Asasantin Retard Capsules
000-0000F
ASASANTIN® RETARD CAPSULES (Dipyridamole & aspirin)
Patient Information Leaflet
This product is known by the above name but will be referred to as Asasantin Retard throughout this leaflet.
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 troublesome 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 Anti-inflammatory 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
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 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.
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. How to store Asasantin Retard
• Asasantin Retard should not be stored above 25°C. Keep in the original container.
Any capsules unused after 6 weeks should either be discarded safely or returned to your pharmacist.
• KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
• If your doctor tells you to stop taking the capsules, please take them back to the pharmacist for safe disposal. Only keep the capsules if your doctor tells you to.
• If the capsules become discoloured or show any other signs of deterioration, you should consult your pharmacist who will advise you what to do.
• 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:
Each capsule contains 200mg of the active ingredient, dipyridamole in a modified release formulation and 25mg of the active ingredient, aspirin. Each hard gelatin capsule has a red cap and a cream body and is unmarked.
Asasantin Retard also contains the following ingredients:
Lactose, microcrystalline cellulose, maize starch, tartaric acid, acacia, povidone, methacrylic acid copolymer, hypromellose phthalate, dimethicone, triacetin, talc, stearic acid, aluminium stearate, colloidal silicon dioxide, hypromellose, sucrose, gelatin, erythrosine (E127), yellow iron oxide (E172), titanium dioxide (E171) and red iron oxide (E172).
Asasantin Retard is available as packs of 60 capsules.
POM
PL No: 6464/0814
This product is manufactured by Boehringer Ingelheim Pharma GmbH & Co. KG, BirkendorferStrasse 65, 88397 Biberach an der Riss, Germany and procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 08.09.2014
ASASANTIN is a registered trademark of BOEHRINGER INGELHEIM PHARMA