HERZASS-

HERZASS-ratiopharm 100 mg tablets

Important notes (mandatory information)

HerzASS-ratiopharm 100 mg 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 circulatory deficiency 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

HerzASS-ratiopharm 100 mg 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 this leaflet contains

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

1. WHAT IS HERZASS-RATIOPHARM 100 MG AND WHAT IS IT USED FOR?

HerzASS-ratiopharm 100 mg inhibits, among other things, the adhesion and clumping of platelets (thrombocytes) and thus prevents the formation of blood clots (thrombi) (thrombocyte aggregation inhibition).

HerzASS-ratiopharm 100 mg 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 circulatory deficiency 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

HerzASS-ratiopharm 100 mg is not suitable for the treatment of pain.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING HERZASS–RATIOPHARM 100 MG?

HerzASS-ratiopharm 100 mg must not be taken:

• if you are allergic to acetylsalicylic acid, other 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 otherwise.
• with acute stomach and intestinal ulcers.
• with abnormally increased bleeding tendency (hemorrhagic diathesis).
• with liver and 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 HerzASS-ratiopharm 100 mg:

• if you are hypersensitive (allergic) to other pain and anti-inflammatory medicines, other medicines for rheumatism or other allergy-triggering substances.
• 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.
• with concomitant treatment with anticoagulant medicines (e.g. coumarin derivatives, heparin – with the exception of low-dose heparin treatment).
• with stomach and intestinal ulcers or a history of stomach and intestinal bleeding.
• with impaired liver function.
• with impaired kidney function or reduced cardiovascular circulation (e.g. kidney vascular disease, heart muscle weakness, reduced 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 interventions such as tooth extraction): increased bleeding tendency may occur. Please inform your doctor or dentist if you have taken HerzASS–ratiopharm 100 mg.
• 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 HerzASS-ratiopharm 100 mg. Minor cuts and injuries (e.g. when shaving) are usually insignificant. In the event of unusual bleeding (at an unusual location or of unusual duration), consult your doctor. Acetylsalicylic acid-containing medicines should not be used for a long time or in high doses without consulting a doctor.

Children and adolescents

HerzASS-ratiopharm 100 mg 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 may be a sign of Reye's syndrome, a very rare but life-threatening illness that requires immediate medical attention.

Taking HerzASS-ratiopharm 100 mg 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 concomitant treatment with HerzASS-ratiopharm 100 mg.

Increased effect up to increased risk of side effects:

• anticoagulant (e.g. coumarin, heparin) and blood clot dissolving medicines: Acetylsalicylic acid can increase the risk of bleeding if it is taken before blood clot dissolving treatment. Therefore, if you are to undergo such treatment, you must watch out for signs of external or internal bleeding (e.g. bruises).
• other thrombocyte aggregation inhibitors (medicines that inhibit the adhesion and clumping of platelets, e.g. ticlopidine, clopidogrel): increased risk of bleeding.
• other pain and anti-inflammatory medicines (non-steroidal analgesics/antiphlogistics) and medicines for rheumatism in general: increased risk of bleeding and ulcers in the gastrointestinal tract
• medicines containing cortisone or cortisone-like substances (with the exception of products that are applied to the skin or in 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.
• 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 (agent 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.

Reduced 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).
• uric acid excreting medicines for gout (e.g. probenecid, benzbromarone).

With concomitant use of ibuprofen-containing medicines or metamizole, the anticoagulant effect of low-dose acetylsalicylic acid (prevention of the formation of blood clots) may be impaired. An interaction is not likely with occasional use of ibuprofen. Metamizole should be used with caution. Before using acetylsalicylic acid, please tell your doctor what other medicines you are already taking. If you use acetylsalicylic acid regularly, talk to your doctor before taking another medicine. This also applies to non-prescription medicines. HerzASS-ratiopharm 100 mg should therefore not be used together with any of the above substances without the doctor's express instructions.

