Thromboass

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Package leaflet: Information for the user

Thromboass 75 mg gastro-resistant tablets

acetylsalicylic acid

[For medicines available only on prescription:]

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

- 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 only. 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 includes any possible side effects not listed in this leaflet. See section 4.

[For medicines available without a prescription:]

Read all of this leaflet carefully before because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

- Keep this leaflet. You may need to read it again.

- Ask your pharmacist if you need more information or advice.

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

- You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet

1. What Thromboass is and what it is used for

2. What you need to know before you take Thromboass

3. How to take Thromboass

4. Possible side effects

5. How to store Thromboass

6. Contents of the pack and other information

1. What Thromboass is and what it is used for

Thromboass contains acetylsalicylic acid, which in low doses belong to a group of medicines called anti-platelet agents. Platelets are tiny cells in the blood that cause the blood to clot and are involved in thrombosis. When a blood clot occurs in an artery it stops the blood flowing and cuts off the oxygen supply. When this happens in the heart it can cause a heart attack or angina; in the brain it can cause a stroke.

Thromboass is taken to reduce the risk of blood clots forming and thereby prevent further:

- heart attacks

- strokes

- cardiovascular problems in patients who suffer from stable or unstable angina (a type of chest pain).

Thromboass is also used to prevent the formation of blood clots after certain types of heart surgery in order to widen or to unblock the blood vessels.

This medicinal product is not recommended for emergencies. It can only be used as a preventive treatment.

2. What you need to know before you take Thromboass

Do not take Thromboass

- if you are allergic to acetylsalicylic acid or any of the ingredients in Thromboass (listed in section 6)

- are allergic to other salicylates or non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs are often used for arthritis or rheumatism and pain.

- if you have had an asthma attack or swelling of some parts of the body e.g. face, lips, throat or tongue (angioedema) after taking salicylates or NSAIDs.

- if you currently have or have ever had an ulcer in your stomach or small intestine or any other type of bleeding like a stroke.

- if you have ever had the problem of your blood not clotting properly

- have severe liver or kidney problems.

if you have severe heart problems which can cause shortness of breath and ankle swelling

- if you are in your last 3 months of pregnancy; you must not use higher doses than 100 mg per day (see section “Pregnancy and breast-feeding”).

- if you are taking a medicine called methotrexate (e.g. for cancer or rheumatoid arthritis) in doses higher than 15 mg per week.

Warnings and precautions

Talk to your doctor before taking Thromboass:

if you have trouble with your kidneys, liver or heart.
if you have or have ever had problems with your stomach or small intestine.
if you have uncontrolled high blood pressure.
if you are asthmatic, have hay fever, nasal polyps or other chronic respiratory diseases; acetylsalicylic acid may induce an asthma attack.
if you have ever had gout.
if you have heavy menstrual periods.
if you suffer from a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD)

You must immediately seek medical advice, if your symptoms get worse or if you experience severe or unexpected side effects e.g. unusual bleeding symptoms, serious skin reactions or any other sign of serious allergy (see section “Possible side effects”).

Inform your doctor if you are planning to have an operation (even a minor one, such as tooth extraction) since acetylsalicylic acid is blood-thinning there may be an increased risk of bleeding.

You should take care not to become dehydrated (you may feel thirsty with a dry mouth) since the use of acetylsalicylic acid at the same time may result in deterioration of kidney function.

This medicinal product is not suitable as a pain killer or fever reducer.

If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist.

Children and adolescents

Acetylsalicylic acid may cause Reye’s syndrome when given to children. Reye’s syndrome is a very rare disease which affects the brain and liver and can be live threatening. For this reason, Thromboass should not be given to children aged under 16 years, unless on the advice of a doctor.

Other medicines and Thromboass

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

The effect of treatment may be influenced if acetylsalicylic acid is taken at the same time as some other medicines for:

- thinning of the blood/prevention of clots or dissolving (e.g. warfarin, heparin, clopidogrel, alteplase)

- rejection of organ after transplantation (cyclosporine, tacrolimus)

- high blood pressure (e.g. diuretics and ACE-inhibitors)

- regulation of the heart beat (digoxin)

- manic-depressive illness (lithium)

- pain and inflammation (e.g. NSAIDs such as ibuprofen, or steroids)

- gout (e.g. probenecid)

- epilepsy (valproate, phenytoin)

- glaucoma (acetazolamide)

- cancer or rheumatoid arthritis (methotrexate; in doses lower than 15 mg per week)

- diabetes (e.g. glibenclamide, insulin)

- depression (selective serotonin re-uptake inhibitors (SSRIs) such as sertraline or paroxetine).

- use as hormone replacement therapy when the adrenal glands or pituitary gland have been destroyed or removed, or to treat inflammation, including rheumatic diseases and inflammation of the intestines (corticosteroids)

Thromboass with food, drink and alcohol

Drinking alcohol may possibly increase the risk of gastrointestinal bleeding and prolong bleeding time.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnant women should not take acetylsalicylic acid during pregnancy unless advised by their doctor.

You should not take Thromboass if you are in the last 3 months of pregnancy, unless you are advised to do so by your doctor and then the daily dose should not exceed 100 mg (see section “Do not take Thromboass”). Regular or high doses of this medicinal product during late pregnancy can cause serious complications in the mother or baby.

Breast-feeding women should not take acetylsalicylic acid unless advised by their doctor.

Driving and using machines
Thromboass should not affect your ability to drive and use machines.

Thromboass contains lactose

If you have been told that you have an intolerance to certain sugars, please inform your doctor before taking this medicine.

Thromboass 75 mg contains sunset-yellow (E110) which may cause allergic reaction.

3. How to take Thromboass

[For medicines available only on prescription:]

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults

Prevention of heart attacks: