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Package leaflet: Information for the user

Nebivolol 10 mg Tablets

Nebivolol (as hydrochloride)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Nebivolol is and what it is used for

2.    What you need to know before you take Nebivolol

3.    How to take Nebivolol

4.    Possible side effects

5.    How to store Nebivolol

6.    Contents of the pack and other information

1. What Nebivolol is and what it is used for

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 contributes as well to 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.

2. What you need to know before you take Nebivolol

Do not take Nebivolol:

if you are allergic to nebivolol or to 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 heart 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

-    metabolic disorder (metabolic acidosis), for example, diabetic ketoacidosis.

Warnings and precautions

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 on 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, as 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.

Other medicines and Nebivolol

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Certain medicines cannot be used at the same time, while other drugs require specific changes (in the dose, for example). Always tell your doctor or pharmacist if you are using or receiving any of the following medicines in addition to Nebivolol:

•    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, nifedipine, nicardipine, 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), e.g. cimetidine: you should take Nebivolol during a meal and the antacid drug between meals.

•    Anti malarials (mefloquine).

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

Pregnancy

Nebivolol should not be taken during pregnancy unless clearly necessary.

Breast-feeding

Breast-feeding is not recommended during administration of Nebivolol

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor 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.

Nebivolol contains lactose

If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Nebivolol

Always take Nebivolol exactly as your doctor has told you.

Check with your doctor or pharmacist 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 5 mg (half a 10 mg tablet, one 5 mg tablet or two 2.5 mg tablets) per day*.

•    Elderly patients and patients with a kidney disorder will usually start with 2.5 mg (half a 5 mg tablet or one 2.5 mg tablet) daily*.

•    It may take up to 4 weeks for this medicine to have full effect.

•    If you are aged over 75 years, your doctor may need to monitor you more closely

•    Nebivolol 2.5 mg and 5 mg tablets are also available on

the market.

•    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 and closely supervised by an experienced physician.

•    Your doctor will start your treatment with 1.25 mg (half a 2.5 mg tablet) per day. This may be increased after 1-2 weeks to 2.5 mg (one 2.5 mg tablet or half a 5 mg tablet) per day, then to 5 mg (two 2.5 mg tablets one 5 mg tablet or half a 10 mg tablet) per day and then to 10 mg (four 2.5 mg tablets, two 5 mg tablets or one 10 mg tablet) per day until the correct dose is reached for you*.

•    The maximum recommended dose is 10 mg.

•    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.