequate control.

Children and adolescents: the efficacy and safety of captopril have not been fully established. The use of captopril in children and adolescents should be initiated under close medical supervision. The initial dose of captopril is about 0.3mg/kg body weight. For patients requiring special precautions (children with renal dysfunction, premature infants, new-borns and infants, because their renal function is not the same with older children and adults) the starting dose should be only 0.15mg captopril/kg weight. Generally, captopril is administered to children 3 times a day, but dose and interval of dose should be adapted individually according to patient's response.


Acetab is contraindicated in the following cases: 1. History of hypersensitivity to captopril, to any of the excipients or any other ACE inhibitor. 2. History of angioedema associated with previous ACE inhibitor therapy. 3. Hereditary / idiopathic angioneurotic oedema. 4. Second and third trimester of pregnancy (see sections 4.4 and 4.6). 5. Lactation (see 4.6). 6. The concomitant use of Acetab tablets, hard with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2)

Hypotension: rarely hypotension is observed in uncomplicated hypertensive patients. Symptomatic hypotension is more likely to occur in hypertensive patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea, vomiting or haemodialysis. Volume and/or sodium depletion should be corrected before the administration of an ACE inhibitor and a lower starting dose should be considered.

Patients with heart failure are at higher risk of hypotension and a lower starting dose is recommended when initiating therapy with an ACE inhibitor. Caution should be used whenever the dose of captopril or diuretic is increased in patients with heart failure.

As with any antihypertensive agent, excessive blood pressure lowering in patients with ischaemic cardiovascular or cerebrovascular disease may increase the risk of myocardial infarction or stroke. If hypotension develops, the patient should be placed in a supine position. Volume repletion with intravenous normal saline may be required.

Renovascular hypertension: there is an increased risk of hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with ACE inhibitors. Loss of renal function may occur with only mild changes in serum creatinine. In these patients, therapy should be initiated under close medical supervision with low doses, careful titration and monitoring of renal function.

Renal impairment: in cases of renal impairment (creatinine clearance ≤40 ml/min), the initial dosage of captopril must be adjusted according to the patient's creatinine clearance (see 4.2), and then as a function of the patient's response to treatment. Routine monitoring of potassium and creatinine are part of normal medical practice for these patients.

Angioedema: angioedema of the extremities, face, lips, mucous membranes, tongue, glottis or larynx may occur in patients treated with ACE inhibitors including Captopril. This may occur anytime during treatment. However, in rare cases, severe angioedema may develop after long-term treatment with an ACE inhibitor. In such cases, Captopril should be discontinued promptly and appropriate monitoring should be instituted to ensure complete resolution of symptoms prior to dismissing the patient. In those instances where swelling has been confined to the face and lips the condition generally resolved without treatment, although antihistamines have been useful in relieving symptoms. Angioedema involving the tongue, glottis or larynx may be fatal. Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, appropriate therapy, which may include subcutaneous epinephrine solution 1:1000 (0.3 ml to 0.5 ml) and/or measures to ensure a patent airway, should be administered promptly. The patient should be hospitalised and observed for at least 12 to 24 hours and should not be discharged until complete resolution of symptoms has occurred.

Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks.

Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor (see 4.3).

Intestinal angioedema has also been reported rarely in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior facial angioedema and C-1 esterase levels were normal. The angioedema was diagnosed by procedures including abdominal CT scan, or ultrasound or at surgery and symptoms resolved after stopping the ACE inhibitor. Intestinal angioedema should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain (see 4.8).

Cough: cough has been reported with the use of ACE inhibitors. Characteristically, the cough is non-productive, persistent and resolves after discontinuation of therapy.

Hepatic failure: rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. The mechanism of this syndrome is not understood. Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up.

Hyperkalaemia: elevations in serum potassium have been observed in some patients treated with ACE inhibitors, including captopril. Patients at risk for the development of hyperkalaemia include those with renal insufficiency, diabetes mellitus, or those using concomitant potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes; or those patients taking other drugs associated with increases in serum potassium (e.g. heparin). If concomitant use of the above mentioned agents is deemed appropriate, regular monitoring of serum potassium is recommended.

Combination with lithium: Acetab is not recommended in association with lithium due to the potentiation of lithium toxicity (see 4.5).

