برجاء الإنتظار ...

Search Results



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)

The name of this medicine is Capril. Each tablet contains captopril (25mg) as the active ingredient.

Capril 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.

Capril 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. Capril works by lowering your blood pressure which reduces this risk.

Capril can also help people whose heart no longer pumps blood as well as it once did.

This condition is known as heart failure.

Capril 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, Capril can be used for the treatment of kidney disease in patients with diabetes.


Do not take Capril tablets if you:

• Are more than 3 months pregnant. (It is also better to avoid Capril in early pregnancy – see pregnancy section.),                                                                                                                                                              • Have ever had an allergic reaction to any ingredients of Capril or to any other medicines, including other ACE inhibitors,

• Have ever had a reaction which included swelling of the hands, lips, face or tongue where the cause was unknown,

• Suffer from any auto-immune disease (e.g. rheumatoid arthritis, systemic lupus erythematosus or scleroderma).

If any of the above affects you, or you are unsure if they do, tell your doctor who will be able to advise you.

Take special care with Capril

You must tell your doctor if you:

• Think you are (or might become) pregnant. Capril is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

• Suffer from kidney disease,

• Suffer from liver disease,

• Are undergoing dialysis,

• Suffer from heart disease, in particular problems with the valves of the heart,

• Have diabetes,

• Have recently suffered from excessive vomiting or diarrhoea,

• Are receiving immuno-suppressant therapy.

● If you are to have desensitization treatment for 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 should tell your doctor you are taking Capril.

Tell your doctor you are taking Capril tablets before you have any blood or urine tests as Capril tablets may interfere with the results of some tests.

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

Taking Capril with other medicines

Do not co-administer aliskiren with Capril in patients with diabetes.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It is especially important to tell your doctor if you are taking any of the following:

·         Non steroidal anti-inflammatory painkillers NSAIDs (e.g. indomethacin, ibuprofen),

·         Immunosuppressants (e.g. azathioprine and cyclophosphamide),

·         Potassium supplements, salt substitutes containing potassium or any other medicines which can increase potassium in your blood, e.g. (amiloride, spironolactone),

·         Water tablets (diuretics),

·         Medicines for gout (e.g. allopurinol),

·         Medicines for diabetes (as the amount you need to use may have to be changed while taking Capril),

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

·         Medicines to treat mental health problems including depression (such as lithium or amitriptyline),

·         Any other medicines to treat high blood pressure (e.g. beta-blockers such as propanolol, atenolol or calcium channel blockers such as amlodipine, nifedipine),

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

·         Patients receiving co-administration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g.,temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioeodema.

·         Dual Blockade RAS: Most patients receiving the combination of the two RAS inhibitors do not obtain any additional benefits compared to mono-therapy. In general, Avoid combined use of RAS inhibitors and other agents that block the RAS.

Pregnancy and breastfeeding

Pregnancy

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

Breastfeeding

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 Capril.

In the case of an older baby your doctor should advise you on the benefits and risks of taking Capril whilst breast-feeding, compared with other treatments.

If you are due to have surgery

Before surgery and anaesthesia (even at the dentist) you should tell your doctor or dentist that you are taking Capril as there may be a sudden fall in your blood pressure.

Taking with Food or Drink

Capril can be taken with or without food.

Driving or operating machinery

Capril 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 Capril tablets, you should not drive or use machinery.

Important information about some of the ingredients in Capril

Capril 25mg to 50mg contains lactose which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.


Take Capril as instructed. Your pharmacist may also help if you are not sure.

The usual doses are:

For the treatment of high blood pressure

The usual starting dose is 12.5 - 25mg twice a day. Your doctor may gradually increase this dose to 100 - 150mg 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 – 12.5mg two or three times a day. Your doctor may gradually increase this dose to a maximum of 150mg a day.

After a heart attack

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

For the treatment of diabetic patients with kidney disease

The usual dose is 75 - 100mg a day.

For children

The starting dose is 0.3mg/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 0.15mg/kg bodyweight.

Doctors sometimes prescribe different doses to the above and if this applies to you, you should discuss it with your doctor.

Sometimes patients may feel dizzy after taking the first one or two doses of Capril. If this happens to you, lie down until these symptoms disappear.

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

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

If you take more Capril than you should

If you or any one 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 Capril

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 Capril:

Do not stop taking Capril unless first tell your doctor.

If you have any further questions on the use of this product, ask your Doctor or Pharmacist.


Like all medicines, Capril may cause some unwanted side effects although not everybody gets them.

If you experience any of the following reactions stop taking Capril 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 (e.g. Raynaud syndrome), 

  • Swelling of the eyes and lips (angioedema),

• 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, or jaundice,

•Liver damage, inflammation of the liver

• Confusion, depression, fainting,

• Stomach ulcers,

• Mini-stroke,  

 • Muscle pain,

• Blurred vision,  

 • Joint pain,

• Heart problems including heart attack,

 • Wheezing or difficulty breathing

• Inflammation of the pancreas,

  • Rashes or skin reactions,

• Runny nose, 

• Swelling of breast in men,

• Swollen tongue,  

    • Fever,

• Impotence,   

  • Sensitivity of the skin to light,

• Stevens-Johnson syndrome (a serious illness with blistering of the skin, in the blood or lymphatic systems mouth, eyes and genitals),  

   • Changes in levels of chemicals  (e.g. potassium, sugars).

 

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


Keep out of the reach and sight of children

Store below 30°C.

Do not use the tablets after the expiry date shown on the label or carton.

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


The active substance is Captopril.

The other ingredients are:

Avicel PH 102, Lactose NF Fast Flow –BMS 35957, MAize Starch, Stearic Acid B.P.C

(see Section 2 ‘Important information about some of the ingredients of Capril Tablets’).


Capril 25mg tablets: Square, biconvex tablets with rounded corners, engraved with “SP 147” on one side and across scored on the other. They are supplied in blister packs containing 20 tablets/ pack

SPIMACO

AlQassim pharmaceutical plant

Saudi Pharmaceutical Industries &

Medical Appliance Corporation


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

اسم هذا الدواء هو كابريل. يحتوى كل قرص على مادة كابتوبريل (25 ملجم) كمادة فعالة.

أقراص كابريل تنتمى إلى مجموعة من الأدوية تعرف باسم "مثبطات الإنزيم المحول لأنجيوتنسين ((ACE. مثبطات ACE تعمل على توسيع الأوعية الدموية, مما يسهل من عملية ضخ الدم من القلب خلالها.

 كابريل يستخدم لعلاج ارتفاع ضغط الدم وبعض حالات القلب. فى حالة عدم التمكن من السيطرة على ارتفاع ضغط الدم قد يزيد ذلك من خطورة الإصابة بأمراض القلب أو السكتة الدماغية. كابريل يعمل على خفض ضغط الدم لديك وبالتالى يقلل من تلك الخطورة.

كابريل يعمل أيضاً على مساعدة الناس الذين لديهم مشكلة بالقلب تؤدى إلى عدم ضخ الدم بشكل جيد كما كان من قبل. هذه الحالة تعرف باسم فشل القلب.

كابريل يستخدم أيضاً لعلاج الناس المصابين بأزمة قلبية مؤخراً. الأزمة القلبية تحدث فى حالة انسداد أحد الشرايين الرئيسية التى تغذى عضلة القلب بالدم. مما يعنى أن القلب لا يستقبل الكمية الكافية التى يحتاج إليها من الأكسجين مما يسبب تلف فى عضلة القلب.

بالإضافة إلى أن كابريل يمكن استخدامه لعلاج أمراض الكلى لدى المرضى المصابين بداء السكرى.

لا تقم بتناول أقراص كابريل فى الحالات الآتية:

●       إذا كنتِ فيما بعد الشهر الثالث من الحمل. (حيث أنه من الأفضل أيضاً تجنب تناول أقراص كابريل فى المرحلة المبكرة من الحمل- انظرى فقرة الحمل).

●       إذا تعرضت مسبقاً لتفاعلات تحسسية لأى من مكونات أقراص كابريل أو أى دواء آخر بما فى ذلك الأدوية المثبطة لإنزيم ACE.

●       إذا تعرضت مسبقاً لتفاعلات تتضمن الآتى: تورم في اليدين والوجه, الشفتين أو اللسان حيث لم يكن السبب معروفاً.

