ASASANTIN RETARD CAPSULES

Active substance: DIPYRIDAMOLE

View full screen / Print PDF » Download PDF ⇩

Transcript
Assessed against UK PIL April 2006
By S.Hunjunt at 12:39 pm, Jun 08, 2007

FINAL DRAFT

ASASANTIN® RETARD CAPSULES
(dipyridamole and aspirin)
PATIENT INFORMATION LEAFLET

This product is be available as the above but will be referred to as Asasantin Retard
throughout this leaflet.
What you should know about your medicine
Please read this leaflet carefully before you start to take your medicine. It contains a
summary of the information available on your medicine. The information in this leaflet
applies to Asasantin Retard only. If after reading this you have any questions about
your treatment ask your doctor or pharmacist. The name of your medicine is Asasantin
Retard. The capsules have a red cap and an ivory body containing pale yellow granules.
Each capsule contains 200mg dipyridamole in a modified release formulation and 25mg
aspirin in a standard release formulation.
The capsule contents also contain the following inactive ingredients: tartaric acid, acacia
(arabic gum), povidone, hypromellose phthalate, hypromellose, dimethicone 350,
triacetin, talc, stearic acid, lactose monohydrate, aluminium stearate, colloidal anhydrous
silica, maize starch, microcrystalline cellulose, sucrose, purified water, methacrylic acidmethyl methacrylate copolymer and titanium dioxide (E171).
The capsule shell contains gelatin, titanium dioxide (E171), red iron oxide (E172) and
yellow iron oxide (E172).
Asasantin Retard is available in packs containing plastic tubs of 20, 50, 60 (3x20) or
100 (2x50) capsules.
Asasantin Retard belongs to a group of medicines called anti-thrombotic agents which
help to prevent the formation of blood clots.
Asasantin Retard is manufactured by: Boehringer Ingelheim Pharma GmbH & Co. KG,
Binger Straße 173, 55216 Ingelheim am Rhein, Germany and are procured from within
the EU by the Product Licence holder: Autumn Healthcare Limited, Wilmot House, St
James Court, Friar Gate, Derby DE1 1BT.
PL 22819/0223

POM

How your medicine helps you
For people who have suffered from a stroke caused by a blood clot in the brain,
Asasantin Retard reduces the risk of having another stroke.
Before taking your medicine
Tell your doctor or pharmacist if:
• You are pregnant, likely to become pregnant, or if you are breastfeeding.













You are hypersensitive or ‘allergic’ to any of the ingredients listed above or to
other medicines containing salicylates.
You have angina or other heart, heart valve or circulation problems.
You are taking treatment for high blood pressure.
You have myasthenia gravis.
You have any bleeding disorders.
You have or have ever had an ulcer in your stomach or small intestine
(duodenum).
You suffer from asthma, allergic rhinitis (hayfever) or nasal polyps (a type of
growth in the nose).
You have kidney or liver problems.
You are taking other non-steroidal anti-inflammatory drugs (for example
ibuprofen) for another condition or you are allergic to this type of medicine.
You are taking corticosteroids, methotrexate, spironolactone or medicines to treat
gout.
You have glucose-6-phosphate dehydrogenase deficiency (a deficiency of an
enzyme in red blood cells which may cause anaemia).

Because Asasantin Retard contains aspirin you should not take any painkiller or other
medicine containing aspirin for any condition without first asking your doctor or
pharmacist.
If you are a diabetic who needs treatment for hypoglycaemia you should tell your doctor
that you are taking Asasantin Retard.
One of the active ingredients of Asasantin Retard, dipyridamole, is sometimes given as
an injection during tests to see if the heart is functioning properly (myocardial imaging).
If you are to be given an injection of dipyridamole, tell the doctor that you are taking
Asasantin Retard.
If you are taking other medicines to prevent blood clots forming (e.g. warfarin), tell the
anticoagulant clinic at your next visit that you are now taking Asasantin Retard.
Also if you are to receive adenosine tell the doctor that you are taking Asasantin Retard.
If in doubt, ask your doctor or pharmacist.
Warnings/Precautions
Asasantin Retard contains lactose and sucrose. If you have been told by your doctor
that you have an intolerance to some sugars, contact your doctor before taking this
medicinal product.
How to take your medicine
Follow your doctor's instructions about when and how to take your medicine and always
read the label. The usual recommended dosage is as follows:

