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Package leaflet: Information for the user

Acetylsalicylsyra Hexal 100 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 you start taking this medicine 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.

What is in this leaflet

1. What Acetylsalicylsyra Hexal is and what it is used for

2. What you need to know before you take Acetylsalicylsyra Hexal

3. How to take Acetylsalicylsyra Hexal

4. Possible side effects

5. How to store Acetylsalicylsyra Hexal

6. Contents of the pack and other information

1. What Acetylsalicylsyra Hexal is and what it is used for

Acetylsalicylsyra Hexal 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.

Acetylsalicylsyra Hexal can only be used as a preventive treatment. It 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).

Acetylsalicylsyra Hexal 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.

2. What you need to know before you take Acetylsalicylsyra Hexal

Do not take Acetylsalicylsyra Hexal if you

- are allergic to acetylsalicylic acid or any of the other ingredients of this medicine (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

- 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

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

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

- have severe liver or kidney problems

- 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”)

- 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 Acetylsalicylsyra Hexal if you:

• have trouble with your kidneys, liver or heart

• have or have ever had problems with your stomach or small intestine

• have high blood pressure

• are asthmatic, have hay fever, nasal polyps or other chronic respiratory diseases; acetylsalicylic acid may induce an asthma attack

• have ever had gout

• have heavy menstrual periods

• 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). Acetylsalicylic acid is blood-thinning and there may be an increased risk of bleeding which may persist for a period of 4–8 days after you stop taking acetylsalicylic acid.

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.

Do not take Acetylsalicylsyra Hexal with other medicines that contain acetylsalicylic acid (such as eg aspirin) or with other pain relievers and anti-inflammatory drugs (NSAIDs, such as ibuprofen).

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 life-threatening. For this reason, Acetylsalicylsyra Hexal should not be given to children and adolescents younger than 16 years, unless on the advice of a doctor.

Other medicines and Acetylsalicylsyra Hexal

Tell your doctor or pharmacist if you are taking, 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 blood clots (e.g. warfarin, heparin, clopidogrel, ticlopidine, dipyridamole, cilostazol, alteplase)

• rejection of organ after transplantation (cyclosporine, tacrolimus)

• high blood pressure (e.g. diuretics, ACE-inhibitors, angiotensin II receptor antagonists, calcium-channel blockers)

• regulation of the heart beat (digoxin)

• manic-depressive illness (lithium)

• pain and inflammation (e.g. NSAIDs such as ibuprofen, other products containing acetylsalicylic acid or steroids)

• gout (e.g. probenecid, sulfinpyrazone)

• epilepsy (valproate, phenytoin)

• glaucoma (acetazolamide)

• cancer or rheumatoid arthritis (methotrexate in doses below 15 mg per week; for doses higher than 15 mg per week see section “Do not take Acetylsalicylsyra Hexal” above)

• 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)

Acetylsalicylsyra Hexal with alcohol

Drinking alcohol may possibly increase the risk of gastrointestinal bleeding and prolong bleeding time. Therefore, the use of alcohol is not recommended.

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 Acetylsalicylsyra Hexal 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 Acetylsalicylsyra Hexal”). 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

Acetylsalicylsyra Hexal should not affect your ability to drive and use machines.

3. How to take Acetylsalicylsyra Hexal

[For medicines available on prescription only:]

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

Adults

Prevention of heart attacks:

- The recommended dose is 100 mg once daily.

Prevention of strokes:

- The recommended dose is 100 mg once daily.

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

- The recommended dose is 100 mg once daily.

Prevention of formation of blood clots after certain types of heart surgery:

- The recommended dose is 100 mg once daily.

[For medicines available without prescription:]

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

Adults

Prevention of heart attacks:

- The recommended dose is [to be completed nationally] mg once daily.

Prevention of strokes:

- The recommended dose is [to be completed nationally] mg once daily.

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

- The recommended dose is [to be completed nationally] mg once daily.

Prevention of formation of blood clots after certain types of heart surgery:

- The recommended dose is [to be completed nationally] mg once daily.

The usual dose for long term use is 100 mg (one tablet) once daily. This medicine should not be used at higher doses unless advised by a doctor, and then the dose should not exceed 300 mg a day.

Older patients

Recommended dose as for younger adults. In general, acetylsalicylic acid should be used with caution in older patients who are more prone to adverse events. Treatment should be reviewed at regular intervals.

Use in children and adolescents

Acetylsalicylic acid should not be given to children and adolescents younger than 16 years, unless on the advice of a doctor (see section 2 “Children and adolescents”).