●       إذا كنت تعانى من أي مرض من أمراض المناعة الذاتية (مثل التهاب المفاصل الروماتويدي أو الذئبة الحمراء أو تصلب الجلد).

فى حالة انطباق أى من الحالات المذكورة أعلاه عليك أو إذا كنت غير متأكد من انطباق أى من تلك الحالات عليك, أخبر طبيبك المعالج للمشورة.

ينبغى توخى الحذر عند تناول أقراص كابريل

يجب عليك إخبار طبيبك المعالج بما يلى:

●       إذا كنتِ تعتقدين بأنكِ (أو قد تصبحين) حاملآً. حيث أنه لا ينصح باستخدام أقراص كابريل فى المرحلة المبكرة من الحمل, ويجب عدم تناول أقراص كابريل إذا كنتِ فيما بعد الشهر الثالث من الحمل حيث أنه قد يسبب أضراراً جسيمة لطفلك إذا ما تم استخدامه خلال هذه المرحلة من الحمل (انظرى فقرة الحمل).

●       إذا كنت تعانى من مرض بالكلية.

●       إذا كنت تعانى من مرض بالكبد.

●       إذا كنت تخضع للغسيل الكلوى.

●       إذا كنت تعانى من مرض بالقلب, خاصةً مشاكل فى صمامات القلب.

●       إذا كنت مصاباً بمرض السكر.

●       إذا أصبت مؤخراً بإسهال شديد أو تقيؤ.

●       إذا كنت تتلقى العلاج القامع للمناعة.

●       إذا كنت ستخضع لعلاج للحساسية, مثل العلاج من لدغ الدبور أو النحل.

●       إذا كنت بصدد التعرض لعلاج لإزالة الكوليسترول من الدم عن طريق ماكينة, (وتسمى تقنية فصل مكونات LDL) يجب عليك إخبار طبيبك المعالج بأنك تتناول أقراص كابريل.

أخبر طبيبك المعالج بأنك تتناول أقراص كابريل قبل التعرض لإجراء أى اختبارات للدم أو البول, حيث أن أقراص كابريل قد تغير من نتائج هذه الاختبارات.

بعض المرضى المنحدرين من منطقة البحر الكاريبي قد تتطلب جرعات أكبر من أقراص كابريل للحصول على الحد الكافي لخفض ضغط الدم.
تناول كابريل مع أدوية أخرى

لا تتناول دواء اليسكيرين مع كابريل في مرضي السكري

فضلاً أخبر طبيبك المعالج أو الصيدلى بشأن أى أدوية أخرى تتناولها أو تناولتها مؤخراً, بما فيها تلك التى حصلت عليها بدون وصفة طبية. ومن الضرورى بشكل خاص إخبار طبيبك المعالج إذا كنت تتناول أياً مما يلى:

●       مسكنات الألم ومضادات الالتهاب غير الإستيرويدية (NSAIDs) (مثل إندوميثازين وإيبوبروفين).

●       مثبطات المناعة (مثل أزاثيوبرين وسيكلوفوسفاميد).

●       مكملات البوتاسيوم أو بدائل الأملاح التى تحتوى على البوتاسيوم أو أى أدوية أخرى قد تسبب زيادة مستوى البوتاسيوم بالدم (مثل ترايمتيرين و سبيرونولاكتون).

●       أقراص الماء (مدرات البول).

●       أدوية لعلاج النقرس (مثل ألوبيورينول).

●       أدوية لعلاج مرض السكر (حيث قد يتطلب الأمر تغيير الجرعة التى تحتاج إليها أثناء تناولك لأقراص كابريل).

●       الأدوية التى تعمل على توسيع الأوعية الدموية (مثل مينوكسيديل وكلونيدين).

●       الأدوية المستخدمة لعلاج المشاكل النفسية بما في ذلك الاكتئاب (مثل الليثيوم وأميتريبتيلين).

●       أى أدوية أخرى تستخدم لعلاج ارتفاع ضغط الدم (مثل حاصرات مستقبلات بيتا مثل بروبرانولول أو أتينولول أو حاصرات قنوات الكالسيوم مثل أملوديبين أوالنيفيديبين).

