BISOPROLOL FUMARATE 7.5 MG TABLETS

Active substance: BISOPROLOL FUMARATE

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PACKAGE INFORMATION LEAFLET
BISOPROLOL FUMARATE 7.5 MG TABLETS
Bisoprolol Fumarate

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, please 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 get 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 Fumarate is and what it is used for.
2. Before you take Bisoprolol Fumarate
3. How to take Bisoprolol Fumarate
4. Possible side effects
5. How to store Bisoprolol Fumarate
6. Further Information.
1. What Bisoprolol Fumarate Tablets are and what they are used for
The active substance in this medicine is Bisoprolol fumarate. Bisoprolol Fumarate belongs to a group of
drugs called beta-blockers. These medicines work by affecting the body’s response to some nerve
impulses especially in the heart. As a result, bisoprolol slows down the heart rate and makes the heart
more efficient at pumping blood around the body. Heart failure occurs when the heart muscle is weak
and unable to pump enough blood to supply the body's needs.
Bisoprolol is used:

To treat stable chronic heart failure. It is used in combination with other medicines suitable for this
condition (such as ACE-inhibitors, diuretics, and heart glycosides).

In treatment of coronary heart disease and chest pain (angina pectoris) caused by shortage of
oxygen in the heart muscle.

In treatment of high blood pressure (hypertension).
2. Before you take Bisoprolol Fumarate Tablets
Do not take Bisoprolol Fumarate Tablets:
Do not take Bisoprolol Fumarate Tablets if one of the following conditions applies to you:

allergic (hypersensitive) to bisoprolol fumarate or any of the other ingredients of Bisoprolol
Fumarate tablets.

severe asthma or severe chronic lung disease

severe blood circulation problems in your limbs (such as Raynaud’s syndrome), which may cause
your fingers and toes to tingle or turn pale or blue

untreated phaeochromocytoma, which is a rare tumour of the adrenal gland

metabolic acidosis, which is a condition when there is too much acid in the blood.
Do not take Bisoprolol Fumarate Tablets if you have one of the following heart problems:

acute heart failure

worsening heart failure requiring injection of medicines into a vein, that increase the
force of contraction of the heart

slow heart rate

low blood pressure

certain heart conditions causing a very slow heart rate or irregular heartbeat

cardiogenic shock, which is an acute serious heart condition causing low blood
pressure and circulatory failure.
Take special care with Bisoprolol Fumarate Tablets:
If you have any of the following conditions tell your doctor before taking this medicine; he or she may
want to take special care (for example give additional treatment or perform more frequent checks):

diabetes

strict fasting

certain heart diseases such as disturbances in heart rhythm, or severe chest pain at rest
(Prinzmetal’s angina)

kidney or liver problems

less severe blood circulation problems in your limbs

less severe asthma or chronic lung disease

history of a scaly skin rash (psoriasis)

a tumour of the adrenal gland (phaeochromocytoma) or if you are currently undergoing treatment
for a tumor of the adrenal gland

thyroid disorder

psoriasis or a history of psoriasis

thyroid problems
Take special care with Bisoprolol Fumarate Tablets if you have Chronic Heart Failure
and one of the following conditions:

insulin dependent diabetes

severe kidney or liver disease

heart condition known as restrictive cardiomyopathy where the blood flow to and from the heart
is slow

inherited heart conditions

problems with the heart valves

heart attack within the last 3 months
In addition, tell your doctor if you are going to have:

desensitization therapy (for example for the prevention of hay fever), because Bisoprolol may make
it more likely that you experience an allergic reaction, or such reaction may be more severe

anaesthesia (for example for surgery), because this medicine may influence how your body reacts
to this situation
Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription. Do not take the following medicines with
Bisoprolol Fumarate without special advice from your doctor:

If you have Chronic Heart failure certain medicines used to treat irregular or abnormal heartbeat
(e.g. Class I antiarrhythmic medicines such as quinidine, disopyramide, lidocaine, phenytoin;
flecainide, propafenone)

Certain medicines used to treat high blood pressure, angina pectoris or irregular heartbeat
(e.g. calcium antagonists such as verapamil and diltiazem)

Certain medicines used to treat high blood pressure. However, do not stop taking these
medicines without checking with your doctor first.
Check with your doctor before taking the following medicines with Bisoprolol Fumarate; your doctor
may need to check your condition more frequently:

If you have had high blood pressure or angina pectoris then certain medicines used to treat
irregular or abnormal heart beat (e.g. Class 1 antiarrhythmic medicines)

Certain medicines used to treat high blood pressure or angina pectoris (dihydropyridine-type
calcium antagonists such as nifedipine, felodipine and amlodipine)

Certain medicines used to treat irregular or abnormal heartbeat (Class III antiarrhythmic medicines
such as amiodarone)

Beta-blocking agents applied locally (such as timolol eye drops for glaucoma treatment)

Certain medicines used to treat for example Alzheimer’s disease or glaucoma
(parasympathomimetics such as tacrine or carbachol) or medicines that are used to treat acute
heart problems (sympathomimetics such as isoprenaline and dobutamine)

Antidiabetic medicines including insulin

Anaesthetic agents (for example during surgery)

Digitalis, used to treat heart failure

Non-steroidal anti-inflammatory medicines (NSAIDs) used to treat arthritis, pain or inflammation
(for example ibuprofen or diclofenac)

Antihypertensives or other drugs that can lower blood pressure

Mefloquine, used for prevention or treatment of malaria
Taking Bisoprolol Fumarate Tablets with food and drink:
Bisoprolol Fumarate 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.
Avoid drinking alcohol altogether, if it makes you more dizzy or more light-headed than usual.
Pregnancy and breast-feeding:
Bisoprolol Fumarate is not recommended during pregnancy. If you are pregnant or planning to become
pregnant, tell your doctor. He or she will decide whether you can take this medicine during pregnancy.
Breastfeeding is not recommended during therapy with Bisoprolol Fumarate Tablets.
Driving and using machines:
Your ability to drive or use machinery may be affected depending on how well you tolerate the
medicine. Please be especially cautious at the start of treatment, when the dose is increased or the
medication is changed, as well as in combination with alcohol.

