Bisoprolol Fumarate 5mg Tablets
PATIENT INFORMATION LEAFLET
Bisoprolol Fumarate 5 mg Tablets Bisoprolol Fumarate 10 mg Tablets
Please read this leaflet carefully before you start to take Bisoprolol Fumarate Tablets.
Keep this leaflet. You may need to read it again. Your pharmacist may have given you this medicine before from another company and it may have looked slightly different. Either brand will have the same effect. Ask your doctor or pharmacist if you have any questions or are not sure about anything.
This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
What’s in this medicine?
The name of this medicine is Bisoprolol Fumarate 5 mg & 10 mg Tablets. The tablets come in two strengths containing either 5 mg or 10 mg of the active ingredient bisoprolol fumarate.
The tablets also contain mannitol (E421), microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171) and macrogol.
Bisoprolol Fumarate Tablets are white, round tablets. The 5 mg tablets are marked on one side with ‘Bisoprolol 5' and the 10 mg tablet is marked with ‘Bisoprolol 10'.
Both the 5 mg and 10 mg tablets may be supplied in packs of 28, 30, 56, 60, 84, 90 or 100 tablets.
Marketing Authorisation Holder
Activase Pharmaceuticals Limited, 11 Boumpoulinas, 3rd floor, P.C. 1060, Nicosia, Cyprus.
Manufacturer
Omega Farma ehf. Karnesbraut 108, Kopavogur, Iceland.
Uses for your medicine
Bisoprolol fumarate is a member of a group of drugs called beta blockers.
Bisoprolol fumarate is used to control hypertension (high blood pressure) and recurring angina pectoris. Angina pectoris is a condition in which the cardiac muscles receive less oxygen than is required. This generally occurs during exercise and the most common symptom associated with the condition is chest pain.
Before you take this medicine
The medicine is not suitable for everyone. Tell your doctor BEFORE taking any tablets if:
• You have allergies.
• You are allergic to bisoprolol fumarate or any of the ingredients contained in the tablets.
• You suffer from heart disease, unstable angina or blood vessel disease (eg Raynaud's Syndrome)
• You have been told you have very low blood pressure or an unusually slow heartbeat (heart rate less than 50 beats/ minute).
• You suffer from asthma or other types of breathing problems, or have family members who suffer from asthma.
• You are/have been suffering from episodes of rapid heartbeat and headaches. This could be due to an untreated tumour near the kidney which is causing your blood pressure to increase (a condition called phaeochromocytoma).
• You are/ have been suffering from symptoms of tiredness, restlessness, thirst and vomiting. These could be due to untreated diabetes or from a long period of fasting.
Also tell your doctor or pharmacist if:
• You have severe kidney or liver problems.
• You are diabetic and are taking insulin or anti-diabetic tablets.
• You have an overactive thyroid gland (causing symptoms such as a rapid heartbeat, sweating, weight loss and anxiety).
• You suffer from the skin condition psoriasis.
• You are pregnant, think you may be pregnant, or are trying to become pregnant.
• You are breast-feeding.
Also tell your doctor or pharmacist if you are taking any of the following:
• Medicines for high blood pressure (in particular clonidine: ‘calcium channel blockers' eg. verapamil, diltiazem; ‘alpha-blockers' eg prazosin) or for heart problems such as abnormal heart rhythm, heart failure or angina.
• Medicines for depression or anxiety.
• Immunosuppressant medicines (eg if you have had a transplant).
• Cimetidine (for the treatment of ulcers), anti-inflammatory pain killers (eg diclofenac, indomethacin), steroids, rifampicin (for the treatment of tuberculosis), the contraceptive pill, hormone replacement therapy, alprostadil (for the treatment of impotence) or thymoxamine (for the treatment of Raynaud's Syndrome).
• Medicines for migraine which contain ergotamine.
• Medicines bought without a prescription, especially old remedies.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed. Other special warnings
• Be careful when drinking alcohol - it may affect you more than usual.
• If you feel dizzy or sleepy when you start to take these tablets, do not drive or work machinery until these effects have worn off.
• If you are going to have a general or local anaesthetic, tell the doctor or dentist in charge that you are taking Bisoprolol Fumarate Tablets.
• Bisoprolol Fumarate Tablets are not suitable for children.
How and when to take Bisoprolol Fumarate Tablets
Always take the number of tablets your doctor has told you to take. This information will also be on the pharmacist's label.
For the treatment of high blood pressure and angina the usual dose is 10mg once daily up to a maximum dose of 20 mg once daily. In some patients (for example if you are over 60 years of age) 5 mg per day may be adequate.
In patients with severe kidney or liver disease, the dosage should not exceed 10 mg once daily.
Bisoprolol Fumarate Tablets should be swallowed whole with a drink of water.
If you are taking the medicine for angina then treatment should not be stopped abruptly.
What to do if you forget to take a tablet
If you forget to take a tablet then take it within 12 hours of your usual time. If it is more than 12 hours you should skip the missed tablet and take your next tablet at the normal time when it is due. Do not take a double dose of tablets to make up for the missed dose.
What to do if you take too many tablets
An overdose of bisoprolol can cause extreme dizziness, slowing of the pulse, reduction of blood pressure and collapse. If you have taken an overdose of Bisoprolol Fumarate Tablets, get medical help immediately, either by calling your doctor or going to the nearest hospital casualty department. Remember to take the labelled medicine container with you, whether there are any tablets left or not.
After taking your medicine
These tablets sometimes cause unwanted side-effects in some people. If you get any of the following rare or uncommon effects tell your doctor as soon as possible:
• Attacks of wheezing or feeling short of breath.
• An irregular heartbeat, either faster or slower than normal.
• Skin rash, itching or bruising or increased sensitivity of the skin to sunlight.
• Dry or sore eyes or problems with vision.
Common side-effects which may occur include:
• Headache, dizziness (sometimes on standing up) or unusual tiredness.
• Upset stomach, a loss of appetite or abdominal pains.
• Worsening of an existing leg pain occurring during walking.
• Sleeplessness.
• Coldness, numbness or tingling in your hands and feet (which may develop a bluish colour).
These effects are often mild and may wear off after a few days treatment. If they are severe or last for more than a few days, tell your doctor.
The following side-effects have also been seen rarely: hallucinations, nightmares, mood changes, confusion, depression, impotence and jaundice (yellowing of the skin). Tell your doctor if you think you get any of the symptoms.
You should tell your doctor or pharmacist if you get any of the unwanted side-effects not mentioned above.
Storing this medicine
This medicine is packed either in aluminium PVC/PVdC blisters or in a plastic bottle with a ‘snap-on' cap. You should store the tablets according to the following instructions depending on which type of pack you have received:
Blisters
Bisoprolol Fumarate 5 mg Tablets should not be stored above 25°C. Bisoprolol Fumarate 10 mg Tablets should not be stored above 30°C. Store the tablets in their original package.
Plastic bottle
Bisoprolol Fumarate 5 mg and 10 mg Tablets should not be stored above 30°C. Keep the container tightly closed.
Store the tablets in a safe place, where children cannot see or reach them.
On the label you will find ‘expiry date' followed by some numbers. These numbers are the date when the medicine is no longer fit for use. Do not use this medicine after this date.
Return any unused tablets to your pharmacist. Only keep them is your doctor tells you to.
This leaflet was last revised in: March 2008