Document: leaflet MAH GENERIC_PL 15773-0674 change

• leaflet MAH GENERIC_PL 00289-1441
• leaflet MAH GENERIC_PL 15773-0674
• leaflet MAH GENERIC_PL 18110-0013

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Bisoprolol Fumarate 1.25 mg Tablets Bisoprolol Fumarate 2.5 mg Tablets Bisoprolol Fumarate 3.75 mg Tablets

What is in this leaflet:

1.    What [Bisoprolol Fumarate] Tablets are and what they are used for.

2.    What you need to know before you take [Bisoprolol Fumarate] Tablets.

3.    How to take [Bisoprolol Fumarate] Tablets.

4.    Possible side effects.

5.    How to store [Bisoprolol Fumarate] Tablets.

6.    Contents of the pack and other Information.

1.    What Bisoprolol Fumarate Tablets are and what they are used for

The active substance in this medicine is Bisoprolol fumarate. Bisoprolol Fumarate belongs to a group of medicines called beta-blocking agents. These medicines work by affecting the body’s response to some nerve impulses, especially in the heart. As a result, bisoprolol slows down the heart rate and makes the heart more efficient at pumping blood around the body.

Heart failure occurs when the heart muscle is weak and unable to pump enough blood to supply the body’s needs. Bisoprolol Fumarate is used to treat stable chronic heart failure. It is used in combination with other medicines suitable for this condition (such as ACE-inhibitors, diuretics, and heart glycosides).

2.    What you need to know before you take Bisoprolol Fumarate Tablets Do not take [Bisoprolol Fumarate] Tablets:

Do not take [Bisoprolol Fumarate] Tablets if one of the following conditions applies to you:

•    allergic to bisoprolol fumarate or any of the other ingredients of this medicine (listed in section 6) tablets.

•    severe asthma or severe chronic lung disease

•    severe blood circulation problems in your limbs (such as Raynaud’s syndrome), which may cause your fingers and toes to tingle or turn pale or blue

•    untreated phaeochromocytoma, which is a rare tumour of the adrenal gland

•    metabolic acidosis, which is a condition when there is too much acid in the blood.

Do not take [Bisoprolol Fumarate] Tablets if you have one of the following heart problems:

•    acute heart failure

•    worsening heart failure requiring injection of medicines into a vein, that increase the force of contraction of the heart

•    slow heart rate

•    low blood pressure

•    certain heart conditions causing a very slow heart rate or irregular heartbeat

•    cardiogenic shock, which is an acute serious heart condition causing low blood pressure and circulatory failure.

Warnings and precautions

If you have any of the following conditions tell your doctor before taking this medicine; he or she may want to take special care (for example give additional treatment or perform more frequent checks):

•    diabetes

•    strict fasting

•    certain heart diseases such as disturbances in heart rhythm, or severe chest pain at rest (Prinzmetal’s angina)

•    kidney or liver problems

•    less severe blood circulation problems in your limbs

•    less severe asthma or chronic lung disease

•    history of a scaly skin rash (psoriasis)

•    tumour of the adrenal gland (phaeochromocytoma)

•    thyroid disorder.

In addition, tell your doctor if you are going to have:

•    desensitization therapy (for example for the prevention of hay fever), because Bisoprolol may make it more likely that you experience an allergic reaction, or such reaction may be more severe

•    anaesthesia (for example for surgery), because this medicine may influence how your body reacts to this situation.

Children and adolescents

Bisoprolol tablets is not recommended for use in children or adolescents.

Other medicines and [Bisoprolol Fumarate] Tablets

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

Do not take the following medicines with I Bisoprolol Fumarate] without special advice from your doctor:

•    Certain medicines used to treat irregular or abnormal heartbeat (Class I antiarrhythmic medicines such as quinidine, disopyramide, lidocaine, phenytoin; flecainide, propafenone)

•    Certain medicines used to treat high blood pressure, angina pectoris or irregular heartbeat (calcium antagonists such as verapamil and diltiazem)

•    Certain medicines used to treat high blood pressure such as clonidine, methyldopa, moxonidine, rilmenidine. However, do not stop taking these medicines without checking with your doctor first.

