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ATRANSIPAR 200MG/25MG MODIFIED-RELEASE CAPSULE HARD

Active substance(s): ACETYLSALICYLIC ACID / DIPYRIDAMOLE / ACETYLSALICYLIC ACID / DIPYRIDAMOLE

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Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any
directly via the Yellow Card Scheme; Website: 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 Atransipar
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Keep the bottle tightly closed. Store in the original container in order to protect
from moisture.
Do not use Atransipar after the expiry date which is stated on 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 30 days, these should not be taken.
Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These
measures will help protect the environment.

What Atransipar looks like and contents of the pack
The capsules are red and ivory. They have the company name “PAR” printed
on cap and ‘730’ on body. Atransipar is available in packs containing 60
capsules.
Marketing Authorisation Holder and Manufacturer:
Par Laboratories Europe, Ltd.
69-71 Meridien House, Clarendon Road,
Watford, WD17 1DS
United Kingdom
This medicinal product is authorised in the Member States of the EEA
under the following names:
The Netherlands : Atransipar 200mg/25mg harde capsules met gereguleerde
afgifte
Sweden
frisättning
Denmark
: Atransipar
Norway
: Atransipar
05 2017

6. Contents of the pack and other information
What Atransipar contains:
• The active substances are Dipyridamole and Aspirin. Each capsule
contains Aspirin 25 mg in standard release form and Dipyridamole 200
mg in prolonged-release form.

capsules, hard
(Dipyridamole and Aspirin)
because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This

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6.

What Atransipar is and what it is used for
What you need to know before you take Atransipar
How to take Atransipar
Possible side effects
How to store Atransipar
Contents of the pack and other information

The name of your medicine is Atransipar. It contains two different medicines
called
• Dipyridamole
• Aspirin
Both belong to a group of medicines called ‘anti-thrombotic medicines’. Aspirin

Aspirin tablet: Core tablet - lactose, alginic acid, pregelatinised starch,
stearic acid; Film-coating - polyvinyl alcohol-part hydrolysed [E1203],
titanium dioxide [E171], talc [E553b], lecithin [E322], xanthan gum [E415].

(NSAID).
Atransipar belongs to a group of medicines called ‘anti-thrombotic agents’.
They are used to stop blood clots forming.
Atransipar is used for people who have had a:
• Stroke
• Transient Ischaemic Attack (TIA)
which are caused by a clot in the brain. This medicine reduces the risk of them
happening again.

Capsule shells: Capsule cap - gelatin, titanium dioxide (E171), Allura red
AC [E129], Sunset yellow FCF [E110], Sodium laurilsulfate; Capsule body
– gelatin, Iron oxide red & yellow [E172].

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PACKAGE LEAFLET: INFORMATION FOR THE USER

1. What Atransipar is and what it is used for

• The other ingredients are: Dipyridamole prolonged-release pellets
(Prolonged-release coating) - tartaric acid, hypromellose, talc, acacia,
stearic acid, povidone, ethylcellulose, hypromellose phthalate, triacetin,
anhydrous colloidal silica.

The ink printed on the capsule shell contains shellac, propylene glycol,
strong ammonium solution, black iron oxide [E172] and potassium
hydroxide.

2. What you need to know before you take Atransipar

Internal Material/JDE code
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Do not take Atransipar if:
• You are allergic to Dipyridamole, Aspirin or any other medicines
containing Aspirin (also called "salicylates") or any of the other
ingredients of this medicine (listed in section 6).
• You have any bleeding problems
• You have ever had an ulcer in your stomach or gut (duodenum)
• You have severe kidney or liver problems
• You are taking methotrexate at doses higher than 15 mg/week
• You have something called “glucose-6-phosphatase dehydrogenase







anaemia
You have ever had abnormal bleeding in the brain
You have had stomach pain when previously taking this medicine
You are in the last three months of pregnancy
You have been told by your doctor that you cannot tolerate or digest
some sugars (have an intolerance to some sugars)
You are allergic to peanut or soya