●       أى دواء قد يستخدم أثناء و بعد الإصابة بأزمة قلبية.

●       المرضي الذين تناولوا مثبطات إنزيم المحول لأنجيوتنسين مع مثطات راباميسين (المستهدف الثدييات) مقل تيمسيروليماس، سيروليماس، إيفروليماس. يحتمل أن يكونوا أكثر عرضة لحدوث وذمة وعائية.

●       الغلق المزدوج لنظام رنين- انجيوتنسين: معظم المرضى الذين تناولوا اثنين من مثبطات نظام رنين - انجيوتنسين لم يحصلوا على أي ميزة إضافية مقارنة بالعلاج بدواء واحد، عامة تجنب تناول أكثر من دواء من مثبطات نظام رنين- انجيوتنسين أو أي دواء أخر يغلق هذا النظام

الحمل والرضاعة

الحمل

يجب عليكِ إخبار طبيبك المعالج إذا كنتِ تعتقدين بأنكِ (أو قد تصبحين) حاملاً. فسوف يكون من الطبيعى أن ينصحك طبيبك المعالج بالتوقف عن تناول أقراص كابريل قبل أن تصبحى حامل أو بمجرد معرفتك بكونك حامل وسوف يصف لكِ علاجاً آخر بدلاً من كابريل. حيث أنه لا ينصح باستخدام أقراص كابريل خلال المرحلة المبكرة من الحمل, ويجب عدم تناول كابريل في مرحلة ما بعد الشهر الثالث من الحمل, حيث أنه قد يسبب ضرراً جسيماً للجنين إذا ما تم استخدامه فيما بعد الشهر الثالث من الحمل.

الرضاعة

أخبرى طبيبك المعالج إذا كنتِ ترضعين طفلكِ طبيعياً أو بصدد البدء فى الرضاعة الطبيعية. حيث أنه لا ينصح بالإرضاع الطبيعى لحديثى الولادة (فى الأسابيع القليلة الأولى بعد الولادة) وبشكل خاص المولودين قبل الأوان أثناء تناول أقراص كابريل. في حالة الأطفال الأكبر سناً يجب أن يخبرك طبيبك المعالج بشأن فوائد ومخاطر تناول كابريل أثناء الرضاعة الطبيعية مقارنة مع العلاجات الأخرى.

إذا كنت بصدد الخضوع لعملية جراحية

قبل الخضوع للجراحة والتخدير (حتى فى عيادة الأسنان) يجب أن تخبر طبيبك المعالج أو طبيب الأسنان بأنك تتناول أقراص كابريل حيث قد تتعرض لهبوط مفاجئ فى ضغط الدم.

تناول أقراص كابريل مع الطعام والشراب

يمكن تناول أقراص كابريل مع الطعام أو بدونه.

القيادة واستخدام الآلات

قد تؤثر أقراص كابريل على قدرتك على القيادة, عادةً عند البدء فى تناول العلاج لأول مرة أو فى حالة قيام طبيبك المعالج بتغيير الجرعة الخاصة بك. إذا شعرت بدوخة أو دوار أثناء تناول كابريل يجب عليك الامتناع عن القيادة أو استخدام الآلات.

معلومات هامة حول بعض مكونات أقراص كابريل

كابريل 25 ملجم إلى 50 ملجم  يحتوى على سكر اللاكتوز. إذا أخبرك طبيبك المعالج بعدم تحملك لبعض أنواع السكر, تواصل مع طبيبك المعالج قبل تناول هذا الدواء.

https://localhost:44358/Dashboard

قم دائماً بتناول أقراص كابريل تماماً كما أخبرك طبيبك المعالج. إذا كنت غير متأكد, تحقق من طبيبك المعالج أو الصيدلى.

الجرعات المعتادة هى:

لعلاج ارتفاع ضغط الدم:

عادةً ما تكون جرعة البداية هى 12.5 ملجم - 25 ملجم مرتين يومياً. قد يزيد طبيبك المعالج الجرعة تدريجياً إلى 100 ملجم - 150 ملجم يومياً إذا لزم الأمر. وقد يصف لك طبيبك المعالج دواءً آخر لخفض ضغط الدم لديك.

