Asasantin Retard Capsules
PACKAGE LEAFLET:
INFORMATION FOR THE USER_
Asasantin® Retard
dipyridamole 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
1. WHAT ASASANTIN RETARD IS AND WHAT IT IS USED FOR
The name of your medicine is ASASANTIN Retard. It contains two different medicines called
• Dipyridamole
• Aspirin
Both belong to a group of medicines called ‘anti-thrombotic medicines’. Aspirin is also a type of medicine called a ‘Non-Steroidal Antiinflammatory Drug’ (NSAID).
ASASANTIN Retard belongs to a group of medicines called ‘anti-thrombotic agents’. They are used to stop blood clots forming.
ASASANTIN Retard 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.
2. BEFORE YOU TAKE ASASANTIN RETARD
Do not take ASASANTIN Retard if you are allergic (hypersensitive) to:
• Dipyridamole
• Aspirin or any other medicines 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
®Boehringer Ingelheim
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 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 • You need treatment to lower your blood sugar
• You have something called ‘glucose -6-phosphate dehydrogenase deficiency’. This is a problem of the red blood cells which can cause anaemia
• You are in the first six months of pregnancy, likely to get pregnant or are breast - feeding • You regularly drink alcohol
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking ASASANTIN Retard.
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, ticlopidine and anagrelide. 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 Antiinflammatory 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.
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 your medicine and see a doctor straight away. The signs may include difficulty breathing, rash which may be severe with itching, or swelling of the throat or face.
Other side effects that have been reported for ASASANTIN Retard 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
Uncommon (affects less than 1 in 100 people but more than 1 in 1,000 people)
- Increased heart beat
- Lowering of blood pressure
- Hot flushes
- 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.
- 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 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 Feeling less alert, convulsions (fits) or swelling of the brain
- Deafness or ringing in the ears
- Irregular heart beats
- Difficulty breathing or fast or shallow breathing
- Swelling in the throat or excess fluid in the lungs
- Perforated ulcers in the stomach
- Blood in the stools or vomiting blood
- Inflammation of the pancreas
- Inflammation of the liver (hepatitis)
- 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 affect on liver test results
- Prolonged pregnancy or labour, bleeding before or after birth, small baby or stillbirth
- Fever or low body temperature (hypothermia)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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. HOWTO 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.
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.
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 May 2015.
© Boehringer Ingelheim Limited 2015
43623-19