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Dipyridamole Tablets 25mg

Document: label-leaflet MAH GENERIC_PL 17521-0005 change

Last page of the leaflet label


Dipyridamole

Tablets 25 mg

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Each tablet contains 25 mg Dipyridamole.

Also contains lactose and sucrose.



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Metwest

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PL 17521/0005


PACKAGE LEAFLET: INFORMATION FOR THE USER

DIPYRIDAMOLE 25 mg TABLETS

/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 become serious, or if you notice any side effects not listed in this

sjeaflet, please tell your doctor or pharmacist.


If you take more Dipyridamole than you should

Contact your doctor or go to a hospital immediately. Take the medicine pack or container with you so the doctor knows what you have taken.

If you forget to take Dipyridamole Don't worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for the one you have missed.

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


4. POSSIBLE SIDE EFFECTS


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


in


THIS LEAFLET CONTAINS


1.    What Dipyridamole is for

2.    Before you take Dipyridamole

3.    How to take Dipyridamole

4.    Possible side effects

5.    How to store Dipyridamole

6.    Further information


1. WHAT DIPYRIDAMOLE IS FOR


Dipyridamole belongs to a group of medicines called the anti-platelet agents.

Dipyridamole helps to stop blood clots forming, particularly when you have artificial heart valves. It can also be used in combination with aspirin to prevent blood clots forming in the legs and to


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

An allergic reaction may include:

•    Skin rash, itching or red and rasied lumps (hives)

•    Swelling of the face, lips, mouth or throat

•    Difficulty in breathing or wheezing.

If you get any of the following side effects, STOP TAKING Dipyridamole and see your doctor as soon as possible:

•    Worsening of the symptoms of heart disease such as chest pain and irregular heart beat

•    Fast heart beat

•    Increased bleeding during or after surgery

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


Front side of the leaflet label


prevent the blockage of blood vessels following surgical procedures such as heart bypass surgery.

If you are not sure why you have been prescribed these tablets then please ask your doctor.


2. BEFORE YOU TAKE DIPYRIDAMOLE


Do not take Dipyridamole

•    If you are allergic to Dipyridamole or any of the other ingredients in the tablets (listed in section 6 of this leaflet). The signs of an allergic reaction include a rash, itching or shortness of breath.

Take special care with Dipyridamole

Tell your doctor before you take this medicine if:

•    You have angina (chest pain), have recently had a heart attack or you have circulation or heart


problems (including low blood pressure)

•    You have a bleeding problem

•    You have myasthenia gravis (severe tiredness and muscle weakness particularly in the face and throat)

•    You suffer from migraines (painful headaches causing nausea, vomiting or problems with your vision).

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken, any other medicines, even medicines bought without a prescription.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how Dipyridamole tablets work:


•    Other medicines to stop blood clots forming, such as Phenindione or Warfarin

•    Aspirin for pain and swelling

•    Adenosine injection for heart problems or tests on the heart

•    Medicines for high blood pressure

•    Medicines that help muscle control, such as Cholinesterase Inhibitors

•    Antacids for indigestion or heartburn.

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 tablets.

Pregnancy and breast-feeding

Do not take Dipyridamole if you are pregnant, planning a pregnancy or breast-feeding, unless your doctor has told you to.

Driving and using machines

Dipyridamole is not likely to affect your ability to

drive or use any tools or machines.

Important information about some of the ingredients of Dipyridamole This medicine contains lactose and sucrose. If you know you have an intolerance to some sugars contact your doctor before taking Dipyridamole.


3. HOW TO TAKE DIPYRIDAMOLE


Always take Dipyridamole tablets exactly as your doctor has told you. Take this medicine by mouth, ideally before meals. Do not crush or chew the tablets. Swallow the tablets whole.

Dosage

Your doctor will decide your dose and length of treatment, as it depends on your condition.

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

Elderly: Same dosage as adults.

Children: Not recommended for children.


•    Low blood pressure causing dizziness and light-headedness

•    Hot flushes.

In patients who have gallstones, Dipyridamole can be absorbed into the gallstones.

The side effects listed below usually go away as treatment continues:

•    Headache or feeling dizzy or faint

•    Nausea, vomiting, indigestion or diarrhoea

•    Muscle pain.

If any of the side effects become 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. Store in the original package or container and keep the container tightly closed.

Do not use these tablets after the expiry date, which is stated on the package or container. 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 Dipyridamole tablets contain

The active ingredient in Dipyridamole 25 mg tablets is dipyridamole. The other ingredients are lactose, maize starch, povidone, pregelatinised starch, magnesium stearate, bleached shellac, sucrose, talc, titanium dioxide (E171), beeswax, carnauba wax and the colour orange.

What Dipyridamole tablets look like and contents of the pack

Dipyridamole 25 mg tablets are round orange sugar-coated tablets.

The tablets come in blister packs and containers of 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000


tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Metwest Pharmaceuticals Limited,

15 Runnelfield, Harrow on the Hill,

Middlesex HA1 3NY Manufacturer

Haupt Pharma Berlin GmbH, GradestraBe 13, MoosrosenstraBe 5 and Britzer Damm 120, 12347 Berlin, Germany For more information about this product, please contact the Marketing Authorisation Holder.

This leaflet was last approved in 11/2011

DIP0005/0025S/LEA005



Dipyridamole

Tablets 25 mg

Each tablet contains 25 mg Dipyridamole.

Also contains lactose.

Metwest

Pharmaceuticals


Tablets for oral use as prescribed by the physician.

MA Holder:

Metwest Pharmaceuticals Ltd,

15 Runnelfield, Harrow, HA1 3NY PL 17521/0005    I POM |

Do not store above 25°C.

Keep the container well closed. Store out of reach and sight of children.

Batch number and expiry date on base.


Back side of the leaflet label


First page of the leaflet label


The text, design and layout is the same for all pack sizes 28, 30, 50, 56, 60, 84, 100, 250, 500 and 100 tablets