Vivacor 10mg Tablets
PC No. 3014
I
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 41318/0032
Bisoprolol Tablets 10 mg: PL 41318/0033
Date of last text revision: July 2016 | POM |
For any information about this medicinal product, please contact : MA Holder:
Globegen Laboratories Ltd.,
1406 Coventry Road, Yardley,
Birmingham, B25 8AE, UK.
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:
• 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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DATE: |
05/07/2016 | ||
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PRODUCT: |
GGL - Bisoprolol 5 mg & 10 mg Tablets 4pp PIL | ||
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SIZE: |
PIL: 4pp - 190mm((h) X 110mm(w) folded size | ||
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PIL CODE: | |||
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SCALING: |
1 : 1 | ||
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AUTHOR: |
ARTWORK VERSION: |
1 | |
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
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.
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.
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.
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.
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
XXXXXXX
®
|
DATE: |
05/07/2016 | ||
|
PRODUCT: |
GGL - Bisoprolol 5 mg & 10 mg Tablets 4pp PIL | ||
|
SIZE: |
PIL: 4pp - 190mm((h) X 110mm(w) folded size | ||
|
PIL CODE: | |||
|
SCALING: |
1 : 1 | ||
|
AUTHOR: |
ARTWORK VERSION: |
1 | |
