Document: leaflet MAH GENERIC_PL 21880-0130 change

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• leaflet MAH GENERIC_PL 42357-0013

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0127-0132/PIL/001/I

•    have a history of a scaly skin rash (psoriasis)

•    are being treated for tumour of the adrenal gland (phaeochromocytoma)

•    have thyroid problems

•    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

•    are going to have anaesthesia (for example for surgery), because Bisoprolol may influence how your body reacts to this situation.

Taking other medicines

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

Do not take the following medicines with Bisoprolol without special advice from your doctor. However, do not stop taking these medicines without checking with your doctor first:

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

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

•    medicines used to treat high blood pressure such as clonidine, methyldopa, moxonodine, rilmenidine.

Check with your doctor before taking the following medicines with Bisoprolol; your doctor may need to check your condition more frequently:

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

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

•    Types of beta-blockers are applied locally ( such as timolol eye drops for glaucoma treatment)

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

•    Antidiabetic medicines including insulin

•    Anaesthetics (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 (called tricyclic antidepressants such as imipramine or amitriptyline), certain medicines used to treat epilepsy or during anaesthesia (called barbiturates such as phenobarbital), or certain medicines to treat mental illness characterized by a loss of contact with reality (called phenothiazines such as levomepromazine)

•    Mefloquine, used for prevention or treatment of malaria

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

Pregnancy and breast-feeding

There is a risk that use of Bisoprolol 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 Bisoprolol during pregnancy.

It is not known whether Bisoprolol passes into human breast milk. Therefore, breastfeeding is not recommended during therapy with Bisoprolol.

Driving and using machines

Your ability to drive or use machinery may be affected depending on how well you tolerate the medicine. 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 TABLETS

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are not sure.

Treatment with this medicine requires regular monitoring by your doctor. This is particularly necessary at the start of treatment and during dose increase.

Take the tablet with some water in the morning, with or without food. Do not crush or chew the tablet.

Treatment with this medicine is usually long-term.

Dosage in 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 the first week of treatment

•    2.5 mg Bisoprolol once daily for the second week of treatment

•    3.75 mg Bisoprolol once daily for the third week of treatment

•    5 mg Bisoprolol once daily for the fourth, fifth, sixth and seventh weeks of treatment

•    7.5 mg Bisoprolol once daily for the eighth, ninth, tenth and eleventh week of treatment

•    10 mg Bisoprolol once daily from the twelfth week for maintenance (on-going) therapy.

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.

The maximum recommended daily dose is 10 mg.

Children

Bisoprolol is not recommended for use in children.

If you take more Bisoprolol than you should

If you have taken more tablets than you should, tell your doctor immediately. Your doctor will decide what measures are necessary.

Symptoms of an overdose may include slowed heart rate, dizziness, low blood pressure, severe difficulty in breathing, worsening of heart failure, or trembling (due to decreased blood sugar).

If you forget to take a tablet

Do not take a double dose to make up for a forgotten dose. Take your usual dose the next morning.

If you stop taking Bisoprolol

Never stop taking Bisoprolol unless told to by your doctor. Otherwise your condition could become much worse.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Bisoprolol tablets can cause side effects, although not everybody gets them. Speak to a doctor immediately if a side effect is severe, occurred suddenly or gets worse rapidly.

Serious Side Effects

The most serious side effects are related to the heart function:

•    slowing of heart rate

•    worsening of heart failure

•    irregular heartbeat

If you feel dizzy or weak, or have breathing difficulties contact your doctor, pharmacist or nearest hospital IMMEDIATELY

Other side effects include:

Common (affects between I in 10 and I in 100 patients)

•    dizziness

•    headache

•    stomach or intestine problems such as nausea, vomiting, diarrhoea or constipation

•    feeling of coldness in the hands or feet

•    low blood pressure

•    weakness or tiredness

This section is continued overleaf —»

0127-0132/PIL/001/I

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