Bisoprolol 10 Mg Film-Coated Tablets.

Document: leaflet MAH GENERIC_PL 17907-0365 change



_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, 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.

The name of your medicine is ‘Bisoprolol 5mg film-coated Tablets or Bisoprolol 10mg film-coated Tablets’ but it will be referred as ‘Bisoprolol Tablets’ throughout the leaflet.

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 what they are used for

The active ingredient in Bisoprolol Tablets is Bisoprolol fumarate.

Bisoprolol belongs to a group of drugs called beta-blockers. These medicines protect the heart against too much activity.

It may be used to treat angina pectoris (pains in the chest caused by blockages in the arteries leading to the heart) or hypertension (high blood pressure).

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

DO NOT take Bisoprolol Tablets if you:

•    are allergic (hypersensitive) to Bisoprolol or any of the other ingredients of Bisoprolol Tablets (See Section 6).

•    have or have had severe wheezing or severe asthma

•    have a slow heart rate (less than 60 beats per minute). Ask your doctor if you are not sure

•    have very low blood pressure

•    have severe blood circulation problems (may cause your fingers and toes to tingle or turn pale or blue) or severe Raynaud’s Syndrome

•    have certain serious heart rhythm problems

•    have heart failure, which has just occurred or which has recently become worse or requires hospital treatment

•    have a condition in which there is an accumulation of excessive acid in the body known as metabolic acidosis. Your doctor will be able to advise you

•    have untreated phaeochromocytoma, a rare tumour of the adrenal gland Tell your doctor if you are not sure about any of the above.

Warnings and precautions

Talk to your doctor before taking Bisoprolol Tablets if you:

•    have liver or kidney problems

•    have diabetes. Bisoprolol Tablets can hide the symptoms of low blood sugar

•    have or have had psoriasis (a recurrent skin disorders involving scaling and dry skin rash)

•    are being treated for hypersensitivity (allergic) reactions. Bisoprolol may make your condition worse or more difficult to treat

•    have been treated for a condition called ‘phaeochromocytoma’ (a rare tumour of the adrenal gland)

•    have a thyroid problem. The tablets can hide the symptoms of overactive thyroid

•    have asthma or chronic lung disease

•    are fasting from solid food

•    have heart failure (the dosage regimen for the treatment of stable chronic heart failure with bisoprolol is very different to that for the treatment of angina or high blood pressure)

•    suffer from Prinzmetal’s angina which is a type of chest pain caused by spasm of the coronary arteries that supply the heart muscle

•    have any problem with the circulation to your hands and feet

•    consult a doctor, attend hospital or the dentist for surgery involving an anaesthetic, let them know what medicines you are taking

Other medicines and Bisoprolol Tablets Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It is particularly important to mention any of the following drugs as their action may be affected:

•    Medicines used for controlling blood pressure or medicines used for the treatment of heart problems, such as: amlodipine, amiodarone, clonidine, diltiazem, disopyramide, digoxin, dobutamine, isoprenaline, methyldopa,

moxonidine, nifedipine, quinidine, rilmenidine, verapamil and beta blocking agents

•    Medicines for the treatment of depression and mental disorders such as, tricyclic antidepressants, phenothiazines, monoamine oxidase inhibitors and barbiturates

•    Medicines used as anaesthetics during an operation

•    Anti-inflammatory medicines known as NSAIDS (for instance diclofenac, indomethacin, ibuprofen, naproxen)

•    Medicines used for diabetes

•    Medicines used for malaria e.g. mefloquine

•    Medicines used for migraine e.g. ergotamine

•    Medicines for asthma

•    Medicines for a blocked nose

•    Medicines for glaucoma (increased pressure in the eye)

•    Medicines used to dilate (widen) the pupil of the eye

All these medicine may influence your blood pressure and/or heart function. With insulin and other medicines used for diabetes, Bisoprolol Tablets may mask the symptoms of a low blood sugar.

Bisoprolol Tablets with food, drink and alcohol

Bisoprolol Tablets may be taken with or without food and should be

swallowed whole with a drink of water.

Pregnancy, breast-feeding and fertility

Bisoprolol Tablets may be harmful to the pregnancy and/or unborn child.

