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Relon "hem

Bisoprolol 5 mg &10 mg Tablets

(Bisoprolol fumarate)

PACKAGE LEAFLET: INFORMATION FORTHE USER

Read all of this leaflet carefully before you start using 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 pharmacist or nurse.

•    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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

2.    What you need to know before you take Bisoprolol Tablets

3.    How to take Bisoprolol Tablets

4.    Possible side effects

5.    How to store Bisoprolol Tablets

6.    Contents of the pack and other information

1.    WHAT BISOPROLOL TABLETS ARE AND WHATTHEYARE USEDFOR

The active ingredient Bisoprolol fumarate is a beta-blocker medicine. Beta-blockers reduce the force and speed of the heartbeat.

Bisoprolol Tablets are used:

•    to reduce high blood pressure (hypertension)

•    to relieve chest pain (angina).

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE BISOPROLOL TABLETS

Do not take Bisoprolol Tablets ifyou have had:

•    An allergic reaction to bisoprolol fumarate or any of the ingredients (see section 6 for ingredients) in the tablet. (An allergic reaction may include a rash, itching or difficulty breathing)

•    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 blue

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

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

Do not take Bisoprolol 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 Bisoprolol Tablets, he orshe 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 Tablets may make it more likely that you experience an allergic reaction, orsuch reaction may be more severe

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

Other medicines and Bisoprolol Tablets

Please tell your doctor or pharmacist ifyou are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Do not take the following medicines with Bisoprolol Tablets without special advice from vour 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 Bisoprolol; your doctor may need to check your condition more frequently:

•    certain medicines used to treat high blood pressure orangina 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 medicinesfor 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.

Taking Bisoprolol Tablets with food and drink

Bisoprolol Tablets should be swallowed with water.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Bisoprolol should not be used during pregnancy unless clearly necessary. If treatment with bisoprolol is considered necessary, foetal growth as well as new born infants should be monitored closely as Bisoprolol can have harmful effects on foetus development during pregnancy.

It is not known whether this drug is excreted in human milk. Therefore, caution should be exercised if using Bisoprolol Tablets when breastfeeding. Your doctor will decide if the benefits outweigh the risks.

Driving and using machines

Bisoprolol Tablets may make you feel dizzy. You must make sure you are not affected before you drive or operate machinery.

3.    HOW TO TAKE BISOPROLOL TABLETS

Always take Bisoprolol Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist ifyou are not sure.

The usual dosage(s) are:

Adults & Elderly

The usual dose is 10mg once daily. The maximum dose is 20mg per day. Some patients may only require 5mg per day. Ifyou are elderly or have severe liver or kidney damage you may be given a smaller dose.

Children

Bisoprolol Tablets are not recommended for children.

Ifyou take more Bisoprolol Tablets than you should

Do not take more tablets than your doctor tells you to. Ifyou ever take too many, go to the nearest emergency department or tell your doctor immediately. Take the container, any remaining tablets and this leaflet with you to show to the doctor.

Symptoms of 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 Tablets

If you forget to take your dose of Bisoprolol Tablets, take it as soon as you remember. Do not take a double dose to make up foraforgotten dose. Ifyou are worried ask your pharmacist or doctor for advice.

Ifyou stop taking Bisoprolol Tablets

This medicine should be taken for as long as your doctor tells you to.

The treatment with bisoprolol is not recommended to be stopped abruptly since this might lead to a worsening of heart failure. If discontinuation is necessary, the dose should be gradually decreased divided into halves weekly. Ask your pharmacist or doctor for advice.

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

4.    POSSIBLESIDEEFFECTS

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)

Ifyou feel dizzy orweak, 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 orworsening ofscaly skin rash (psoriasis); psoriasis-like rash.

Reporting of side effects

Ifyou get any side effects, talk to your doctor, pharmacist or nurse. 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 TABLETS

Do not store the tablets above 30°C and keep them in the original package.

Keep out of the sight and reach of children.

Do not use the tablets after the expiry date (use by) date shown on the outer carton.

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 Bisoprolol Tablets contain

•    The active substance is bisoprolol fumarate.

•    The other ingredients are: maize starch, microcrystalline cellulose, crospovidone, calcium hydrogen phosphate, magnesium stearate and anhydrous silica. The coating contains: hypromellose, titanium dioxide (E171), macrogol, dimethicone and iron oxide (E172).

What Bisoprolol Tablets look like and the contents of the pack

The 5mg tablets are round, ivory coloured, biconvex tablets that are marked with a break line on one face. The 10mg tablets are round, light brown coloured, biconvex tablets and are also marked with a break line on one face.

Bisoprolol Tablets are available in a pack size of 28 tablets.

Marketing Authorisation Holder and Manufacturer

Relonchem Limited Cheshire House, Gorsey Lane Widnes, Cheshire, WA8 0RP, UK

Date Leaflet Revised: March 2015.