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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)

Bivocard contains nebivolol, a cardiovascular drug belonging to the group of selective beta-blocking agents (i.e. with a selective action on the cardiovascular system). It prevents increased heart rate, controls heart pumping strength. It also exerts a dilating action on blood vessels, which contributes as well to lower blood pressure.

It is used to treat raised blood pressure (hypertension).

Bivocard is also used to treat mild and moderate chronic heart failure in patients aged 70 or over, in addition to other therapies.


Do not take Bivocard

  • if you are allergic to nebivolol or any of the other ingredients of this medicine (listed in section 6).
  • if you have one or more of the following disorders:
    • low blood pressure
    • serious circulation problems in the arms or legs
    • very slow heartbeat (less than 60 beats per minute)
    • certain other serious heart rhythm problems (e.g. 2nd and 3rd degree atrioventricular block, heart conduction disorders).
    • heart failure, which has just occurred or which has recently become worse, or you are receiving treatment for circulatory shock due to acute heart failure by intravenous drip feed to help your heart work
    • asthma or wheezing (now or in the past)
    • untreated phaeochromocytoma, a tumour located on top of the kidneys (in the adrenal glands)
    • liver function disorder
    • a metabolic disorder (metabolic acidosis), for example, diabetic ketoacidosis.

Warnings and precautions

Talk to your doctor or pharmacist before taking Bivocard.

Inform your doctor if you have or develop one of the following problems:

  • abnormally slow heartbeat
  • a type of chest pain due to spontaneously occurring heart cramp called Prinzmetal angina
  • untreated chronic heart failure
  • 1st degree heart block (a kind of light heart conduction disorder that affects heart rhythm)
  • poor circulation in the arms or legs, e.g. Raynaud’s disease or syndrome, cramp-like pains when walking
  • prolonged breathing problems
  • diabetes: This medicine has no effect on blood sugar, but it could conceal the warning signs of a low sugar level (e.g. palpitations, fast heartbeat).
  • overactive thyroid gland: This medicine may mask the signs of an abnormally fast heart rate due to this condition
  • allergy: This medicine may intensify your reaction to pollen or other substances you are allergic to
  • psoriasis (a skin disease - scaly pink patches) or if you have ever had psoriasis
  • if you have to have surgery, always inform your anaesthetist that you are on Bivocard before being anaesthetised.

If you have serious kidney problems do not take Bivocard for heart failure and tell your doctor.

You will be regularly monitored at the beginning of your treatment for chronic heart failure by an experienced physician (see section 3).

This treatment should not be stopped abruptly unless clearly indicated and evaluated by your doctor (see section 3).

Children and adolescents

Because of the lack of data on the use of the product in children and adolescents, Bivocard is not recommended for use in them.

Other medicines and Bivocard

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

Always tell your doctor if you are using or receiving any of the following medicines in addition to Bivocard:

  • Medicines for controlling the blood pressure or medicines for heart problems (such as amiodarone, amlodipine, cibenzoline, clonidine, digoxin, diltiazem, disopyramide, felodipine, flecainide, guanfacin, hydroquinidine, lacidipine, lidocaine, methyldopa, mexiletine, moxonidine, nicardipine, nifedipine, nimodipine, nitrendipine, propafenone, quinidine, rilmenidine, verapamil).
  • Sedatives and therapies for psychosis (a mental illness) e.g. barbiturates (also used for epilepsy), phenothiazine (also used for vomiting and nausea) and thioridazine.
  • Medicines for depression e.g. amitriptyline, paroxetine, fluoxetine.
  • Medicines used for anesthesia during an operation.
  • Medicines for asthma, blocked nose or certain eye disorders such as glaucoma (increased pressure in the eye) or dilation (widening) of the pupil.
  • Baclofen (an antispasmodic drug); Amifostine (a protective medicine used during cancer treatment)

All these drugs as well as nebivolol may influence the blood pressure and/or heart function.

  • Medicines for treating excessive stomach acid or ulcers (antacid drug): you should take Bivocard during a meal and the antacid drug between meals.

Bivocard with food and drink

Please refer to section 3.

Pregnancy and breast-feeding

Bivocard should not be used during pregnancy, unless clearly necessary.

It is not recommended for use while breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

This medicine may cause dizziness or fatigue. If affected, do not drive or operate machinery.

Bivocard contains lactose

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

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


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

Bivocard may be taken before, during or after the meal, but, alternatively, you can take it independently of meals. The tablet is best taken with some water.

Treatment of raised blood pressure (hypertension)

  • The usual dose is 5 mg Nebivolol per day. The dose should be taken preferably at the same time of the day.
  • Elderly patients and patients with a kidney disorder will usually start with 2.5 Nebivolol mg tablet daily.
  • The therapeutic effect on blood pressure becomes evident after 1-2 weeks of treatment. Occasionally, the optimal effect is reached only after 4 weeks.

Treatment of chronic heart failure

  • Your treatment will be started and closely supervised by an experienced physician.
  • Your doctor will start your treatment with 1.25 mg Nebivolol per day. This may be increased after 1-2 weeks to 2.5 Nebivolol mg per day, then to 5 mg Nebivolol per day and then to 10 mg Nebivolol per day until the correct dose is reached for you. Your doctor will prescribe the dose that is right for you at each step and you should closely follow his/her instructions.
  • The maximum recommended dose is 10mg Nebivolol a day.
  • You will need to be under the close supervision for 2 hours by an experienced physician when you start treatment and every time your dose is increased
  • Your doctor may reduce your dose if necessary
  • You should not stop treatment abruptly as this can make your heart failure worse.
  • Patients with serious kidney problems should not take this medicine.
  • Take your medicine once daily, preferably at about the same time of day.
  • Your doctor may decide to combine Bivocard tablets with other medicines to treat your condition.
  • Do not use in children or adolescents.

If you take more Bivocard than you should

If you accidentally take an overdose of this medicine, tell your doctor of pharmacist immediately. The most frequent symptoms and signs of a Bivocard overdose are very slow heart beat (bradycardia), low blood pressure with possible fainting (hypotension), breathlessness such as in asthma (bronchospasm), and acute heart failure.

You can take activated charcoal (which is available at your pharmacy) while you wait for the arrival of the doctor.

