Document: leaflet MAH BRAND_PLPI 18067-0429 change

• leaflet MAH BRAND_PLPI 18067-0429
• leaflet MAH BRAND_PLPI 19065-0381

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504160/PL1b

®

Persantin Retard 200 mg Modified Release, Hard Capsules

(dipyridamole)

Patient Information Leaflet

This medicine is available using the above name but will be referred to as Persantin® Retard throughout this leaflet.

In this leaflet:

1)    What Persantin® Retard is and what it is used for

2)    Before you take Persantin Retard

3)    How to take Persantin® Retard

4)    Possible side effects

5)    How to store Persantin® Retard

6)    Further information

The name of your medicine is Persantin® Retard. 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® Retard is used:

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

•    In people who have had a stroke caused by a blood clot in the brain. This medicine reduces the risk of having another stroke.

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

•    Dipyridamole

•    Any of the other ingredients of Persantin® Retard (see section 6: Further Information)

Take special care with Persantin® Retard

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

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

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'

•    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^® Retard

If you are having heart tests

Persantin® Retard 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® Retard.

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^® Retard should only be used during breast-feeding if your doctor considers it essential.

Driving and using machines

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

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:

•    One capsule twice a day

•    Usually one in the morning and one in the evening

•    It is best to take it with food

•    Swallow the capsule whole

•    Do not crush or chew it

Do not give to children.

If you take more Persantin® Retard 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 capsules left.

If you forget to take Persantin® Retard

•    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 the forgotten dose

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

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^® Retard can affect the way some other medicines work. Also some other medicines can affect the way Persantin Retard works.

Continued overleaf

4) POSSIBLE SIDE EFFECTS

Like all medicines Persantin® Retard 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® Retard 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 or increased heart rate

•    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.

What Persantin^® Retard looks like and contents of the pack

Hard gelatine capsules consisting of a red cap and an orange body.

_®

Persantin Retard is available in packs of 60 capsules. Product Licence Holder

Procured from within the EU. Product Licence Holder Ginova Ltd, repackager Ginova UK Ltd, both of St James' House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Strasse 65, Biberach D-88397, Germany

Persantin® Retard 200 mg Modified Release, Hard Capsules    _

PL No: 18067/0429    |POM|

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

This leaflet was last approved on 11^th June 2015.

To request a copy of this leaflet in Braille, large print or audio please call 01622 690172.

•    Keep out of the sight and reach of children.

•    Do not store above 30°C.

•    Keep the bottle tightly closed.

•    Store in the original package.

•    Protect from moisture.

•    Do not use Persantin® Retard after the expiry date which is stated on the carton and container label after EXP. The expiry date refers to the last day of that month.

•    Do not open the container until you are ready to start taking the capsules. If you have any capsules left after six weeks, these should not be taken.

•    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 protect the environment.

6) FURTHER INFORMATION

What Persantin Retard contains

The active substance is dipyridamole.

Each modified release capsule contains 200 mg dipyridamole. Persantin® Retard is a modified release capsule which releases the active substance slowly in your body over a number of hours.

The other ingredients in Persantin® Retard are: hypromellose, tartaric acid, arabic gum, povidone, Eudragit, hypromellose phthalate, dimethicone, triacetin, talc and stearic/palmitic acid. The capsule shells contain gelatin, titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172).