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Bisoprolol 10mg Tablets

Document: leaflet MAH GENERIC_PL 20416-0299 change

PACKAGE LEAFLET: INFORMATION FOR THE USER

Bisoprolol 5mg Tablets Bisoprolol 10mg Tablets (bisoprolol hemifumarate)

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 Tablets are and what they are used for

2.    Before you take Bisoprolol Tablets

3.    How to take Bisoprolol Tablets

4.    Possible side effects

5.    How to store Bisoprolol Tablets

6.    Further information

1.    WHAT BISOPROLOL TABLETS ARE AND WHAT THEY ARE USED FOR

Bisoprolol belongs to a group of medicines called beta-blockers, which are a type of anti-hypertensive medicine (medicines used for lowering blood pressure).

These tablets are used to treat high blood pressure and recurring angina pectoris. Angina pectoris is a disease in which the heart muscles receive less oxygen than they need. This generally occurs during exercise and the most common symptom associated with this condition is chest pain.

2.    BEFORE YOU TAKE BISOPROLOL TABLETS Do not take Bisoprolol Tablets if you:

•    are hypersensitive (allergic) to bisoprolol or any of the ingredients in the product (see Section 6 “What Bisoprolol Tablets contain ”)

   have a history of breathing difficulties due to a narrowing of the airways (bronchospasm) or asthma

•    have a heart problem such as heart block, sick sinus syndrome, slow heart rate (bradycardia), or congestive heart failure

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

•    have unusually low blood pressure

•    have uncontrolled heart failure or Prinzmetal's angina (a form of unstable angina)

•    have an untreated phaeochromocytoma (a lump/tumour in the adrenal gland)

•    have metabolic acidosis disease (increased acid levels in the blood)

Take special care with Bisoprolol Tablets

You should talk to your doctor before taking these tablets if you:

•    have heart disease/failure, as withdrawal from Bisoprolol Tablets must be gradual to avoid re-occurrence of symptoms.

•    Suffer from peripheral circulatory disorder (circulation problems, e.g. Raynaud's disease).

•    have a history of allergy, asthma or any other lung disease

•    have a history of psoriasis

•    suffer from diabetes, as Bisoprolol may mask the symptom of hypoglycaemia

•    suffer from kidney or liver disease.

•    have portal hypertension (high blood pressure) your doctor may want to monitor your liver function.

•    have heart failure due to thyroid problems.

•    are having blood tests or other laboratory tests, as Bisoprolol may interfere with some of these.

Taking other medicines:

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

In particular, tell your doctor if you are taking:

•    antihypertensive drugs e.g. reserpine, methyldopa and clonidine.

•    antiarrythmic drugs e.g. amiodarone, disopyramide or quinidine.

•    calcium antagonists e.g. verapamil, diltiazem

•    rifampicin (an antibiotic)

•    oral diabetic tablets and insulin

Pregnancy and breast-feeding:

Tell your doctor or pharmacist immediately if you are pregnant or planning to become pregnant. If you are taking Bisoprolol Tablets do not breast feed your baby and consult your doctor for further advice.

Effects on the ability to drive and use machines:

As this medicine may cause dizziness, you should not drive or operate machinery until you know how the drug affects you.

3.    HOW TO TAKE BISOPROLOL TABLETS

Always take Bisoprolol Tablets exactly as your doctor has told you. The pharmacist's label should tell you how much to take and how often.

For oral use only.

The tablets must be swallowed with a glass of water.

The usual oral dose is:-

Adults: 10mg once daily, up to a maximum 20mg daily. In some patients 5mg daily is sufficient.

Patients with kidney and liver problems: In patients with final stage impairment of renal (creatinine clearance <20ml/min) or liver function, the daily dose should not exceed 10mg.

Elderly: The usual dose is the same as the adult dose. A lower dose may be adequate. Your doctor will adjust your dose as appropriate.

Children:

Not recommended for use in children.

If you take more Bisoprolol Tablets than you should

If you take too many tablets or someone else takes your tablets, contact your doctor, pharmacist or hospital emergency department immediately. Always take any tablets left over with you and also the box, as this will allow easier identification of the tablets.

If you forget to take Bisoprolol Tablets

If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose though, do not double up on the dose just carry on as before.

If you stop taking Bisoprolol Tablets

Do not stop taking your tablets without first discussing this with your doctor as this may be harmful.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Bisoprolol Tablets can cause side effects, although not everyone gets them.

If you experience any of the following, tell your doctor immediately:

•    skin rashes or itching

•    sore throat or repeated infections.

These may be a sign of an allergic reaction.

Bisoprolol may cause other unwanted effects including:

Common:

•    Tiredness, exhaustion, dizziness, headache.

•    Feeling or being sick or diarrhoea.

Uncommon:

•    Muscular weakness, cramps and joint ache

•    Slow heart beat

• Decrease in blood pressure

• Coldness of extremities, oedema

•    Light-headedness, especially on suddenly standing up

•    Sleep disturbances

•    Sweating

•    Dry eyes

•    Patients with asthma or a history of breathing problems may experience difficulty in breathing Rare:

•    Nightmares or hallucinations

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.

5    HOW TO STORE BISOPROLOL TABLETS

Keep all medicines out of the reach and sight of children.

Do not store above 25°C.

Store in the original package

This medicine should not be used after the expiry date printed on the pack.

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    FURTHER INFORMATION What Bisoprolol Tablets contain:

The active ingredient is bisoprolol hemifumarate. The tablets contain 5mg and 10mg of bisoprolol hemifumarate respectively.

Other ingredients are maize starch, microcrystalline cellulose, crospovidone, anhydrous calcium hydrogen phosphate, magnesium stearate, colloidal anhydrous silica, hypromellose, titanium dioxide (E171), macrogol 6000. dimeticone 350 and iron oxide yellow (E172). Bisoprolol 10mg Tablets also contain iron oxide red (E172).

What Bisoprolol Tablets looks like and contents of the pack:

Bisoprolol 5mg tablets are round film-coated, ivory coloured tablets with a break-line on one side and '5' embossed on the other.

Bisoprolol 10mg Tablets are round film-coated, light brown coloured tablets with a break-line on one side and '10' embossed on the other.

Bisoprolol 5mg and 10mg Tablets are available in blister packs of 28 tablets

Marketing Authorisation Holder and Manufacturer:

Crescent Pharma Limited,

Units 3 & 4 Quidhampton Business Units,

Polhampton Lane, Overton,

Hampshire, RG25 3ED, UK

This leaflet was last approved in November 2014.