Method of administration

For oral use.

The tablets should be swallowed whole with sufficient fluid (1/2 glass of water). The tablets have a gastro-resistant coating which prevents irritant effects on the gut, and should therefore not be crushed, broken or chewed.

If you take more Acetylsalicylsyra Hexal than you should

If you (or someone else) accidentally take too many tablets, you should tell your doctor at once or contact immediately the nearest casualty department. Show any left over medicines or the empty packet to the doctor.

Symptoms of overdose may include ringing in ears, hearing problems, headache, dizziness, confusion, nausea, vomiting and abdominal pain. A large overdose can lead to more rapid breathing than normal (hyperventilation), fever, excess sweating, restlessness, seizures, hallucinations, low blood sugar, coma and shock.

If you forget to take Acetylsalicylsyra Hexal

If you miss a dose, wait until it is time for your next dose, then go on as normal.

Do not take a double dose to make up for a forgotten tablet.

If you stop taking Acetylsalicylsyra Hexal

Do not interrupt or stop your treatment with Acetylsalicylsyra Hexal, without having previously agreed this with your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most common side effects are disorders in the stomach or gut, including nausea and vomiting.

If you notice any of the following rare but serious side effects, stop taking Acetylsalicylsyra Hexal and contact a doctor immediately:

Rare side effects, may affect up to 1 in 1,000 people

• Sudden wheezing, swelling of your lips, face or body, rash, fainting or difficulties swallowing (severe allergic reaction)

• Reddening of the skin with blisters or peeling and may be associated with a high fever and joint pains. This could by erythema multiforme, Stevens-Johnson syndrome or Lyell’s syndrome

• Unusual bleeding, such as coughing up blood, blood in your vomit or urine, or black stools

• Changes in behavior with nausea and vomiting could be an early sign of Reye’s syndrome, a possibly fatal disease which requires immediate medical treatment (see also section 2 “Children and adolescents”

Other side effects:

Common side effects, may affect up to 1 in 10 people

• Nausea, vomiting, diarrhoea

• Indigestion

• Increased tendency for bleeding

Uncommon side effects, may affect up to 1 in 100 people

• Hives

• Runny noses

• Breathing difficulty

Rare side effects, may affect up to 1 in 1,000 people

• Severe bleeding in the stomach or intestines, brain haemorrhage; altered number of blood cells

• Cramps in the lower respiratory tract, asthma attack

• Inflammation in the blood vessels

• Bruising with purple spots (cutaneous bleeding)

• Severe skin reactions such as rash known as erythema multiforme and it’s life threatening forms Stevens-Johnson syndrome and Lyell’s syndrome

• Hypersensitivity reactions, such as swelling of e.g. lips, face or body, or shock

• Reye's syndrome (a very rare disease in children which affects the brain and liver (see section 2 “Children and adolescents”)

• Abnormal heavy or prolonged menstrual periods

Side effects with frequencynot known, frequency cannot be estimated from the available data

- Ringing in your ears (tinnitus) or reduced hearing ability

- Headache

- Dizziness

- Ulcers in stomach or small intestine and perforation

- Prolonged bleeding time

- Impaired kidney function, acute renal failure

- Impaired liver function; increased liver enzymes

- High level of uric acid or low levels of sugar in the blood

Reporting of side effects

If you get any side effects talk toyour doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via [the national reporting system; to be completed nationally]. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Acetylsalicylsyra Hexal

Keep this medicine out of the sight and reach of children.

Store below 25°C.

Store in the original package in order to protect from moisture.

Do not use Acetylsalicylsyra Hexal after the expiry date which is stated on the carton or blister after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Acetylsalicylsyra Hexal contains

The active substance is acetylsalicylic acid. Each gastro-resistant tablet contains 100 mg of acetylsalicylic acid.

The other ingredients are: tablet core: microcrystalline cellulose, maize starch, colloidal anhydrous silica, stearic acid; film-coating: methacrylic acid – ethyl acrylate copolymer (1:1), polysorbate 80, sodium laurilsulfate, triethyl citrate, talc.

What Acetylsalicylsyra Hexal looks like and contents of the pack

Acetylsalicylsyra Hexal gastro-resistant tablets 100 mg are round, white, biconvex film-coated tablets with a diameter of 7.2 mm.

Pack sizes:

Blisters: 30, 50, 100 gastro-resistant tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

[To be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following names:

[To be completed nationally]

This leaflet was last revised in

2015-12-05