If you forget to take Bivocard

If you forget a dose of Bivocard, but remember a little later on that you should have taken it, take that day’s dose as usual. However, if a long delay has occurred (e.g. several hours), so that the next due dose is near, skip the forgotten dose and take the next, scheduled, normal dose at the usual time. Do not take a double dose. Repeated skipping, however, should be avoided.

If you stop taking Bivocard

You should always consult with your doctor before stopping Bivocard treatment, whether you are taking it for high blood pressure or chronic heart failure.

You should not stop Bivocard treatment abruptly as this can temporarily make your heart failure worse. If it is necessary to stop Bivocard treatment for chronic heart failure, the daily dose should be decreased gradually, by halving the dose, at weekly intervals.

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


Like all medicines, this medicine can cause side effects, although not everybody gets them.

When Bivocard is used for the treatment of raised blood pressure, the possible side effects are:

Common side effects (may affect up to 1 in 10 people):

  • headache
  • dizziness
  • tiredness
  • an unusual itching or tingling feeling
  • diarrhoea
  • constipation
  • nausea
  • shortness of breath
  • swollen hands or feet.

Uncommon side effects (may affect up to 1 in 100 people):

  • slow heartbeat or other heart complaints
  • low blood pressure
  • cramp-like leg pains on walking
  • abnormal vision
  • impotence
  • feelings of depression
  • digestive difficulties (dyspepsia), gas in stomach or bowel, vomiting
  • skin rash, itchiness
  • breathlessness such as in asthma, due to sudden cramps in the muscles around the airways (bronchospasm)
  • nightmares.

Very rare side effects (may affect up to 1 in 10,000 people):

  • fainting
  • worsening of psoriasis (a skin disease - scaly pink patches).

The following side effects have been reported only in some isolated cases during Bivocard treatment:

  • whole-body allergic reactions, with generalised skin eruption (hypersensitivity reactions);
  • rapid-onset swelling, especially around the lips, eyes, or of the tongue with possible sudden difficulty breathing (angioedema);
  • kind of skin rash notable for pale red, raised, itchy bumps of allergic or non-allergic causes (urticaria).

In a clinical study for chronic heart failure, the following side effects were seen:

Very common side effects (may affect more than 1 in 10 people):

  • slow heart beat
  • dizziness

Common side effects (may affect up to 1 in 10 people):

  • worsening of heart failure
  • low blood pressure (such as feeling faint when getting up quickly)
  • inability to tolerate this medicine
  • a kind of light heart conduction disorder that affects heart rhythm (1st degree AV-block)
  • swelling of the lower limbs (such as swollen ankles).

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.


Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

This medicinal product does not require any special storage conditions. Do not use this medicine after the expiry date which is stated on the carton label and blister foil after EXP. The expiry date refers to the last day of that month.

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


  • The active substance is nebivolol. Each tablet contains 2.5 or 5 mg nebivolol (as nebivolol hydrochloride): 2.5 mg of d-nebivolol and 2.5 mg of l-nebivolol.
  • The other ingredients are: Lactose BP 200, Avicel PH 101, Maize Starch, Croscarmellose Sodium Type A, Hydroxypropyl Methylcellulose, Polysorbate 80, Purified Water BP, Croscarmellose Sodium Type A, Colloidal Silicon Dioxide, Magnesium Stearate

Bivocard 2.5mg Tablets: A yellow colored round uncoated tablet plain on one side and break line on the other side Bivocard 5mg Tablets: A white to off-white round biconvex uncoated tablet, cross sect on one side and engraved "111" on the other side. Each cartoon contains 30 tablets. (Not all pack sizes may be marketed)

SPIMACO

AlQassim pharmaceutical plant

Saudi Arabia


August 2021.
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

يحتوي بيڤوكارد على نيبيڤولول ، وهو دواء للقلب والأوعية الدموية ينتمي إلى مجموعة حاصرات بيتا الانتقائية (أي تعمل بصورة انتقائية على نظام القلب والأوعية الدموية). يمنع زيادة معدل ضربات القلب ، ويتحكم في قوة ضخ القلب. كما أنه يعمل على ارتخاء الأوعية الدموية ، مما يساهم أيضًا في خفض ضغط الدم.

يتم استخدامه لعلاج ارتفاع ضغط الدم .

يستخدم بيڤوكارد أيضًا لعلاج قصور القلب المزمن الخفيف والمتوسط ​​لدى المرضى الذين تزيد أعمارهم عن 70 عامًا ، بالإضافة إلى العلاجات الأخرى.

لا تتناول بيڤوكارد

·        إذا كان لديك حساسية من نيبيڤولول أو أي من المكونات الأخرى لهذا الدواء (المدرجة في القسم 6).

·        إذا كنت تعاني من واحد أو أكثر من الاضطرابات التالية:

o      ضغط دم منخفض

o      مشاكل خطيرة في الدورة الدموية في الذراعين أو الساقين

o      بطء ضربات القلب (أقل من 60 نبضة في الدقيقة).

o      بعض المشاكل الخطيرة الأخرى المرتبطة بضربات القلب (على سبيل المثال الإحصار الأذيني البطينيّ من الدرجة الثانية والثالثة ، واضطرابات التوصيل فى القلب)

o      فشل القلب ، الحالى أو الذي تفاقم مؤخرًا ، أو اذا كنت تتلقى علاجًا لصدمة الدورة الدموية - بسبب قصور القلب الحاد - عن طريق التغذية بالتنقيط في الوريد لمساعدة قلبك على العمل.

o      الربو أو الصفير (الآن أو في الماضي)

o      ورم القواتم غير المعالج ، ورم يقع أعلى الكلى (في الغدد الكظرية)

o      اضطراب وظائف الكبد

o      اضطراب التمثيل الغذائي (الحماض الاستقلابي) ، على سبيل المثال ، الحماض الكيتوني السكري.

المحاذير والإحتياطات

تحدث إلى طبيبك أو الصيدلي قبل تناول بيڤوكارد .

أخبر طبيبك إذا كنت تعاني أو تفاقم لديك أحد المشاكل التالية:

·       بطء ضربات القلب بشكل غير طبيعي

·       نوع من آلام الصدر بسبب تقلصات القلب التي تحدث بشكل مفاجئ تسمى الذبحة الصدرية  (نوع برينزميتال)

·       قصور القلب المزمن غير المعالج

·       إحصار القلب من الدرجة الأولى (نوع من اضطراب التوصيل فى القلب الذي يؤثر على ضربات القلب) 

·       ضعف الدورة الدموية في الذراعين أو الساقين ، مثل مرض أو متلازمة رينود ، وآلام تشبه التشنج عند المشي

·       مشاكل في التنفس لفترات طويلة

·       مرض السكري: لا يؤثر هذا الدواء على نسبة السكر في الدم ، ولكن يمكن أن يخفي العلامات التحذيرية لانخفاض مستوى السكر (مثل خفقان القلب وسرعة ضربات القلب).

