BISOPROLOL FUMARATE 10MG TABLETS

Active substance: BISOPROLOL FUMARATE (2:1)

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PACKAGE LEAFLET : INFORMATION FOR THE USER
Bisoprolol 5 mg Tablets
Bisoprolol 10 mg 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 or pharmacist.
- 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 or pharmacist. This includes any possible side
effects not listed in this leaflet.
What is in this leaflet
1. What Bisoprolol tablets is and what it is 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 is and what it is used for
Bisoprolol belongs to a group of medicines called beta-blockers. This medicine is used to treat high
blood pressure and recurring angina pectoris. Angina pectoris is a disease in which the cardiac (heart)
muscles receive less oxygen than is necessary. This generally occurs during exercise and the most
common symptom associated with this condition is chest pain.
2. What you need to know before you take Bisoprolol tablets
Do not take Bisoprolol tablets
- if you are allergic to bisoprolol or any of the other ingredients of this medicine (listed in section 6)
- if you are in acute heart failure or if you require injection of inotropic drugs (drugs which increase
the force of contraction of the heart)
- if you have had cardiogenic shock (where your heart is unable to pump enough blood to your
body).
- if you suffer from heart block and do not have a pacemaker
- if you suffer from slow heart beats (less than 60/minute) or sick sinus syndrome.
- if you have very poor circulation or severe Raynaud’s Syndrome
- if you have extremely low blood pressure
- if you have a tumour of the adrenal gland (phaeochromocytoma) which is not currently being
treated.
- if you suffer from severe asthma or have severe breathing difficulties.
- if you suffer from metabolic acidosis (disorder of the metabolism causing the blood to become
acidic)
- if you are already taking floctafenine (painkillers) or sultopride (antipsychotic drug).
Warnings and precautions
Talk to your doctor or pharmacist before taking Bisoprolol tablets
- if you suffer from asthma or from any other breathing difficulties.
- if you suffer from diabetes mellitus, as low blood sugar levels may be masked by this medicine.
- if you suffer from an excessive production of thyroid hormones.
- if you have a history of allergies, including any for which you are undergoing desensitising
treatment.

- if you are fasting.
- if you suffer from an irregular heart beat, or from circulatory problems (e.g. less severe forms of
Raynaud's syndrome resulting in temporary discoloration of the skin and numbness of the fingers
and toes).
- if you experience sudden onset of chest pain, or if you already suffer from a mild form of angina.
- if you suffer from phaeochromocytoma (marked by high blood pressure, raised heart rate and
headache). This condition should be treated first, prior to taking Bisoprolol Tablets.
- if you suffer from or have suffered from psoriasis (marked by severe skin rashes).
If you go into hospital to have an operation, tell the anaesthetist or other medical staff that you are
taking Bisoprolol Tablets.
If you have a heart condition, treatment must not be stopped abruptly. The dose must be
decreased gradually. For best advice, please contact your doctor.
Children and adolescents
Bisoprolol tablets is not recommended for use in children or adolescents.
Other medicines and Bisoprolol tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
-

Floctafenine or other NSAIDs (non-steroidal anti-inflammatory drugs – painkillers).
Sultopride (antipsychotic medicine).
Verapamil, diltiazem, bepridil (medicines used in the treatment of angina and high blood pressure).
Clonidine (a medicine used to treat high blood pressure, ) and other centrally acting
antihypertensives, such as methyldopa, guanfacin, moxonidine and rilmenidine.
Any other drugs used for high blood pressure treatment
Medicines for depression or mental illness (monoamine-oxidase inhibitors, tricyclic antide
pressants or phenothiazines).
Disopyramide, quinidine or amiodarone (medicines used to treat irregular heartbeat).
Calcium antagonists or beta-blockers (medicines used in the treatment of angina and high blood
pressure including beta-blockers in eye drops).
Anticholinesterase drugs (including Tacrine) - medicines used in Alzheimer's disease.
Insulin or other medicines for diabetes.
Anaesthetics.
Digitalis glycosides (medicines used in heart failure).
Prostaglandin synthetase inhibiting drugs (medicines used to relieve the pain, tenderness,
inflammation and stiffness caused by gout, arthritis, and other inflammatory conditions).
Ergotamine derivatives (medicines for migraine).
Sympathomimetic agents (medicines used in heart problems or low blood pressure).
Barbiturates (medicines used in sleep disorders).
Baclofen (used to treat muscle spasms associated with multiple sclerosis and spinal cord injury).
Iodine containing contrast media (used when you have an X-ray).
Mefloquine (an anti-malarial drug).
Corticosteroids (medicines used for the treatment of asthma).
Amifostine (from a class of drugs known as chemoprotectants).

Bisoprolol tablets with food, drink and alcohol
Bisoprolol tablets should be taken in the morning, before, with or after breakfast. They should be
swallowed whole with liquid and should not be chewed or crushed. Avoid drinking excessive alcohol,
since it may increase the blood pressure-lowering effect of Bisoprolol.