3. How to take Bisoprolol Fumarate tablets
Always take Bisoprolol Fumarate tablets exactly as your doctor has told you. You should check with
your doctor or your pharmacist if you are not sure. Bisoprolol Fumarate Tablets should be taken in the
morning, before, with or after breakfast. Swallow the tablet/s whole with some water and do not chew
or crush them.
This treatment should be initiated by a specialist in cardiology or internal medicine.
Children: Bisoprolol Fumarate Tablets are not recommended for use in children.
Adults and the Elderly:
Hypertension or angina pectoris
The maximum daily dose is 20mg once a day.
Stable chronic heart failure
The treatment should be managed by a doctor experienced in treating chronic heart failure.
The maximum recommended dose is 10 mg once daily.
Renal or liver disease:
Patients with hypertension or angina pectoris: The dosage should not exceed 10 mg once daily in
patients with severe kidney or liver problems.
If you take more Bisoprolol Fumarate Tablets than you should:
Contact your doctor or local emergency ward immediately. Take this leaflet and any tablets you still have
with you. Your doctor will decide what measures are necessary. The most common signs of an overdose
may include slowed heart rate, severe difficulty in breathing feeling dizzy, or trembling (due to decreased
blood sugar).
If you forget to take Bisoprolol Fumarate Tablets:
If you forget to take a dose, take it as soon as you remember it unless it is nearly time for your next dose.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Bisoprolol Fumarate Tablets:
Do not stop treatment suddenly or change the recommended dose without talking to your doctor first.
If you need to stop treatment, it must be done gradually, to avoid side effects.
If you have any further questions on the use of this product, ask you doctor or pharmacist.
4. Possible side effects
Like all medicines, Bisoprolol Fumarate Tablets can cause side effects, although not everybody gets
them.
To prevent serious reactions, speak to a doctor immediately if a side effect is severe, occurred suddenly
or gets worse rapidly. The most serious side effects are related to the heart function:

slowing of heart rate (affects more than 1 person in 10)

worsening of heart failure (affects less than 1 person in 10)

slow or irregular heartbeat (affects less than 1 person in 100)
If you feel dizzy or weak, or have breathing difficulties please contact your doctor as soon as possible.
Further side effects are listed below according to how frequently they may occur:
Very common:
Common:
Uncommon:
Rare:
Very rare:

≥ 10%
≥ 1% and ≤ 10%
≥ 0.1% and ≤ 1%
≥ 0.01% and ≤ 0.1%
< 0.01%

Very Common:
Slow heart rate (in patients with chronic heart failure)

Common:

tiredness*

feeling weak (in patients with chronic heart failure)

dizziness*, headache*

feeling of coldness or numbness in hands or feet

low blood pressure

stomach or intestine problems such as nausea, vomiting, diarrhoea, or constipation

worsening of pre-existing heart failure (in patients with chronic heart failure)
* These symptoms occur at the beginning of therapy in patients with hypertension or angina pectoris.
They are usually mild and disappear within 1-2 weeks.
Uncommon:

sleep disturbances

depression

breathing problems in patients with asthma or chronic lung disease

muscle weakness, muscle cramps

worsening of pre-existing heart failure or slow heart rate (in patients with hypertension or angina pectoris)

feeling weak (in patients with hypertension or angina pectoris)

changes in the normal heart rate
Rare:

hearing problems

allergic runny nose

reduced tear flow

inflammation of the liver which can cause yellowing of the skin or whites of the eyes

certain blood test results for liver function or fat levels differing from normal

allergy-like reactions such as itching, flush, rash

impaired erection

nightmares, hallucinations

fainting

allergic runny nose with sneezing and itching
Very rare:

irritation and redness of the eye (conjunctivitis)

hair loss

appearance or worsening of scaly skin rash (psoriasis); psoriasis-like rash.
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 Fumarate tablets
Keep out of the reach and sight of children.
Do not use Bisoprolol Fumarate Tablets after the expiry date which is stated on the blister and the
carton. The expiry date refers to the last day of that month. This medicinal product does not require any
special storage conditions.
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 Fumarate tablets contain:
The active substance is bisoprolol fumarate
Each 7.5 mg tablet contains 7.5 mg bisoprolol fumarate.
The other ingredients are microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium,
sodium starch glycolate (type A) and magnesium stearate.
What Bisoprolol Fumarate Tablets look like and contents of the pack:
Bisoprolol Fumarate 7.5 mg tablets are white to off white round biconvex tablets with a break line on
one side.
They come in packs of 28 tablets.
Marketing Authorisation Holder: Chanelle Medical U.K Limited, United Kingdom.
Manufacturer: Chanelle Medical, Loughrea, Co Galway, Ireland
The leaflet was last revised in: 02/2014

LA7672

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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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