·       فرط نشاط الغدة الدرقية: قد يخفي هذا الدواء علامات معدل ضربات القلب السريع بشكل غير طبيعي بسبب هذه الحالة

·       الحساسية: قد يزيد هذا الدواء من رد فعلك تجاه حبوب اللقاح أو المواد الأخرى التي لديك حساسية منها

·       الصدفية (مرض جلدي - بقع وردية متقشرة) أو إذا كنت قد عانيت من قبل من الصدفية

·       إذا كان عليك إجراء عملية جراحية ، فأخبر طبيب التخدير دائمًا أنك تستخدم بيڤوكارد قبل أن يتم تخديرك .

إذا كنت تعاني من مشاكل خطيرة في الكلى فلا تتناول بيڤوكارد لفشل القلب وأخبر طبيبك.

ستتم مراقبتك بانتظام في بداية علاجك لفشل القلب المزمن من قبل طبيب متمرس (انظر القسم 3).

لا ينبغي إيقاف هذا العلاج بشكل مفاجئ ما لم يتم تحديده بوضوح وتقييمه من قبل طبيبك (انظر القسم 3).

الأطفال والمراهقون

نظرا لعدم وجود بيانات عن استخدام المنتج في الأطفال والمراهقين، بيڤوكارد و لا ينصح للاستخدام في هذه الفئة.  

الأدوية الأخرى و بيڤوكارد

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

أخبر طبيبك دائمًا إذا كنت تستخدم أو تتلقى أيًا من الأدوية التالية بالإضافة إلى بيڤوكارد :

  • أدوية للتحكم في ضغط الدم أو أدوية لمشاكل القلب (مثل أميودارون ، أملوديبين ، سيبنزولين ، كلونيدين ، ديجوكسين ، ديلتيازيم ، ديسوبيراميد ، فيلوديبين ، فليكاينيد ، جوانفاسين ، هيدروكينيدين ، لاسيديبين ، ليدوكايين ، ميثيل دوبا ، ميكسيليتين ، موكسونيدين ، نيكارديبين،  نيفيديبين، نيموديبين ، نيترينديبين ، بروبافينون ، كينيدين ، ريلمينيدين ، فيراباميل).
  • المهدئات والعلاجات للذهان (مرض عقلي) مثل الباربيتورات (تستخدم أيضًا للصرع) ، الفينوثيازين (يستخدم أيضًا للقيء والغثيان) وثيوريدازين.
  • أدوية للاكتئاب مثل أميتريبتيلين ، باروكستين ، فلوكستين.
  • الأدوية المستخدمة للتخدير أثناء العملية.
  • أدوية الربو أو انسداد الأنف أو بعض اضطرابات العين مثل الجلوكوما (زيادة الضغط في العين) أو تمدد (اتساع) الحدقة.
  • باكلوفين (دواء مضاد للتشنج) ؛ أميفوستين (دواء وقائي يستخدم أثناء علاج السرطان)

كل هذه الأدوية بالإضافة إلى النيبيڤولول قد تؤثر على ضغط الدم و / أو وظائف القلب.

  • أدوية لعلاج فرط حموضة المعدة أو القرحة (دواء مضاد للحموضة): يجب تناول بيڤوكارد أثناء الوجبة ومضاد الحموضة بين الوجبات.

بيڤوكارد مع الطعام والشراب

·       يرجى الرجوع إلى القسم 3.

الحمل والرضاعة

لا ينبغي استخدام بيڤوكارد أثناء الحمل ، ما لم يكن ذلك ضروريًا بشكل واضح.

لا ينصح باستخدامه أثناء الرضاعة الطبيعية.

إذا كنت حاملاً أو مرضعة ، تعتقدين أنك حامل أو تخططين لإنجاب طفل ، اسألي طبيبك أو الصيدلي للحصول على المشورة قبل تناول هذا الدواء.

القيادة واستعمال الآلات. 

قد يسبب هذا الدواء الدوار أو التعب. إذا شعرت بهذه الأعراض ، لا تقود أو تشغل الآلات.  

يحتوي بيڤوكارد على اللاكتوز

يحتوي هذا المنتج على اللاكتوز . إذا أخبرك طبيبك أنك لا تتحمل بعض السكريات ، فاتصل بطبيبك قبل تناول هذا الدواء.   

https://localhost:44358/Dashboard

احرص دائمًا على تناول هذا الدواء تمامًا كما أخبرك طبيبك. استشر طبيبك أو الصيدلي إذا لم تكن متأكدًا.

يمكن تناول بيڤوكارد قبل أو أثناء أو بعد الوجبة ، ولكن ، كحل بديل ، يمكنك تناولها بشكل مستقل عن الوجبات. من الأفضل تناول القرص مع بعض الماء.

علاج ارتفاع ضغط الدم (ارتفاع ضغط الدم)

·   الجرعة المعتادة هي 5 ملجم نيبيڤولول في اليوم. يفضل تناول الجرعة في نفس الوقت من اليوم.

·   يبدأ المرضى المسنون والمرضى المصابون باضطراب في الكلى عادةً بتناول 2.5 ملجم نيبيڤولول يوميًا.

·   يتضح التأثير العلاجي لضغط الدم بعد أسبوع إلى أسبوعين من العلاج.  أحبانا لا يتم الوصول إلى التأثير الأمثل إلا بعد 4 أسابيع.

علاج قصور القلب المزمن

·   سيبدأ علاجك ويشرف عليه طبيب متمرس.

·   سيبدأ طبيبك علاجك بـ 1.25 ملجم نيبيڤولول يوميًا. يمكن زيادة هذا بعد أسبوع إلى أسبوعين إلى 2.5 ملجم نيبيڤولول في اليوم ، ثم إلى 5 ملجم نيبيڤولول في اليوم ثم إلى 10 ملجم نيبيڤولول في اليوم حتى الوصول إلى الجرعة الصحيحة. سيصف لك طبيبك الجرعة المناسبة لك في كل خطوة ويجب عليك اتباع تعليماته / تعليماتها عن كثب.