فى حالة فشل القلب:

عادةً ما تكون جرعة البداية هى 6.25 ملجم – 12.5 ملجم مرتين أو ثلاث مرات يومياً. قد يزيد طبيبك المعالج هذه الجرعة تدريجياً إلى 150 ملجم فى اليوم كحد أقصى.

بعد الإصابة بأزمة قلبية:

عادةً ما تكون جرعة البداية هى 6.25 ملجم, والتى قد تزداد تدريجياً تحت إشراف طبيبك المعالج كى تصل إلى 150 ملجم فى اليوم كحد أقصى.

فى حالة علاج مرضى السكر المصابين بمرض كلوى:

تكون الجرعة المعتادة هى 75 – 100 ملجم يومياً.
للأطفال:

جرعة البداية هى 0.3 ملجم لكل كيلوجرام من وزن الطفل يومياً. إذا لزم الأمر, قد يلجأ الطبيب إلى زيادة الجرعة تدريجياً.

للأطفال الذين يعانون من مشاكل في الكلى و الأطفال المولودين قبل الأوان والأطفال حديثي الولادة والرضع:

يجب أن تكون جرعة البداية هى 0.15 ملجم / كجم من وزن الطفل.

أحياناً يصف الأطباء جرعات مختلفة عما ذكر أعلاه وإذا كان هذا ينطبق عليك يجب أن تناقش ذلك مع الطبيب.

أحياناً يشعر المرضى بدوخة بعد تناول أول جرعة أو جرعتين من أقراص كابريل. إذا حدث لك ذلك, استلقِ حتى تختفي هذه الأعراض.

يجب أن تحاول تناول أقراص كابريل فى نفس الوقت تقريباً من صباح كل يوم. يمكن تناول هذه الأقراص قبل أو مع أو بعد الطعام. يجب عليك الاستمرار فى تناول علاجك من أقراص كابريل حتى لو كنت تشعر بأنك فى حالة جيدة ما لم يخبرك طبيبك المعالج بخلاف ذلك.

فى حالة تناولك لأقراص كابريل أكثر مما ينبغى:

فى حالة قيامك أو قيام أى شخص آخر بابتلاع العديد من أقراص كابريل, اتصل بالطبيب أو بقسم الطوارئ فى أقرب مستشفى فوراً. واحرص على أن تأخذ معك علبة الدواء وأى أقراص متبقية.

فى حالة نسيان تناول الجرعة من أقراص كابريل:

إذا نسيت تناول الجرعة الخاصة بك لا تقلق. فقط تناول الجرعة التالية فى الوقت المقرر لها. لا تقم بمضاعفة الجرعة لتعويض الجرعة المفقودة.

فى حالة التوقف عن تناول أقراص كابريل:

لا تتوقف عن تناول أقراص كابريل إلا بعد استشارة طبيبك المعالج أولاً.

إذا كانت لديك أية أسئلة إضافية بشأن استخدام هذا الدواء, اسأل الطبيب أو الصيدلى.

مثل جميع الأدوية, أقراص كابريل قد تسبب آثاراً جانبية, وإن لم تكن تحدث لكل من يتناول هذا الدواء.

إذا تعرضت لأى من التفاعلات الآتية, توقف عن تناول أقراص كابريل واتصل بطبيبك المعالج فوراً:

●       تورم اليدين, الوجه, الشفتين أو اللسان,

●       صعوبة فى التنفس,

●       طفح جلدى أو حرق أو احمرار أو تقشير الجلد بشكل مفاجئ وغير متوقع,

●       التهاب الحلق أو حمى,

●       دوار شديد أو إغماء,

●       ألم حاد بالمعدة,

●       تسارع أو عدم انتظام ضربات القلب بشكل غير معتاد,

●       اصفرار الجلد و/ أو اصفرار بياض العينين (اليرقان).

أعراض جانبية شائعة (والتى تصيب ما بين 1 لكل 10 و 1 لكل 100 مستخدم لهذا الدواء)

●       دوار,

●       جفاف الحلق,

●       حكة بالجلد,

●       مشاكل بالنوم,

●       طفح جلدى,

●       إسهال أو إمساك,

●       تساقط الشعر,

●       سعال جاف ومزعج,

●       تغيرات فى حاسة التذوق,

●       اضطراب في المعدة, غثيان, آلام في البطن

●       ضيق في التنفس.

