Document: leaflet MAH BRAND_PL 00015-5016R change

• leaflet MAH BRAND_PL 00015-5016R
• leaflet MAH BRAND_PLPI 15184-1527

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PACKAGE LEAFLET:

INFORMATION FOR THE USER_

Persantin® Tablets

(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 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.

In this leaflet:

1.    What PERSANTIN Tablets are and what they are used for

2.    Before you take PERSANTIN Tablets

3.    How to take PERSANTIN Tablets

4.    Possible side effects

5.    How to store PERSANTIN Tablets ■ 6. Further information

1. 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.

2. 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 breastfeeding

•    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.

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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.

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 breastfeeding 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.

3. 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

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

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.

5. HOW TO STORE PERSANTIN TABLETS

Keep out of the sight and reach of children.

The tablets should not be stored above 30°C. Keep the tablets in the foil packaging until required.

Do not use PERSANTIN Tablets after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.

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 PERSANTIN Tablets contains

The active substance is dipyridamole. Each coated tablet contains 100 mg of dipyridamole Ph Eur.

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

What PERSANTIN Tablets look like and contents of the pack

PERSANTIN Tablets are white and are available in blister packs of 84 tablets.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation is held by:

Boehringer Ingelheim Limited,

Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS, United Kingdom.

and the tablets are manufactured by:

Delpharm Reims S.A.S.

10 Rue Colonel Charbonneaux 51100 Reims,

France

This leaflet was revised in January 2015. © Boehringer Ingelheim Limited 2015

316079-003