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Bisoprolol 5mg Tablets

Document: leaflet MAH GENERIC_PL 00142-0509 change

Package leaflet: information for the patient

Bisoprolol 5mg & 10mg 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, ask your doctor, 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, pharmacist or nurse. This includes any possible side effects not listed in this 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

3.    How to take

4.    Possible side effects

5.    How to store

6.    Contents of the pack and other information

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

Bisoprolol fumarate belongs to a group of medicines called beta-blockers. It is used to treat:

•    high blood pressure

•    angina pectoris (pain in the chest caused by blockages in the arteries leading to the heart).

2.    What you need to know before you take Do not take Bisoprolol tablets if you

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

•    suffer from severe asthma or from other severe breathing difficulties

•    have acute heart failure or are in shock caused by heart problems

•    suffer with heart conduction or rhythm problems (2nd or 3rd degree AV-block, sick sinus syndrome or sinoatrial block)

•    have a slow heart rate of less than 60 beats per minute before starting treatment.

•    have low blood pressure

•    suffer from severely blocked blood vessels, including blood ciruculation problems (which may cause your fingers and toes to tingle or turn pale or blue)

•    suffer from increased acidity of the blood (metabolic acidosis)

•    suffer from untreated phaeochromocytoma (high blood pressure due to a tumour of the adrenal medulla, a gland located near the kidney).

•    are already treated with floctafenine (product for pain) or sultopride (product for mental illness). See also “Taking other medicines”.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Bisoprolol tablets:

•    have a heart weakness

•    suffer from asthma or any other breathing difficulties

•    suffer from diabetes mellitus (low blood sugar levels may be hidden by this medicine)

•    have an overactive thyroid (symptoms such as increased heart rate, sweating, tremor, anxiety, increased appetite or weight loss may be hidden by this medicine).

•    are on a strict fasting diet

•    are having treatment to reduce allergic reactions. Bisoprolol tablets may increase your hypersensitivity to the substances you are allergic to and increase the severity of allergic reactions.

•    If you suffer from a tight, painful feeling in the chest in periods of rest (Prinzmetal’s angina). Bisoprolol tablets may increase the number and the length of attacks

•    suffer from treated phaeochromocytoma (high blood pressure due to a tumour of the adrenal medulla, a gland located near a kidney)

•    have or have suffered from psoriasis (severe skin rashes)

•    suffer from blood circulation problems (in the fingers, toes, arms and legs), including less severe forms of Raynaud's phenomenon and intermittent claudication (a cramp like pain in the calves brought on by exercise or walking). The complaints may be worse, particularly at the beginning of the treatment

•    suffer from a certain heart conduction disorder (so-called 1st degree AV block).

If you are going to have an anaestethic, please tell your doctor or dentist that you are taking Bisoprolol tablets. It may be necessary to stop taking this medicine up to 48 hours before receiving the anaesthetic.

Other medicines and Bisoprolol TabletsOther medicines may be affected by bisoprolol fumarate. They in turn may affect how well bisoprolol fumarate works. Bisoprolol can interact with:

•    medicines used for the treatment of pain and which exhibit an anti-inflammatory or fever inhibiting effect (NSAIDS) such as floctafenine.

•    medicines used for the treatment of psychiatric disorders (anxiety, psychoses or depression) such as sultopride, MAO-A inhibitors, tricyclic antidepressants, phenothiazines (also used for vomiting and nausea) and barbiturates (also used for epilepsy).

•    medicines used for controlling the blood pressure or medicines used for heart problems such as calcium antagonists, centrally acting anti-hypertensives (e.g. clonidine, methyldopa, guanfacin, moxonidine, rilmenidine), anti arrhythmics (e.g. disopyramide, quinidine, amiodarone), digitalis glycosides, sympathicommimetics (e.g. isoprenaline, dobutamine, noradrenaline, adrenaline) other beta-blockers (including eye drops which are used for the treatment of increased eye pressure).

•    medicines with a stimulating action on a certain part of the nervous system (parasympathicomimetics) which, amongst others, are used for the treatment of Alzheimer’s disease (e.g. tacrine).

•    medicines used for anaesthesia during surgery.

•    medicines used to treat migraine (e.g ergotamine).

•    a certain medicines that muscle relaxant (baclofen).

•    a medicines that decreases the side effects of cancer treatment (amifostine).

•    a certain medicines for malaria prevention (mefloquine).

•    adrenal cortex hormones that have, amongst others, an anti-inflammatory action (corticosteroids).

•    iodated contrast products, used for making certain organs and blood vessels visible on a scan.

•    sympathomimetics that activate both beta- and alpha-adrenoceptors (e.g. norepinephrine, epinephrine)

The combination of bisoprolol fumarate and any of the drugs listed above, may influence the blood pressure and/or heart function.

•    medicines used for the treatment of diabetes; for example, insulin and anti-diabetic medicines in tablet form. Bisoprolol fumarate may increase the blood sugar lowering effect and can mask the symptoms of low blood sugar content.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

Bisoprolol tablets are not recommended during pregnancy or breastfeeding. If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

This medicines could have a minor influence on the ability to drive and use machines.

Bisoprolol tablets may make you feel tired and dizzy. Make sure you are not affected before you drive or operate machinery, particularly at start of treatment, after any change in dose or medicine and if taken with alcohol.

