ASASANTIN RETARD CAPSULES

Active substance: DIPYRIDAMOLE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
­­­

Asasantin® Retard
d
­ ipyridamole and aspirin

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 trouble-
some 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 ASASANTIN Retard is and
what it is used for
2. Before you take ASASANTIN Retard
3. How to take ASASANTIN Retard
4. Possible side effects
5. How to store ASASANTIN Retard
6. Further information

ABCD
Do not take ASASANTIN Retard if:
• You have any bleeding problems
• You have ever had an ulcer in your
stomach or gut (duodenum)
• You are in the last three months of
pregnancy
• You are a child under 16 (see section
3: How to take ASASANTIN Retard)
• You have been told by your doctor
that you cannot tolerate or digest
some sugars (have an intolerance to
some sugars)
Do not take this medicine if any of the
above apply to you. If you are not sure,
talk to your doctor or pharmacist
before taking ASASANTIN Retard.

Take special care with ASASANTIN
Retard
Check with your doctor or pharmacist
before taking your medicine if:
• You have an increased risk of
bleeding as you might require careful
1. WHAT ASASANTIN RETARD IS AND follow up by your doctor
WHAT IT IS USED FOR
• You have angina or other heart
The name of your medicine is
problems (including heart valve or
ASASANTIN Retard. It contains two
circulation problems)
different medicines called
• You have myasthenia gravis (a rare
• Dipyridamole
muscle problem)
• Aspirin
• You have asthma, hayfever or nasal
Both belong to a group of medicines
polyps (a type of growth in the nose)
called ‘anti-thrombotic medicines’.
• You have kidney or liver problems
Aspirin is also a type of medicine
• You need treatment to lower your
called a ‘Non-Steroidal Anti-
blood sugar
inflammatory Drug’ (NSAID).
• You have something called ‘glucose-
6-phosphate dehydrogenase
ASASANTIN Retard belongs to a group deficiency’. This is a problem of the
of medicines called ‘anti-thrombotic
red blood cells which can cause
agents’. They are used to stop blood
anaemia
clots forming.
• You are in the first six months of
pregnancy, likely to get pregnant or
ASASANTIN Retard is used for people
are breast-feeding
who have had a:
• You regularly drink alcohol
• Stroke
• Transient Ischaemic Attack (TIA)
If you are not sure if any of the above
which are caused by a clot in the brain. apply to you, talk to your doctor or
This medicine reduces the risk of them pharmacist before taking ASASANTIN
happening again.
Retard.



2. BEFORE YOU TAKE ASASANTIN
RETARD
Do not take ASASANTIN Retard if you
are allergic (hypersensitive) to:
• Dipyridamole
• ­ spirin or any other medicines
A
containing aspirin (also called
‘salicylates’)
• Any of the other ingredients of
ASASANTIN Retard (see section 6:
Further Information)
• Non-steroidal anti-inflammatory
drugs (NSAIDs) such as ibuprofen

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 ASASANTIN
Retard can affect the way some other
medicines work. Also some other
medicines can affect the way
ASASANTIN Retard works.

In particular, tell your doctor or
pharmacist if you are taking any of the
following medicines:
• Aspirin or medicines containing
aspirin (or planning to for any
condition)
• Medicines for high blood pressure
• Medicines for gout
• Medicines to thin the blood such as
warfarin, heparin, coumarins,
clopidogrel and ticlopidine. If you
attend an anticoagulant clinic tell
them at your next visit
• Medicines for depression called
‘selective serotonin reuptake
inhibitors’ such as fluoxetine,
paroxetine or sertraline
• Other Non-Steroidal Anti-
inflammatory Drugs (such as
ibuprofen) for another condition
• Steroids such as prednisolone
• Methotrexate - used for joint
problems or cancer
• Adenosine injection - used for heart
problems or tests on the heart
• Spironolactone - a water tablet
• Valproic acid - used for the over
excited and ‘high’ feeling (manic
episode) that people with bipolar
disorder get
• Phenytoin - used to treat epilepsy
(seizures)
If you are having heart tests
ASASANTIN 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 ASASANTIN
Retard.
Pregnancy and breast-feeding
• Do not take ASASANTIN Retard if
you are in the last three months of
pregnancy
• If you are in the first six months of
pregnancy, likely to get pregnant or
are breast-feeding, talk to your
doctor before taking this medicine
Driving and using machines
You may feel dizzy or confused while
taking ASASANTIN Retard. If this
happens do not drive or use any tools
or machines.

3. HOW TO TAKE ASASANTIN
RETARD
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 with a
glass of water
• Do not crush or chew it
If you get a severe migraine-like
headache at the start of your treatment
tell your doctor as they may need to
change your dose for a short period of
time. DO NOT take painkillers
containing aspirin to treat your
headache.
Do not give to children under 16 years
This is because there is a possible
association between aspirin and Reye’s
syndrome when given to children.
• Reye’s syndrome is a very rare
disease, which can be fatal
• For this reason aspirin should not be
given to children aged under 16
years, unless on the advice of a
doctor
If you take more ASASANTIN 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 ASASANTIN
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.

