Bisoprolol

• Used to treat high blood pressure and angina pectoris
• Take in the morning
• Can cause dizziness
• Avoid drinking alcohol while taking this medicine

The active substance in this medicine is bisoprolol fumarate. Bisoprolol fumarate belongs to group of medicines called beta blockers. Beta blockers protect the heart from too much activity. They slow your heart rate and make the heart more efficient at pumping blood around the body, thereby lowering blood pressure.

Always take this medicine exactly as your doctor or pharmacist has told you. When in doubt, ask your doctor or pharmacist.

Bisoprolol fumarate tablets should be taken in the morning. Swallow the tablets whole with some water.

Limit or stop drinking alcohol while taking this medicine as this is likely to trigger or worsen side effects such as dizziness. The ability to drive or operate machinery may be affected, depending on how well you tolerate the medicine.

Dosage

Always take this medicine exactly as your doctor has told you. Your doctor will usually start treatment with the lowest possible dose (5 mg). The usual dose is:

• Adults: 10 mg once daily with a maximum recommended dose of 20 mg a day. The tablets should be taken every day at about the same time.

Patients with severe liver or kidney disease should not exceed 10 mg of Bisoprolol once daily. Please consult your doctor before starting to use this medicine.

This medicine is not suitable for use in adolescents and children under 12 years of age.

Driving/alcohol

Bisoprolol can cause tiredness, sleepiness or dizziness. Do not drive or not operate machinery if you experience these side effects as it is likely to trigger or worsen the side effects. Limit or stop drinking alcohol while taking this medicine.

Taken too much/forgot to take/stop taking Bisoprolol

Missed a dose? If you forget to take a dose, take it as soon as you remember. If more than 12 hours have passed, skip the dose you missed and take the next scheduled dose as normal.

If you have taken more Bisoprolol tablets than you should, tell your doctor immediately.

Do not stop treatment without talking to your doctor first. If you need to stop treatment, it must be done gradually to avoid side effects.

Bisoprolol is not suitable for everyone. Do not take this medicine if you have or have had any of the following medical conditions:

• Severe asthma or chronic obstructive lung disease.
• Certain heart conditions where the electrical activity controlling your heart rate does not work properly, causing a very slow heart rate or uneven heart beating.
• Hypotension (low blood pressure), causing dizzy spells when you stand up.
• Severe blood circulation problems.
• An allergy to the active ingredient or to any of the other ingredients in this medicine listed at the end of this leaflet under 'What Bisoprolol contains'.
• Severe heart failure that is not controlled medically, cardiogenic shock or worsening heart failure requiring injection of medicines into a vein.
• Metabolic acidosis, when there is too much acid in the blood.
• Untreated phaeochromocytoma, a rare tumour of the adrenal gland.

When should this medicine be used with caution?

Consult a doctor on the use of Bisoprolol if:

• You have liver or kidney problems.
• You suffer from heart failure.
• You are taking medication for high blood sugar (diabetes).
• You have a history of a scaly skin rash (psoriasis).
• You have allergies to any other medicines, foods, preservatives or dyes.
• You have a tumour of the adrenal gland (phaeochromocytoma).
• You have a thyroid disorder.
• You suffer from wheezing or respiratory problems (asthma).
• You are fasting from solid food.
• You are aware that you have a heart condition known as first-degree atrioventricular (AV) block.
• You have Prinzmetal’s angina.
• You have severe blood circulation problems in your limbs, such as hands and feet.
• You are going to have anaesthesia (for example for surgery). In this case, you should tell the doctor or dentist what medicines you are taking.

Pregnancy and breastfeeding

There is a risk that Bisoprolol fumarate tablets can harm the baby if it is used during pregnancy. There is an increased possibility of premature birth, miscarriage, low blood sugar level and reduced heart rate of the child. The growth of the baby may also be affected. Bisoprolol should therefore not be taken during pregnancy unless medically necessary and advised by a doctor.

It is not known if bisoprolol fumarate is excreted in the breast milk and therefore it is not recommended while breastfeeding.

Other medicines and Bisoprolol

Bisoprolol and some medicines may interfere with each other. It is therefore very important to tell the doctor what medicines or nutritional supplements you are currently taking. Do not take the following medicines with Bisoprolol without special advice from your doctor:

• Certain medicines used to treat high blood pressure or heart problems, such as adrenalin, bepridil, clonidine, diltiazem, digoxin, lidocaine, verapamil and other beta blockers.
• Certain medicines for depression and psychiatric disorders such as tricyclic antidepressants, phenothiazines, monoamine oxidase inhibitors (MAO inhibitors) and barbiturates.
• Anaesthetic agents (for example during surgery).
• Non-steroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen or naproxen.
• Medicines used for prevention or treatment of malaria (mefloquine) and migraine headaches (ergotamine).
• Antidiabetic medicines.
• Medicines used for asthma, nasal congestion or certain eye conditions, such as glaucoma or pupil dilation.

For a complete list of medicines that may interfere with the way Bisoprolol works, please see the package leaflet. It is important to tell your doctor if you are taking any of these medicines before you start treatment with Bisoprolol.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects are listed below according to how frequently they may occur.

Common (may affect up to 1 in 10 people)

• Tiredness, dizziness, headache. (These symptoms occur especially at beginning of treatment. They are generally mild or often disappear within one to two weeks.)
• Feeling of coldness or numbness in hands, feet, ears or nose. Muscular weakness or cramps in legs while walking.
• Nausea or vomiting.
• Diarrhoea.
• Stomach pain.
• Constipation.
• Lightheadedness, especially on standing up, which may be due to low blood pressure.

Uncommon (may affect up to 1 in 100 people)

• Sleep disturbances.
• Depression.
• Slow or irregular heart beating.
• Signs of worsening heart failure.
• Breathing problems in patients with asthma or chronic lung disease.
• Muscle weakness, muscle cramps or pain.

For a list of rare side effects, please see the package leaflet. Consult a doctor if the side effects are severe or if you experience side effects that are not listed on the package leaflet.

The active substance is bisoprolol fumarate.

• Each 5-mg tablet contains 5 mg bisoprolol fumarate.
• Each 10-mg tablet contains 10 mg bisoprolol fumarate.

The other ingredients in this medicine are: lactose monohydrate, cellulose microcrystalline, magnesium stearate and crospovidone.

• Each 5-mg tablet also contains iron oxide yellow.
• Each 10-mg tablet also contains iron oxide red and yellow.

The manufacturers of Bisoprolol fumarate tablets are:

Niche Generics Ltd
Unit 5

151 Baldoyle Industrial Estate

Dublin 13
Ireland

Dexcel Pharma GmbH
Rontgenstr. 1

63755 Alzenau
Germany

Kwizda Pharma GmbH
Effingergasse 21

A-1160 Vienna
Austria

Read the package leaflet before use.