·   الجرعة القصوى الموصى بها هي 10 ملجم نيبيڤولول في اليوم.

·   ستحتاج إلى أن تكون تحت إشراف دقيق لمدة ساعتين من قبل طبيب متمرس عند بدء العلاج وفي كل مرة يتم زيادة جرعتك.

·   طبيبك قد يقلل جرعتك إذا لزم الأمر

·   يجب ألا تتوقف عن العلاج بشكل مفاجئ لأن ذلك قد يزيد من سوء حالة قصور القلب لديك.  

·   يجب على المرضى الذين يعانون من مشاكل خطيرة في الكلى عدم تناول هذا الدواء.

·   تناول دوائك مرة واحدة يوميًا ، ويفضل أن يكون ذلك في نفس الوقت تقريبًا من اليوم.

·   قد يقرر طبيبك دمج أقراص بيڤوكارد مع أدوية أخرى لعلاج حالتك.

·   لا يستخدم في الأطفال أو المراهقين.

إذا أخذت كمية من بيڤوكارد أكثر مما ينبغي

إذا تناولت بالخطأ جرعة زائدة من هذا الدواء ، أخبر طبيبك أو الصيدلي على الفور . الأعراض والعلامات الأكثر شيوعًا لجرعة زائدة من بيڤوكارد هي بطء ضربات القلب (بطء القلب) ، وانخفاض ضغط الدم مع احتمال حدوث إغماء ، وضيق التنفس مثل الربو (تشنج قصبي) ، وفشل القلب الحاد. 

يمكنك تناول الفحم المنشط (المتوفر في الصيدلية) أثناء انتظار وصول الطبيب.

إذا نسيت تناول بيڤوكارد

إذا نسيت جرعة من بيڤوكارد ، لكن تذكرت بعد ذلك بقليل أنه كان يجب أن تتناولها ، فتناول جرعة ذلك اليوم كالمعتاد. ومع ذلك ، إذا حدث تأخير طويل (على سبيل المثال عدة ساعات) ، بحيث تكون الجرعة التالية قريبة ، تخطي الجرعة المنسية وتناول الجرعة التالية ، المجدولة ، العادية في الوقت المعتاد. لا تتناول جرعة مضاعفة. وأيضا ، يجب تجنب التخطي المتكرر.  

إذا توقفت عن تناول بيڤوكارد

يجب عليك دائمًا استشارة طبيبك قبل التوقف عن علاج بيڤوكارد ، سواء كنت تتناوله لارتفاع ضغط الدم أو قصور القلب المزمن.

يجب ألا تتوقف عن علاج بيڤوكارد فجأة لأن ذلك قد يزيد من سوء حالة قصور القلب لديك بشكل مؤقت. إذا كان من الضروري إيقاف علاج بيڤوكارد لفشل القلب المزمن ، يجب تقليل الجرعة اليومية تدريجياً ، عن طريق خفض الجرعة إلى النصف ، على فترات أسبوعية.

إذا كان لديك أي أسئلة أخرى حول استخدام هذا المنتج ، اسأل طبيبك أو الصيدلي.

مثل جميع الأدوية ، يمكن أن يسبب هذا الدواء أعراضا جانبية ، على الرغم من عدم حدوثها لدى الجميع.

عندما يستخدم بيڤوكارد  لعلاج ارتفاع ضغط الدم ، والأعراض الجانبية المحتملة هي: 

أعراض جانبية شائعة (قد تظهر لدى حتى 1 من كل 10 أشخاص):

·       صداع الراس

·       دوخة

·       تعب

·       شعور غير عادي بالحكة أو الوخز

·       إسهال

·       إمساك

·       غثيان

·       ضيق في التنفس

·       تورم اليدين أو القدمين.

أعراض جانبية غير شائعة (قد تظهر لدى حتى 1 من كل 100 شخص):

·       بطء ضربات القلب أو غيرها من شكاوى القلب

·       ضغط دم منخفض

·       آلام تشبه تقلصات الساق عند المشي

·       رؤية غير طبيعية

·       ضعف جنسى

·       مشاعر الاكتئاب

·       صعوبات في الجهاز الهضمي (عسر الهضم) ، غازات في المعدة أو الأمعاء ، قيء

·       طفح جلدي ، حكة

·       ضيق التنفس مثل الربو ، بسبب تقلصات مفاجئة في العضلات حول الشعب الهوائية (تشنج قصبي)

·       كوابيس.

أعراض جانبية نادرة جدًا (قد تظهر لدى حتى 1 من بين 10000 شخص):

·       إغماء

·       تفاقم الصدفية (مرض جلدي - بقع وردية متقشرة).

تم الإبلاغ عن الأعراض الجانبية التالية فقط في بعض الحالات الفردية أثناء العلاج ب بيڤوكارد :

·       ردود فعل تحسسية لكامل الجسم ، مع طفح جلدي معمم (تفاعلات فرط الحساسية) ؛

·       تورم سريع الظهور، خاصة حول الشفتين أو العينين أو اللسان مع احتمال صعوبة التنفس المفاجئ (الوذمة الوعائية) ؛

·       نوع من الطفح الجلدي ملحوظ عبارة عن نتوءات حمراء باهتة ومثيرة للحكة لأسباب الحساسية أو غير التحسسية (الشرى).

في دراسة سريرية لفشل القلب المزمن ، شوهدت الأعراض الجانبية التالية:  

أعراض جانبية شائعة جدًا (قد تظهر لدى أكثر من 1 من كل 10 أشخاص):

·       بطء ضربات القلب

·       دوخة

أعراض جانبية شائعة (قد تظهر لدى حتى 1 من كل 10 أشخاص):

·       تفاقم قصور القلب

·       انخفاض ضغط الدم (مثل الشعور بالإغماء عند الوقوف بسرعة)

·       عدم القدرة على تحمل هذا الدواء

·       نوع من اضطراب التوصيل فى القلب الذي يؤثر على ضربات القلب (الإحصار الأذيني البطينيّ من الدرجة الأولى)

·       تورم الأطراف السفلية (مثل تورم الكاحلين).

إذا عانيت من أي أعراض جانبية ، فتحدث إلى طبيبك أو الصيدلي أو الممرضة. يتضمن ذلك أي أعراض جانبية محتملة غير مذكورة في هذه النشرة.

