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Dipyridamole 100mg Tablets

Document: leaflet MAH BRAND_PLPI 15184-1527 change

Ref: 1527/180815/1/F

Persantin ® 100mg Tablets

(dipyridamole)

Patient Information Leaflet

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

Your medicine is called Persantin 100mg Tablets, but will be reffered to as Persantin Tablets throughout this leaflet.

In this leaflet:

What Persantin Tablets are and what they are used for Before you take Persantin Tablets How to take Persantin Tablets Possible side effects How to store Persantin Tablets .6 Further information

What Persantin Tablets are and what they are used for

The name of your medicine is Persantin Tablets. 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.

Persantin Tablets help stop blood clots which may occur if you have had your heart valves replaced.

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'

*    Antacids - for indigestion

*    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 Persantin Tablets.

If you are having heart tests

Persantin Tablets 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 Persantin Tablets.

Pregnancy and breast-feeding

*    Tell your doctor if you are pregnant or planning to get pregnant

*    Tell your doctor if you are breast-feeding as Persantin Tablets should only be used during breast-feeding if your doctor considers it essential

Driving and using machines

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

Important information about some of the ingredients of Persantin Tablets

Persantin tablets contain sucrose. If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.

Before you take Persantin Tablets

Do not take Persantin Tablets if you are allergic (hypersensitive) to:

*    Dipyridamole

Any of the other ingredients of Persantin Tablets (see section 6: Further information)

Take special care with Persantin tablets

Check with your doctor or pharmacist before taking your medicine if:

*    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 rare muscle problem)

*    You have any bleeding problems

*    You are pregnant or planning to become pregnant or are breast-feeding

*    You have been told by your doctor that you have an intolerance to some sugars

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

Taking other medicines

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

How to take Persantin tablets

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

The usual dose is

*    Between a total of 300 and 600 mg each day

*    This is taken in three or four separate doses

*    The most you can take in a day is 600 mg

*    It is best to take the tablets before meals

*    Swallow the tablets whole

*    Do not crush or chew the tablets

Do not give to children.

If you take more Persantin Tablets 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 tablets left.

If you forget to take Persantin Tablets

*    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 dose

(dipyridamole)

Patient Information Leaflet (continued)

[4 Possible side effects

Like all medicines, Persantin tablets 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 for Persantin Tablets 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

*    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, 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 at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

^ Further information

What Persantin Tablets contain:

The active substance is dipyridamole.

Each tablet contains 100mg of dipyridamole.

The other ingredients are calcium hydrogen phosphate anhydrous, maize starch, colloidal anhydrous silica, magnesium stearate, sucrose, talc, acacia, titanium dioxide (E171), macrogol 6000, carnauba wax and bleached wax.

What Persantin Tablets look like and contents of the pack

Persantin Tablets are round, white, biconvex, shiny, sugar-coated tablets. Each blister pack contains 50 tablets.

Manufacturer and Licence Holder

Manufactured by Delpharm Reims, S.A.S 10 Rue Colonel Charbonneaux, 51100 Reims France and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

POM PL 15184/1527 Persantin 100mg Tablets

Persantin is a registered trademark of Boehringer Ingelheim Pharma GmbH & Co. KG.

Revision date: 18/08/15

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

How to store Persantin Tablets

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not store above 30°C.

Protect from light.

Do not take Persantin Tablets after the expiry date which is stated on the carton and blister label. The expiry date refers to the last day of that month. If your medicine becomes discoloured or show any other signs of deterioration, ask your pharmacist who will advise you what to do. 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.

Patient Information Leaflet

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

Your medicine is called Dipyridamol 100mg Tablets, but will be reffered to as Dipyridamol Tablets throughout this leaflet.

In this leaflet:

What Dipyridamol Tablets are and what they are used for Before you take Dipyridamol Tablets ^ How to take Dipyridamol Tablets ^ Possible side effects ^ How to store Dipyridamol Tablets Further information

What Dipyridamol Tablets are and what they are used for

The name of your medicine is Dipyridamol Tablets. 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.

Dipyridamol Tablets help stop blood clots which may occur if you have had your heart valves replaced.

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'

*    Antacids - for indigestion

*    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 Dipyridamol Tablets.

If you are having heart tests

Dipyridamol Tablets 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 Dipyridamol Tablets.

Pregnancy and breast-feeding

*    Tell your doctor if you are pregnant or planning to get pregnant

*    Tell your doctor if you are breast-feeding as Dipyridamol Tablets should only be used during breast-feeding if your doctor considers it essential

Driving and using machines

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

Important information about some of the ingredients of Dipyridamol Tablets

Dipyridmol tablets contain sucrose. If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.

[2) Before you take Dipyridamol Tablets

Do not take Dipyridamol Tablets if you are allergic (hypersensitive) to:

*    Dipyridamole

Any of the other ingredients of Dipyridamol Tablets (see section 6: Further information)

Take special care with Dipyridamol tablets

Check with your doctor or pharmacist before taking your medicine if:

*    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 rare muscle problem)

*    You have any bleeding problems

*    You are pregnant or planning to become pregnant or are breast-feeding

*    You have been told by your doctor that you have an intolerance to some sugars

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

Taking other medicines

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

[3) How to take Dipyridamol tablets

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

The usual dose is

*    Between a total of 300 and 600 mg each day

*    This is taken in three or four separate doses

*    The most you can take in a day is 600 mg

*    It is best to take the tablets before meals

*    Swallow the tablets whole

*    Do not crush or chew the tablets

Do not give to children.

If you take more Dipyridamol Tablets 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 tablets left.

If you forget to take Dipyridamol Tablets

*    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 dose

^ Further information

What Dipyridamol Tablets contain:

The active substance is dipyridamole.

Each tablet contains 100mg of dipyridamole.

The other ingredients are calcium hydrogen phosphate anhydrous, maize starch, colloidal anhydrous silica, magnesium stearate, sucrose, talc, acacia, titanium dioxide (E171), macrogol 6000, carnauba wax and bleached wax.

What Dipyridamol Tablets look like and contents of the pack

Dipyridamol Tablets are round, white, biconvex, shiny, sugar-coated tablets. Each bister pack contains 100 tablets.

Manufacturer and Licence Holder

Manufactured by Delpharm Reims, S.A.S 10 Rue Colonel Charbonneaux, 51100 Reims France and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.


Patient Information Leaflet (continued)

[4 Possible side effects

Like all medicines, Dipyridamol tablets 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 for Dipyridamol Tablets 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

*    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, 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 at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

POM PL 15184/1527 Dipyridamol 100mg Tablets Revision date: 18/08/15

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

How to store Dipyridamol Tablets

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not store above 30°C.

Protect from light.

Do not take Dipyridamol Tablets after the expiry date which is stated on the carton and blister label. The expiry date refers to the last day of that month. If your medicine becomes discoloured or show any other signs of deterioration, ask your pharmacist who will advise you what to do. 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.