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VIVACOR 10MG TABLETS

Active substance(s): BISOPROLOL FUMARATE

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PC No. 3014

Very rare (affects less than 1 person in 10,000):
• irritation and redness of the eye (conjunctivitis)
• hair loss
• appearance or worsening of scaly skin rash (psoriasis); psoriasislike rash.
Tell your doctor or your pharmacist if you notice any of the side effects
listed above or any other unwanted or unexpected effects.
How to look after your medicine?
Bisoprolol Tablets also contain: maize starch, microcrystalline
cellulose, crospovidone, calcium hydrogen phosphate, magnesium
stearate and silica.
The film coat contains: hypromellose, titanium dioxide (E171),
macrogol, dimethicone and iron oxide (E172). Bisoprolol Tablets are
marketed in pack sizes of 28.
Bisoprolol Fumarate is a beta-blocker medicine. Beta-blockers reduce
the force and speed of your heart beat.
The 5 mg tablets are round, ivory coloured biconvex tablets and are
marked with a score line on one face.
The 10 mg tablets are round, light brown coloured biconvex tablets
and are also marked with a score line on one face.
Do not use the tablets after the expiry date (use by) date shown on the
product packaging.
Do not store the tablets above 30°C and keep them in the original
packaging.
Keep your tablets out of sight and reach of children. Return any unused
medicine to the pharmacist.
Bisoprolol Tablets 5 mg:
PL No.: 42311/0001
Bisoprolol Tablets 10 mg: PL No.: 42311/0002
Date of last text revision: 06/2013

Bisoprolol 5 mg and 10 mg Tablets
Patients Information Leaflet
This leaflet gives you some important information about your
medicine. Please read it carefully before you start taking your
medicine.
About your medicine
Bisoprolol Tablets are coated tablets containing either 5 mg or 10 mg
of the active ingredient Bisoprolol fumarate.
What is your medicine used for?
Bisoprolol Tablets are used:
• to reduce high blood pressure (hypertension).
• to relieve chest pain (angina)
Before you take Bisoprolol Tablets
Do not use Bisoprolol tablets if you:
• have you ever had an allergic (hypersensitive) reaction to
bisoprolol fumarate or any of the ingredients in the tablet with
symptoms of a rash, itching or difficulty breathing.
• have suffered from sudden heart failure, irregular heart beats or a
slow heart rate
• suffer from extremely low blood pressure
• suffer from lung disease, asthma, have a family history of asthma.
• suffer from diseases which affect blood flow to your fingers and
toes e.g Raynaud’s syndrome
• have untreated adrenal gland tumour called phaeochromocytoma
• have metabolic acidosis which would be measured by a blood test
by your doctor
Take special care with Bisoprolol tablets
Tell your doctor or pharmacist before you start using these tablets
if you:

POM

For any information about this medicinal product, please contact :
MA Holder:

Pharmacare (London) Ltd.,
The Office, Heath View, Blindley Heath,
Lingfield, RH7 6LH, UK.

• suffer from any heart disease, including heart failure and angina
• suffer from bronchospasm associated with bronchial asthma and
other lung diseases
• suffer from severe kidney or liver disease
• suffer from uncontrolled diabetes
• are fasting





having desensitisation treatment for allergies
suffer from psoriasis or have a history of psoriasis
have thyroid problems
are due to go into hospital for an operation then tell your doctor.

Treatment with Bisoprolol should not be stopped suddenly especially in
patients already with heart disease.
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PC No. 3014

Taking other medicines
Please tell your doctor or pharmacist if you are taking any of the
following medicines
• diltiazem, verapamil or other calcium blockers used to treat heart
problems
• clonidine, methyldopa, moxonidine or rilmenidine used to treat high
blood pressure
• nifedipine, isoprenaline or dobutamine used to treat heart
conditions
• amiodarone, dis oyramide, quinidine, mefloquine or digoxin used to
treat problems with heart rhythms
• eye drops used to treat glaucoma
• insulin, glibenclamide or metformin used to treat diabetes
• some anaesthetics
• Non steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen used
to treat pain
• adrenaline used to treat allergic reactions
• antidepressants such as amitriptyline, imipramine, barbiturates,
chlorpromazine, levomepromazine and Monoamine-oxidase inhibitors
(MAOIs) such as phenelzine
• moxisylate used to treat circulation problems such as Raynaud’s
syndrome

Swallow these tablets with water.
This medicine should be taken for as long as your doctor tells you to. It
may be dangerous to stop without their advice. Follow your doctor's
advice on how to stop taking this medicine. You should not stop taking
them abruptly.
If you forget to take a dose, take one as soon as you remember. DO NOT
take two doses at the same time. If you are worried, ask your pharmacist
or doctor for advice.
Do not take more tablets than your doctor tells you to. If you ever take
too many, go to the nearest hospital casualty department or tell your
doctor immediately. Take the container, any remaining tablets and this
leaflet with you to show to the doctor.
What side effects may occur?
This medicine sometimes causes unwanted effects in some people.
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)
Inflammation of the liver which can cause the yellowing of the skin or
whites of the eyes.
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:
Common (affects less than 1 person in 10):
• tiredness, feeling weak, 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.

Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
Pregnancy and breastfeeding
Do not take this medicine if you are pregnant or breast-feeding. If you
are taking it and think that you may be pregnant or are planning a
family, consult your doctor.

Uncommon (affects less than 1 person in 100):
• sleep disturbances
• depression
• dizziness when standing up
• breathing problems in patients with asthma or chronic lung disease
• muscle weakness, muscle cramps.

Driving and using machines:
It is possible that you may react to Bisoprolol. Reactions may vary from
person to person and may impair your ability to drive or operate
machinery. This applies particularly at the start of treatment, on
changing the medication and in combination with alcohol.
How to take your medicine
You should follow your doctor's instructions. You can check the
pharmacy label to see how many tablets the doctor has recommended
you take and how often you should take them.
The usual dosage(s) are:
Indication
Dosage
Adults & Elderly: The usual dose is 10 mg once daily.
The
maximum dose is 20 mg per day.
Some patients may only require 5 mg per day.
If you are elderly or have severe liver or kidney
damage you may be given a smaller dose.
Children:
Bisoprolol Tablets are not recommended for
children.
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Rare (affects less than 1 person in 1,000):
• hearing problems
• allergic runny nose
• reduced tear flow
• 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

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DATE:

24.06.2013

PRODUCT:

01 & 02 Pharmacare Bisoprolol 5 mg & 10 mg Tablets 4pp PIL

SIZE:

PIL: 4pp - 190mm((h) X 110mm(w) folded size

BARCODE:

0000000000000

PIL CODE:

JOB REF:

SCALING:

1:1

AUTHOR:

ARTWORK VERSION:

1

v1 24.06.2013

DATE APPROVED BY:
Signed:

1st CORRECTIONS by DS:
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Date final file supplied:

NOTES:

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DESIGN STUDY LIMITED

45 DOWNS COURT ROAD, PURLEY, SURREY CR8 1BF

TELEPHONE: 020 8763 2582

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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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