أعراض جانبية غير شائعة (والتى تصيب ما بين 1 لكل 100 و 1 لكل 1000 مستخدم لهذا الدواء)

●       تسارع وعدم انتظام وارتفاع صوت ضربات القلب,

●       إرهاق,

●       ألم بالصدر,

●       شعور عام بالإعياء,

●       انخفاض ضغط الدم,

●       شحوب,

●       نقص تدفق الدم لليدين والقدمين (مثل متلازمة رينود),

●       تورم في العينين والشفتين (وذمة وعائية),

●       احمرار الوجه.

أعراض جانبية نادرة (والتى تصيب ما بين 1 لكل 1000 و 1 لكل 10,000 مستخدم لهذا الدواء)

●       فقدان الشهية,

●       تقرحات بالفم,

●       دوار,

●       اضطرابات أو فشل بالكلى,

●       صداع,

●       تغيرات فى معدل التبول,

●       شعور بوخز إبر أو دبابيس أو تنميل.

أعراض جانبية نادرة جداً (والتى تصيب أقل من 1 لكل 10,000 مستخدم لهذا الدواء)

●       فشل فى وظائف الكبد وارتفاع إنزيمات الكبد, أو اليرقان,

●       تلف بالكبد أو التهاب الكبد,

●       ارتباك, اكتئاب أو إغماء,

●       تقرحات بالمعدة,

●       سكتة دماغية مصغرة,

●       ألم بالعضلات,

●       عدم وضوح الرؤية,

●       ألم بالمفاصل,

●       مشاكل بالقلب وتشمل الأزمة القلبية,

●       أزيز أو صعوبة في التنفس,

●       التهاب البنكرياس,

●       طفح جلدى أو تفاعلات جلدية,

●       ارتشاح الأنف,

●       تضخم الثديين عند الرجال,

●       تورم اللسان,

●       حمى,

●       عجز جنسى,

●       حساسية الجلد تجاه الضوء,

●       متلازمة ستيفنز جونسون (وهى مرض خطير يصاحبه ظهور تقرحات في الجلد والعينين والفم والأعضاء التناسلية),

●       تغيرات فى مستوى بعض المواد الكيماوية (مثل البوتاسيوم, السكريات).

إذا أصبح أي من الأعراض الجانبية خطيراً, أو إذا لاحظت أى أعراض جانبية غير المدرجة فى هذه النشرة, فضلاً أخبر طبيبك المعالج أو الصيدلى فوراً.

يحفظ هذا الدواء بعيداً عن متناول ونظر الأطفال.

يحفظ فى درجة حرارة أقل من °30 درجة مئوية.

لا تستخدم هذه الأقراص بعد تاريخ الصلاحية المدون على الشريط أو العبوة.

لا يجب 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.

محتويات أقراص كابريل

المادة الفعالة هى كابتوبريل

مكونات أخرى وهى:

أفيسيل PH 102, لاكتوز سريع التدفق – بى إم إس 35957, نشاء الذرة, حمض دهني B.P.C

(انظر الفقرة 2 "معلومات هامة حول بعض مكونات أقراص كابريل")

أقراص كابريل 25 ملجم: أقراص مربعة, ثنائية التحدب بزوايا مدورة, منقوش “SP 147” على جانب واحد وقابلة للقسمة من الجانب الآخر. تتوافر هذه الأقراص فى شرائط داخل العبوة يحتوى كل شريط على 20 قرصاً.

إنتاج الدوائية

مصنع الأدوية بالقصيم

الشركة السعودية للصناعات الدوائية والمستلزمات الطبية.

المملكة العربية السعودية

فبراير 2018.
 Read this leaflet carefully before you start using this product as it contains important information for you

Capril Tablets 25 mg

Capril 25 mg Tablets: Each tablet contains captopril, 25 mg. These tablets contain Lactose. If the patient has an intolerance to some sugars, he must contact the doctor before taking this medicine. For a full list of excipients, see section 6.1

Tablets Capril 25mg: Square, biconvex tablets with rounded corners, engraved with “SP 147” on one side and across scored on the other.

