PACKAGE LEAFLET: INFORMATION FOR THE USER

■MerckSerono

I

Emcor® LS 5 mg film coated tablets Emcor® 10 mg film coated tablets

bisoprolol fumarate

Read all of this leaflet carefully before you start taking this medicine.

-    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Emcor is and what it is used for

2.    Before you take Emcor tablets

3.    How to take Emcor tablets

4.    Possible side effects

5.    How to store Emcor tablets

6.    Further information

1.    WHAT EMCOR IS AND WHAT IT IS USED FOR

The active substance in Emcor tablets 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.

Emcor tablets are used to treat high blood pressure (hypertension) and to help prevent chest pain (angina pectoris).

2.    BEFORE YOU TAKE EMCOR TABLETS

Do not take Emcor tablets

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

•    allergy (hypersensitivity) to bisoprolol or to any of the other ingredients (see section 6 'What Emcor 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 in which the blood is too acidic.

Do not take Emcor tablets if you have one of the following heart problems:

•    acute heart failure

•    worsening heart failure requiring an injection of medicines into a vein to increase the force of contraction of the heart

•    low blood pressure

•    certain heart conditions causing a very slow heart rate or irregular heartbeat and you have not been fitted with a pacemaker

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

Take special care with Emcor tablets

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

•    heart failure (although bisoprolol can be used to treat heart failure the dosage is very different)

•    first degree heart block (a condition in which nerve signals to the heart are disturbed, possibly causing it occasionally to skip a beat, or beat irregularly)

•    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 allergies

•    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 Emcor tablets may make it more likely that you experience an allergic reaction, or such a reaction may be more severe

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

Taking other medicines

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

Do not take the following medicines with Emcor tablets without special advice from your doctor:

•    certain medicines used to treat high blood pressure, angina pectoris or irregular heartbeat (known as 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 Emcor tablets; your doctor may need to check your condition more frequently:

•    certain    medicines    used    to    treat    irregular

or abnormal heartbeat (known as Class I antiarrhythmic medicines, such as quinidine and disopyramide)

• certain medicines used to treat high blood pressure or angina pectoris (known as dihydropyridine-type calcium antagonists, such as nifedipine)

•    certain    medicines    used    to    treat    irregular

or abnormal heartbeat known as Class III antiarrhythmic medicines, such as amiodarone)

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

•    certain medicines used to treat conditions such as Alzheimer's disease or glaucoma (known as parasympathomimetics, such as tacrine or carbachol) or medicines that are used to treat acute heart problems (known as 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)

•    sympathomimetics such as adrenaline and noradrenaline which are used in the treatment of heart attack and low blood pressure. Adrenaline is also used to treat allergic reactions. Higher doses of adrenaline may be necessary for treatment of allergic reactions if Emcor is being taken at the same time.

•    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

•    moxisylyte, which is used to treat circulatory problems like Raynaud's syndrome

Pregnancy and breast-feeding

There is a risk that use of Emcor tablets 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 Emcor tablets during pregnancy.

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

Some of the possible side effects listed in section 4 below could affect you when driving. If you feel tired, dizzy or faint or get any muscle weakness or cramps you should not drive.

3. HOW TO TAKE EMCOR TABLETS

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

Take the tablet with some water in the morning, with or without food. Do not crush or chew the tablet. Treatment with Emcor tablets is usually long-term. Adults:

The usual daily dose is 10 mg bisoprolol.

Depending on how well you respond to the medicine, your doctor may decide to decrease the dose to 5 mg or he may decide to increase it to 20 mg. The dose should not exceed 20 mg in one day. Your doctor will tell you what to do. The label will also tell you how many tablets to take and how often to take them. Your pharmacist will help if you are unsure.

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. Children

Emcor tablets are not recommended for use in children.

If you take more Emcor tablets than you should

If you have taken more Emcor tablets than you should, tell your doctor or hospital accident and emergency department immediately. Take your tablets with you. Your doctor will decide what measures are necessary.

MC1.0-0417-2012