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DIPYRIDAMOLE 50 MG/5 ML ORAL SUSPENSION

Active substance(s): DIPYRIDAMOLE / DIPYRIDAMOLE / DIPYRIDAMOLE

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DUMMY

DUMMY

PATIENT INFORMATION LEAFLET

If you take more Dipyridamole than you should
If you have taken more Dipyridamole than you should, contact your doctor immediately or go to your nearest hospital accident and
emergency department. Take this leaflet and/or the bottle with you.

DIPYRIDAMOLE 50 mg/5 ml ORAL SUSPENSION
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.
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 of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
What is in this leaflet:
1.
What Dipyridamole is and what it is used for
2.
What you need to know before you take Dipyridamole
3.
How to take Dipyridamole
4.
Possible side effects
5.
How to store Dipyridamole
6.
Contents of the pack and other information
1.

WHAT DIPYRIDAMOLE IS AND WHAT IT IS USED FOR

Dipyridamole belongs to a group of medicines called anti-platelet agents. Dipyridamole 50 mg/5 ml Oral Suspension (“Dipyridamole”) helps
to prevent the formation of blood clots which sometimes occur if you have artificial heart valves.
2.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIPYRIDAMOLE

DO NOT take Dipyridamole

if you are allergic (hypersensitive) to dipyridamole or any of the other ingredients in the product (see Section 6 and end of Section 2).
Warnings and precautions
Talk to your doctor if you have

narrowed or blocked arteries, angina, heart valve, circulation or other heart problems, or if you have had a recent heart attack

myasthenia gravis (a nerve disease which causes muscle weakness) as your medicines may need to be adjusted

any blood clotting disorders

a hereditary intolerance to fructose

planned to become pregnant, are pregnant or breast-feeding.
Dipyridamole is sometimes given as an injection during some tests on your heart (e.g. myocardial imaging). If this applies to you, tell your
doctor that you are already taking Dipyridamole. You may be advised to stop taking your usual medicine 24 hours before your test.
Other medicines and Dipyridamole
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, but
particularly if you are taking:

adenosine (e.g. for heart problems)

medicines for high blood pressure

aspirin, because the effects on blood platelets may be increased

any drug for myasthenia gravis (a nerve disease that causes muscle weakness) because your medicines may need to be adjusted

any other medicines to prevent blood clots forming (e.g. warfarin). Tell the anticoagulant clinic at your next visit that you are now
taking Dipyridamole

medicine to reduce stomach acid (e.g. antacids for indigestion).

If you forget to take Dipyridamole
If you miss a dose, take it as soon as you remember and then take any remaining doses that day at evenly spaced intervals.
Do not take a double dose to make up for the forgotten dose.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, Dipyridamole can cause side effects, although not everybody gets them.
You should STOP using Dipyridamole and contact your doctor immediately if you experience a rare allergic reaction, including
swelling of the face and neck or skin rashes, difficulty breathing, loss of consciousness, and fever or shock.
The following side effects usually only occur early in your treatment:

being, or feeling sick

diarrhoea

dizziness

feeling faint

indigestion

headache

myalgia (muscular pain).
Dipyridamole may act to widen your blood vessels which can cause:

hot flushes

lowering of blood pressure (hypotension). You may feel light-headed or faint.

increased heart rate

worsening of the symptoms of heart disease (e.g. chest pain and irregular heart rhythm).
If you have gallstones, dipyridamole has been found in them.
Very rarely, the following symptoms have been reported:

increased bleeding during or after surgery

a blood disorder causing bruising and extending your blood clotting time (thrombocytopenia).
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
aslo report side effects directly via the national reporting systems listed below:
United Kingdom:
Yellow Card Scheme
Website: http://www.mhra.gov.uk/yellowcard
Ireland:
IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517; Website: www.imb.ie;
e-mail: imbpharmacovigilance@imb.ie
By reporting side effects you can help provide more information on the safety of this medicine.
5.

HOW TO STORE DIPYRIDAMOLE

Keep out of the reach and sight of children. Store in the original packaging. Do not store above 25˚C. Do not use Dipyridamole after the
expiry date which is stated on the label or carton. The expiry date refers to the last day of that month. Use within 30 days of first opening.

Dipyridamole with food and drink
It is best to take this medicine before meals

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.

Pregnancy and breast-feeding
Tell your doctor if you are pregnant or planning to become pregnant. Tell your doctor if you are breast-feeding as Dipyridamole should only be
used during breast-feeding if your doctor considers it essential.

6.

Important information about some of the ingredients of this medicine
Dipyridamole 50 mg/5 ml Oral Suspension contains:

Liquid Maltitol (E965): If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicinal product. This product contains 2.8 g maltitol per 5 ml of suspension and may have a mild laxative effect.
Maltitol has a calorific value of 2.3 kcal/g.

Methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216) and ethyl parahydroxybenzoate (E214): may cause
allergic reactions (possibly delayed).
3.

HOW TO TAKE DIPYRIDAMOLE

Always take Dipyridamole exactly as your doctor has told you. You should check with your doctor if you are not sure about the dose you
should take.

Usual doses are :

Children:

Between:
• Two (5 ml) spoonfuls 3 times a day
and
• Three (5 ml) spoonfuls 4 times a day.
Your doctor will advise on the best dose for you. (The maximum
recommended daily dose is 600 mg or 12 spoonfuls).
Not recommended for use.

DUMMY

This product contains:

the active ingredient: dipyridamole (50 mg in 5 ml of the suspension).

other ingredients: magnesium aluminium silicate, xanthan gum, glycerol (E422), liquid maltitol (E965), disodium phosphate
dodecahydrate, saccharin sodium, banana flavour, polysorbate 80, simeticone, methyl parahydroxybenzoate (E218), propyl
parahydroxybenzoate (E216), ethyl parahydroxybenzoate (E214), propylene glycol, citric acid monohydrate, purified water. (See
end of Section 2 for further information).
What Dipyridamole looks like and contents of the pack
Dipyridamole 50 mg/5 ml Oral Suspension is a yellow sugar free suspension with a banana flavour and odour, and is available in amber glass
bottles of 150 ml.
Marketing Authorisation Holder and Manufacturer
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
This medicinal product is authorised in the Member States of the EEA under the following names:
IE:
Dipyridamole 50 mg/5 ml Oral Suspension
UK:
Dipyridamole 50 mg/5 ml Oral Suspension

This medicine should only be taken by mouth and just before meals.
Shake the bottle thoroughly before use, as the contents may settle.
Adults:

CONTENTS OF THE PACK AND OTHER INFORMATION

MA Numbers: PL 04917/0084
PA 281/149/1
This leaflet was last revised in 04/2014

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DUMMY

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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