Nebivolol 5 Mg Tablets
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Nebivolol
Read all this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Nebivolol is and what it is used for
2. Before you take Nebivolol
3. How to take Nebivolol
4. Possible side effects
5. How to store Nebivolol
6. Further information
Nebivolol 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 also contributes to a lower blood pressure.
It is used to treat raised blood pressure (hypertension).
Nebivolol 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 Nebivolol
• if you are allergic (hypersensitive) to nebivolol or any of the other ingredients of Nebivolol
• 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.
Take special care with Nebivolol
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 Nebivolol before being anaesthetised.
If you have serious kidney problems do not take Nebivolol 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 is not recommended for use in them.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Certain medicines cannot be used at the same time, while other drugs require specific changes (in the dose, for example).
Always tell your doctor if you are using or receiving any of the following medicines in addition to Nebivolol:
• Medicines for controlling 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.
• Amifostine used during cancer treatment
• Baclofen used to treat epilepsy
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), e.g. cimitedine; you should take Nebivolol during a meal and the antacid drug between meals.
Taking Nebivolol with food and drink
Nebivolol can be taken with food or on an empty stomach, but the tablet is best taken with some water.
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 or using machines
This medicine may cause dizziness or fatigue. If affected, do not drive or operate machinery.
Important information about some of the ingredients of Nebivolol
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.
Always take Nebivolol exactly as your doctor has told you. You should check with your doctor if you are not sure.
Nebivolol 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 1 tablet 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 1/2 (half) a 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 a % (quarter) tablet per day. This may be increased after 1-2 weeks to % (half) a tablet per day, then to 1 tablet per day and then to 2 tablets 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 2 tablets (10mg) 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
Tablet dividing instructions
If you have been told by your doctor to take a % or % (two quarters) tablet, place the tablet onto a flat, hard surface, such as a table, with the score facing up. Press evenly on the entire tablet surface until a snapping sound is heard.
The tablet has now been divided into 4 parts which can be carefully separated.
Your doctor may decide to combine Nebivolol tablets with other medicines to treat your condition.
Do not use in children or adolescents.
If you take more Nebivolol 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 Nebivolol 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
If you forget a dose of Nebivolol, 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 nearer, 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 Nebivolol
You should always consult with your doctor before stopping Nebivolol treatment, whether you are taking it for high blood pressure or chronic heart failure.
You should not stop Nebivolol treatment abruptly as this can temporarily make your heart failure worse. If it is necessary to stop Nebivolol 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.
• 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 (fewer than 1 person in every 10,000 treated):
• fainting
• swelling of the lips, eyes or tongue, with possible sudden difficulty breathing
• worsening of psoriasis (a skin disease - scaly pink patches).
Not known (cannot be estimated from the available data):
• Hypersensitivity
• angioneurotic oedema (swelling of face, lips, mouth, tongue or throat)
In a clinical study for chronic heart failure, the following side effects seen were:
Very common side effects (more than 1 person in every 10 treated):
• slow heart beat
• dizziness
Common side effects (more than 1 person in every 100 but less than 1 person in every 10 treated):
• 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Do not take Nebivolol after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Nebivolol 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.
Like all medicines, Nebivolol can cause side effects, although not everybody gets them.
When Nebivolol is used for the treatment of raised blood pressure, the possible side effects are:
Common side effects (more than 1 person in every 100 treated but fewer than 1 person in every 10 treated):
• headache
• dizziness
• tiredness
• an unusual itching or tingling feeling
• diarrhoea
• constipation
• nausea
• shortness of breath
• swollen hands or feet.
Uncommon side effects (more than 1 person in every 1,000 treated, but fewer than 1 person in every 100 treated):
• slow heartbeat or other heart complaints
• low blood pressure
• cramp-like leg pains on walking
• abnormal vision
• impotence
• feelings of depression
What Nebivolol contains
• The active substance is nebivolol. Each tablet contains 5mg nebivolol equivalent to 5.45 mg of nebivolol hydrochloride.
• The other ingredients are: croscarmellose sodium, lactose monohydrate, maize starch, cellulose microcrystalline, hypromellose 5 cps, silica colloidal anhydrous, magnesium stearate.
What Nebivolol looks like and contents of the pack
Nebivolol 5 mg Tablets are white or almost white, round, bevelled tablets, scored twice on one side and are available in PVC/aluminium blisters/polyethylene bottles of 7,10,14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Ltd., Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR.
United Kingdom.
Manufacturer
Salutas Pharma GmbH, Otto-von-Guericke-Alle 1, 38179 Barleben, Germany Saltuas Pharma GmbH, Dieselstrasse 5, 70839 Gerlingen, Germany
LEK S.A., Ul. Podlipie 16 C, 95 010 Strykow, Poland LEK S.A., Ul. Domaniewska 50 C, 02-672 Warszawa, Poland
Lek Pharmacueticals d.d, Verovskova 57,1526 Ljubljana, Slovenia
This leaflet was last approved in 02/2011 (to be
amended after approval).
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