ASS

ASS 100 HEXAL tablets

Important notes (mandatory information)

ASS 100 mg Hexal Tablets. Active ingredient: Acetylsalicylic acid. Areas of application: for unstable angina pectoris (heart pain due to circulatory disorders in the coronary arteries) - as part of standard therapy; for acute heart attack - as part of standard therapy; for the prevention of another heart attack after the first heart attack (for reinfarction prophylaxis); after operations or other interventions on arterial blood vessels (after arterial vascular surgical or interventional interventions, e.g. after aortocoronary vein bypass [ACVB], with percutaneous transluminal coronary angioplasty [PTCA]); for the prevention of temporary insufficient blood circulation in the brain (TIA: transient ischemic attacks) and strokes, after precursor stages (e.g. temporary paralysis in the face or arm muscles or temporary loss of vision) have occurred.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

ASS 100 mg Hexal Tablets
Active ingredient: Acetylsalicylic acid

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may need to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. See section 4.
• If you do not feel better or even worse, talk to your doctor.

What is in this leaflet

1. WHAT IS ASS 100 MG HEXAL AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING ASS 100 MG HEXAL?
3. HOW TO TAKE ASS 100 MG HEXAL?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE ASS 100 MG HEXAL?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS ASS 100 MG HEXAL AND WHAT IS IT USED FOR?

ASS 100 mg Hexal inhibits, among other things, the adhesion and clumping of platelets (thrombocytes) and thus prevents the formation of blood clots (thrombi) (platelet aggregation inhibition).

ASS 100 mg Hexal is used:

• for unstable angina pectoris (heart pain due to circulatory disorders in the coronary arteries) – as part of standard therapy.
• for acute heart attack – as part of standard therapy.
• for the prevention of another heart attack after the first heart attack (for reinfarction prophylaxis).
• after operations or other interventions on arterial blood vessels (after arterial vascular surgical or interventional interventions, e.g. after aortocoronary vein bypass [ACVB], with percutaneous transluminal coronary angioplasty [PTCA]).
• for the prevention of temporary insufficient blood circulation in the brain (TIA: transient ischemic attacks) and strokes, after precursor stages (e.g. temporary paralysis in the face or arm muscles or temporary loss of vision) have occurred.

Note

Due to its active ingredient content, ASS 100 mg Hexal is not suitable for the treatment of pain.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING ASS 100 MG HEXAL?

ASS 100 mg Hexal must not be taken:

• if you are allergic to acetylsalicylic acid, salicylates or any of the other ingredients of this medicine listed in section 6.
• if you have had allergic reactions to certain medicines for pain, fever or inflammation (salicylates or other non-steroidal anti-inflammatory drugs) in the past with asthma attacks or in other ways.
• with acute stomach and intestinal ulcers.
• with abnormally increased bleeding tendency (hemorrhagic diathesis).
• with liver or kidney failure.
• with severe, non-drug-controlled heart muscle weakness (heart failure).
• if you are taking 15 mg or more of methotrexate per week at the same time.
• in the last 3 months of pregnancy at a dosage of more than 150 mg acetylsalicylic acid per day (see also section "Pregnancy and breast-feeding").

Warnings and precautions

Please talk to your doctor or pharmacist before taking ASS 100 mg Hexal:

• if you are hypersensitive (allergic) to other painkillers and anti-inflammatory drugs, other medicines for rheumatism or other allergy-triggering substances.
• if you are taking non-steroidal anti-inflammatory drugs such as ibuprofen and naproxen (medicines for pain, fever or inflammation) at the same time (see also section "Weakening of the effect").
• if you have other allergies (e.g. with skin reactions, itching, hives).
• with bronchial asthma, hay fever, swelling of the nasal mucosa (nasal polyps) or chronic respiratory diseases.
• if you are taking anticoagulants (e.g. coumarin derivatives, heparin – with the exception of low-dose heparin treatment) at the same time.
• with stomach and intestinal ulcers or a history of gastrointestinal bleeding.
• with impaired liver function.
• with impaired kidney function or reduced cardiovascular circulation (e.g. vascular disease of the kidneys, heart muscle weakness, reduction in blood volume, major operations, blood poisoning or major bleeding): Acetylsalicylic acid can further increase the risk of kidney dysfunction and acute kidney failure.
• before operations (even minor procedures such as tooth extraction): Increased bleeding tendency may occur. Please inform your doctor or dentist if you have taken ASS 100 mg Hexal.
• in patients with severe glucose-6-phosphate dehydrogenase deficiency: Acetylsalicylic acid can cause accelerated degradation or breakdown of red blood cells or a specific form of anemia. This risk can be increased by factors such as high dosage, fever or acute infections.