Pregnancy and breast-feeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.
This medicine is not recommended during pregnancy unless clearly necessary.
This medicine is not recommended during breast-feeding.
Driving and using machines
Bisoprolol tablets may cause side effects that may affect a person's ability to drive and use machinery
particularly during the first few weeks of your treatment. You may find that your reactions are
impaired, especially if you have also consumed alcohol. Examples of side effects include visual
disturbances, drowsiness or dizziness. If you suffer from any of these side effects it is advisable to
refrain from driving or using machinery.
Important information about some of the ingredients of Bisoprolol tablets
This product 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
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 a glass of water. Try to take the tablets the same time
each day.
The tablet can be divided into equal doses.
It is important that you take this medicine for as long as your doctor prescribes them. Do not stop
taking your medication without consulting with your doctor first.
Adults and the elderly:
The doctor will decide the dose you require and take into account any other medicines you may
be taking. In some patients 5 mg per day may be adequate. The usual dose is 10 mg once daily
with a maximum recommended dose of 20 mg.
Patients with kidney disease:
Patients with severe kidney disease should not exceed 10 mg of bisoprolol once daily. This dosage
may eventually be halved. 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 once daily . Please consult
your doctor before starting to use this medicine.
If you take more Bisoprolol tablets than you should
Contact your nearest casualty department or tell your doctor/pharmacist immediately. Take this leaflet
and any left over tablets with you to show them.
If you forget to take Bisoprolol tablets
Try to take your tablets daily as prescribed. However, if you miss a dose, just take it as soon as
you remember that day. Do not take a double dose to make up for a forgotten dose.
If you stop taking Bisoprolol tablets
Do not stop treatment suddenly or change the recommended dose without talking to your doctor first.
If you need to stop the treatment, it most be done gradually to avoid side effects.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking your tablets and seek immediate medical advice if you experience any of the
following rare side effects:
allergic reaction - itchy skin, rash, swelling of the face, lips, tongue, throat, or difficulty breathing
or swallowing
Common (may affect up to 1 in 10 people):
Feeling of coldness or numbness in the extremities (fingers or toes, ears and nose), Raynaud’s
disease (a condition where the blood supply to the tips of the fingers or toes may become so
restricted as to cause tissue damage), worsening of cramp-like pain (intermittent claudication) that
occurs in the legs when walking.
Hypotension
Tiredness, exhaustion, dizziness, headache (especially at the beginning of therapy, these are
generally mild and often disappear within 1-2 weeks).
Nausea, vomiting, diarrhoea, abdominal pain, constipation.
Uncommon (may affect up to 1 in 100 people):
Muscular weakness, muscular cramps and joint ache.
Feeling weak
Slow or irregular heart beat.
Worsening of heart failure (a condition in which the pumping action of the ventricle of the heart is
inadequate).
Sleep disturbances, depression.
Patients with asthma or a history of breathing problems may experience difficulty in breathing.
Light-headedness, especially on suddenly standing up.
Rare (may affect up to 1 in 1,000 people):
Nightmare, hallucinations.
Low blood sugar levels.
Increased liver enzymes (you would notice a yellowing of the skin or the whites of your eyes).
Increased triglycerides (certain lipids in the blood).
Hepatitis (an inflammation of the liver).
Inflammatory skin disease (lupus syndrome), which-disappear upon ending of treatment.
Reduced sexual performance.
Hearing impairment, runny nose.
Reduced tear flow (especially if the patient uses contact lenses).
Fainting.
Very rare (may affect up to 1 in 10,000 people):
This medicine may aggravate psoriasis or induce psoriasis-Iike rash, hair loss.
Itchiness or redness of the eye.
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet.
5. How to store Bisoprolol tablets
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.

If you notice any defects or signs of deterioration in the tablets (such as broken tablets), please inform
your pharmacist.
Do not use this medicine after the expiry date which is stated on the blister strip and carton. The
expiry date refers to the last day of that month.
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 protect the environment.
6. Contents of the pack and other information
What Bisoprolol tablets contain
The active substance is bisoprolol fumarate.
Each tablet contains 5 mg / 10 mg bisoprolol fumarate.
The other ingredients are
Bisoprolol 5 mg tablets
lactose monohydrate, microcrystalline cellulose, magnesium stearate, crospovidone, iron oxide yellow
(E172)
Bisoprolol 10 mg tablets
lactose monohydrate, microcrystalline cellulose, magnesium stearate, crospovidone, iron oxide yellow
(E172), iron oxide red (E172)
What Bisoprolol tablets looks like and contents of the pack
Bisoprolol 5 mg tablets are mottled pale yellow, round, convex, with a breakline and '5' embossed on
the right hand side.
Bisoprolol 10 mg tablets are mottled beige, round, convex, with a breakline and '1' embossed on the
left and '0' embossed on the right
Both strengths are available in blister packs containing 28 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
ratiopharm GmbH, Graf-Arco-Str. 3, D-89079 Ulm, Germany.
Manufacturer:
Merckle GmbH, Ludwig-Merckle-Str. 3, D-89143 Blaubeuren, Germany.
For a large print, audio, Braille or CD-rom version of this patient information leaflet, phone 02392
313592.
Revision date: August 2013

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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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