احفظ هذا الدواء بعيدًا عن متناول و نظرالأطفال.

لا يحفظ في درجة حرارة أعلى من 30 درجة مئوية

لا يتطلب هذا المنتج الطبي أي شروط تخزين خاصة. لا تستخدم هذا الدواء بعد تاريخ انتهاء الصلاحية المدون على ملصق الكرتون و الشرائط بعد كلمة EXP  يشير تاريخ انتهاء الصلاحية إلى اليوم الأخير من نفس الشهر.

لا يجوز رمي أي دواء في مياه الصرف الصحي أو النفايات المنزلية. اسأل الصيدلي عن كيفية التخلص من الأدوية التي لم تعد تستخدمها. ومن شأن هذه التدابير أن تساعد على حماية البيئة.

·   المادة الفعالة هي نيبيڤولول. يحتوي كل قرص على 2.5 أو 5 ملجم نيبيفولول (على شكل نيبيفولول هيدروكلوريد).

·   المكونات الأخرى هي: اللاكتوز BP 200، افيسيل بى اتش 101، نشا الذرة  ، كروسكارميلوز الصوديوم النوع A، هيدروكسي بروبيل ميثيل سيليلوز، بوليسوربات 80، مياه نقية BP، كروسكارميلوز الصوديوم النوع A، ثاني أكسيد السيليكون  الصمغي  ، مغنيسيوم إستيريت

أقراص بيڤوكارد  2.5 ملجم : قرص أصفر مستدير غير مطلي جلي السطح على جانب واحد وبه خط  فاصل للكسرعلى الجانب الآخر

أقراص بيڤوكارد 5 ملجم: قرص مستدير من الوجهين أبيض إلى أبيض مائل للصفرة غير مطلي ، به مقطع عرضي على جانب واحد ومحفور ب "111" على الجانب الآخر.

تحتوي كل علبة على 30 قرص

قد لا يتم تسويق جميع احجام العبوات.

إنتاج الدوائية

مصنع الأدوية بالقصيم

المملكة العربية السعودية

أغسطس 2021
 Read this leaflet carefully before you start using this product as it contains important information for you

BIVOCARD 2.5 mg tablets BIVOCARD 5 mg tablets

Each BIVOCARD 2.5 mg tablets contains 2.5 mg of nebivolol (as nebivolol hydrochloride). Excipient with known effect: 142.815 mg of Lactose BP 200 Each BIVOCARD 5 mg tablets contains 5 mg of nebivolol (as nebivolol hydrochloride). Excipient with known effect: 140.320 mg of Lactose BP 200 (See section 4.4 and 6.1). For the full list of excipients, see section 6.1.

Tablets Nebivolol 2.5mg Tablets: A yellow colored round uncoated tablet plain on one side and break line on the other side Nebivolol 5mg Tablets: A white to off-white round biconvex uncoated tablet, cross sect on one side and engraved "111" on the other side

Hypertension

Treatment of essential hypertension.

Chronic heart failure (CHF)

Treatment of stable mild and moderate chronic heart failure in addition to standard therapies in elderly patients ≥ 70 years.


Posology

Hypertension

Adults

The dose is 5 mg daily, preferably at the same time of the day.

The blood pressure lowering effect becomes evident after 1-2 weeks of treatment. Occasionally, the optimal effect is reached only after 4 weeks.

Combination with other antihypertensive agents

Beta-blockers can be used alone or concomitantly with other antihypertensive agents. To date, an additional antihypertensive effect has been observed only when Bivocard 5 mg is combined with hydrochlorothiazide 12.5-25 mg.

Patients with renal insufficiency

In patients with renal insufficiency, the recommended starting dose is 2.5 mg daily. If needed, the daily dose may be increased to 5 mg.

Patients with hepatic insufficiency

Data in patients with hepatic insufficiency or impaired liver function are limited. Therefore the use of Bivocard in these patients is contra-indicated.

Older people

In patients over 65 years, the recommended starting dose is 2.5 mg daily. If needed, the daily dose may be increased to 5 mg. However, in view of the limited experience in patients above 75 years, caution must be exercised and these patients monitored closely.

Paediatric population

The efficacy and safety of Bivocard in children and adolescents aged below 18 years has not been established. No data are available. Therefore, use in children and adolescents is not recommended.

Chronic heart failure (CHF)

The treatment of stable chronic heart failure has to be initiated with a gradual uptitration of dosage until the optimal individual maintenance dose is reached.

Patients should have stable chronic heart failure without acute failure during the past six weeks. It is recommended that the treating physician should be experienced in the management of chronic heart failure.

For those patients receiving cardiovascular drug therapy including diuretics and/or digoxin and/or ACE inhibitors and/or angiotensin II antagonists, dosing of these drugs should be stabilized during the past two weeks prior to initiation of Bivocard treatment.

The initial up titration should be done according to the following steps at 1-2 weekly intervals based on patient tolerability:

1.25 mg nebivolol, to be increased to 2.5 mg nebivolol once daily, then to 5 mg once daily and then to 10 mg once daily.

The maximum recommended dose is 10 mg nebivolol once daily.

Initiation of therapy and every dose increase should be done under the supervision of an experienced physician over a period of at least 2 hours to ensure that the clinical status (especially as regards blood pressure, heart rate, conduction disturbances, signs of worsening of heart failure) remains stable.

Occurrence of adverse events may prevent all patients being treated with the maximum recommended dose. If necessary, the dose reached can also be decreased step by step and reintroduced as appropriate.

During the titration phase, in case of worsening of the heart failure or intolerance, it is recommended first to reduce the dose of nebivolol, or to stop it immediately if necessary (in case of severe hypotension, worsening of heart failure with acute pulmonary oedema, cardiogenic shock, symptomatic bradycardia or AV block).

Treatment of stable chronic heart failure with nebivolol is generally a long-term treatment.

The treatment with nebivolol is not recommended to be stopped abruptly since this might lead to a transitory worsening of heart failure. If discontinuation is necessary, the dose should be gradually decreased divided into halves weekly.

Patients with renal insufficiency

No dose adjustment is required in mild to moderate renal insufficiency since up titration to the maximum tolerated dose is individually adjusted. There is no experience in patients with severe renal insufficiency (serum creatinine ≥ 250μmol/L). Therefore, the use of nebivolol in these patients is not recommended.