What else do you need to watch out for?
Acetylsalicylic acid reduces uric acid excretion in low doses. In appropriately susceptible patients, this can under certain circumstances trigger a gout attack. If you cut or injure yourself, it may take a little longer than usual for the bleeding to stop. This is related to the effect of ASS 100 mg Hexal. Minor cuts and injuries (e.g. when shaving) are usually irrelevant. In the event of unusual bleeding (at an unusual location or of unusual duration), contact your doctor. Acetylsalicylic acid-containing medicines should not be used for a long time or in higher doses without consulting a doctor.

Children and adolescents

ASS 100 mg Hexal should only be used in children and adolescents with feverish illnesses on the instructions of a doctor and only if other measures do not work. If persistent vomiting occurs during these illnesses, this could be a sign of Reye's syndrome, a very rare but life-threatening illness that requires immediate medical attention.

Taking ASS 100 mg Hexal with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

The effect of the following active ingredients or groups of preparations can be influenced by simultaneous treatment with ASS 100 mg Hexal

Increased effect up to increased risk of side effects:

• anticoagulants (e.g. coumarin, heparin) and thrombolytic drugs: Acetylsalicylic acid can increase the risk of bleeding if it is taken before thrombolytic treatment. Therefore, if you are to undergo such treatment, you must watch out for signs of external or internal bleeding (e.g. bruises).
• other platelet aggregation inhibitors (medicines that inhibit the adhesion and clumping of platelets), e.g. ticlopidine, clopidogrel: Increased risk of bleeding.
• Medicines containing cortisone or cortisone-like substances (with the exception of cortisone replacement therapy for Addison's disease): Increased risk of side effects in the gastrointestinal tract.
• Alcohol: The risk of stomach and intestinal ulcers and bleeding is increased.
• other painkillers and anti-inflammatory drugs (non-steroidal analgesics/antiphlogistics) and other medicines for rheumatism in general: Increased risk of bleeding and ulcers in the gastrointestinal tract.
• blood sugar lowering medicines (antidiabetics): Blood sugar levels may drop.
• Digoxin (medicine to strengthen the heart).
• Methotrexate (medicine for the treatment of cancer or certain rheumatic diseases).
• Valproic acid (medicine for the treatment of seizures of the brain [epilepsy]).
• selective serotonin reuptake inhibitors (certain medicines for the treatment of depression): The risk of bleeding in the gastrointestinal tract increases.

Weakening of the effect:

• special medicines that cause increased urine output (diuretics: so-called aldosterone antagonists such as spironolactone and canrenoate; loop diuretics, e.g. furosemide).
• certain blood pressure lowering medicines (especially ACE inhibitors).
• uricosuric medicines for gout (e.g. probenecid, benzbromarone).
• some non-steroidal anti-inflammatory drugs (excluding acetylsalicylic acid) such as ibuprofen and naproxen: Weakening of the inhibition of adhesion and clumping of platelets caused by ASS 100 mg Hexal; may reduce the protection against heart attack and stroke provided by ASS 100 mg Hexal.
• Metamizole (medicine for the treatment of pain and fever) can reduce the effect of acetylsalicylic acid on platelet aggregation (clumping of platelets and formation of a blood clot) if taken at the same time. Therefore, this combination should be used with caution in patients taking low-dose acetylsalicylic acid for heart protection.

Please tell your doctor which other medicines you are already taking before using acetylsalicylic acid. If you use acetylsalicylic acid regularly, talk to your doctor before taking another medicine. This also applies to non-prescription medicines. ASS 100 mg Hexal should therefore not be used together with any of the above substances without the doctor's express instructions.

Taking ASS 100 mg Hexal with alcohol

Please note that acetylsalicylic acid should not be taken together with alcohol.