4. POSSIBLE SIDE EFFECTS
Like all medicines ASASANTIN Retard
can cause side effects, although not
everybody gets them. The following side
effects may happen with this medicine.
Bleeding
Bleeding at different sites within the
body can occur which in some cases
may be serious. The following have
been seen with ASASANTIN Retard.
Common (affects less than 1 in 10
people but more than 1 in 100 people)
- Bleeding in the brain
- Bleeding in the stomach or gut
- Nosebleeds
Uncommon (affects less than 1 in 100
people but more than 1 in 1,000 people)
- Bleeding in the eye.

Rare (affects less than 1 in 1,000 people
but more than 1 in 10,000 people)
- A blood problem called
‘thrombocytopenia’ which can cause
bruising or prolonged bleeding.
- Inflammation of the stomach
In addition, there are other side effects
that are known for the active ingredients
dipyridamole and aspirin when taken
on their own. These are listed below
and also apply to ASASANTIN Retard.
Dipyridamole
In people who have gallstones,
dipyridamole can be absorbed into the
gallstones.

Aspirin
- Blood clotting problems and
bleeding gums
- Severe allergic reactions especially in
Unknown (incidence cannot be
patients who have asthma
estimated)
- High or low blood sugar levels
- Prolonged bleeding from wounds
- Increased uric acid in the blood, which
including during or after surgery or
may cause gout, or other changes in
other medical procedures
the composition of the blood
- Bruising or swellings where blood
- Feeling thirsty or becoming
has collected (haematoma)
dehydrated
- Feeling confused or restless
Allergic reactions
- Feeling less alert, convulsions (fits)
Allergic reactions are common. If you
or swelling of the brain
have an allergic reaction stop taking
- Deafness or ringing in the ears
your medicine and see a doctor straight - Irregular heart beats
- Difficulty breathing or fast or shallow
away. The signs may include difficulty
breathing, rash which may be severe with breathing
itching, or swelling of the throat or face. - Swelling in the throat or excess fluid
in the lungs
Other side effects that have been
- Perforated ulcers in the stomach
reported for ASASANTIN Retard are:
- Blood in the stools or vomiting blood
- Inflammation of the pancreas
Very Common (affects more than 1 in
- Inflammation of the liver (hepatitis)
10 people)
- Reye’s syndrome – a rare disease
- Headache, sometimes migraine. This which can be fatal especially if
is more common at the start of
aspirin is given to children
treatment and usually goes away as - Rash with blisters
treatment continues
- Muscle breakdown
- Feeling dizzy
- Kidney failure and other kidney
- Feeling sick (nausea)
problems
- Stomach ache
- Possible affect on liver test results
- Indigestion or diarrhoea
- Prolonged pregnancy or labour,
bleeding before or after birth, small
Common (affects less than 1 in 10
baby or stillbirth
people but more than 1 in 100 people) - Fever or low body temperature
- ­ naemia, which may sometimes be (hypothermia)
A
due to internal bleeding into the
stomach
Reporting of side effects
- Worsening of the symptoms of heart If you get any side effects, talk to your
disease such as chest pain and
doctor, pharmacist or nurse. This
shortness of breath
includes any possible side effects not
- Being sick (vomiting)
listed in this leaflet. You can also
- Muscle pain
report side effects directly via the
- Fainting
Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By
Uncommon (affects less than 1 in 100
reporting side effects you can help
people but more than 1 in 1,000 people) provide more information on the
- Increased heart beat
safety of this medicine.
- Lowering of blood pressure
- Hot flushes
- Stomach ulcers

5. HOW TO STORE ASASANTIN
RETARD
Keep out of the sight and reach of
children.
Store below 30°C.
Keep the bottle tightly closed. Store in
the original container in order to
protect from moisture.
Do not use ASASANTIN Retard after
the expiry date which is stated on the
top flap of the carton and the bottle
label. 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 6
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.

Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation Holder
for ASASANTIN Retard is held by:

Boehringer Ingelheim Limited
Ellesfield Avenue
Bracknell
Berkshire
England
RG12 8YS
and the capsules are manufactured by:
Boehringer Ingelheim Pharma
GmbH & Co. KG
Birkendorfer Strasse 65
88397 Biberach an der Riss
Germany
This leaflet was revised in August 2014.
© Boehringer Ingelheim Limited 2014

6. FURTHER INFORMATION
What ASASANTIN Retard contains
The active substances are dipyridamole
and aspirin. Each capsule contains
dipyridamole Ph Eur 200 mg in
modified release form and 25 mg
aspirin Ph Eur in standard release
form.
The other ingredients are: tartaric acid,
acacia, povidone, methacrylic
acid-methyl methacrylate copolymer
(1:2), hypromellose phthalate,
hypromellose, Dimethicone 350,
triacetin, talc, stearic acid, lactose,
aluminium stearate, colloidal silica,
maize starch, microcrystalline cellulose,
sucrose and titanium dioxide (E171).
The capsule shells contain gelatin,
titanium dioxide (E171) and red and
yellow iron oxides (E172). The ink
printed on the capsule shell contains
shellac, ethyl alcohol, isopropyl
alcohol, propylene glycol, n-butyl
alcohol, ammonium hydroxide,
potassium hydroxide, purified water
and red iron oxide (E172).
What ASASANTIN Retard looks like
and contents of the pack
The capsules are red and ivory. They
have the company logo and the figures
“01A” printed on them. ASASANTIN
Retard is available in packs containing
60 capsules.

43623-18

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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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