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DIPYRIDAMOLE 200MG/5ML ORAL SUSPENSION

Active substance(s): DIPYRIDAMOLE / DIPYRIDAMOLE / DIPYRIDAMOLE

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Package leaflet: Information for the user

Dipyridamole 200mg/5ml Oral Suspension
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.

The name of your medicine is
Dipyridamole 200mg/5ml
Oral Suspension but it will be
referred to as Dipyridamole
throughout this leaflet.

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

1. What Dipyridamole is and
what it is used for
Dipyridamole belongs to a group of
medicines called ‘anti-thrombotic
agents’, which are used to help stop
blood clots forming.
Dipyridamole helps stop blood clots
which may occur if you have had
your heart valves replaced.

2. What you need to know
before you take
Dipyridamole
Do not take
Dipyridamole if:


You are allergic (hypersensitive)
to dipyridamole or any of the
other ingredients of this
medicine (listed in section 6:
Contents of the pack and other
information).

PIL/UK/MFG015/03/v1

Warnings and precautions

Talk to your doctor or pharmacist
before taking Dipyridamole 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 applies to you, talk to your
doctor or pharmacist before taking
Dipyridamole.

Other medicines and
Dipyridamole
Tell your doctor or pharmacist if
you are taking or have recently
taken or might take any other
medicine. This includes medicines
obtained without a prescription and
herbal medicines. Dipyridamole
may affect or be affected by other
medicines.
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 Dipyridamole.

If you are having heart tests

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
Dipyridamole.

Pregnancy and
Breast-feeding





If you are pregnant, think you
may be pregnant or are
planning to have a baby, ask
your doctor for advice before
taking this medicine.
Tell your doctor if you are
breast-feeding or about to start
breast-feeding as Dipyridamole
should only be used during
breast-feeding if your doctor
considers it essential.

Driving and using machines

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

Dipyridamole contains:
Liquid maltitol (E965): If you
have been told by your doctor that
you have an intolerance to some
sugars, contact your doctor before
taking this medicinal product.
Methyl (E218) and propyl
parahydroxybenzoates (E216):
May cause allergic reactions
(possibly delayed).
Dipyridamole also contains
545.20mg/5ml propylene glycol
(E1520) as an ingredient necessary
for the medicine to work properly.

3. How to take Dipyridamole
Always take this medicine exactly
as your doctor has told you. Check
with your doctor or pharmacist if
you are not sure.

The usual dose is:





The usual dose is 300-600mg
each day.
This is taken in three or four
separate doses.
The most you can take in a day
is 600mg.
It is best to take the
Dipyridamole before meals.

Do not give to children.
Route and Method of
administration

This medicinal product must be
taken orally.
This product may settle during
storage. Shake well before use.



Use only the dosing spoon supplied
with the pack (see figure below).
Measure the exact quantity of
dipyridamole using the dosing
spoon, 2.5ml (small end) contains
100mg of dipyridamole, and 5ml
(large end) contains 200mg of
dipyridamole.
TURN OVER

► Swallow the suspension.
► Wash the spoon with clean water

 Worsening of the symptoms of
heart disease such as chest
pain and shortness of breath

after taking every dose.

2.5-5ml double-ended spoon

Not known

 Hot flushes
 Lowering of blood pressure
 A blood problem called

If you take more
Dipyridamole than you should
Call your doctor or go to your
nearest hospital casualty
department straight away. Take the
medicine pack with you, even if
there is no Dipyridamole left.

If you forget to take
Dipyridamole





If you forget a dose, take it as
soon as you remember.
However, if it is nearly time for
the next dose, skip the missed
dose.
Do not take a double dose to
make up for a forgotten dose.

If you stop taking
Dipyridamole


Do not stop taking Dipyridamole
unless your doctor tells you to.

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

‘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.
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.

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

5. How to store
Dipyridamole

4. Possible side effects

 Keep out of the sight and reach

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

 Do not use after the expiry date

of children.

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 Dipyridamole are:

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)

PIL/UK/MFG015/03/v1







which is printed on the carton
and bottle label after ‘Exp’. The
expiry date refers to the last
day of that month.
Do not store above 25°C.
Discard after 60 days of first
opening.
Do not use this medicine if you
notice that the suspension
becomes discoloured or shows
any signs of deterioration. Seek
the advice of your pharmacist.
Do not throw away any
medicines via wastewater or
household waste. Ask your
pharmacist how to dispose of
medicines you no longer use.
These measures will help protect
the environment.

6. Contents of the pack
and other information
What Dipyridamole contains
The active substance is
dipyridamole.
Each 5ml of oral suspension
contains 200mg dipyridamole.
The other ingredients are methyl
parahydroxybenzoate (E218),
propyl parahydroxybenzoate
(E216), polysorbate 80 (E433),
simeticone emulsion 30% (containing
polydimethylsiloxane, sorbitan
monostearate, polyoxyethylene 20
sorbitan, silicon dioxide, xanthan gum,
benzoic acid, sorbic acid, potassium
hydroxide, hydrogen chloride and
deionised water), liquid maltitol (E965),
xanthan gum (E415), aluminium
magnesium silicate (E553a), citric acid
monohydrate (E330), disodium
phosphate anhydrous (E339),
ammonium glycyrrhizinate, propylene
glycol (E1520), orange flavour
[containing propylene glycol (E1520)]
and purified water.

What Dipyridamole looks like
and contents of the pack
Dipyridamole is a uniform yellow
coloured suspension with orange
flavour supplied in an amber glass
bottle with a tamper evident child
resistant plastic cap and a 2.5ml5ml double-ended plastic spoon for
measuring and administering the
dose.
Dipyridamole is supplied in bottles
containing 150ml and 300ml of
oral suspension.
Not all pack sizes may be marketed.
POM

Marketing Authorisation
Holder and Manufacturer:

Syri Limited t/a Thame Laboratories,
Unit 4, Bradfield Road,
Ruislip, Middlesex
HA4 0NU, UK.
This medicinal product is authorised
in the Member States of the EEA
under the following names:
UK and IE: Dipyridamole 200mg/5ml
Oral Suspension
This leaflet was last revised in 12/2015.

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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