Pregnancy and

breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

If you become pregnant while taking ASS 100 mg Hexal, please notify your doctor immediately. In the 1st and 2nd trimester of pregnancy, you may only take ASS 100 mg Hexal on the instructions of your doctor. In the last 3 months of pregnancy, you must not take acetylsalicylic acid, the active ingredient of ASS 100 mg Hexal, at a dosage of more than 150 mg per day due to an increased risk of complications for mother and child before and during birth (see also section "ASS 100 mg Hexal must not be taken"). Acetylsalicylic acid up to 150 mg per day may only be taken in the last trimester of pregnancy on the instructions of your doctor.

Breast-feeding

The active ingredient acetylsalicylic acid and its degradation products pass into breast milk in small amounts. Since adverse effects on the infant have not been reported to date, it will usually not be necessary to interrupt breast-feeding when using a daily dose of up to 150 mg. In the case of higher doses (over 150 mg daily dose), breastfeeding should be discontinued.

Driving and operating machinery

No special precautions are required.

3. HOW TO TAKE ASS 100 MG HEXAL?

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

The recommended dose is:

• For unstable angina pectoris (heart pain due to circulatory disorders in the coronary arteries): A daily dose of 1 tablet ASS 100 mg Hexal (equivalent to 100 mg acetylsalicylic acid per day) is recommended.
• For acute heart attack: A daily dose of 1 tablet ASS 100 mg Hexal (equivalent to 100 mg acetylsalicylic acid per day) is recommended.
• For the prevention of another heart attack after the first heart attack (reinfarction prophylaxis): A daily dose of 3 tablets ASS 100 mg Hexal (equivalent to 300 mg acetylsalicylic acid per day) is recommended.
• After operations or other interventions on arterial blood vessels (after arterial vascular surgical or interventional interventions; e.g. after ACVB; with PTCA): A daily dose of 1 tablet ASS 100 mg Hexal (equivalent to 100 mg acetylsalicylic acid per day) is recommended. The most favorable time to start treatment with ASS 100 mg Hexal after aortocoronary vein bypass (ACVB) appears to be 24 hours after the operation.
• For the prevention of temporary insufficient blood circulation in the brain (TIA) and strokes, after precursor stages have occurred: A daily dose of 1 tablet ASS 100 mg Hexal (equivalent to 100 mg acetylsalicylic acid per day) is recommended.

Method of administration

Take the tablets with plenty of water, preferably after meals. Do not take on an empty stomach! For treatment of acute heart attack, the 1st tablet should be chewed or crushed. The break notch is only for dividing the tablet if you have difficulty swallowing it whole.

Duration of use

ASS 100 mg Hexal is intended for long-term use. The duration of use is determined by the treating doctor.

If you have taken more ASS 100 mg Hexal than you should

Dizziness and ringing in the ears can be signs of serious poisoning, especially in children and the elderly. If you suspect an overdose of ASS 100 mg Hexal, please notify your doctor immediately. He can decide on the measures to be taken, if necessary, depending on the severity of the overdose/poisoning.

If you forget to take ASS 100 mg Hexal

If you have taken too little ASS 100 mg Hexal or missed a dose, do not take double the amount next time, but continue taking it as described in the dosage instructions or as prescribed by your doctor.

If you stop taking ASS 100 mg Hexal

Please do not interrupt or stop treatment with ASS 100 mg Hexal without first talking to your doctor.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

The following frequency information is used to assess side effects:
Very common:	more than 1 in 10 treated patients
Common:	1 to 10 in 100 treated patients
Uncommon:	1 to 10 in 1,000 treated patients
Rare:	1 to 10 in 10,000 treated patients
Very rare:	less than 1 in 10,000 treated patients
Not known:	frequency cannot be estimated from the available data.

Gastrointestinal disorders:

• Common: Gastrointestinal complaints such as heartburn, nausea, vomiting, abdominal pain and diarrhea; minor blood loss from the gastrointestinal tract (microbleeding).
• Uncommon: Gastric or intestinal bleeding. After prolonged use of ASS 100 mg Hexal, anemia (iron deficiency anemia) may occur due to hidden blood loss from the stomach or intestinal tract. Gastric or intestinal ulcers, which can very rarely lead to perforation; gastrointestinal inflammation. If black stools or bloody vomit (signs of severe gastric bleeding) occur, you must notify your doctor immediately (see also section "Countermeasures").

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