NEBIVOLOL 5 MG TABLETS - patient leaflet, side effects, dosage

2. what you need to know before you take nebivolol 5 mg tablets

Do not take Nebivolol 5 mg Tablets if:

• ■ you are allergic (hypersensitive) to Nebivolol or any of the other ingredients of Nebivolol 5 mg Tablets (Listed in section 6).

• ■ you suffer from liver problems.

• ■ you have low blood pressure or poor circulation in the arms or legs.

• ■ you have a very slow heart beat (less than 60 beats per minute).

• ■ you have certain serious heart rhythm problems (e.g. 2nd and 3rd degree atrioventricular block, heart conduction disorders).

• ■ you have the condition 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.

• ■ you have asthma or wheezing (now or in the past).

• ■ you have been told by your doctor that you have a tumour in your adrenal gland which is located on top of the kidneys (the medical term for this is an untreated phaeochromocytoma).

• ■ liver function disorder

• ■ you have metabolic acidosis such as diabetic ketoacidosis.

If you are unsure, contact your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Nebivolol 5 mg tablets.

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

• ■ you notice that your heart rate is abnormally slow or you experience shortness of breath or dizziness.

• ■ untreated chronic heart failure.

• ■ poor blood circulation which makes the toes and fingers numb and pale (Raynaud’s di­sease).

• ■ a type of chest pain due to spontaneously occurring heart cramp called Prinzmetal angina.

• ■ 1st degree heart block (a kind of light heart conduction disorder that affects heart rhythm)

• ■ a persistent obstruction of your airway such as chronic bronchitis.

• ■ diabetes, as it can hide the warning signs of low sugar levels (e.g. palpitations, fast heartbeat).

• ■ over activity of the thyroid gland (Hyperthyroidism).

• ■ 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 need to have an operation and need an anaesthetic, it is important that you tell the surgeon or dentist that you are taking this medicine.

If you have serious kidney problems do not take Nebivolol 5 mg tablet 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, Nebivolol 5 mg tablet is not recommended for use in them.

Other medicines and Nebivolol 5 mg tablets

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

The following medicines may interact with nebivolol by decreasing or increasing its effects:

• ■ 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 anaesthesia 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 Nebivolol during a meal and the antacid drug between meals.

Nebivolol 5 mg Tablets with food and drink Nebivolol can be taken with or without food unless you take antacids (see section 3). The tablet should be swallowed with a glass of water or other liquid.

Pregnancy and breast-feeding

Nebivolol should not be used during pregnancy, unless clearly necessary. It is not recommended for use while breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Nebivolol may cause fatigue and/or dizziness and if you are affected you should not drive or use any machines or tools.

Nebivolol 5 mg Tablets contains lactose

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

Information on sodium content

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

3. how to take nebivolol 5 mg tablets

Always take Nebivolol 5 mg Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Nebivolol 5mg tablets 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 high blood pressure (hypertension)

The recommended dose is one tablet (5mg) daily, although elderly patients and patients with kidney problems may begin treatment on a lower dose.

The blood pressure lowering effect may take up to 1–2 weeks of treatment to become evident. Occasionally, the optimal effect is only reached after 4 weeks.

Treatment of chronic heart failure

The recommended initial dose is 1.25mg daily. This may

be increased after 1–2 weeks to half a tablet daily (2.5mg) and then to 1 tablet daily (5mg). This may be further increased to a maximum recommended dose of 2 tablets daily (10mg).

Your doctor may reduce your dose if necessary. Every time your dose is changed, your doctor will monitor you for approximately two hours.

Your doctor may decide to combine your tablets with other medicines for your condition.

Children and Adolescents

There are limited data in children and hence Nebivolol 5 mg Tablets are not recommended in children and adolescents under 18 years of age.

If you take more Nebivolol 5mg Tablets than you should If you accidentally take too much nebivolol, tell your doctor immediately or go to your nearest accident and emergency department. The most frequent symptoms and signs of a Nebivolol 5mg tablet 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 Nebivolol 5mg Tablets

If you forget to take a dose, take one as soon as you remember, unless it is almost time for your next dose. Then go on as before. Do not take a double dose to make up for a forgotten dose.

If you stop taking Nebivolol 5mg Tablets

You should not stop treatment abruptly as this can worsen heart failure. Your doctor will reduce your dose of nebivolol gradually.

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

4. possible side effects

Like all medicines, Nebivolol 5mg Tablets can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, stop taking Nebivolol and tell your doctor immediately:

• ■ whole-body allergic reaction, with generalised skin eruption (hypersensitivity reactions)

• ■ rapid-onset swelling, especially around the lips, eyes, or ofthe tongue with sudden difficulty breathing (angioedema).

• ■ breathlessness such as in asthma, due to sudden cramps in the muscles around the airways (bronchospasm)

Other possible side effects

When Nebivolol is used in the treatment of high blood pressure (Hypertension), the side effects reported in people taking nebivolol for hypertension are listed below:

Common Side Effects (may affect up to 1 in 10 people)

• ■ Headache

• ■ Dizziness

• ■ Tiredness

• ■ An unusual itching or tingling feeling

• ■ Diarrhoea

• ■ Constipation

• ■ Nausea (feeling sick)

• ■ 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 (difficulty in getting an erection)

• ■ Depressive feelings

• ■ Indigestion

• ■ Gas in stomach or bowel

• ■ Vomiting

• ■ Skin rash, itchiness

• ■ 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 Nebivolol treatment

• skin rash notable for pale red, raised, itchy bumps of allergic or non allergic causes (urticaria).

Chronic Heart Failure

The side effects reported in people taking nebivolol for chronic heart failure are listed below:

Very Common Side Effects (may affect more than 1 in 10 people)

• Slow heartbeat
• Dizziness

Common Side Effects (may affect up to 1 in 10 people)

• ■ Worsening of heart failure

• ■ Low blood pressure (with symptoms such as feeling faint when you get up quickly)

• ■ Inability to tolerate the medicine

• ■ a kind of light heart conduction disorder that affects heart rhythm (1st degree AV-block)

• ■ Swollen legs, ankles, or feet

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at or search for MHA Yellow Card on Google Play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store nebivolol 5 mg tablets

Keep out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use Nebivolol 5mg Tablets after the expiry date which is stated on the carton after Exp. The expiry date refers to the last day of that month.

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.

6. contents of the pack and other information

What Nebivolol 5mg Tablets contain

The active substance is nebivolol hydrochloride corresponding to 5mg nebivolol.

The other ingredients are silica colloidal anhydrous, magnesium stearate, croscarmellose sodium, macrogol 6000, and lactose monohydrate.

What Nebivolol 5mg Tablets looks like and contents of the pack

Round, white, biconvex tablets with a cross-score on one side and marked “N5” on the other. The tablets can be divided into equal quarters.

Pack sizes:

Nebivolol 5mg Tablets are provided in either blister packs or HDPE containers of 7, 14, 28, 30, 50, 56, 90, 100, or 500 Tablets.

• [Not all pack sizes may be marketed.]