Package leaflet: Information for the patient

Bisoprolol Fumarate 1.25 mg, 2.5 mg, 3.75 mg, 5 mg &10 mg Tablets

bisoprolol fumarate

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, please askyour doctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even iftheirsigns ofillness arethesameasyours.

• If you get any side effects, talkto your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Bisoprolol Fumarate is and what it is used for

2.    Whatyou need to know beforeyou take Bisoprolol Fumarate

3.    How to take Bisoprolol Fumarate

4.    Possible side effects

5.    How to store Bisoprolol Fumarate

6.    Contents of the pack and other information

1. What Bisoprolol Fumarate is and what it is used for

The active substance in this medicine is bisoprolol fumarate. Bisoprolol fumarate belongs to a group of medicines called beta-blockers.These medicines workby 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. Heartfailure occurs when the heart muscle is weakand unable to pump enough blood to supply the body's needs.

Bisoprolol 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).

•    In treatment ofcoronary heart disease and chest pain (angina pectoris) caused by shortage ofoxygen in the heart muscle.

•    In treatment of high blood pressure (hypertension).

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

Do not take Bisoprolol Fumarate:

Do not take Bisoprolol Fumarate Tablets ifone ofthefollowing conditions applies toyou:

•    Allergic to bisoprolol fumarateor anyofthe other ingredients ofthis medicine (listed in section 6)

•    Severeasthma

•    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 isa raretumouroftheadrenal gland

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

Do not take Bisoprolol Fumarate ifyou have one ofthefollowing heart problems:

•    Acuteheartfailure

•    Worsening heartfailurerequiring injectionofmedicinesintoavein,thatincreasetheforceof contraction ofthe heart

•    Slowheartrate

•    Very 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 circulatoryfailure.

Warnings and precautions:

Ifyou have any ofthefollowing 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

•    Strictfasting

•    Certain heart diseases such as disturbances in heart rhythm, or severe chest pain at rest (prinzmetal's angina)

•    Kidneyorliverproblems

•    Less severe blood circulation problems in your limbs

•    Less severe asthma or chronic lung disease

•    Previously had or currently have scaly skin rash (psoriasis)

•    Atumor oftheadrenal gland (phaeochromacytoma) or ifyou are currently undergoing treatmentfor a tumorof the adrenalgland.

•    Thyroid disorder

•    Thyroid problems.

During Treatment

Talkto your doctor or pharmacist ifyou:

•    Are going to have desensitization therapy (for examplefor the prevention ofhayfever), 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 (forexamplefor surgery), because this medicine may influence howyour body reacts to this situation

•    Have chronic lung disease or less severe asthma please inform your doctor immediately ifyou start to experience new difficulties in breathing, cough, wheezing after exercise, etc. when using bisoprolol.

Other medicines and Bisoprolol Fumarate

Tell your doctor or pharmacist ifyou are taking, have recentlytaken or might take any other medicines.

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

•    Ifyou have chronic heartfailure certain medicines used to treat irregular or abnormal heartbeat (e.g.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 (e.g.calcium antagonists such as verapamil and diltiazem)

•    Certain medicines used to treat high blood pressure (e.g.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 Bisoprolol Fumarate; your doctor may need to checkyourcondition morefrequently:

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

• Certain medicines to treat clinical shock (e.g. adrenaline, dobutamine, noradrenaline)

• 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 glycosides, used to treat heart failure

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

•    Medicines for asthma or medicines used for a blocked nose

•    Mefloquine, used for prevention or treatment of malaria.

•    Any medicine which can lower blood pressure as a desired 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 characterised bya loss ofcontact with reality (phenothiazines such as levomepromazine)

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

Pregnancy and breast-feeding:

Bisoprolol Fumarate is not recommended during pregnancy. There is a risk that use of bisoprolol during pregnancy may harm the baby. Ifyou 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, breast-feeding 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. Check with your doctor or your pharmacist if you are not sure.

This treatment should be initiated by a specialist in cardiology or internal medicine.

Adults and the Elderly:

Hypertension or angina pectoris

The maximum daily dose is 20mg once a day.

Stable chronic heart failure

The treatment should be managed by a doctor experienced in treating chronic heart failure.

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

•    5mg bisoprolol once daily for four weeks

•    7.5 mg bisoprolol once daily for four weeks

•    10mg bisoprolol oncedailyfor maintenance (on-going) therapy.

The maximum recommended dose islOmg once daily.

Depending on how well you tolerate the medicine, your doctor may also decide to lengthen the time between dose increases. Ifyour condition gets worseoryou 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 thanlOmg bisoprolol may be sufficient.

Your doctor will tell you what to do.