Aortic and mitral valve stenosis/Obstructive hypertropic cardiomyopathy: ACE inhibitors should be used with caution in patients with left ventricular valvular and outflow tract obstruction and avoided in cases of cardiogenic shock and haemodynamically significant obstruction.

Neutropenia/Agranulocytosis: neutropenia/agranulocytosis, thrombocytopenia and anaemia have been reported in patients receiving ACE inhibitors, including captopril. In patients with normal renal function and no other complicating factors, neutropenia occurs rarely. Captopril should be used with extreme caution in patients with collagen vascular disease, immunosuppressant therapy, treatment with allopurinol or procainamide, or a combination of these complicating factors, especially if there is pre-existing impaired renal function. Some of these patients developed serious infections which in a few instances did not respond to intensive antibiotic therapy.

If captopril is used in such patients, it is advised that white blood cell count and differential counts should be performed prior to therapy, every 2 weeks during the first 3 months of captopril therapy, and periodically thereafter. During treatment all patients should be instructed to report any sign of infection (e.g. sore throat, fever) when a differential white blood cell count should be performed. Captopril and other concomitant medication (see 4.5) should be withdrawn if neutropenia (neutrophils less than 1000/mm³) is detected or suspected.

In most patients neutrophil counts rapidly return to normal upon discontinuing captopril.

Proteinuria: proteinuria may occur particularly in patients with existing renal function impairment or on relatively high doses of ACE inhibitors.

Total urinary proteins greater than 1 g per day were seen in about 0.7% of patients receiving captopril. The majority of patients had evidence of prior renal disease or had received relatively high doses of captopril (in excess of 150mg/day), or both. Nephrotic syndrome occurred in about one-fifth of proteinuric patients. In most cases, proteinuria subsided or cleared within six months whether or not captopril was continued. Parameters of renal function, such as BUN and creatinine, were seldom altered in the patients with proteinuria.

Patients with prior renal disease should have urinary protein estimations (dip-stick on first morning urine) prior to treatment, and periodically thereafter.

Anaphylactoid reactions during desensitisation: sustained life-threatening anaphylactoid reactions have been rarely reported for patients undergoing desensitising treatment with hymenoptera venom while receiving another ACE inhibitor. In the same patients, these reactions were avoided when the ACE inhibitor was temporarily withheld, but they reappeared upon inadvertent rechallenge. Therefore, caution should be used in patients treated with ACE inhibitors undergoing such desensitisation procedures.

Anaphylactoid reactions during high-flux dialysis / lipoprotein apheresis membrane exposure: anaphylactoid reactions have been reported in patients’ haemodialysed with high-flux dialysis membranes or undergoing low-density lipoprotein apheresis with dextran sulphate absorption. In these patients, consideration should be given to using a different type of dialysis, membrane or a different class of medication.

Surgery/Anaesthesia: hypotension may occur in patients undergoing major surgery or during treatment with anaesthetic agents that are known to lower blood pressure. If hypotension occurs, it may be corrected by volume expansion.

Diabetic patients: the glycaemia levels should be closely monitored in diabetic patients previously treated with oral antidiabetic drugs or insulin, namely during the first month of treatment with an ACE inhibitor.

Risk of hypokalaemia: the combination of an ACE inhibitor with a thiazide diuretic does not rule out the occurrence of hypokalaemia. Regular monitoring of kalaemia should be performed.

Lactose: Acetab contains lactose; therefore it should not be used in cases of congenital galactosaemia, glucose and galactose malabsorption or lactase deficiency syndromes (rare metabolic diseases).

Ethnic differences: as with other angiotensin converting enzyme inhibitors, captopril is apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of a higher prevalence of low-renin states in the black hypertensive population.

Pregnancy: ACE inhibitors should not be initiated during pregnancy. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started (see 4.3 and 4.6).

Dual blockade of the renin-angiotensin-aldosterone system (RAAS): There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended (see sections 4.5 and 5.1).

If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.

ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.

Fetal Toxicity

·         When Pregnancy is detected, discontinue Acetab tablets, as soon as possible.

