Bisoprolol 5mg and 10mg Tablets

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 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 Bisoprolol is and what it is used for

2.    Before you take Bisoprolol

3.    How to take Bisoprolol

4.    Possible side effects

5.    How to store Bisoprolol

6.    Further information

1. What Bisoprolol is and what it is used for

The name of this medicine is Bisoprolol 5mg Tablets or Bisoprolol 10mg Tablets referred to as Bisoprolol throughout this leaflet.

Bisoprolol belongs to a group of medicines commonly called 'beta-blockers ' which work by blocking the transmission of certain nerve impulses. Bisoprolol is used to help treat :

•    angina pectoris (chest pain)

•    hypertension (high blood pressure).

2. Before you take Bisoprolol

Do not take Bisoprolol if you:

•    are allergic (hypersensitive) to bisoprolol or any of the other ingredients in this medicine (listed in Section 6)

•    are in acute heart failure or if you require injection of inotropic drugs (drugs which increase the force of contraction of the heart)

•    have had cardiogenic shock (a condition in which your heart is unable to pump enough blood to your body)

•    suffer from heart block and do not have a pacemaker

•    suffer from low heart rate or your heart rate is abnormal because of a condition known as sick sinus syndrome

•    have very poor circulation or Raynaud's Syndrome

•    have unusually low blood pressure

•    have a tumour of the adrenal gland (phaeochromocytoma)

•    suffer from severe asthma or have severe breathing difficulties

•    suffer from metabolic acidosis (a disorder of the metabolism which causes the blood to become acidic)

Do not take Bisoprolol if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Bisoprolol.

Take special care with Bisoprolol

Check with your doctor or pharmacist before taking your medicine if any of the following apply to you. You may need to be given a different dose or a different medicine if:

•    you suffer from heart failure (the treatment of heart failure is very different)

•    you suffer from asthma or any other lung disease

•    you have diabetes mellitu s (sugar diabetes)

•    you have a history of allergies, including any for which you are undergoing desensitising treatment

•    you have first degree heart block

•    you suffer chest pain at rest

•    you have poor circulation

•    you have psoriasis (a type of rash)

•    you have an overactive thyroid

•    you have a tumour of the adrenal gland (phaeochromocytoma) which is being treated with drugs

•    you have kidney or liver disease

•    you are pregnant, might become pregnant or are breast -feeding

•    you are fasting

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Bisoprolol.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription or herbal medicines. This is because Bisoprolol can affect the way some other medicines work. Also some other medicines can affect the way Bisoprolol works.

Please tell your doctor or pharmacist if you are taking any of the following:

•    medication to treat heart disease or high blood pressure

•    medication for irregular heartbeat

•    medication for angina or poor blood circulation

•    medication for epilepsy, depression or mental illness

•    medication for migraine such as clonidine

•    medication for diabetes such as insulin or oral diabetic drugs

•    cough medicines

•    eye or nose drops

•    moxisylyte used to treat erectile dysfunction

•    mefloquine used as an anti-malarial drug

•    rifampicin used as an antibiotic

•    anaesthetics

Tests and operations

If you are going to have an operation or any form of surgery (even at the dentist) please inform your doctor and ensure that the anaesthetist or dentist and other relevant medical personnel know that you are taking Bisoprolol.

Pregnancy

Do not take Bisoprolol if you are pregnant or trying to become pregnant , unless you have been advised to do so by your doctor.

Breast-feeding

Do not take Bisoprolol if you are breast-feeding.

Driving and using machines

You may find that your reactions are impaired when taking Bisoprolol, particularly during the first few weeks of your treatment, during changes to your medication or i f you have also drunk alcohol. Therefore it is very important that you do not drive or use any tools or machines if you are affected.

Always take Bisoprolol exactly as your doctor has told you. The doctor, depending on your needs and the condition being treated, will decide the dose of Bisoprolol. You should check wi th your doctor or pharmacist if you are not sure.

Taking this medicine

•    Swallow the tablets whole with a glass of water

•    If you have the impression that the effect of Bisoprolol is too strong or too weak, talk to your doctor or pharmacist.

How much to take - adults and older people

•    The usual dose is either two 5mg tablets or one 10mg tablet (10mg) daily.

•    Your doctor may decide to increase or decrease this dose.

•    The dose should not exceed 20mg in one day.

•    Do not stop taking this medicine except on your doctor's advice. In some cases, it may be necessary to stop taking your medicine gradually

Patients with severe liver or kidney problems

•    Your doctor may decide to decrease the usual adult dose.

•    The dose should not exceed 10mg in one day.

Children (less than 18 years of age)

Do not give to children aged less than 18 years.

If you take more Bisoprolol than you should

If you take more Bisoprolol than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.

If you forget to take Bisoprolol

•    If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose

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

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 can cause side effects, although not everybody gets them. The following side effects may occur with this medicine.

See a doctor or go to a hospital straight away, if you notice any of the following serious side effects - you may need urgent medical treatment:

•    skin rash, itching, swollen or lumpy skin, swollen face, lips, tongue or throat, difficulty breathing

Common side effects (between 1 in 10 and 1 in 100 patients):

•    feeling of coldness or numbness in the fingers or toes,

•    tiredness, exhaustion, dizziness or headache

•    nausea, vomiting, diarrhoea or constipation

Uncommon side effects (between 1 in 100 and 1in 1,000 patients):

•    muscle weakness and cramps

•    interference with the normal heart rate, worsening of heart failure, low blood pressure upon standing up

•    sleep disturbances, depression

•    worsening of breathing problems in patients with a history of such problems.

Rare side effects (between 1 in 1,000 and 1 in 10,000 patients):

•    nightmares, hallucinations

•    skin reactions (itching, flushing, rash)

•    hepatitis and increased liver enzymes (yellowing of your skin or the whites of your eyes)

•    increased blood levels of some fats

•    an inability to achieve or maintain an erection in men (impotence)

•    hearing loss, runny nose or dry eyes.

Very rare side effects (less than 1 in 10,000 patients):

•    red itching inflammation in the eye (conjunctivitis), visual disturbance

•    worsening of psoriasis or the development of a psoriasis-like rash, alopecia (hair loss)

•    chest pain.

Side effects more usual in heart failure patients:

•    a lowered or increased heart rate, dizziness, low blood pressure

•    fatigue, viral infection, shortness of breath or pneumonia.

Side effects more usual at the beginning of treatment with Bisoprolol:

•    tiredness, exhaustion, dizziness or headache

These side effects at the beginning are usually mild and disappear after 1 -2 weeks of treatment.

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.

Reporting of side effects

if you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects via the Yellow Card Scheme at: www.mhra.gov.uk/vellowcard. By reporting side effects you can help provide information on the safety of this medicine.

5. How to store Bisoprolol

•    Keep out of the reach and sight of children

•    Do not store above 30°C.

•    Do not use Bisoprolol after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required which will help protect the environment .

6. Further information

What Bisoprolol contains

•    The drug substance is bisoprolol. Each film-coated tablet contains either 5mg or 10mg of the drug substance as bisoprolol fumarate .

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

What Bisoprolol Tablets look like and contents of the pack

•    Bisoprolol 5mg Tablets are ivory, film-coated tablets with a scoreline.

•    Bisoprolol 10mg Tablets are ivory, film-coated tablets with a scoreline.

Bisoprolol is only available from your pharmacist on prescription in pack sizes of 28 tablets.

MA Holder: Medley Pharma Limited, Unit 2A, Olympic Way, Sefton Business Park,

Liverpool L30 1RD, UK

Distributed by: Zanza Laboratories Limited, Liverpool, UK

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