One capsule twice a day - usually one in the morning and one in the evening preferably
with food.
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.
The capsules should be swallowed whole without chewing.
Do not take more than your doctor has prescribed. In the event of overdosage consult a
doctor immediately.
If you forget to take a dose, take it as soon as you remember but if it is near to the time
for the next dose, wait until this is due. Do not take a double dose. Then go on as before.
After taking your medicine
All medicines can cause side-effects. Asasantin Retard may cause sickness, diarrhoea,
dizziness, indigestion, nausea, headache and pain in the muscles. In most cases, these
side-effects are mild and may disappear with continued treatment.
Other less common side-effects include hot flushes, lowering of blood pressure, increased
heart rate and in rare cases worsening of the symptoms of heart disease. Very rarely,
thrombocytopenia (a blood disorder which can cause bruising and prolonged bleeding
from wounds) and increased bleeding during or after surgery have been reported.
Aspirin can sometimes cause stomach ulcers or inflammation of the stomach which can
cause internal bleeding. The level of iron in the blood may fall, causing anaemia, if
bleeding occurs over a long period.
Allergic reactions to aspirin and dipyridamole include rash, bronchoconstriction
(narrowing of the airways), rhinitis, severe rash with itching and swelling and swelling
around the eye. Dizziness and tinnitus (noises in the ears) can also occur.
In people who have gallstones, it has been found that one of the active ingredients of
Asasantin Retard, dipyridamole, can be incorporated into the gallstones.
If you experience any of these effects and they persist or become troublesome, consult
your doctor.
If you experience any other effects not mentioned above, consult your doctor or
pharmacist.
How to store your medicine
• Keep this medicine in a safe place, out of the reach of children.
• Do not use this medicine after the expiry date shown on the label.






Do not open the container until you are ready to begin taking this course of
treatment. Any capsules remaining 6 weeks after first opening should either be
discarded safely or returned to your pharmacist.
Do not store above 25°C. Store in the original container.
If your doctor stops treating you with this medicine, return any left over capsules
to a pharmacist. Only keep them if the doctor tells you to.
If the capsules become discoloured or show any other signs of deterioration,
consult your pharmacist who will tell you what to do.

Important
REMEMBER this medicine is for your use only. Only a doctor can prescribe it for you.
Never give it to someone else. It may harm them even if their symptoms are similar.
This leaflet does not tell you everything about your medicine. If you have any questions
or are not sure about anything, ask your doctor or pharmacist.
This leaflet was last revised: 06/06/2007

MOCK-UP

By S.Hunjunt at 12:35 pm, Jun 08, 2007

assessed against UK PIL April
2006

®

ASASANTIN RETARD CAPSULES
(dipyridamole and aspirin)
PATIENT INFORMATION LEAFLET
This product is be available as the above but will be referred to as Asasantin Retard throughout this leaflet.
What you should know about your medicine
Please read this leaflet carefully before you start to take your medicine. It contains a summary of the information available on your medicine.
The information in this leaflet applies to Asasantin Retard only. If after reading this you have any questions about your treatment ask your
doctor or pharmacist. The name of your medicine is Asasantin Retard. The capsules have a red cap and an ivory body containing pale
yellow granules.
Each capsule contains 200mg dipyridamole in a modified release formulation and 25mg aspirin in a standard release formulation.
The capsule contents also contain the following inactive ingredients: tartaric acid, acacia (arabic gum), povidone, hypromellose phthalate,
hypromellose, dimethicone 350, triacetin, talc, stearic acid, lactose monohydrate, aluminium stearate, colloidal anhydrous silica, maize
starch, microcrystalline cellulose, sucrose, purified water, methacrylic acid-methyl methacrylate copolymer and titanium dioxide (E171).
The capsule shell contains gelatin, titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172).
Asasantin Retard is available in packs containing plastic tubs of 20, 50, 60 (3x20) or 100 (2x50) capsules.
Asasantin Retard belongs to a group of medicines called anti-thrombotic agents which help to prevent the formation of blood clots.
Asasantin Retard is manufactured by: Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Straße 173, 55216 Ingelheim am Rhein,
Germany and are procured from within the EU by the Product Licence holder: Autumn Healthcare Limited, Wilmot House, St James Court,
Friar Gate, Derby DE1 1BT.
PL 22819/0223

POM

How your medicine helps you
For people who have suffered from a stroke caused by a blood clot in the brain, Asasantin Retard reduces the risk of having another stroke.
Before taking your medicine
Tell your doctor or pharmacist if:

You are pregnant, likely to become pregnant, or if you are breastfeeding.