Hypertension: Capril is indicated for the treatment of hypertension.
 

Heart Failure: Capril is indicated for the treatment of chronic heart failure with reduction of systolic ventricular function, in combination with diuretics and, when appropriate, digitalis and beta-blockers.
 

 

Myocardial Infarction:
 

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

- long-term prevention of symptomatic heart failure: Capril is indicated in clinically stable patients with asymptomatic left ventricular dysfunction (ejection fraction ≤40%).
 

Type I Diabetic Nephropathy: Capril is indicated for the treatment of macroproteinuric diabetic nephropathy in patients with type I diabetes. (See Section 5.1).


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

Capril 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. Captopril 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.
 

Heart failure: treatment with captopril 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: Capril treatment should begin in hospital as soon as possible following the appearance of the signs and/or symptoms in patients with stable hemodynamics. 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 hemodynamic 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 hemodynamic and management of any residual ischemia). 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 hemodynamic reactions. The recommended dose for effective cardio protection 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 (see above and section 4.4).
 

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 body 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.


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).

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, diarrhea, 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 ischemic 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.
 

Reno-vascular 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 particularly during the first weeks of treatment. However, in rare cases, severe angioedema may develop after long-term treatment with an ACE inhibitor. Treatment should be discontinued promptly. Angioedema involving the tongue, glottis or larynx may be fatal. Emergency therapy should be instituted. The patient should be hospitalized and observed for at least 12 to 24 hours and should not be discharged until complete resolution of symptoms has occurred.

 

Patients receiving co-administration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g.,temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioeodema.

 

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.
 

Lithium: the combination of lithium and captopril is not recommended (see 4.5).
 

Aortic and mitral valve stenosis/Obstructive hypertrophic 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 desensitization: sustained life-threatening anaphylactoid reactions have been rarely reported for patients undergoing desensitizing 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 desensitization 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.
 

Lactose: Capril 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 sections 4.3 and 4.6).


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.

Dual Blockade RAS: Most patients receiving the combination of the two RAS inhibitors do not obtain any additional benefits compared to mono-therapy. In general, Avoid combined use of RAS inhibitors and other agents that block the RAS

Do not co-administer aliskiren with Capril in patients with diabetes.


 

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.
 

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.


Pregnancy: Controlled studies with ACE inhibitors have not been done in humans, but limited number of cases of first trimester exposures have not shown malformations. The use of ACE inhibitors is not recommended during the first trimester of pregnancy (see section 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 fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia). (See section 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 sections 4.3 and 4.4).
 

Lactation:
 

Limited pharmacokinetic data demonstrate very low concentrations in breast milk (see section 5.2). Although these concentrations seem to be clinically irrelevant, the use of Capril 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 Capril 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.


 

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, diarrhea, constipation, dry mouth.
 

Rare: stomatitis/aphthous ulcerations
 

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:
 

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):

·         The National Pharmacovigilance and Drug Safety Centre (NPC)

Fax: +966-11-205-7662

Call NPC at:      +966-11-2038222          Exts: 2317-2356-2353-2354-2334-2340.

Toll free phone: 8002490000

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

Website: www.sfda.gov.sa/npc

 

 


  


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 synthesized 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 reduced 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 vasodilatation 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 hospitalization due to heart failure compared to placebo. There was also a reduction in re-infarction and in cardiac revascularization 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 revascularization 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 duration of one month) significantly reduced overall mortality after 5 weeks compared to placebo. The favorable 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.


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

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 remainder 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 fetal toxicity in several species, including fetal 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.


Avicel PH 102

Lactose NF Fast Flow –BMS 35957

Maize Starch

Stearic Acid B.P.C


Not applicable.


3 years.

Store below 30°C.
 

Store in the original package


Blister packs
 

Pack size: 20 tablets.


No special instructions.


SPIMACO Al-Qassim pharmaceutical plant Saudi Pharmaceutical Industries & Medical Appliance Corporation Saudi Arabia

February 2018.
}

صورة المنتج على الرف

الصورة الاساسية