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Dipyridamole 50mg/5ml Oral Suspension

Document: label-leaflet MAH GENERIC_PL 00427-0133 change

Patient Information Leaflet

Dipyridamole 50mg/5ml Oral Suspension

•    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 or pharmacist.

•    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 or pharmacist.

In this leaflet:

1.    What Dipyridamole Oral Suspension is and what it is used for

2.    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.    Further information

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1. What Dipyridamole Oral Suspension is and what it is used for

The name of your medicine is Dipyridamole Oral Suspension (called dipyridamole in this leaflet). It contains dipyridamole. This belongs to a group of medicines called anti-platelet agents.

Dipyridamole helps to stop blood clots forming, particularly when you have artificial heart valves.

2. Before you take Dipyridamole Oral Suspension

Do not take Dipyridamole and tell your doctor if:

•    You are allergic (hypersensitive) to dipyridamole or any other ingredients in this liquid (listed in Section 6 below). 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.

Take special care with Dipyridamole

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.

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

Taking other medicines

Please 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

•    Med icines that stop clots from forming, such as warfarin

•    Medicines that lower blood pressure

•    Med icines 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.

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Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, planning to become pregnant or are breast-feeding.

Driving and using machines

This medicine is not likely to affect you being able to drive or use any tools or machines. Important information about what is in Dipyridamole Oral Suspension

This medicine contains:

•    Methyl and propyl parahydroxybenzoates. These may cause an allergic reaction. This allergy may happen some time after starting the medicine

•    Liquid maltitol. If your doctor has told you that you cannot tolerate some sugars, see your doctor before taking this medicine.

3. How to take Dipyridamole Oral Suspension

Take this medicine as your doctor or pharmacist has told you. Look on the label and ask the doctor or pharmacist if you are not sure.

Taking this medicine

•    Th dicine contains 50mg of dipyridamole in each 5ml

•    Take this medicine by mouth

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•    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.

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

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PL 00427/0133 L????


Each 5ml contains 50mg Dipyridamole.

The product also includes liquid maltitol (E965), methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216) and propylene glycol (E1520).

See leaflet for further information.

Administration:

For oral use.

Shake the bottle well before use.

Read the package leaflet before use.

Storage:

Do not store above 25°C.

Use within 1 month of opening.

Keep out of the reach and sight of children.

Manufactured by the MA Holder:

Rosemont Pharmaceuticals Ltd., Leeds, LS11 9XE, UK.


4. Possible side effects

Like all medicines, Dipyridamole Oral Suspension can cause side effects although not everybody gets them.

If you have an allergic reaction to Dipyridamole Oral Suspension see a doctor straight away 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.

If you get any of the following side effects, stop taking Dipyridamole Oral Suspension and see your doctor as soon as possible:

•    Worsening of your symptoms of heart disease

•    Faster heart rate

•    Increased bleeding after an operation

•    Red marks on the skin and bruising easily. This could be the sign of a blood disorder

•    Dizziness and feeling light headed. This may be a sign that you have low blood pressure

•    Worsening of the symptoms that are linked to having gallstones.

Tell your doctor if you get any of these side effects:

•    Headache

•    Feeing sick (nausea) or being sick (vomiting)

•    Diarrhoea

•    Upset stomach. You may fell full, bloated, sick and have indigestion

•    Muscle pain.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to Store Dipyridamole

•    Keep out of the reach and sight of children

•    Do not store above 25°C

•    After you open the bottle, this medicine expires after one month. Take this medicine back to the pharmacy one month after you first open it.

•    Do not use after the expiry date which is stated on the label and carton (Exp: month, year)

•    The expiry date refers to the last day of that month

Marketing Authorisation Holder and Manufacturer

Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.

This leaflet was last approved in February 2008.

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SUGAR FREE 150ml e

Dipyridamole 50mg/5ml Oral Suspension


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Each 5ml contains 50mg Dipyridamole.

The product also includes liquid maltitol (E965), methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216) and propylene glycol (E1520).

See leaflet for further information.

Administration:

For oral use.

Shake the bottle well before use.

Read the package leaflet before use.

Storage:

Do not store above 25°C.

Use within 1 month of opening.

Keep out of the reach and sight of children.

Manufactured by the MA Holder:

Rosemont Pharmaceuticals Ltd., Leeds, LS11 9XE, UK.


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•    Do not use Dipyridamole Oral Suspension if you notice a change in the appearance or smell of the medicine. Talk to your pharmacist

•    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.

6. Further information

What Dipyridamole Oral Suspension contains

•    The active ingredient is dipyridamole

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   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.

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What Dipyridamole Oral Suspension looks like and contents of the pack

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A bright yellow suspension with an odour of almond.

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