Patients with hepatic insufficiency

Data in patients with hepatic insufficiency are limited. Therefore, the use of Bivocard in these patients is contra-indicated.

Older people

No dose adjustment is required since up titration to the maximum tolerated dose is individually adjusted.

Paediatric population

The efficacy and safety of Bivocard in children and adolescents aged below 18 years has not been established. Therefore, use in children and adolescents is not recommended. No data are available.

Method of administration

Oral use.

Tablets may be taken with meals.


- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Liver insufficiency or liver function impairment. - Acute heart failure, cardiogenic shock or episodes of heart failure decompensation requiring i.v. inotropic therapy. In addition, as with other beta-blocking agents, Bivocard is contra-indicated in: • sick sinus syndrome, including sino-atrial block. • second and third degree heart block (without a pacemaker). • history of bronchospasm and bronchial asthma. • untreated phaeochromocytoma. • metabolic acidosis. • bradycardia (heart rate < 60 bpm prior to start therapy). • hypotension (systolic blood pressure < 90 mmHg). • severe peripheral circulatory disturbances.

See also 4.8 Undesirable effects.

The following warnings and precautions apply to beta-adrenergic antagonists in general.

Anaesthesia

Continuation of beta-blockade reduces the risk of arrhythmias during induction and intubation. If beta-blockade is interrupted in preparation for surgery, the beta-adrenergic antagonist should be discontinued at least 24 hours beforehand.

Caution should be observed with certain anaesthetics that cause myocardial depression. The patient can be protected against vagal reactions by intravenous administration of atropine.

Cardiovascular

In general, beta-adrenergic antagonists should not be used in patients with untreated congestive heart failure (CHF), unless their condition has been stabilised.

In patients with ischaemic heart disease, treatment with a beta-adrenergic antagonist should be discontinued gradually, i.e. over 1-2 weeks. If necessary replacement therapy should be initiated at the same time, to prevent exacerbation of angina pectoris.

Beta-adrenergic antagonists may induce bradycardia: if the pulse rate drops below 50-55 bpm at rest and/or the patient experiences symptoms that are suggestive of bradycardia, the dosage should be reduced.

Beta-adrenergic antagonists should be used with caution:

• in patients with peripheral circulatory disorders (Raynaud's disease or syndrome, intermittent claudication), as aggravation of these disorders may occur;

• in patients with first degree heart block, because of the negative effect of beta-blockers on conduction time;

• in patients with Prinzmetal's angina due to unopposed alphareceptor mediated coronary artery vasoconstriction: beta-adrenergic antagonists may increase the number and duration of anginal attacks.

Combination of nebivolol with calcium channel antagonists of the verapamil and diltiazem type, with Class I antiarrhythmic drugs, and with centrally acting antihypertensive drugs is generally not recommended, for details please refer to section 4.5.

Metabolic/Endocrinological

Bivocard does not affect glucose levels in diabetic patients. Care should be taken in diabetic patients however, as nebivolol may mask certain symptoms of hypoglycaemia (tachycardia, palpitations).

Beta-adrenergic blocking agents may mask tachycardic symptoms in hyperthyroidism. Abrupt withdrawal may intensify symptoms.

Respiratory

In patients with chronic obstructive pulmonary disorders, beta-adrenergic antagonists should be used with caution as airway constriction may be aggravated.

Other

Patients with a history of psoriasis should take beta-adrenergic antagonists only after careful consideration.

Beta-adrenergic antagonists may increase the sensitivity to allergens and the severity of anaphylactic reactions.

The initiation of Chronic Heart Failure treatment with nebivolol necessitates regular monitoring. For the posology and method of administration please refer to section 4.2. Treatment discontinuation should not be done abruptly unless clearly indicated. For further information please refer to section 4.2.

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


Pharmacodynamic interactions:

The following interactions apply to beta-adrenergic antagonists in general.

Combinations not recommended:

Class I antiarrhythmics (quinidine, hydroquinidine, cibenzoline, flecainide, disopyramide, lidocaine, mexiletine, propafenone): effect on atrio-ventricular conduction time may be potentiated and negative inotropic effect increased (see section 4.4).

Calcium channel antagonists of verapamil/diltiazem type: negative influence on contractility and atrio-ventricular conduction. Intravenous administration of verapamil in patients with ß-blocker treatment may lead to profound hypotension and atrio-ventricular block (see section 4.4).

Centrally-acting antihypertensives (clonidine, guanfacin, moxonidine, methyldopa, rilmenidine): concomitant use of centrally acting antihypertensive drugs may worsen heart failure by a decrease in the central sympathetic tonus (reduction of heart rate and cardiac output, vasodilation) (see section 4.4). Abrupt withdrawal, particularly if prior to beta-blocker discontinuation, may increase risk of “rebound hypertension”.

Combinations to be used with caution

Class III antiarrhythmic drugs (Amiodarone): effect on atrio-ventricular conduction time may be potentiated.

Anaesthetics - volatile halogenated: concomitant use of beta-adrenergic antagonists and anaesthetics may attenuate reflex tachycardia and increase the risk of hypotension (see section 4.4). As a general rule, avoid sudden withdrawal of beta-blocker treatment. The anaesthesiologist should be informed when the patient is receiving Bivocard.

Insulin and oral antidiabetic drugs: although nebivolol does not affect glucose level, concomitant use may mask certain symptoms of hypoglycaemia (palpitations, tachycardia).

Baclofen (antispastic agent), amifostine (antineoplastic adjunct): concomitant use with antihypertensives is likely to increase the fall in blood pressure, therefore the dosage of the antihypertensive medication should be adjusted accordingly.

Combinations to be considered

Digitalis glycosides: concomitant use may increase atrio-ventricular conduction time. Clinical trials with nebivolol have not shown any clinical evidence of an interaction. Nebivolol does not influence the kinetics of digoxin.

Calcium antagonists of the dihydropyridine type (amlodipine, felodipine, lacidipine, nifedipine, nicardipine, nimodipine, nitrendipine): concomitant use may increase the risk of hypotension, and an increase in the risk of a further deterioration of the ventricular pump function in patients with heart failure cannot be excluded.

Antipsychotics, antidepressants (tricyclics, barbiturates and phenothiazines): concomitant use may enhance the hypothensive effect of the beta-blockers (additive effect).

Non steroidal anti-inflammatory drugs (NSAID): no effect on the blood pressure lowering effect of nebivolol.