Check with your doctor before taking the following medicines with I Bisoprolol Fumarate]; your doctor may

need to check your condition more frequently:

•    Certain medicines used to treat high blood pressure or angina or abnormal heart beat (dihydropyridine-derivative calcium antagonists such as nifedipine)

•    Certain medicines used to treat high blood pressure or angina pectoris (dihydropyridine-type calcium antagonists such as felodipine and amlodipine)

•    Certain medicines used to treat irregular or abnormal heartbeat (Class III antiarrhythmic medicines such as amiodarone)

•    Beta-blocking agents applied locally (such as timolol eye drops for glaucoma treatment)

•    Certain medicines used to treat for example Alzheimer’s disease or glaucoma (parasympathomimetics such as tacrine or carbachol) or medicines that are used to treat acute heart problems (sympathomimetics such as isoprenaline and dobutamine)

•    Antidiabetic medicines including insulin

•    Anaesthetic agents (for example during surgery)

•    Digitalis, used to treat heart failure

•    Non-steroidal anti-inflammatory medicines (NSAIDs) used to treat arthritis, pain or inflammation (for example ibuprofen or diclofenac)

•    Any medicine, which can lower blood pressure as a desired or undesired effect such as antihypertensives, certain medicines for depression (tricyclic antidepressants such as imipramine or amitriptyline), certain medicines used to treat epilepsy or during anaesthesia (barbiturates such as phenobarbital), or certain medicines to treat mental illness characterized by a loss of contact with reality (phenothiazines such as levomepromazine)

•    Moxisylate, used for treatment raynauds disease (poor circulation which makes toes and fingers numb and pale.

•    Mefloquine, used for prevention or treatment of malaria

•    Depression treatment medicines called monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide.

Taking [Bisoprolol Fumarate] Tablets with food and drink

[Bisoprolol Fumarate] Tablets should be taken in the morning, before, with or after breakfast. They should be swallowed whole with liquid and should not be chewed or crushed.

Pregnancy and breast-feeding:

There is a risk that use of [Bisoprolol Fumarate] during pregnancy may harm the baby. If you are pregnant or planning to become pregnant, tell your doctor. He or she will decide whether you can take this medicine during pregnancy. It is not known whether bisoprolol passes into human breast milk. Therefore, breastfeeding is not recommended during therapy with Bisoprolol Fumarate.

Driving and using machines:

Your ability to drive or use machinery may be affected depending on how well you tolerate the medicine. Please be especially cautious at the start of treatment, when the dose is increased or the medication is changed, as well as in combination with alcohol.

3. How to take Bisoprolol Fumarate tablets

Always take this medicine exactly as your doctor has told you. You should check with your doctor or your pharmacist if you are not sure. Always take [Bisoprolol Fumarate] tablets in the morning, before, with, or after breakfast. Swallow the tablet/s whole with some water and do not chew or crush them.

Bisoprolol Fumarate 2.5 mg Tablet only: The tablet can be divided into equal doses.

This treatment should be initiated and stopped by a specialist in cardiology or internal medicines.

Adults including the elderly: Treatment with bisoprolol must be started at a low dose and increased gradually. Your doctor will decide how to increase the dose, and this will normally be done in the following way:

•    1.25 mg bisoprolol once daily for one week

•    2.5 mg bisoprolol once daily for one week

•    3.75 mg bisoprolol once daily for one week

•    5 mg bisoprolol once daily for four weeks

•    7.5 mg bisoprolol once daily for four weeks

•    10 mg bisoprolol once daily for maintenance (on-going) therapy.

The maximum recommended daily dose is 10 mg bisoprolol.