Bisoprolol tablets contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains lactose.

3. How to take

Method of administration:

The tablet should be swallowed with a sufficient amount of fluid (e.g. one glass of water) at the same time each day. The tablet can be taken with or without food.

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

The recommended doses are:

•    Adults: Initial dose: Your doctor will start the treatment with the lowest possible dose. Sometimes 5 mg per day (24 hours) can be sufficient. 10mg once daily with a maximum recommended dose of 20mg.

•    Patients with kidney disease: patients with severe kidney disease should not take more than 10mg once daily. This dosage may eventually be halved and divided into two 5mg doses

•    Patients with liver disease: patients with severe kidney disease should not take more than 10mg once daily. This dosage may eventually be halved and divided into two 5mg doses

•    Elderly: it is recommended to start with the lowest possible dose.

•    Children under 12 years old and adolescents: Bisoprolol tablets are not recommended for use in children below 12 years old due to a lack of data.

If you take more Bisoprolol tablets than you should

If you have accidentally taken more than the prescribed dose, contact your nearest casualty department or tell your doctor or pharmacist at once. Symptoms of overdose are: slowed heart beat, asthma, low blood sugar, reduced blood pressure (possibly causing you to feel faint, dizzy or light-headed) and acute heart failure (fluid retention, breathlessness and tiredness).

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

Do not suddenly stop taking Bisoprolol tablets as this could cause your condition to worsen (an exacerbation of a disorder of the heart may occur or your blood pressure may become high again). Your doctor will reduce the dose gradually or replace it by another medicine.

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

4. Possible side effects

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

Stop treatment and contact a doctor at once if you have symptoms of an allergic reaction such as itchy skin rash, flushing, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing. This is a very serious but rare side effect (occurs in less than 1 in 1000 patients). You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

•    Common (occurs in less than 1 in 10 users but more than 1 in 100): tiredness, exhaustion, dizziness and headache (especially at the beginning of treatment). These are generally mild and often disappear within 1-2 weeks. Feeling of coldness or numbness in the extremities (Raynaud’s disease), increase of existing limping (intermittent claudication), low blood pressure, feeling or being sick, diarrhoea, abdominal pain, constipation.

•    Uncommon (occurs in less than 1 in 100 users but more than 1 in 1000): dizziness or fainting when standing up due to low blood pressure, lack of muscle strength, sleep disturbances, depression, slow or irregular heart beat, worsening of heart failure, muscle weakness and cramps, joint disease. Patients with asthma or a history of breathing problems may experience difficulty in breathing.

•    Rare (occurs in less than 1 in 1000 users but more than 1 in 10,000): loss of consciousness, nightmares, hallucinations, hearing impairment, dry eyes (to be considered if you wear contact lenses), reduced sexual performance, inflammation of the lining of the nose caused by an allergy, increased levels of fat (triglycerides) in your blood’, low blood sugar levels (hypoglycaemia), increased levels of enzymes in your blood (ALAT, ASAT) which indicate how your liver is functioning), inflammation of the liver causing yellowing of the skin or eyes (hepatitis), the appearance of certain blood cells could cause symptoms of lupus syndrome such as joint swelling, fever, tiredness, hayfever (allergic rhinitis), skin rash, (symptoms usually disappear when treatment is stopped).

• Very rare (occurs in less than 1 in 10,000 users): conjunctivitis (red, sore, itching or weeping eyes), psoriasis-like rash or worsening of psoriasis, hair loss, shock due to low blood sugar levels.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet.

5. How to store

Keep this medicine out of the sight and reach of children.

Do not take this medicine after the expiry date which is stated on the carton and blister label after EXP.

The expiry date refers to the last day of that month.

Do not store above 30°C.

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

6. Contents of the pack and other information

What Bisprolol tablets contains

-    The active substance is Bisoprolol fumarate.

Each Tablet contains contains either 4.24mg or 8.49mg bisoprolol equivalent to either 5mg or 10mg Bisoprolol fumarate

-    the other ingredients are lactose monohydrate, microcrystalline cellulose, magnesium stearate, crospovidone.

-    The 5mg tablet contains a yellow pigment blend 22812 (which contains lactose and iron oxide yellow (E172)).

-    The 10mg tablet contains a beige pigment blend 27215 (which contains lactose and iron oxide yellow and red (E172)).

What Bisprolol tablets look like and contents of the pack

Blisters comprising of PVC/PVdC/aluminium foil, contained within a printed carton box.

The 5mg tablets are mottled pale yellow, round and convex, with ‘BI’ ‘above a breakline with ‘5’ below.

The 10mg tablets are mottled beige, round and convex, with ‘BI’ above a breakline with ‘ 10’ below.

The tablets can be divided into equal halves.

Pack sizes: 10, 20, 28, 30, 50, 56, 60 or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Actavis, Barnstaple, EX32 8NS, UK.

Manufacturers:

Niche Generics Ltd

Unit 5, 151 Baldoyle Industrial Estate, Dublin 13 Ireland

Actavis Group PTC ehf.

Reykjavikurvegur 76-78 IS-220 Hafnarfjordur Iceland

This leaflet was last revised in January 2014.

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