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BISOPROLOL 5MG TABLETS

Active substance(s): BISOPROLOL FUMARATE / BISOPROLOL HEMIFUMARATE / BISOPROLOL FUMARATE / BISOPROLOL HEMIFUMARATE / BISOPROLOL FUMARATE / BISOPROLOL HEMIFUMARATE

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Package leaflet: information for the patient
Bisoprolol 5 mg and 10 mg tablets
Bisoprolol fumarate
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
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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. See section 4.

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

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 Bisoprolol tablets

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)
if you suffer from severe asthma or from other severe breathing difficulties
if you have acute heart failure or are in shock caused by heart problems
if you suffer with heart conduction or rhythm problems (2nd or 3rd degree AV-block, sick
sinus syndrome or sinoatrial block)
if you have a slow heart rate of less than 60 beats per minute before starting treatment.
if you have low blood pressure
if you suffer from severely blocked blood vessels, including blood circulation problems
(which may cause your fingers and toes to tingle or turn pale or blue)
if you suffer from increased acidity of the blood (metabolic acidosis)
if you suffer from untreated phaeochromocytoma (high blood pressure due to a tumour of
the adrenal medulla, a gland located near the kidney).
if you are already treated with floctafenine (product for pain) or sultopride (product for mental
illness). See also “Other medicines and Bisoprolol tablets”.

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Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Bisoprolol tablets:
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if you have a heart weakness
if you suffer from asthma or any other breathing difficulties
if you suffer from diabetes mellitus (low blood sugar levels may be hidden by this medicine)
if you have an overactive thyroid (symptoms such as increased heart rate, sweating, tremor,
anxiety, increased appetite or weight loss may be hidden by this medicine).
if you are on a strict fasting diet
if you 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
if you suffer from treated phaeochromocytoma (high blood pressure due to a tumour of the
adrenal medulla, a gland located near a kidney)
if you have or have suffered from psoriasis (severe skin rashes)
if you 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
if you suffer from a certain heart conduction disorder (so-called 1st degree AV block).

If you are going to have an anaesthetic, 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.
Children and adolescents
Bisoprolol tablets are not recommended for use in children due to a lack of data.
Other medicines and Bisoprolol tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Other medicines may be affected by bisoprolol fumarate. They in turn may affect how well
bisoprolol fumarate works. Bisoprolol can interact with:
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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, sympathomimetics (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
(parasympathomimetics) which, amongst others, are used for the treatment of Alzheimer’s
disease (e.g. tacrine).
medicines used for anaesthesia during surgery.
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medicines used to treat migraine (e.g. ergotamine).
a certain medicine that is a muscle relaxant (baclofen).
a medicine that decreases the side effects of cancer treatment (amifostine).
a certain medicine 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.
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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.
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 medicine 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 by your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicine.

3.

How to take Bisoprolol tablets

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. 10 mg once daily with a maximum
recommended dose of 20 mg.
• Patients with kidney disease: patients with severe kidney disease should not take more than
10 mg once daily. This dosage may eventually be halved and divided into two 5 mg doses
• Patients with liver disease: patients with severe kidney disease should not take more than
10 mg once daily. This dosage may eventually be halved and divided into two 5 mg doses
• Elderly: it is recommended to start with the lowest possible dose.
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• 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 lightheaded) 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 (may affect up to 1 in 10 people): 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 (may affect up to 1 in 100 people): 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 (may affect up to 1 in 1,000 people): 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 (may affect up to 1 in 10,000 people): conjunctivitis (red, sore, itching or weeping
eyes), psoriasis-like rash or worsening of psoriasis, hair loss, shock due to low blood sugar
levels.
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Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Bisoprolol tablets

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 Bisoprolol tablets contain
- The active substance is Bisoprolol fumarate.
Each Bisoprolol tablet contains contains either 4.24 mg or 8.49 mg bisoprolol equivalent to
either 5 mg or 10 mg Bisoprolol fumarate.
- The other ingredients are lactose monohydrate, microcrystalline cellulose, magnesium stearate,
crospovidone.
- The 5 mg tablet contains a yellow pigment blend 22812 (which contains lactose and iron oxide
yellow (E172)).
- The 10 mg tablet contains a beige pigment blend 27215 (which contains lactose and iron oxide
yellow and red (E172)).
What Bisoprolol tablets look like and contents of the pack
Blisters comprising of PVC/PVdC/aluminium foil, contained within a printed carton box.
The 5 mg tablets are mottled pale yellow, round and convex, with ‘BI’ ‘above a breakline with ‘5’
below.
The 10 mg 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:
Actavis UK Limited (Trading style: Actavis)
Whiddon Valley
Barnstaple
Devon
EX32 8NS
UK

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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 February 2016.

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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