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Pyridantin Bp 100mg

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Document: leaflet MAH BRAND_PL 33414-0042 change

CURRENT

PATIENT INFORMATION LEAFLET

PYRIDANTIN TABLETS

Dipyridamole BP

PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE.

KEEP THIS LEAFLET UNTIL YOU HAVE FINISHED ALL THE PRESCRIBED COURSE OF PYRIDANTIN.

IF YOU HAVE ANY QUESTIONS CONCERNING YOUR MEDICINE ASK YOUR DOCTOR OR PHARMACIST FOR MORE INFORMATION.

What is in your medicine?

The name of this medicine is Pyridantin and it contains a substance called dipyridamole.

Pyridantin tablets come in two strengths: Pyridantin 25 mg or Pyridantin 100 mg.

Pyridantin 25 mg contains 25mg dipyridamole, together with the excipients lactose, maize starch, povidone, pregelatinised starch, magnesium stearate, bleached shellac, sucrose, talc, titanium dioxide, beeswax, carnauba wax and the colour orange.

Pyridantin 100 mg contains 100 mg dipyridamole, together with the excipients lactose, maize starch, povidone, pregelatinised starch, magnesium stearate, bleached shellac, sucrose, talc, titanium dioxide, beeswax, carnauba wax.

Pyridantin tablets of both strengths are available in containers and blister packs of 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1,000 tablets.

How does Pyridantin work?

Pyridantin belongs to a group of medicines, the anticoagulants, which act by preventing the clotting of blood.

If you are not sure why you have been prescribed Pyridantin, then please ask your doctor.

The Manufacturer of Pyridantin is:

Dr Reddy's Laboratories (UK) Ltd., 208-214 York Road, Battersea, London SW11 3SD

The Product Licence holder is:

Chelonia Healthcare Limited, Boumpoulinas 11, 3rd Floor, Nicosia, P.C. 1060, Cyprus

Why have you been prescribed Pyridantin?

Pyridantin tablets are used mainly as a medicine to prevent blood clotting in veins and arteries, and in the prevention of blocking of blood vessels after grafting of arteries following on operations such heart/by-pa ss surgery.

Pyridantin is also used as an anti-coagulant for the prevention of thromboembolism, a condition associated with artificial heart valves.

Check before you take these tablets

Before taking this medicine, tell your doctor if you have ever had any unusual or allergic reactions to dipyridamole or any of the other ingredients of Pyridantin, or other anti-coagulant medicines.

Also tell your doctor or pharmacist if you are allergic to any other substances such as foods, preservatives or dyes.

Do not use Pyridantin tablets if you are pregnant, or likely to become pregnant. Tell your doctor or pharmacist if you are breast-feeding.

The presence of other medical problems may affect the use of this medicine. Make sure, therefore, to tell your doctor or pharmacist if you have any other medical problems, especially:

•    Cardiac conduction    difficulties    (alteration in    the

regularity of heart beats)

•    Coagulation disorders.

•    Angina which is getting    worse.

•    Sub-valvular aortic stenosis (hardening of the main artery of the body just below the heart valves.

•    A recently occurring    myocardial    infarction (coronary

thrombosis).

Can you take Pyridantin with other medicines?

You can take these tablets with other medicines, but there are some medicines which can interfere with Pyridantin tablets. It is very important to tell your doctor or pharmacist about all the medicines which you are taking, whether or not any medicines were prescribed by your doctor or bought without a prescription from the pharmacy or elsewhere, such as any antacid products, any other anti-coagulant medicines. Avoid taking antacids. Pyridantin may increase the effects of other anti-coagulants. If you are to receive adenosine tell your doctor you are taking Pyridantin.

When and how to take Pyridantin

Pyridantin tablets should be taken by mouth, usually before meals in dosages prescribed by your physcian.

Common Dosages:

Adults and the Elderly:

300 - 600 mg daily in three or four doses.

Children:

The normal total oral daily dose is 5 mg/kg bodyweight in divided doses.

What to do if too many tablets are taken at the same time

If you accidentally take more tablets than recommended contact your doctor or hospital Accident & Emergency Department at once.

What to do if you miss a dose

If you miss a dose, skip the missed dose and go back to your regular dosage schedule. Do not double the dose.

If you feel that this medicine is not working as well after you have taken it for a short time (1-2 weeks) do not increase the dose, instead check with your doctor.

What side effects can Pyridantin tablets have?

If side effects do occur, it is usually during the early stage of treatment and the side effects are often related to the dose. Occasionally headache may occur which normally disappears with dosage reduction. Also, occasionally, dizziness, faintness, indigestion, mild diarrhoea and myalgia (pain in the muscles) have been reported.

Other less common side effects include: hot flushes, low blood pressure, increased heart rate, hypersensitivity reactions such as rash, itching, swelling and wheezing, worsening of the symptoms of heart disease.

Very rarely increased bleeding times during or after surgery and blood disorders have been reported.

Tell your doctor if any of the above symptoms persist, or indeed any other symptoms not mentioned above become troublesome during treatment.

Storing your medicine

You must keep the medicine in a safe place where children cannot get it. Your medicine could harm them.

Store below 25°C in well closed containers. Protect from light.

On the label you will find the words "Expiry Date" followed by numbers indicating the day, month and year. This is the date when the medicine is no longer fit for use. Do not use Pyridantin after this date.

A reminder

REMEMBER this medicine is for you. Never give it to someone else, even if their symptoms are the same as yours.

This leaflet does not contain the complete information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who have access to additional information.

This leaflet was revised in February 2009