Drugs that act directly on the rennin-Angiotensin system can cause injury and death to the developing fetus


Potassium sparing diuretics or potassium supplements: ACE inhibitors attenuate diuretic induced potassium loss. Potassium sparing diuretics (e.g. spironolactone, triamterene or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium. If concomitant use is indicated because of demonstrated hypokalaemia they should be used with caution and with frequent monitoring of serum potassium (see 4.4).

Diuretics (thiazide or loop diuretics): prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with captopril (see 4.4). The hypotensive effects can be reduced by discontinuation of the diuretic, by increasing volume or salt intake or by initiating therapy with a low dose of captopril. However, no clinically significant drug interactions have been found in specific studies with hydrochlorothiazide or furosemide.

Other antihypertensive agents: captopril has been safely co-administered with other commonly used anti-hypertensive agents (e.g. beta-blockers and long-acting calcium channel blockers). Concomitant use of these agents may increase the hypotensive effects of captopril. Treatment with nitroglycerine and other nitrates, or other vasodilators, should be used with caution.

Alpha blocking agents: concomitant use of alpha blocking agents may increase the antihypertensive effects of captopril and increase the risk of orthostatic hypotension.

Treatments of acute myocardial infarction: captopril may be used concomitantly with acetylsalicylic acid (at cardiologic doses), thrombolytics, beta-blockers and/or nitrates in patients with myocardial infarction.

Lithium: reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors. Concomitant use of thiazide diuretics may increase the risk of lithium toxicity and enhance the already increased risk of lithium toxicity with ACE inhibitors. Use of captopril with lithium is not recommended, but if the combination proves necessary, careful monitoring of serum lithium levels should be performed (see 4.4)

Tricyclic antidepressants / Antipsychotics: ACE inhibitors may enhance the hypotensive effects of certain tricyclic antidepressants and antipsychotics (see 4.4). Postural hypotension may occur.

Allopurinol, procainamide, cytostatic or immunosuppressive agents: concomitant administration with ACE inhibitors may lead to an increased risk for leucopenia especially when the latter are used at higher than currently recommended doses.

Probenecid: The renal clearance of captopril is reduced in the presence of probenecid.

Clonidine: It has been suggested that the anti-hypertensive effect of captopril can be delayed when patients treated with clonidine are changed to captopril

Non-steroidal anti-inflammatory medicinal products: it has been described that non-steroidal anti-inflammatory medicinal products (NSAIDs) and ACE inhibitors exert an additive effect on the increase in serum potassium whereas renal function may decrease. These effects are, in principle, reversible. Rarely, acute renal failure may occur, particularly in patients with compromised renal function such as the elderly or dehydrated. Chronic administration of NSAIDs may reduce the antihypertensive effect of an ACE inhibitor.

Sympathomimetics: may reduce the antihypertensive effects of ACE inhibitors; patients should be carefully monitored.

Antidiabetics: pharmacological studies have shown that ACE inhibitors, including captopril, can potentiate the blood glucose-reducing effects of insulin and oral antidiabetics such as sulphonylurea in diabetics. Should this very rare interaction occur, it may be necessary to reduce the dose of the antidiabetic during simultaneous treatment with ACE inhibitors.

Clinical Chemistry: Captopril may cause a false-positive urine test for acetone.

Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1)


Pregnancy: Controlled studies with ACE inhibitors have not been done in humans, but limited number of cases of first trimester exposures has not shown malformations. The use of ACE inhibitors is not recommended during the first trimester of pregnancy (see 4.4). The use of ACE inhibitors is contraindicated during the second and third trimesters of pregnancy (see section 4.3 and 4.4).

Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.

When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started. Exposure to ACE inhibitor therapy during the second and third trimesters is known to induce human feototoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see 5.3). Should exposure to ACE inhibitors have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended. Infants whose mothers have taken ACE inhibitors should be closely observed for hypotension (see 4.3 and 4.4).

Lactation: Limited pharmacokinetic data demonstrate very low concentrations in breast milk (see 5.2). Although these concentrations seem to be clinically irrelevant, the use of Acetab in breastfeeding is not recommended for preterm infants and for the first few weeks after delivery, because of the hypothetical risk of cardiovascular and renal effects and because there is not enough clinical experience.

In the case of an older infant, the use of Acetab in a breast-feeding mother may be considered if this treatment is necessary for the mother and the child is observed for any adverse effect.


