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Dipyridamole Tablets 100mg

Document: leaflet MAH GENERIC_PL 04569-0038 change

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PACKAGE LEAFLET: INFORMATION FOR THE USER

DIPYRIDAMOLE TABLETS 100 mg

(dipyridamole)

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, 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 side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Dipyridamole is and what it is used for.

2.    Before you take Dipyridamole.

3.    How to take Dipyridamole.

4.    Possible side effects.

5.    How to store Dipyridamole.

6.    Further information.

1.    WHAT DIPYRIDAMOLE IS AND WHAT IT IS USED FOR

Dipyridamole belongs to a group of medicines called anti-thrombotics. It helps to prevent the clots forming in your blood. It is usually taken at the same time as medicines that thin your blood (anticoagulants) when you have a mechanical heart valve fitted.

2.    BEFORE YOU TAKE DIPYRIDAMOLE

Do not take Dipyridamole:

•    if you are hypersensitive (allergic) to dipyridamole or any of the other ingredients of these tablets.

Take special care with Dipyridamole

You should tell your doctor before taking this

medicine if:

•    you have recently had a heart attack

•    you have angina, and the symptoms are quickly becoming much worse

•    you have narrowing of the aortic valve in the heart (aortic stenosis)

•    you have a condition that stops your blood clotting as quickly as it should

•    you have myasthenia gravis

•    you have been told by your doctor that you have an intolerance to some sugars.

Taking other medicines

Please tell your doctor if you are taking any other medicines including medicines obtained without a prescription, herbal medicines or any of the following. This is because Dipyridamole Tablets can affect the way some other medicines work. Also some other medicines can affect the way Dipyridamole Tablets work:

•    Aspirin (for any condition)

•    antacids (used for indigestion or to reduce stomach acid)

•    medicines, to thin the blood (anti- coagulants). Your doctor may need to change your dose

•    medicines to treat high blood pressure

•    adenosine (for heart conditions)

•    medicines to treat muscle weakness (e.g. cholinesterase inhibitor)

•    warfarin or other medicines to stop blood clots forming. Please tell the medical staff at your next visit to the anticoagulant clinic that you are now taking Dipyridamole Tablets

•    if you are having a test which requires a Dipyridamole injection, stop taking Dipyridamole Tablets 24 hours before the test.

If you are having heart tests

Dipyridamole Tablets contain dipyridamole. Dipyridamole is also sometimes given as an injection during tests to see if the heart is working properly (also called 'myocardial imaging'). This means that the test and your medicine may contain the same substance. If you are going to have an injection of dipyridamole, tell the doctor that you are taking Dipyridamole Tablets.

Pregnancy and breast-feeding

If you are pregnant or thinking of becoming pregnant, ask your doctor or pharmacist for advice before taking Dipyridamole Tablets. You may be advised not to take Dipyridamole by your doctor. Do not breast-feed your baby while taking Dipyridamole. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Dipyridamole should not affect your ability to drive or use machines.

Important information about some of the ingredients of Dipyridamole

Dipyridamole Tablets contain lactose and sucrose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE DIPYRIDAMOLE

Always take Dipyridamole exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.    m38iAB

•    swallow the tablets with a glass of water

•    take the tablets on an empty stomach, half to one hour before a meal.

•    take your tablets regularly, at evenly spaced time intervals.

•    Do not crush or chew the tablets.

Your doctor will start you on a low dose of Dipyridamole and gradually increase the dose depending on your condition. The usual doses are:

Adults (including the elderly) - The usual dose is 300-600 mg (3-6 tablets) daily, divided into 3 or 4 doses spread throughout the day.

Children - Dipyridamole tablets are not recommended for children.

If you take more Dipyridamole than you should

If you take more Dipyridamole than you should contact your doctor or hospital emergency department immediately. Take this leaflet and any remaining tablets with you. The signs and symptoms of Dipyridamole overdose include a warm feeling, flushes, sweating, restlessness, feeling of weakness, dizziness, headache, stomach upset, low blood pressure, a racing or irregular heartbeat and in some cases, chest pain.

If you forget to take Dipyridamole

If you forget to take a dose of Dipyridamole take it as soon as you remember 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 Dipyridamole

Do not stop taking Dipyridamole without talking to your doctor first.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Dipyridamole can cause side effects, although not everybody gets them.

If any of the following happen, stop taking Dipyridamole and tell your doctor immediately or go to your nearest hospital emergency department:

•    skin rash

•    wheezing or difficulty breathing

•    swelling of the neck, throat and mouth.

These side effects are rare but serious. You may need medical attention.

Side effects which have been reported include:

•    chest pain, especially if you have ischaemic

heart disease, if this happens, tell your doctor as he may want to adjust your dose


•    headache, which usually disappears with

long-term use of the medicine

•    dizziness or faintness, especially on standing up after sitting or lying down

•    nausea, vomiting, indigestion, mild diarrhoea

•    muscle pain

•    hot flushes

•    low blood pressure

•    a racing or irregular heartbeat

•    increased bleeding during or after surgery

•    unusual bleeding or bruising of the skin

•    in people who have gallstones, the dipyridamole in this medicine can be absorbed into the gallstones.

If any side effect gets serious, or if you notice any side effects not mentioned in the leaflet, please tell your pharmacist or doctor.

5.    HOW TO STORE DIPYRIDAMOLE

Keep out of the reach and sight of children.

Do not take Dipyridamole after the expiry date which is stated on the label or carton after 'EXP'. The expiry date refers to the last day of that month. Store in a dry place, at a temperature below 25°C. Store in the original package in order to protect from light.

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 Dipyridamole contains

The active substance is dipyridamole. Each tablet contains 100 mg of dipyridamole. The other ingredients are lactose, maize starch, methyl cellulose, magnesium stearate, silicon dioxide, talc, gelatin, sucrose, titanium dioxide (E171) and Opaglos.

What Dipyridamole looks like and contents of the pack

Tablets are white, sugar coated and marked 'G' in red. Dipyridamole is available in plastic bottles and blister packs of 28, 30, 50, 60, 84, 90, 100 or 500 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Generics [UK] Limited t/a Mylan, Potters Bar, Hertfordshire, EN6 1TL, U.K.

Manufacturer

Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL, U.K.


This leaflet was last approved in: June 2009 LT1381AB 10001493


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