Sympathicomimetic agents: concomitant use may counteract the effect of beta-adrenergic antagonists. Beta-adrenergic agents may lead to unopposed alpha-adrenergic activity of sympathicomimetic agents with both alpha- and beta-adrenergic effects (risk of hypertension, severe bradycardia and heart block).

Pharmacokinetic interactions:

As nebivolol metabolism involves the CYP2D6 isoenzyme, co-administration with substances inhibiting this enzyme, especially paroxetine, fluoxetine, thioridazine and quinidine may lead to increased plasma levels of nebivolol associated with an increased risk of excessive bradycardia and adverse events.

Co-administration of cimetidine increased the plasma levels of nebivolol, without changing the clinical effect. Co-administration of ranitidine did not affect the pharmacokinetics of nebivolol. Provided Bivocard is taken with the meal, and an antacid between meals, the two treatments can be co-prescribed.

Combining nebivolol with nicardipine slightly increased the plasma levels of both drugs, without changing the clinical effect. Co-administration of alcohol, furosemide or hydrochlorothiazide did not affect the pharmacokinetics of nebivolol. Nebivolol does not affect the pharmacokinetics and pharmacodynamics of warfarin.


Pregnancy

Nebivolol has pharmacological effects that may cause harmful effects on pregnancy and/or the foetus/newborn. In general, beta-adrenoceptor blockers reduce placental perfusion, which has been associated with growth retardation, intrauterine death, abortion or early labour. Adverse effects (e.g. hypoglycaemia and bradycardia) may occur in the foetus and newborn infant. If treatment with beta-adrenoceptor blockers is necessary, beta1-selective adrenoceptor blockers are preferable.

Nebivolol should not be used during pregnancy unless clearly necessary. If treatment with nebivolol is considered necessary, the uteroplacental blood flow and the foetal growth should be monitored. In case of harmful effects on pregnancy or the foetus alternative treatment should be considered. The newborn infant must be closely monitored. Symptoms of hypoglycaemia and bradycardia are generally to be expected within the first 3 days.

Breast-feeding

Animal studies have shown that nebivolol is excreted in breast milk. It is not known whether this drug is excreted in human milk. Most beta-blockers, particularly lipophilic compounds like nebivolol and its active metabolites, pass into breast milk although to a variable extent. Therefore, breastfeeding is not recommended during administration of nebivolol.


No studies on the effects on the ability to drive and use machines have been performed. Pharmacodynamic studies have shown that Bivocard 5 mg does not affect psychomotor function. When driving vehicles or operating machines it should be taken into account that dizziness and fatigue may occasionally occur.


Adverse events are listed separately for hypertension and CHF because of differences in the background diseases.

Hypertension

The adverse reactions reported, which are in most of the cases of mild to moderate intensity, are tabulated below, classified by system organ class and ordered by frequency:

SYSTEM ORGAN CLASS

Common

(≥1/100 to < 1/10)

Uncommon

(≥1/1,000 to ≤1/100)

Very Rare

(≤1/10,000)

Not Known

Immune system disorders

   

angioneurotic oedema, hypersensitivity

Psychiatric disorders

 

nightmares;

depression

  

Nervous system disorders

headache, dizziness, paraesthesia

 

syncope

 

Eye disorders

 

impaired vision

  

Cardiac disorders

 

bradycardia, heart failure, slowed AV conduction/AV-block

  

Vascular disorders

 

hypotension, (increase of) intermittent claudication

  

Respiratory, thoracic and mediastinal disorders

dyspnoea

bronchospasm

  

Gastrointestinal disorders

constipation, nausea, diarrhoea

dyspepsia, flatulence, vomiting

  

Skin and subcutaneous tissue disorders

 

pruritus, rash erythematous

psoriasis aggravated

urticaria

Reproductive system and breast disorders

 

impotence

  

General disorders and administration site conditions

tiredness, oedema

   

The following adverse reactions have also been reported with some beta adrenergic antagonists: hallucinations, psychoses, confusion, cold/cyanotic extremities, Raynaud phenomenon, dry eyes, and oculo-mucocutaneous toxicity of the practolol-type.

Chronic heart failure

Data on adverse reactions in CHF patients are available from one placebo-controlled clinical trial involving 1067 patients taking nebivolol and 1061 patients taking placebo. In this study, a total of 449 nebivolol patients (42.1%) reported at least possibly causally related adverse reactions compared to 334 placebo patients (31.5%). The most commonly reported adverse reactions in nebivolol patients were bradycardia and dizziness, both occurring in approximately 11% of patients. The corresponding frequencies among placebo patients were approximately 2% and 7%, respectively.

The following incidences were reported for adverse reactions (at least possibly drug-related) which are considered specifically relevant in the treatment of chronic heart failure:

- Aggravation of cardiac failure occurred in 5.8 % of nebivolol patients compared to 5.2% of placebo patients.

- Postural hypotension was reported in 2.1% of nebivolol patients compared to 1.0% of placebo patients.

- Drug intolerance occurred in 1.6% of nebivolol patients compared to 0.8% of placebo patients.

- First degree atrio-ventricular block occurred in 1.4% of nebivolol patients compared to 0.9% of placebo patients.

- Oedema of the lower limb were reported by 1.0% of nebivolol patients compared to 0.2% of placebo patients.

Reporting of suspected adverse reactions:

The National Pharmacovigilance Centre (NPC):

·       Fax: +966-11-205-7662

·       Call NPC at +966-11-2038222, Ext 2317-2356-2340

·       SFDA Call Center: 19999

·       E-mail: npc.drug@sfda.gov.sa

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

 


No data are available on overdosage with Bivocard.

Symptoms

Symptoms of overdosage with beta-blockers are: bradycardia, hypotension, bronchospasm and acute cardiac insufficiency.

Treatment

In case of overdosage or hypersensitivity, the patient should be kept under close supervision and be treated in an intensive care ward. Blood glucose levels should be checked. Absorption of any drug residues still present in the gastro-intestinal tract can be prevented by gastric lavage and the administration of activated charcoal and a laxative. Artificial respiration may be required. Bradycardia or extensive vagal reactions should be treated by administering atropine or methylatropine. Hypotension and shock should be treated with plasma/plasma substitutes and, if necessary, catecholamines. The beta-blocking effect can be counteracted by slow intravenous administration of isoprenaline hydrochloride, starting with a dose of approximately 5 μg/minute, or dobutamine, starting with a dose of 2.5 μg/minute, until the required effect has been obtained. In refractory cases isoprenaline can be combined with dopamine. If this does not produce the desired effect either, intravenous administration of glucagon 50-100 μg/kg i.v. may be considered. If required, the injection should be repeated within one hour, to be followed -if required- by an i.v. infusion of glucagon 70 μg/kg/h. In extreme cases of treatment-resistant bradycardia, a pacemaker may be inserted.