Warnings and precautions
Talk to your doctor or pharmacist before taking Atransipar if:
• You have an increased risk of bleeding as you might require careful
follow up by your doctor
• You have angina or other heart problems (including heart valve or
circulation problems)
• You have myasthenia gravis (a rare muscle problem)
• You have asthma, hayfever or nasal polyps (a type of growth in the nose)
• You have kidney or liver problems. If these are severe, do not take this
medicine
• You need treatment to lower your blood sugar
• You have long-term or recurring stomach or intestine problems, causing
your stools to be darker in colour
• You are about to have surgery such as having a tooth removed. Your
doctor may want you to stop taking this medicine up to 7 days before
• You regularly drink alcohol
If you get a severe migraine-like headache at the start of your treatment tell
your doctor. Do not take painkillers containing Aspirin to treat your headache.
Children
Atransipar should not be given to children under 16 years old, unless
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Other medicines and Atransipar
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines. This includes herbal medicines. This is because
Atransipar can affect the way some other medicines work. Also some other
medicines can affect the way Atransipar 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’


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)
• Medicines to lower your blood sugar
• Cholinesterase inhibitors. The effect of these medicines could be reduced
leading to a worsening of myasthenia gravis.






If you are having heart tests
Atransipar 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 Atransipar.
Taking Atransipar with alcohol
Do not take Atransipar at the same time as an alcohol drink. Avoid drinking
excessive amounts of alcohol because the risk of side effects to your stomach
and intestines could be increased.
Pregnancy and breast-feeding
• Do not take Atransipar if you are in the last three months of pregnancy

to get pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine
3

Driving and using machines
You may feel dizzy or confused while taking Atransipar. If this happens do not
drive or use any tools or machines.
Atransipar contains lactose, if you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor before taking this
medicinal product.
Atransipar contains sunset yellow (E110) and Allura red AC (E129) which may
cause allergic reactions.
3. How to take Atransipar
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 recommended dose is:
• One capsule twice a day
• Usually one in the morning and one in the evening
• 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.
Use in Children
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 Atransipar than you should
If you take more of this medicine than you should, talk to a doctor or go to a
hospital straight away. You may experience symptoms of dizziness, confusion,
tinnitus (ringing in your ears), breathing too fast, feeling sick, being sick,
weakness or heart problems. Take this medicine pack with you, even if there
are no capsules left.
If you forget to take Atransipar
• 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.
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4. Possible side effects
Like all medicines Atransipar 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 Atransipar.
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.
Unknown (incidence cannot be estimated)
- Prolonged bleeding from wounds including during or after surgery or
other medical procedures
- Bruising or swellings where blood has collected (haematoma)
Allergic reactions
Allergic reactions are common. If you have an allergic reaction stop taking
breathing, rash which may be severe with itching, or swelling of the throat or
face.
Other side effects that have been reported for Atransipar are:
Very Common (affects more than 1 in 10 people)
- Headache, sometimes migraine. This is more common at the start of
treatment and usually goes away as treatment continues
- Feeling dizzy
- Feeling sick (nausea)
- Stomach ache
- Indigestion or diarrhoea
Common (affects less than 1 in 10 people but more than 1 in 100 people)
- Anaemia, which may sometimes be due to internal bleeding into the
stomach
- Worsening of the symptoms of heart disease such as chest pain and
shortness of breath
- Being sick (vomiting)
- Muscle pain
- Fainting

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Uncommon (affects less than 1 in 100 people but more than 1 in 1,000
people)
- Increased heart beat
- Lowering of blood pressure
- Stomach ulcers
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.
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 Atransipar.
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 patients who have asthma
- High or low blood sugar levels
- Increased uric acid in the blood, which may cause gout, or other changes
in the composition of the blood
- Feeling thirsty or becoming dehydrated
- Feeling confused or restless
- Deafness or ringing in the ears
- Irregular heart beats
- Perforated ulcers in the stomach
- Blood in the stools or vomiting blood
- Reye’s syndrome – a rare disease which can be fatal especially if
Aspirin is given to children
- Rash with blisters
- Muscle breakdown
- Kidney failure and other kidney problems
- Possible effect on liver test results
- Prolonged pregnancy or labour, bleeding before or after birth, small baby
or stillbirth
- Fever or low body temperature (hypothermia)
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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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