You are hypersensitive or ‘allergic’ to any of the ingredients listed above or to other medicines containing salicylates.

You have angina or other heart, heart valve or circulation problems.

You are taking treatment for high blood pressure.

You have myasthenia gravis.

You have any bleeding disorders.

You have or have ever had an ulcer in your stomach or small intestine (duodenum).

You suffer from asthma, allergic rhinitis (hayfever) or nasal polyps (a type of growth in the nose).

You have kidney or liver problems.

You are taking other non-steroidal anti-inflammatory drugs (for example ibuprofen) for another condition or you are allergic to this
type of medicine.

You are taking corticosteroids, methotrexate, spironolactone or medicines to treat gout.

You have glucose-6-phosphate dehydrogenase deficiency (a deficiency of an enzyme in red blood cells which may cause
anaemia).
Because Asasantin Retard contains aspirin you should not take any painkiller or other medicine containing aspirin for any condition without
first asking your doctor or pharmacist.
If you are a diabetic who needs treatment for hypoglycaemia you should tell your doctor that you are taking Asasantin Retard.
One of the active ingredients of Asasantin Retard, dipyridamole, is sometimes given as an injection during tests to see if the heart is
functioning properly (myocardial imaging).
If you are to be given an injection of dipyridamole, tell the doctor that you are taking Asasantin Retard.
If you are taking other medicines to prevent blood clots forming (e.g. warfarin), tell the anticoagulant clinic at your next visit that you are now
taking Asasantin Retard.
Also if you are to receive adenosine tell the doctor that you are taking Asasantin Retard. If in doubt, ask your doctor or pharmacist.
Warnings/Precautions
Asasantin Retard contains lactose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.
How to take your medicine
Follow your doctor's instructions about when and how to take your medicine and always read the label. The usual recommended dosage is
as follows:
One capsule twice a day - usually one in the morning and one in the evening preferably with food.

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.
The capsules should be swallowed whole without chewing.
Do not take more than your doctor has prescribed. In the event of overdosage consult a doctor immediately.
If you forget to take a dose, take it as soon as you remember but if it is near to the time for the next dose, wait until this is due. Do not take a
double dose. Then go on as before.
After taking your medicine
All medicines can cause side-effects. Asasantin Retard may cause sickness, diarrhoea, dizziness, indigestion, nausea, headache and pain
in the muscles. In most cases, these side-effects are mild and may disappear with continued treatment.
Other less common side-effects include hot flushes, lowering of blood pressure, increased heart rate and in rare cases worsening of the
symptoms of heart disease. Very rarely, thrombocytopenia (a blood disorder which can cause bruising and prolonged bleeding from
wounds) and increased bleeding during or after surgery have been reported.
Aspirin can sometimes cause stomach ulcers or inflammation of the stomach which can cause internal bleeding. The level of iron in the
blood may fall, causing anaemia, if bleeding occurs over a long period.
Allergic reactions to aspirin and dipyridamole include rash, bronchoconstriction (narrowing of the airways), rhinitis, severe rash with itching
and swelling and swelling around the eye. Dizziness and tinnitus (noises in the ears) can also occur.
In people who have gallstones, it has been found that one of the active ingredients of Asasantin Retard, dipyridamole, can be incorporated
into the gallstones.
If you experience any of these effects and they persist or become troublesome, consult your doctor.
If you experience any other effects not mentioned above, consult your doctor or pharmacist.
How to store your medicine

Keep this medicine in a safe place, out of the reach of children.

Do not use this medicine after the expiry date shown on the label.

Do not open the container until you are ready to begin taking this course of treatment. Any capsules remaining 6 weeks after first
opening should either be discarded safely or returned to your pharmacist.

Do not store above 25°C. Store in the original container.

If your doctor stops treating you with this medicine, return any left over capsules to a pharmacist. Only keep them if the doctor tells
you to.

If the capsules become discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do.
Important
REMEMBER this medicine is for your use only. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them
even if their symptoms are similar.
This leaflet does not tell you everything about your medicine. If you have any questions or are not sure about anything, ask your doctor or
pharmacist.
This leaflet was last revised: 06/06/2007

Expand view ⇕

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.

Hide
(web4)