As with other antihypertensives, the ability to drive and use machines may be reduced, namely at the start of the treatment, or when posology is modified, and also when used in combination with alcohol, but these effects depend on the individual's susceptibility.


Frequency is defined using the following convention: common (> 1/100, < 1/10), uncommon (> 1/1,000, < 1/100), rare (> 1/10,000, < 1/1,000) and very rare (< 1/10,000).

Undesirable effects reported for captopril and/or ACE inhibitor therapy include:

Blood and lymphatic disorders:

Very rare: neutropenia/agranulocytosis (see 4.4), pancytopenia particularly in patients with renal dysfunction (see 4.4), anaemia (including aplastic and haemolytic), thrombocytopenia, lymphadenopathy, eosinophilia, auto-immune diseases and/or positive ANA-titres.

Metabolism and nutrition disorders:

Rare: anorexia

Very rare: hyperkalaemia, hypoglycaemia (see 4.4)

Psychiatric disorders:

Common: sleep disorders

Very rare: confusion, depression.

Nervous system disorders:

Common: taste impairment, dizziness

Rare: drowsiness, headache and paraesthesia

Very rare: cerebrovascular incidents, including stroke, and syncope.

Eye disorders:

Very rare: blurred vision

Cardiac disorders:

Uncommon: tachycardia or tachyarrhythmia, angina pectoris, palpitations.

Very rare: cardiac arrest, cardiogenic shock

Vascular disorders:

Uncommon: hypotension (see 4.4), Raynaud syndrome, flush, pallor

Respiratory, thoracic and mediastinal disorders:

Common: dry, irritating (non-productive) cough (see 4.4) and dyspnoea

Very rare: bronchospasm, rhinitis, allergic alveolitis / eosinophilic pneumonia

Gastrointestinal disorders:

Common: nausea, vomiting, gastric irritations, abdominal pain, diarrhoea, constipation, dry mouth.

Rare: stomatitis/aphthous ulcerations, intestinal angioedema (see 4.4).

Very rare: glossitis, peptic ulcer, pancreatitis.

Hepato-biliary disorders:

Very rare: impaired hepatic function and cholestasis (including jaundice), hepatitis including necrosis, elevated liver enzymes and bilirubin.

Skin and subcutaneous tissue disorders:

Common: pruritus with or without a rash, rash, and alopecia.

Uncommon: angioedema (see 4.4)

Very rare: urticaria, Stevens Johnson syndrome, erythema multiforme, photosensitivity, erythroderma, pemphigoid reactions and exfoliative dermatitis.

Musculoskeletal, connective tissue and bone disorders:

Very rare: myalgia, arthralgia.

Renal and urinary disorders:

Rare: renal function disorders including renal failure, polyuria, oliguria, increased urine frequency.

Very rare: nephrotic syndrome.

Reproductive system and breast disorders:

Very rare: impotence, gynaecomastia.

General disorders and administration site conditions:

Uncommon: chest pain, fatigue, malaise

Very rare: fever

Investigations:

Very rare: proteinuria, eosinophilia, increase of serum potassium, decrease of serum sodium, elevation of BUN, serum creatinine and serum bilirubin, decreases in haemoglobin, haematocrit, leucocytes, thrombocytes, positive ANA-titre, elevated ESR.

To report any side effect(s):

·   Saudi Arabia:

 

The National Pharmacovigilance and Drug Safety Centre (NPC)

§  Fax: +966-11-205-7662

§  Call NPC at: +966-11-2038222, Ext.: 2317-2356-2340.

§  Reporting hotline:19999

§  E-mail: npc.drug@sfda.gov.sa

§  Website: www.sfda.gov.sa/npc

·   In another countries refer to the health Authorities


 

Symptoms of overdosage are severe hypotension, shock, stupor, bradycardia, electrolyte disturbances and renal failure.

 

 

 

Measures to prevent absorption (e.g. gastric lavage, administration of adsorbents and sodium sulphate within 30 minutes after intake) and hasten elimination should be applied if ingestion is recent. If hypotension occurs, the patient should be placed in the shock position and salt and volume supplementations should be given rapidly. Treatment with angiotensin-II should be considered. Bradycardia or extensive vagal reactions should be treated by administering atropine. The use of a pacemaker may be considered.