Depending on how well you tolerate the medicine, your doctor may also decide to lengthen the time between dose increases. If your condition gets worse or you no longer tolerate the drug, it may be necessary to reduce the dose again or to interrupt treatment. In some patients a maintenance dose lower than 10 mg bisoprolol may be sufficient. Your doctor will tell you what to do. If you have to stop treatment entirely, your doctor will usually advise you to reduce the dose gradually, as otherwise your condition may become worse.

Renal or liver disease: The dosage should be increased very gradually and cautiously in patients with severe kidney or liver problems

If you take more [Bisoprolol Fumarate] Tablets than you should:

Contact your doctor or local emergency ward immediately. Take this leaflet and any tablets you still have with you. Your doctor will decide what measures are necessary. Symptoms of an overdose may include slowed heart rate, severe difficulty in breathing feeling dizzy, or trembling (due to decreased blood sugar).

If you forget to take [Bisoprolol Fumarate] Tablets:

If you forget to take a dose, take it as soon as you remember it unless it is nearly time for your next dose. Do not take a double dose to make up for a forgotten dose.

Do not stop treatment suddenly or change the recommended dose without talking to your doctor first. If you need to stop treatment, it must be done gradually, to avoid side effects.

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

4. Possible side effects

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

To prevent serious reactions, speak to a doctor immediately if a side effect is severe, occurred suddenly or gets worse rapidly. The most serious side effects are related to the heart function:

•    slowing of heart rate (may affect more than 1 in 10 people)

•    worsening of heart failure (may affect up to 1 in 10 people)

•    slow or irregular heartbeat (may affect up to 1 in 100 people)

If you feel dizzy or weak, or have breathing difficulties please contact your doctor as soon as possible. Further side effects are listed below according to how frequently they may occur:

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

•    tiredness, feeling weak, dizziness, headache

•    feeling of coldness or numbness in hands or feet

•    low blood pressure • stomach or intestine problems such as nausea, vomiting, diarrhoea, or constipation.

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

•    sleep disturbances

•    depression

•    dizziness when standing up

•    breathing problems in patients with asthma or chronic lung disease

•    muscle weakness, muscle cramps.

Rare (may affect up to 1 in 1,000 people):

•    hearing problems

•    allergic runny nose

•    reduced tear flow

•    inflammation of the liver which can cause yellowing of the skin or whites of the eyes

•    certain blood test results for liver function or fat levels differing from normal

•    allergy-like reactions such as itching, flush, rash

•    impaired erection

•    loss of consciousness/fainting

•    nightmares, hallucinations.

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

•    irritation and redness of the eye (conjunctivitis)

•    hair loss

•    appearance or worsening of scaly skin rash (psoriasis); psoriasis-like rash.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Bisoprolol Fumarate tablets

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

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

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

6. Contents of the pack and other information

What [Bisoprolol Fumarate] Tablets contain

The active substance is bisoprolol fumarate Each 1.25 mg tablet contains 1.25 mg bisoprolol fumarate. Each 2.5 mg tablet contains 2.5 mg bisoprolol fumarate. Each 3.75 mg tablet contains 3.75 mg bisoprolol fumarate.

The other ingredients are cellulose, microcrystalline, silica, colloidal anhydrous, croscarmellose sodium, sodium starch glycolate (type A) and magnesium stearate.

What [Bisoprolol Fumarate] Tablets look like and contents of the pack:

1.25 mg: White to off white round biconvex tablets.

2.5 mg: White to off white round biconvex tablets with a break line on one side 3.75 mg: White to off white round biconvex tablets

Packsizes of 20, 21, 28, 30, 50, 56, 60, 90 and 100 tablets (not all pack sizes may be marketed).

Marketing Authorisation Holder: The marketing authorisation holder is ratiopharm GmbH, Graf-Arco-Str. 3, D-89079 Ulm, Germany.

Manufacturer: The manufacturer is Merckle GmbH, Ludwig-Merckle-Str. 3, D-89143 Blaubeuren, Germany.

For a large print, audio, Braille or CD-rom version of this patient information leaflet, phone 02392 313592.

This leaflet was last approved in: March 2016.