Dipyridamole 50mg/5ml Oral Suspension (Rosemont Pharmaceuticals Ltd)

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

Do not take Dipyridamole and tell your doctor if:

• You are allergic to dipyridamole or any of the other ingredients of this medicine (listed in section 6). The signs of an allergic reaction include a rash, itching or shortness of breath.

If this applies to you, do not take this medicine and talk to your doctor.

Warnings and precautions

Before you take Dipyridamole, tell your doctor if:

• You have angina, have recently had a heart attack or you have heart or circulation problems
• You have a bleeding problem
• You have myasthenia gravis. This is a disorder that causes severe tiredness and muscle weakness particularly in the face and throat.

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

Other medicines and Dipyridamole

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

This includes medicines you buy without a prescription, including herbal medicines. This is because dipyridamole can affect the way some other medicines work. Also, some medicines can affect the way dipyridamole works.

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

• Aspirin, a medicine to thin your blood
• Medicines that stop clots from forming, such as warfarin
• Medicines that lower blood pressure
• Medicines that help muscle control, such as neostigmine
• Antacids, used to treat indigestion.

If you are to have an injection of adenosine that is used to treat unusual heart rhythms, tell the doctor that you are taking Dipyridamole Oral Suspension.

Having a heart test using an injection of dipyridamole

Dipyridamole is sometimes given as an injection to see if the heart is working properly (myocardial imaging). If you are going to have an injection of dipyridamole, tell the doctor that you are taking Dipyridamole Oral Suspension.

Pregnancy and breast-feeding

You should not be given Dipyridamole if you are pregnant, likely to get pregnant, or are breast-feeding.

Driving and using machines

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

Dipyridamole 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.
• Propylene glycol (E1520). This medicine contains 136.3mg in each 5 ml. If your baby is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol.
• Ethanol. This medicine contains 10.4 mg of alcohol (ethanol) in each 5 ml. The amount in 5 ml of this medicine is equivalent to less than 3 ml beer or 1 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.
• Methyl and propyl parahydroxybenzoates. These may cause an allergic reaction. This allergy may happen some time after starting the medicine.
• This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.

Taking this medicine

• This medicine contains 50mg of dipyridamole in each 5ml
• Take this medicine by mouth
• Take this medicine before meals
• Shake the bottle well before use.

Adults

The usual dose for adults is:

• The usual dose is 300 mg a day
• The maximum dose is 600mg a day
• This total daily dose can be split into two or three smaller doses to be taken through the day.

Children

This medicine is not usually given to children under the age of 18.

If you take more Dipyridamole Oral Suspension than you should

Talk to a doctor or go to a hospital straight away. Take the medicine pack with you so the doctor knows what you have taken.

If you forget to take Dipyridamole Oral Suspension

Do not take a double dose (two doses at the same time) to make up for a forgotten dose. Take your next dose as soon as you remember, then go on as before. However, if it is nearly time for the next dose, skip the missed dose.

Allergic reactions

An allergic reaction may include:

• Any kind of skin rash, flaking skin, boils or sore lips and mouth
• Sudden wheezing, fluttering or tightness of the chest or collapse.

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

Very common (affects more than 1 in 10 people)

• Headache
• Dizziness
• 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

• Faster heartrate
• Hot flushes
• Lowering of blood pressure
• 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 the leaflet. You can also report side effects directly via the Yellow Card Scheme at 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.

What Dipyridamole Oral Suspension contains

• The active ingredient is dipyridamole
• The other ingredients are methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), propylene glycol (E1520), xanthan gum (E415), ammonium glycyrrhizinate, almond flavour (including ethanol and propylene glycol), levomenthol, liquid maltitol (E965), polysorbate 80 (E433), simethicone emulsion, aluminium magnesium silicate, disodium hydrogen phosphate (E339), citric acid monohydrate (E330) and purified water.

What Dipyridamole Oral Suspension looks like and contents of the pack

A bright yellow suspension with an odour of almond.

It comes in a brown glass bottle holding 150ml or 500ml of suspension.

Marketing Authorisation Holder and Manufacturer