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Bisoprolol Hemifumarate 2.5mg Tablets

Cardicor® 2.5mg Tablets/ Bisoprolol Hemifumarate 2.5mg Tablets

(bisoprolol hemifumarate)


PACKAGE LEAFLET: INFORMATION FOR THE USER

Your medicine is available using the names Cardicor 2.5mg Tablets / Bisoprolol Hemifumarate 2.5mg Tablets, but will be referred to as Cardicor throughout this leaflet. Other strengths 1.25mg, 3.75mg, 5mg, 7.5mg & 10mg are also available.

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 your 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.

What is in this leaflet:

1.    What Cardicor is and what it is used for

2.    What you need to know before you take Cardicor

3.    How to take Cardicor

4.    Possible side effects

5.    How to store Cardicor

6.    Contents of the pack and other information

1. What Cardicor is and what it is used for

The active substance in Cardicor is bisoprolol. Bisoprolol belongs to a group of medicines called beta-blockers. 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. Cardicor 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 Cardicor

Do not take Cardicor

Do not take Cardicor if one of the following conditions applies to you:

■    allergy (hypersensitivity) to bisoprolol or to any of the other ingredients (see section 6 'What Cardicor contains')

■    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 Cardicor 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 Cardicor; 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 Cardicor may make it more likely that you experience an allergic reaction, or such reaction may be more severe

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

Children and adolescents

Cardicor is not recommended for use in children or adolescents.

Other medicines and Cardicor

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 Cardicor 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, moxonodine, rilmenidine. However, do not stop taking these medicines without checking with your doctor first.

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

■    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-blockers 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)

■    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 Cardicor 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 Cardicor during pregnancy.

It is not known whether bisoprolol passes into human breast milk. Therefore, breast-feeding is not recommended during therapy with Cardicor.

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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 Cardicor

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

Treatment with Cardicor requires regular monitoring by your doctor. This is particularly necessary at the start of treatment, during dose increase, and when you stop treatment.

Take the tablet with some water in the morning, with or without food. Do not crush or chew the tablet. The scored tablets can be divided into two equal doses.

Treatment with Cardicor is usually long-term.

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:

■    1.25mg bisoprolol once daily for one week

■    2.5mg bisoprolol once daily for one week

■    3.75mg bisoprolol once daily for one week

■    5mg bisoprolol once daily for four weeks

■    7.5mg bisoprolol once daily for four weeks

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

The maximum recommended daily dose is 10mg 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 10mg 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.

If you take more Cardicor than you should

If you have taken more Cardicor 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, severe difficulty in breathing, feeling dizzy, or trembling (due to decreased blood sugar).

If you forget to take Cardicor

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

If you stop taking Cardicor

Never stop taking Cardicor unless on your doctor's advice. 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, 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 (affects more than 1 person in 10)

■    worsening of heart failure (affects less than 1 person in 10)

■    slow or irregular heartbeat (affects less than 1 person in 100)

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 (affects less than 1 person in 10):

■    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 (affects less than 1 person in 100):

■    sleep disturbances

■    depression

■    dizziness when standing up

■    breathing problems in patients with asthma or chronic lung disease

■    muscle weakness, muscle cramps.

Rare (affects less than 1 person in 1,000):

■    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

■    nightmares, hallucinations

■    fainting.

Very rare (affects less than 1 person in 10,000):

■    irritation and redness of the eye (conjunctivitis)

■    hair loss

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

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

5.    How to store Cardicor

■    Keep out of sight and reach of children.

■    Do not store above 25°C.

■    Do not use any tablets after the expiry date on the pack. The expiry date refers to the last date of that month.

■    Unused tablets or tablets older than their expiry date should be returned to a pharmacy for safe disposal.

■    If your tablets appear to be discoloured or show any other signs of deterioration, please return them to your pharmacist for safe disposal.

■    Medicines 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.

6.    Contents of the pack and other information

What Cardicor contains

The active ingredient is bisoprolol. Each film-coated tablet contains 2.5mg bisoprolol hemifumarate.

Cardicor also contains the following inactive ingredients: colloidal silica anhydrous, magnesium stearate, crospovidone, microcrystalline cellulose, maize starch, anhydrous calcium hydrogen phosphate, dimethicone, macrogol 400, titanium dioxide (E171) and hypromellose.

What Cardicor looks like and contents of the pack

Cardicor are white, heart shaped, scored film-coated tablets.

Your tablets are available in calendar blister packs of 28 tablets: The translation of the days of the week are as follows:

Manufacturer

Your tablets are manufactured by: Merck KGaA,

Frankfurter Strasse 250, D-64293, Darmstadt, Germany.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder: BR Lewis Pharmaceuticals Ltd., Kirk Sandall, Doncaster, DN3 1QR.

PL No: 08929/0522

Leaflet revision and issue date 30.08.13

Cardicor® is a registered trademark of Merck KGaA.

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