Patient leaflet - Dipyridamole 200 mg prolonged-release capsules

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

The name of your medicine is Dipyridamole capsules. It contains a medicine called Dipyridamole. This belongs to a group of medicines called ‘anti-thrombotic agents’, which are used to help stop blood clots forming.

Dipyridamole capsules are used:

To help stop blood clots which may occur if you have had your heart valves replaced.
In people who have had a stroke caused by a blood clot in the brain. This medicine reduces the risk of having another stroke.

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

Do not take Dipyridamole capsules:

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 Dipyridamol capsules if:

have angina or other heart problems (including heart valve or circulation problems) or have had a recent heart attack
You have myasthenia gravis (a rare muscle problem)
You have any bleeding problems
You are pregnant or planning to become pregnant or are breast-feeding

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking this medicine.

Children and adolescents

Dipyridamole should not be given to children.

Other medicines and Dipyridamole capsules

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription or herbal medicines.

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’
Aspirin (or planning to take aspirin for any condition)
Adenosine injection - used for heart problems or tests on the heart
Warfarin or other medicines to stop blood clots forming. If so, tell them at your next visit to the anticoagulant clinic that you are now taking dipyridamole.

If you are having heart tests

This medicine contains 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 capsules.

Dipyridamole capsules with alcohol

Do not take this medicine with alcohol because the risk of side effects may be increased.

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 should only be used during breast-feeding if your doctor thinks it is necessary.

Driving and using machines

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

3. How to take Dipyridamole capsules

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

One capsule twice a day
Usually one in the morning and one in the evening
It is best to take it with food
Swallow the capsule whole
Do not crush or chew it

Use in children and adolescents

This medicine is not recommended for children.

If you take more Dipyridamole capsules than you should

If you take more of this medicine than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you, even if there are no capsules left.

If you forget to take Dipyridamole capsules

If you forget a dose, take it as soon as you remember it
However, if it is time for the next dose, skip the missed dose
Do not take a double dose to make up for a forgotten capsule.

If you stop taking Dipyridamole capsules

Do not stop taking this medicine until you have spoken to your doctor.

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

161 x 280 mm

4. Possible side effects

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

Allergic reactions

If you have an allergic reaction, stop taking your medicine and see a doctor straight away. The signs may include feeling breathless, runny nose, severe rash with itching, swelling and swelling around the eyes.

Other side effects that have been reported are described below. They are listed as either very common, common, or not known.

Very common (affects more than 1 in 10 people)

Headache
Feeling dizzy
Feeling sick (nausea)
Diarrhoea

Common (affects less than 1 in 10 people but more than 1 in 100 people)

Muscle pain
Being sick (vomiting)
Worsening of the symptoms of heart disease such as chest pain and shortness of breath

Not Known

Hot flushes
Lowering of blood pressure or increased heart rate
A blood problem called ‘thrombocytopenia’ which can cause bruising and 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Dipyridamole capsules

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special temperature storage conditions. Store in the original package in order to protect from moisture. Keep the bottle tightly closed.

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 capsules contain

The active substance is dipyridamole. Each capsule contains 200mg of dipyridamole.

The other ingredients are tartaric acid, povidone, co-povidone, talc, isopropyl alcohol, hypromellose,

simeticone emulsion, butylated methacrylate copolymer, hypromellose phthalate, stearic acid, triacetin and acetone.

The capsule shell contains gelatin and titanium dioxide (E171).

The ink printed on the capsule shell contains shellac, propylene glycol, black iron oxide (E172) and potassium hydroxide.

What Dipyridamole capsules look like and contents of the pack

Each prolonged-release capsule contains yellow coloured pellets encapsulated in opaque, white hard gelatin capsule shells (approximately 23 mm x 8 mm). Each capsule is imprinted with “RENATA” on the cap and “DPY 200” on the body with edible black ink.

Each 30 capsule bottle contains 1 silica gel bag and a molecular sieve bag to protect the capsules from moisture. Do not eat or swallow.

Each 50 and 60 capsule bottle contains 2 silica gel bags and a molecular sieve bag to protect the capsules from moisture. Do not eat or swallow.

Dipyridamole capsules are available in bottles containing 30, 60 or 100 (2 x 50) capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Renata (UK) Limited

Greenway Business Centre

Harlow Business Park

Harlow

CM19 5QE

United Kingdom

Manufacturer:

Elara Pharmaservices Limited

5 Garden Court

Lockington Hall

Main Street, Lockington

Derby, DE74 2RH