Taking HerzASS-ratiopharm 100 mg with food, drinks and 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

In the first and second trimesters of pregnancy, you should only take HerzASS-ratiopharm 100 mg on the instructions of your doctor. In the last three months of pregnancy, you must not take acetylsalicylic acid, the active ingredient of HerzASS-ratiopharm 100 mg, 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 section "HerzASS-ratiopharm 100 mg 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 for the infant have not been reported to date, discontinuation of breast-feeding is usually not necessary when a daily dose of up to 150 mg is used. If higher doses (over 150 mg daily dose) are taken, breast-feeding should be discontinued.

Driving and ability to operate machinery

No special precautions are required.

3. HOW TO TAKE HERZASS-RATIOPHARM 100 MG?

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

Dosage - unless otherwise prescribed by your doctor, the recommended dose is:

• For unstable angina pectoris (heart pain due to circulatory disorders in the coronary arteries): A daily dose of 1 tablet HerzASS–ratiopharm 100 mg (corresponding to 100 mg acetylsalicylic acid per day) is recommended.
• For acute heart attack: A daily dose of 1 tablet HerzASS–ratiopharm 100 mg (corresponding 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 HerzASS–ratiopharm 100 mg (corresponding 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 HerzASS–ratiopharm 100 mg (corresponding to 100 mg acetylsalicylic acid per day) is recommended. The most favorable time to start treatment with HerzASS–ratiopharm 100 mg after aortocoronary vein bypass (ACVB) appears to be 24 hours after the operation.
• For the prevention of temporary circulatory deficiency in the brain (TIA) and strokes, after precursor stages have occurred: A daily dose of 1 tablet HerzASS–ratiopharm 100 mg (corresponding to 100 mg acetylsalicylic acid per day) is recommended.

Method of administration

Please take the tablets unchewed, if possible after a meal, with plenty of liquid (e.g. a glass of water). Do not take on an empty stomach! For treatment of acute heart attack, the first tablet should be chewed or crushed.

Duration of use

HerzASS-ratiopharm 100 mg is intended for long-term use. The duration of use is determined by the attending physician.

If you have taken more HerzASS-ratiopharm 100 mg 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 HerzASS-ratiopharm 100 mg, please notify your doctor immediately. He can decide on the measures to be taken, if necessary, depending on the severity of an overdose/poisoning.

If you forget to take HerzASS-ratiopharm 100 mg

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

If you stop taking HerzASS-ratiopharm 100 mg

Please do not interrupt or stop treatment with HerzASS-ratiopharm 100 mg without first discussing it with your doctor.

If you have any further questions about the use of 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.

Blood and lymphatic system disorders

Rarely (may affect up to 1 in 1,000 people) to very rarely (may affect up to 1 in 10,000 people) serious bleeding such as brain bleeding, especially in patients with uncontrolled high blood pressure and/or concomitant treatment with anticoagulant medicines, has also been reported, which in individual cases may be life-threatening. Accelerated degradation or breakdown of red blood cells and a specific form of anemia in patients with severe glucose-6-phosphate dehydrogenase deficiency. Bleeding such as nosebleeds, gum bleeding, skin bleeding or bleeding of the urinary tract and genitals with possible prolongation of bleeding time. This effect can persist for 4 to 8 days after ingestion.

Immune system disorders

Rarely (may affect up to 1 in 1,000 people)

Hypersensitivity reactions of the skin, respiratory tract, gastrointestinal tract and cardiovascular system, especially in asthmatics. The following symptoms may occur: e.g. drop in blood pressure, shortness of breath, inflammation of the nasal mucosa, blocked nose, allergic shock, swelling of the face, tongue and larynx (Quincke's edema).

Metabolism and nutrition disorders

Very rarely (may affect up to 1 in 10,000 people):

• Lowering of blood sugar levels (hypoglycemia).
• Acetylsalicylic acid reduces uric acid excretion in low doses. In appropriately susceptible patients, this can under certain circumstances trigger a gout attack.

Nervous system disorders

Headaches, dizziness, impaired hearing or tinnitus (ringing in the ears) and confusion can be signs of an overdose (see section 3 under "If you have taken more HerzASS-ratiopharm 100 mg than you should").

Gastrointestinal disorders

Common (may affect