Captopril may be removed from circulation by haemodialysis.


Pharmacotherapeutic group: ACE inhibitors, plain, ATC code: C09AA01.

Captopril is a highly specific, competitive inhibitor of angiotensin-I converting enzyme (ACE inhibitors).

The beneficial effects of ACE inhibitors appear to result primarily from the suppression of the plasma renin-angiotensin-aldosterone system. Renin is an endogenous enzyme synthesised by the kidneys and released into the circulation where it converts angiotensinogen to angiotensin-I a relatively inactive decapeptide. Angiotensin-I is then converted by angiotensin converting enzyme, a peptidyldipeptidase, to angiotensin-II. Angiotensin-II is a potent vasoconstrictor responsible for arterial vasoconstriction and increased blood pressure, as well as for stimulation of the adrenal gland to secrete aldosterone. Inhibition of ACE results in decreased plasma angiotensin-II, which leads to decreased vasopressor activity and to reduce aldosterone secretion. Although the latter decrease is small, small increases in serum potassium concentrations may occur, along with sodium and fluid loss. The cessation of the negative feedback of angiotensin-II on the renin secretion results in an increase of the plasma renin activity.

Another function of the converting enzyme is to degrade the potent vasodepressive kinin peptide bradykinin to inactive metabolites. Therefore, inhibition of ACE results in an increased activity of circulating and local kallikrein-kinin-system which contributes to peripheral vasodilation by activating the prostaglandin system; it is possible that this mechanism is involved in the hypotensive effect of ACE inhibitors and is responsible for certain adverse reactions.

Reductions of blood pressure are usually maximal 60 to 90 minutes after oral administration of an individual dose of captopril. The duration of effect is dose related. The reduction in blood pressure may be progressive, so to achieve maximal therapeutic effects, several weeks of therapy may be required. The blood pressure lowering effects of captopril and thiazide-type diuretics are additive.

In patients with hypertension, captopril causes a reduction in supine and erect blood pressure, without inducing any compensatory increase in heart rate, nor water and sodium retention.

In haemodynamic investigations, captopril caused a marked reduction in peripheral arterial resistance. In general there were no clinically relevant changes in renal plasma flow or glomerular filtration rate. In most patients, the antihypertensive effect began about 15 to 30 minutes after oral administration of captopril; the peak effect was achieved after 60 to 90 minutes. The maximum reduction in blood pressure of a defined captopril dose was generally visible after three to four weeks.

In the recommended daily dose, the antihypertensive effect persists even during long-term treatment. Temporary withdrawal of captopril does not cause any rapid, excessive increase in blood pressure (rebound). The treatment of hypertension with captopril leads also to a decrease in left ventricular hypertrophy.

Haemodynamic investigations in patients with heart failure, showed that captopril caused a reduction in peripheral systemic resistance and a rise in venous capacity. This resulted in a reduction in pre-load and after-load of the heart (reduction in ventricular filling pressure). In addition, rises in cardiac output, work index and exercise capacity have been observed during treatment with captopril. In a large, placebo-controlled study in patients with left ventricular dysfunction (LVEF ≤ 40%) following myocardial infarction, it was shown that captopril (initiated between the 3rd to the 16th day after infarction) prolonged the survival time and reduced cardiovascular mortality. The latter was manifested as a delay in the development of symptomatic heart failure and a reduction in the necessity for hospitalisation due to heart failure compared to placebo. There was also a reduction in re-infarction and in cardiac revascularisation procedures and/or in the need for additional medication with diuretics and/or digitalis or an increase in their dosage compared to placebo.

A retrospective analysis showed that captopril reduced recurrent infarcts and cardiac revascularisation procedures (neither were target criteria of the study).

Another large, placebo-controlled study in patients with myocardial infarction showed that captopril (given within 24 hours of the event and for a duration of one month) significantly reduced overall mortality after 5 weeks compared to placebo. The favourable effect of captopril on total mortality was still detectable even after one year. No indication of a negative effect in relation to early mortality on the first day of treatment was found.

Captopril cardioprotection effects are observed regardless of the patient's age or gender, location of the infarction and concomitant treatments with proven efficacy during the post-infarction period (thrombolytic agents, beta-blockers and acetylsalicylic acid).

