Dipyridamole Dr. Reddys 200 mg Modified-Release Capsules, Hard

Patient Leaflet Updated 03-Oct-2019 | Dr. Reddy's Laboratories (UK) Ltd

Dipyridamole Dr. Reddys 200 mg Modified-Release Capsules, Hard

PACKAGE LEAFLET: INFORMATION FOR THE USER

Dipyridamole Dr Reddy’s 200 mg Modified-Release Capsules, Hard

Dipyridamole

Throughout this leaflet Dipyridamole Dr Reddy’s 200 mg Modified-Release Capsules, Hard is referred to as Dipyridamole MR.

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 MR is and what it is used for
2. What you need to know before you take Dipyridamole MR
3. How to take Dipyridamole MR
4. Possible side effects
5. How to store Dipyridamole MR
6. Contents of the pack and other information

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

Dipyridamole belongs to a group of medicines called anti-thrombotic agents, which are used to prevent the formation of blood clots. Each capsule contains 200 mg of dipyridamole, which is slowly released in your body over a number of hours.

Dipyridamole MR is used to

  • help prevent blood clots which sometimes occur with the use of artificial heart valves
  • reduce the risk of having another stroke (a blood clot in the brain) in people who have already suffered a stroke.
2. What you need to know before you take Dipyridamole MR
Do not take Dipyridamole MR 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 your medicine if:

  • you are pregnant, likely to become pregnant, or if you are breast-feeding
  • you have angina or other heart problems (including heart valve or circulation problems), or have had a recent heart attack
  • you have myasthenia gravis (a condition characterised by extreme tiredness and muscle weakness)
  • you have a bleeding disorder.

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

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

If you are having heart tests

Dipyridamole can also be given by injection into a vein to test if the heart is functioning properly (myocardial imaging). This means that the test and your medicine may contain the same substance. If you are going to have this test, you should stop taking the capsules 24 hours before you have this test.

Other medicines and Dipyridamole MR

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because Dipyridamole MR can affect the way some other medicines work. Also some other medicines can affect the way Dipyridamole MR works.

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

  • adenosine (for heart problems or tests on the heart)
  • blood thinning medicines (such as warfarin). If so, tell them at your next visit to the anticoagulant clinic that you are now taking Dipyridamole MR.
  • medicines for high or low blood pressure
  • medicines for muscle weakness such as something called a ‘cholinesterase inhibitor’
  • aspirin (or planning to take aspirin for any condition).
Dipyridamole MR with alcohol

Do not take Dipyridamole MR at the same time as an alcoholic drink.

Pregnancy and breast-feeding

Tell your doctor if you are

  • pregnant or likely to get pregnant
  • breast-feeding

Your doctor will advise you whether to take Dipyridamole MR.

Driving and using machines

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

Dipyridamole MR contains ponceau 4R (E124)

Dipyridamole MR capsules contain the colouring agent ponceau 4R (E124), which may cause allergic reactions.

3. How to take Dipyridamole MR

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

Swallow the capsule whole without chewing/ crushing it.

Adults: One capsule in the morning and one in the evening with meals.

Children: Do not give to children.

If you take more Dipyridamole MR than you should

Do not take more than your doctor has prescribed.

It may cause symptoms such as feeling warm, sweating, racing of pulse, restlessness, weakness, dizziness and chest pain. If you take more than the recommended daily dose, consult 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 MR

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

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 MR can cause side effects, although not everybody gets them.

Contact your doctor at once if you develop any of the following rare allergic reactions:
  • breathing difficulties
  • large welts or swelling of the skin near the eyes, lips, hands, feet or inside of the throat (which may cause difficulty breathing), runny nose and severe rash with itching.

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

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

  • headache
  • feeling dizzy
  • feeling sick (nausea)
  • diarrhoea

Common (may affect up to 1 in 10 people)

  • muscle pain
  • being sick (vomiting)
  • worsening of symptoms of heart disease such as chest pain (angina) and heart beat problems (arrhythmias), fatigue, breathlessness

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

  • 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.
Reporting of side effects

If you get any side effects, talk to your doctor, hospital 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, 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 MR

Keep out of the sight and reach of children.

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

Do not open the container until you are ready to begin taking this course of treatment. Discard any remaining capsules 30 days after first opening the bottle.

Do not use Dipyridamole MR after the expiry date which is stated on the bottle/label after ‘Exp’. 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 to protect the environment.

6. Content of the pack and other information
What Dipyridamole MR contains

The active substance (which makes the medicine work) is 200 mg dipyridamole.

The other ingredients are: hypromellose, tartaric acid, acacia, povidone, methacrylic acid-methyl methacrylate copolymer (1:2), hypromellose phthalate, dimethicone, triacetin, talc and stearic acid.

The HPMC capsule shell contains: Hypromellose, brilliant blue (E133), ponceau 4R (E124), quinoline yellow (E104), titanium dioxide (E171), Carrageenan and Potassium Acetate. The white imprinting ink contains: shellac, potassium hydroxide and titanium dioxide (E171).

What Dipyridamole MR looks like and contents of the pack

Dipyridamole MR is a modified-release capsule filled with yellow to orange coloured pellets filled in size “0xel” hard capsules with opaque dark red cap and opaque dark orange body, imprinted ‘DPM’ on cap and ‘200’ on body with white ink.

Dipyridamole MR capsules are supplied in HDPE bottles, with desiccant.

Pack size: 60 capsules per bottle.

Marketing authorisation holder and manufacturer
Dr. Reddy’s Laboratories (UK) Ltd.
6 Riverview Road
Beverley
HU17 0LD

This leaflet was last updated in 09/2019

Company Contact Details
Dr. Reddy's Laboratories (UK) Ltd
Address

Dr. Reddy's Laboratories (UK) Limited, 410 Cambridge Science Park, Milton Road, Cambridge, CB4 0PE, UK

Telephone

+44 (0)1223 728 010

Medical Information Direct Line

+44 (0)1748 828 873

Customer Care direct line

+44 (0)1223 651 475

WWW

http://www.drreddys.com/united-kingdom

E-mail
Medical Information e-mail