Kidney or liver disease

Patients with hypertension or angina pectoris:Thedosage should not exceed 10mg once daily in patients with severe kidney or liver problems.

Use in children and adolescents

Bisoprolol Fumarate is not recommended for use in children and adolescents.

Take your medicine

Bisoprolol Fumarate Tablets should be taken in the morning, before,with or after breakfast. Swallow the tablet/s whole with some water and do not chem or crush them.

The 2.5 mg, 5 mg and 10mg tablets can be divided into equal doses.The 1.25 mg and 3.75 mg tablets should not be broken.

Ifyou take more Bisoprolol Fumaratethan you should

Contactyour doctor or local emergency ward immediately. Take this leaflet and any tabletsyou still have with you. Your doctor will decide what measures are necessary.

The most common signs ofan 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

Ifyou forget to take a dose, take it as soon asyou remember it unless it is nearly timeforyour next dose.

Do not take a double dose to make up for a forgotten dose.

Ifyou stop taking Bisoprolol Fumarate

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.

Ifyou have anyfurther questions on the useofthis medicine, askyour doctor or pharmacist.

4. Possiblesideeffects

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

To prevent serious reactions, speakto 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:

• Slowingofheartrate(mayaffectmorethan1 inlOpeople)

• Worseningofheartfailure(mayaffectupto1 inlOpeople)

•    Slow or irregular heartbeat (may affect uptol in100 people)

Ifyou feel dizzy or weak, or have breathing difficulties please contact your doctoras soon as possible.

Other serious side effects are:

Uncommon (may affect uptol inlOO people):

•    depression

•    breathing problems in patients with asthma or chronic lung disease Rare (may affect up to 1 in 1,000 people):

•    inflammation ofthe liver which can causeyellowing ofthe skin or whites ofthe eyes

Further side effects are listed below according to howfrequentlythey may occur:

Common (may affect uptol inlO people):

•    Tiredness*

•    Fleadache*

•    Feeling ofcoldness or numbness in hands orfeet

•    Low blood pressure

•    Stomach or intestine problems such as nausea, vomiting, diarrhoea, or constipation.

•    These symptoms occur at the beginning oftherapy in patients with hypertension or angina pectoris. They are usually mild and disappearwithin 1-2 weeks.

Uncommon (may affect uptol inlOO people):

•    Sleep disturbances

•    Muscleweaknessandmusclecramps

•    Changes in the normal heart rate

•    Dizziness when standing up.

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

•    Flearing problems

•    Allergic runny nose

•    Reduced tear flow

•    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 (may affect uptol in10,000 people):

•    Irritation and redness ofthe eye (conjunctivitis)

•    Flairloss

•    Appearance or worsening ofscaly skin rash (psoriasis); psoriasis-like rash.

Reporting of side effects

Ifyou get any side effects, talkto your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directlyvia theYellowCard Scheme Website at: www.mhra.aov.uk/vellowcard

By reporting side effectsyou can help provide more information on the safety ofthis 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 ofthat month.This medicine does not require anyspecial storage conditions.

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

6. Contents ofthe packand other information

What Bisoprolol Fumarate contains:

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.

Each 5 mg tablet contains 5 mg bisoprolol fumarate.

Each 10mg tablet contains 10mg bisoprolol fumarate.

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

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

1.25 mg: White to offwhite round biconvextablets.

2.5 mg: White to offwhite round biconvex tablets with a breakline on one side.

3.75 mg: White to offwhite round biconvextablets.

5 mg: White to offwhite round biconvex tablets with a breakline on one side.

10mg: White to offwhite round biconvextablets with a breaklineon one side.

Bisoprolol Fumarate 2.5 mg, 5 mg and 10mg Tablets only:Thetablet can bedivided into equal doses. Blisters: Packsizes of20,21,28,30,50,56,60,90 and 100 tablets. Not all packsizes may be marketed.

Marketing Authorisation Holder:

Chanelle Medical UK Limited,The Lodge, Stanford Bridge Farm, Station Road, Pluckley, Ashford, Kent,TN27 0RS, United Kingdom.

Manufacturer:

Chanelle Medical, Loughrea, Co Galway, Ireland

McDermott Laboratories Ltd (t/a Gerard Laboratories), 35-36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

Pharma-Pack Kft, 2040 Budaors,Vasut u. 13, Hungary

This medicinal product is authorised in the Member States of the EEA under the following names: United Kingdom : Bisoprolol Fumarate 1.25 mg, 2.5 mg, 3.75 mg, 5 mg &10 mg Tablets Italy: Bisoprololo Mylan Generics Portugal: Bisoprolol Anova

This leafletwas last revised in April 2016.