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DIPYRIDAMOLE TABLETS 25MG

Active substance(s): DIPYRIDAMOLE / DIPYRIDAMOLE / DIPYRIDAMOLE

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Product:

Dipyridamole
25 mg Tablets

Printing Colours:

Non-Printing Colours:

Black

Profile

MA Holder:

Genethics Europe

PL No.:

42976/0003

Pack Size:

All Pack

Dimensions:

150 x 250 mm

Livery:

Genethics Europe

Created By:

DTawde

Manufacturer:

-

Artwork Code:

GE0003/O/PIL/GE2

Bar Code:

-

Font Type:
Font Size:

Arial Narrow
9.5 pt

Market:

UK

Component:

Leaflet

Final Preparation Date For Submission: 11/01/2017

Packing Site Technical Approval:

00/00/0000
Authority Approval Date:
Latest Implementation Deadline:
Print Proof Approval:

00/00/0000
00/00/0000
00/00/0000

PACKAGE LEAFLET: INFORMATION FOR THE USER

DIPYRIDAMOLE
25 mg TABLETS

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
- 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
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same
as yours.
- If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet
1. What Dipyridamole Tablets are
and what they are used for
2. What you need to know before
you take Dipyridamole Tablets
3. How to take Dipyridamole Tablets
4. Possible side effects
5. How to store Dipyridamole
Tablets
6. Contents of the pack and other
information

 If you have myasthenia gravis (a rare muscle
problem)
 If you are pregnant or planning to become
pregnant or are breast-feeding
 If you have been told by your doctor that you
have an intolerance to some sugars
Use in Children: Not recommended for children
Other medicines and Dipyridamole tablets
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
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 anticoagulants medicines to stop blood
clots forming, such as Phenindione or Warfarin
 Aspirin (or planning to take aspirin for any
condition)
 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
If you are having heart tests Dipyridamole is
sometimes given as an injection to see if the heart is
working properly (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 Dipyridamole tablets.

Pregnancy and Breast-feeding
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask
1. What Dipyridamole Tablets are and
your doctor or pharmacist for advice before taking
what they are used for
this medicine.
Dipyridamole tablets contains the active substance Tell your doctor if you are breast-feeding as
dipyridamole. Dipyridamole tablets belong to a Dipyridamole tablets should only be used during
group of medicines called the anti-platelet agents.
breast-feeding if your doctor considers it essential.
Dipyridamole tablets help to stop blood clots
forming, particularly when you have artificial heart Driving and using machines
You may feel dizzy while taking Dipyridamole
valves.
tablets. If this happens do not drive or use any tools
You must talk to a doctor if you do not feel better or or machines.
if you feel worse.
Dipyridamole tablets contain lactose and
2. What you need to know before you
sucrose
take Dipyridamole Tablets
This medicine contains lactose and sucrose. If you
have been told by your doctor that you cannot
Do not take Dipyridamole tablets
tolerate or digest some sugars, talk to your doctor
 If you are allergic to Dipyridamole or any of the
before taking Dipyridamole tablets.
other ingredients of this medicine (listed in
section 6)
3. How to take Dipyridamole Tablets
 If you have irregular heart rate (Cardiac
Always take Dipyridamole tablets exactly as your
conduction difficulties or dysrhythmias)
doctor has told you. Check with your doctor or
Warnings and Precautions
pharmacist if you are not sure.
Talk to your doctor or pharmacist before taking
Take this medicine by mouth, ideally before meals.
Dipyridamole tablets:
Do not crush or chew the tablets. Swallow the
 If you have angina (chest pain), have
tablets whole.
recently had a heart attack or you have
circulation or heart problems (including low
blood pressure)
 If you have any bleeding problems

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

Adults: The recommended dose is 300 mg – 600
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.
Use in Children: Not recommended for children.

By reporting side effects you can help provide more
information on the safety of this medicine.

If you take more Dipyridamole tablets 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.

Do not store above 25°C. Store in the original
package or container and keep the container tightly
closed.

If you forget to take Dipyridamole tablets
Don’t worry, just take your next scheduled dose at
the correct time. Do not take a double dose to make
up for a forgotten dose.
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 tablets can cause
side effects, although not everybody gets them.
If you have an allergic reaction to Dipyridamole
tablets, stop taking your medicine and see a
doctor straight away.
An allergic reaction may include:
 Skin rash, redness, itching
 Swelling of the face, lips, mouth or throat
 Difficulty in breathing or wheezing, runny nose
Other side effects that have been reported for
Dipyridamole tablets are described below.
Very Common (may affect more than 1 in 10
people)
 Headache
 Feeling dizzy
 Feeling sick (nausea)
 Diarrhoea
Common (may affect up to 1 in 10 people)
 Muscle pain
 Being sick (vomiting)
 Worsening of the symptoms of heart disease
such as chest pain and shortness of breath
Not know (frequency cannot be estimated from
the available data)
 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 or
pharmacist. 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.

5. How to store Dipyridamole Tablets
Keep this medicine out of the sight and reach of
children.

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.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These
measures will help protect the environment.

6. Contents of the pack and other
information
What Dipyridamole tablets contain
The active substance 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
Genethics Europe Limited,
41 – 43 Klimentos, Klimentos Tower,
Nicosia 1061, Cyprus
Manufacturer
Haupt Pharma Berlin GmbH, Gradestraße 13,
Moosrosenstraße 5 and Britzer Damm 120,
12347 Berlin, Germany
For more information about this product, please
contact the Marketing Authorisation Holder.
This leaflet was last revised in 01/2017

GE0003/O/PIL/GE2

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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