Type I diabetic nephropathy

In a placebo-controlled, multicentre double blind clinical trial in insulin-dependent (Type I) diabetes with proteinuria, with or without hypertension (simultaneous administration of other antihypertensives to control blood pressure was allowed), captopril significantly reduced (by 51%) the time to doubling of the baseline creatinine concentration compared to placebo; the incidence of terminal renal failure (dialysis, transplantation) or death was also significantly less common under captopril than under placebo (51%). In patients with diabetes and microalbuminuria, treatment with captopril reduced albumin excretion within two years.

The effects of treatment with captopril on the preservation of renal function are in addition to any benefit that may have been derived from the reduction in blood pressure.

Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) have examined the use of the combination of an ACE-inhibitor with an angiotensin II receptor blocker.

ONTARGET was a study conducted in patients with a history of cardiovascular or cerebrovascular disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage. VA NEPHRON-D was a study in patients with type 2 diabetes mellitus and diabetic nephropathy.

These studies have shown no significant beneficial effect on renal and/or cardiovascular outcomes and mortality, while an increased risk of hyperkalaemia, acute kidney injury and/or hypotension as compared to monotherapy was observed. Given their similar pharmacodynamic properties, these results are also relevant for other ACE-inhibitors and angiotensin II receptor blockers.

ACE-inhibitors and angiotensin II receptor blockers should therefore not be used concomitantly in patients with diabetic nephropathy.

ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) was a study designed to test the benefit of adding aliskiren to a standard therapy of an ACE-inhibitor or an angiotensin II receptor blocker in patients with type 2 diabetes mellitus and chronic kidney disease, cardiovascular disease, or both. The study was terminated early because of an increased risk of adverse outcomes. Cardiovascular death and stroke were both numerically more frequent in the aliskiren group than in the placebo group and adverse events and serious adverse events of interest (hyperkalaemia, hypotension and renal dysfunction) were more frequently reported in the aliskiren group than in the placebo group.


Captopril is an orally active agent that does not require biotransformation for activity.

Absorption and Distribution

The average minimal absorption is approximately 75%. Peak plasma concentrations are reached within 60-90 minutes. The presence of food in the gastrointestinal tract reduces absorption by about 30-40%. Approximately 25-30% of the circulating drug is bound to plasma proteins.

 

Metabolism and Elimination

The apparent elimination half-life of unchanged captopril in blood is about 2 hours. Greater than 95% of the absorbed dose is eliminated in the urine within 24 hours; 40-50% is unchanged drug and the remainders are inactive disulphide metabolites (captopril disulphide and captopril cysteine disulphide). Impaired renal function could result in drug accumulation. Therefore, in patients with impaired renal function the dose should be reduced and/or dosage interval prolonged (see 4.2).

Studies in animals indicate that captopril does not cross the blood-brain barrier to any significant extent.

 

Lactation:

In the report of twelve women taking oral captopril 100mg 3 times daily, the average peak milk level was 4.7μg/L and occurred 3.8 hours after the dose. Based on these data, the maximum daily dosage that a nursing infant would receive is less than 0.002% of the maternal daily dosage


Animal studies performed during organogenesis with captopril have not shown any teratogenic effect but captopril has produced foetal toxicity in several species, including foetal mortality during late pregnancy, growth retardation and postnatal mortality in the rat. Preclinical data reveal no other specific hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicology, genotoxicity and carcinogenicity


The excipients of one tablet are:

 

Acetab 25mg & 50mg Tablets

Lactose monohydrate

Pregelatinized starch

Microcrystalline cellulose

Stearic acid


None known.


3 years from the manufacturing date. The expiry date refers to the last day of the month

Keep in a safe place, out of the reach and sight of children.

• Store below 30ºC,


The tablets are packaged in PVC/aluminium blisters in Carton Box contain 20 or 30 Tablets.

PVC-film (Upper part of the Blister)

Aluminum foil for blister pack (Lower part of the Blister)

 

Carton Box for Acetab contain 30 Tablets


No special requirements.


Kuwait Saudi Pharmaceutical Industries Company Tel: +965 24745012/3/4 Fax: +965 24745361, P. O. Box: 5512 , postal code: 13056 Safat, Kuwait Website: www.kspico.com

01/12/2019
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