There is an increased possibility of premature birth, miscarriage, low blood

sugar level and reduced heart rate of the child. The growth of the baby may

also be affected. Therefore, Bisoprolol Tablets should not be taken during


It is not known if Bisoprolol is excreted in the breast milk and therefore it is not recommended while breast-feeding. Ask your doctor or pharmacist for advice before taking any medicinal product.

Driving and using machines

Take special care if you drive or operate machinery, particularly during the first weeks of your treatment. You may find that your reactions are impaired, especially if you have also drunk alcohol.

_3. How to take Bisoprolol Tablets_

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The tablets should be swallowed whole with water.

The breakline is not intended for breaking the tablets.    |




Bisoprolol Insert


290 x 160 mm

Your doctor will tell you correct dosage and will usually start with the lowest dose (5mg). The maximum recommended dose is 20 mg. The tablets should be taken at about the same time each day.

Patients with kidney disease

Patients with severe kidney disease should not exceed 10mg of Bisoprolol Tablets once daily. Please consult your doctor before starting to use this medicine.

Patients with liver disease

Patients with severe liver disease should not exceed 10 mg of Bisoprolol Tablets once daily. Please consult your doctor before starting to use this medicine.

Children under 12 years and adolescents

Not recommended as there is no experience with this medicine in children under 12 years and adolescents.

If you take more Bisoprolol Tablets than you should If you have accidentally taken more than the prescribed dose, tell your doctor/pharmacist immediately. Take any remaining tablets or this leaflet with you so the medical staff know exactly what you have taken.

If you forget to take Bisoprolol Tablets

If you forget to take a dose, take it as soon as you remember, then go on as

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

If you stop taking Bisoprolol Tablets

Treatment with Bisoprolol Tablets must not be stopped abruptly, particularly if you have had angina or a heart attack. If you suddenly stop the use of Bisoprolol Tablets your condition may get worse or your blood pressure may start to rise again. Instead, it must be reduced gradually over one or two weeks as advised by your doctor.

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 Tablets can cause side effects, although not everybody gets them.

Stop taking Bisoprolol and talk to your doctor straight away, if you notice any of the following:

•    Worsening of heart failure causing increased breathlessness and/or retention of fluid

•    Allergic reactions (itching, flushed appearance, rash)

•    Inflammation of the liver (hepatitis), causing abdominal pain, loss of appetite and sometimes jaundice with yellowing of the whited of the skin and dark urine

The most frequently occuring side effects are:

•    Tiredness, dizziness, headache (especially at the beginning of therapy: these symptoms are generally mild and often disappear within 1 -2 weeks)

•    Cold or numbness of hands and/or feet

•    Feeling sick (nausea), being sick (vomiting)

•    Diarrhoea

•    Constipation

•    Low blood pressure

Other side effects reported are:

Uncommon (affects less than 1 in 100 people)

•    Sleep disturbances

•    Depression

•    Slow or irregular heartbeat

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

•    Muscle weakness, cramps

Rare (affects less than 1 in 1000 people)

•    Nightmares

•    Hallucinations

•    Hearing impairment

•    Inflammation of the lining of the nose, causing a runny nose with irritation.

•    Dry eyes from reduced tear flow (can be very troublesome if you see contact lenses)

•    Reduced sexual performance

•    Changes in blood test results

Very Rare (affects less than 1 in 10,000 people)

•    Aggravation of psoriasis or cause a similar dry, scaly rash

•    Hair loss

•    Inflammation of the eye (conjuctivitis)

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 out of the sight and reach of children.

•    Do not store above 25°C.

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

•    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Bisoprolol Tablets contain

The inactive 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 yellow iron oxide (E172).

Bisoprolol 10mg Tablets also contain red iron oxide (E172)

What Bisoprolol Tablets look like and contents of the pack Bisoprolol 5mg tablets are ivory coloured, round, biconvex film-coated tablets, with a break line.

Bisoprolol 10 mg tablets are light brown coloured, round, biconvex film-coated tablets with a break line.

They are each available in blister packs of 28 tablets.

Marketing Authorisation Holder/Manufacturer Name and address: Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road,

Berkhamsted, Hertfordshire,

160 mm

HP41EG, United Kingdom Telephone:    0044(0)1442200922

Fax:    0044 (0)1442 873717


Bisoprolol 5mg Film-coated Tablets; PL 17907/0364 Bisoprolol 10mg Film-coated Tablets; PL 17907/0365 This leaflet was last revised in July 2012 To request a copy of this leaflet in braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.


290x 160mm