PACKAGE LEAFLET: INFORMATION FOR THE USER Dipyridamole Tablets 25mg & 100mg (dipyridamole)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Dipyridamole Tablets are and what they are used for

2.    What you need to know before you take Dipyridamole Tablets

3.    How to take Dipyridamole Tablets

4.    Possible side effects

5.    How to store Dipyridamole Tablets

6.    Contents of the pack and other information

1. What Dipyridamole Tablets are and what they are used for

Dipyridamole Tablets belong to a group of medicines called anti-coagulants, which are used to prevent the formation of blood clots (deep vein thrombosis).

Dipyridamole Tablets are used to prevent blood clots

•    when other anti-coagulants have not worked

•    after grafting of arteries in heart operations such as heart by pass surgery

•    occurring with the use of artificial heart valves.

2. What you need to know before you take Dipyridamole Tablets

Do not take Dipyridamole Tablets:

•    if you are allergic to dipyridamole or any of the other ingredients of this medicine(listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Dipyridamole Tablets:

•    if you have angina (chest pains) or other heart problems (including circulation problems) or have had a recent heart attack

•    if you have myasthenia gravis (a rare muscle problem)

•    if you have any bleeding problems

•    if you are pregnant or planning to become pregnant or are breast-feeding

•    if you have been told by your doctor that you are intolerant to some sugars

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Dipyridamole Tablets.

Other medicines and Dipyridamole Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those bought without a prescription. This is because Dipyridamole Tablets can affect the way some other medicines work. Also some other medicines can affect the way Dipyridamole Tablets work.

In particular tell your doctor or pharmacist if you are taking any of the following medicines:

•    medicines for high blood pressure

•    medicines for muscle weakness such as something called a 'cholinesterase inhibitor'

•    antacids (for indigestion)

•    aspirin or clopidogrel (to thin the blood)

•    other anticoagulants (blood thinning medicines such as heparin or warfarin).

•    adenosine (for heart rhythm problems)

If you are having heart tests

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 breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Dipyridamole Tablets should not be used in pregnancy especially in the first 3 months, unless advised by a doctor. Dipyridamole Tablets should only be used during breast-feeding if your doctor considers it essential.

Driving and using machines

You may feel dizzy while taking Dipyridamole Tablets. If this happens do not drive or use any tools or machines.

Important information about some of the ingredients in Dipyridamole Tablets

The 25mg tablets contain sunset yellow (E110) which can cause allergic type reactions including asthma. Allergy is more common in people who are allergic to aspirin.

The 25mg and 100mg tablets contain sugars called lactose and sucrose. If a doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Dipyridamole Tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Dipyridamole tablets should be taken before meals.

The usual dose is

•    Between a total of 300 and 600mg each day

•    This is taken in three or four separate doses

•    The most you can take in a day is 600 mg

Do not give to children.

If you take more Dipyridamole Tablets than you should

Do not take more than your doctor has prescribed. It may cause symptoms such as headache, stomach or intestinal problems, low blood pressure and chest pain in patients with heart disease. If you take more than the recommended daily dose, consult a doctor at once.

If you forget to take Dipyridamole Tablets

If you forget to take a dose, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.

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

4. Possible side effects

Like all medicines, Dipyridamole Tablets can cause side effects, although not everybody gets them. If these occur, it is usually during the early part of treatment and with higher doses.

Contact your doctor at once if you develop any of the following rare allergic reactions:

•    breathing difficulties including feeling breathless

•    large welts or swelling of the skin near the eyes, lips, hands, feet or inside of the throat

•    severe rash with itching

Dipyridamole tablets may occasionally cause a throbbing headache which normally disappears when the dose is reduced.

Other side effects include:

Very common (may affect more than 1 in 10 people):

•    headache

•    dizziness

•    headache

•    feeling sick

•    diarrhoea.

Common (may affect up to 1 in 10 people):

•    muscle pain

•    being sick (vomiting)

•    worsening of the symptoms of heart disease such as chest pain and shortness of breath.

Not known (frequency cannot be estimated from the available data):

•    hot flushes

•    lowering of blood pressure

•    a blood problem called 'thrombocytopenia' which can cause bruising or prolonged bleeding from wounds, including during or after surgery.

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www. mhra.gov.u k/yellowca rd By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Dipyridamole Tablets

Keep this medicine out of the sight and reach of children. Do not store above 25°C.

Do not open the container until you are ready to begin taking this course of treatment.

Do not use this medicine after the expiry date which is stated on the bottle/label after 'Exp (MM/YY)'. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Dipyridamole Tablets contain

The active substance (which makes the medicine work) is Dipyridamole. Each tablet contains either 25mg or 100mg of Dipyridamole. The tablets also contain: lactose, maize starch, povidone, pregelatinised starch, magnesium stearate, bleached shellac, sucrose, talc, titanium dioxide (E171), beeswax, carnauba wax. The 25mg Tablets also contain the colouring E110 (sunset yellow), which can cause allergic reactions, including asthma.

What Dipyridamole Tablets look like and contents of the pack

The 25mg Tablets are orange and the 100mg tablets are white.

Both 25mg and 100mg strengths are available in containers and blister packs of 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1,000 tablets.

Marketing Authorisation Holder and Manufacturer    Dipyridamole 25mg Tablets PL 08553/0079

Dr Reddy's Laboratories (UK) Ltd, 6 Riverview Road, Beverley, HU17 0LD Dipyridamole 100mg Tablets PL 08553/0080 Leaflet last revised: April 2015 © Dr. Reddy's Laboratories (UK) Ltd