Pharmacotherapeutic group: Beta blocking agent, selective.

ATC code: C07AB12

Nebivolol is a racemate of two enantiomers, SRRR-nebivolol (or d-nebivolol) and RSSS-nebivolol (or l-nebivolol). It combines two pharmacological activities:

• It is a competitive and selective beta-receptor antagonist: this effect is attributed to the SRRR-enatiomer (d-enantiomer).

• It has mild vasodilating properties due to an interaction with the L-arginine/nitric oxide pathway.

Single and repeated doses of nebivolol reduce heart rate and blood pressure at rest and during exercise, both in normotensive subjects and in hypertensive patients. The antihypertensive effect is maintained during chronic treatment.

At therapeutic doses, nebivolol is devoid of alpha-adrenergic antagonism.

During acute and chronic treatment with nebivolol in hypertensive patients systemic vascular resistance is decreased. Despite heart rate reduction, reduction in cardiac output during rest and exercise may be limited due to an increase in stroke volume. The clinical relevance of these haemodynamic differences as compared to other beta1 receptor antagonists has not been fully established.

In hypertensive patients, nebivolol increases the NO-mediated vascular response to acetylcholine (ACh) which is reduced in patients with endothelial dysfunction.

In a mortality–morbidity, placebo-controlled trial performed in 2128 patients ≥ 70 years (median age 75.2 years) with stable chronic heart failure with or without impaired left ventricular ejection fraction (mean LVEF: 36 ± 12.3%, with the following distribution: LVEF less than 35% in 56% of patients, LVEF between 35% and 45% in 25% of patients and LVEF greater than 45% in 19% of patients) followed for a mean time of 20 months, nebivolol, on top of standard therapy, significantly prolonged the time to occurrence of deaths or hospitalisations for cardiovascular reasons (primary end-point for efficacy) with a relative risk reduction of 14% (absolute reduction: 4.2%). This risk reduction developed after 6 months of treatment and was maintained for all treatment duration (median duration: 18 months). The effect of nebivolol was independent from age, gender, or left ventricular ejection fraction of the population on study. The benefit on all cause mortality did not reach statistical significance in comparison to placebo (absolute reduction: 2.3%).

A decrease in sudden death was observed in nebivolol treated patients (4.1% vs 6.6%, relative reduction of 38%).

In vitro and in vivo experiments in animals showed that Nebivolol has no intrinsic sympathicomimetic activity.

In vitro and in vivo experiments in animals showed that at pharmacological doses nebivolol has no membrane stabilising action.

In healthy volunteers, nebivolol has no significant effect on maximal exercise capacity or endurance.

Available preclinical and clinical evidence in hypertensive patients has not shown that nebivolol has a detrimental effect on erectile function.


Both nebivolol enantiomers are rapidly absorbed after oral administration. The absorption of nebivolol is not affected by food; nebivolol can be given with or without meals.

Nebivolol is extensively metabolised, partly to active hydroxy-metabolites. Nebivol is metabolised via alicyclic and aromatic hydroxylation, N-dealkylation and glucuronidation; in addition, glucuronides of the hydroxy-metabolites are formed. The metabolism of nebivolol by aromatic hydroxylation is subject to the CYP2D6 dependent genetic oxidative polymorphism. The oral bioavailability of nebivolol averages 12% in fast metabolisers and is virtually complete in slow metabolisers. At steady state and at the same dose level, the peak plasma concentration of unchanged nebivolol is about 23 times higher in poor metabolisers than in extensive metabolisers. When unchanged drug plus active metabolites are considered, the difference in peak plasma concentrations is 1.3 to 1.4 fold. Because of the variation in rates of metabolism, the dose of Bivocard should always be adjusted to the individual requirements of the patient: poor metabolisers therefore may require lower doses.

In fast metabolisers, elimination half-lives of the nebivolol enantiomers average 10 hours. In slow metabolisers, they are 3-5 times longer. In fast metabolisers, plasma levels of the RSSS-enantiomer are slightly higher than for the SRRR-enantiomer. In slow metabolisers, this difference is larger. In fast metabolisers, elimination half-lives of the hydroxymetabolites of both enantiomers average 24 hours, and are about twice as long in slow metabolisers.

Steady-state plasma levels in most subjects (fast metabolisers) are reached within 24 hours for nebivolol and within a few days for the hydroxy-metabolites.

Plasma concentrations are dose-proportional between 1 and 30 mg. The pharmacokinetics of nebivolol are not affected by age.

In plasma, both nebivolol enantiomers are predominantly bound to albumin.

Plasma protein binding is 98.1% for SRRR-nebivolol and 97.9% for RSSS-nebivolol.

One week after administration, 38% of the dose is excreted in the urine and 48% in the faeces. Urinary excretion of unchanged nebivolol is less than 0.5% of the dose.


Preclinical data reveal no special hazard for humans based on conventional studies of genotoxicity and carcinogenic potential.


Ingredient Name 

2.5mg 

5mg 

Quantity 

Quantity 

 

Nebivolol hydrochloride 

2.725 mg 

5.450 mg 

Lactose BP 200 

142.815 mg 

140.320 mg 

Avicel PH 101 

34.5 mg 

34.5 mg 

Maize Starch 

30 mg 

30 mg 

Croscarmellose Sodium Type A 

5.750 mg 

5.750 mg 

Iron Oxide Yellow  

0.230 mg 

 

Hydroxypropyl Methylcellulose 

5000 mg 

5000 mg 

Polysorbate 80 

0.230 mg 

0.230 mg 

Purified Water BP 

QS  

QS  

Croscarmellose Sodium Type A 

5.750 mg 

5.750 mg 

10 

Colloidal Silicon Dioxide 

1 mg 

1 mg 

11 

Magnesium Stearate 

2 mg 

2 mg 

 


Not applicable


24 months.

Do not store above 30°C.


30 Tablets, Blister and carton


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SPIMACO AlQassim pharmaceutical plant Saudi Arabia

August 2021
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