ASPIRIN CARDIO 100 TABLETS 100 mg

4.1 Therapeutic indications

Acetylsalicylic acid is indicated in adults for the following cardiovascular uses:

Inhibition of platelet aggregation:

• in unstable angina pectoris
• in acute myocardial infarction
• in reinfarction prophylaxis
• after arterial surgery or interventions (e.g. PTCA)
• for the prevention of transient ischemic attacks (TIA) and cerebral infarction after the onset of precursor stages
• to prevent thrombosis of the coronary blood vessels in patients with multiple risk factors

4.3 Contraindications

Acetylsalicylic acid must not be used in the following cases:

• hypersensitivity to acetylsalicylic acid or other salicylates, or to any other components of the product (see section “List of excipients” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)
• a history of asthma induced by the administration of salicylates or substances with a similar action, notably non-steroidal anti-inflammatory drugs,
• in the presence with gastric or duodenal ulcers,
• hemorrhagic diathesis,
• severe renal failure,
• severe hepatic failure,
• severe cardiac failure,
• combination with methotrexate at doses of 15mg/week or more (see section “Interaction with other medicinal products and other forms of interaction” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information),
• last trimester of pregnancy (see section “Pregnancy” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Dosage and method of administration

4.2.1 Dosage regimen

In unstable angina pectoris, in reinfarction prophylaxis, after arterial surgery or interventions: Daily doses of 100–300mg acetylsalicylic acid are recommended.

In acute myocardial infarction:

Daily doses of 100–160 mg acetylsalicylic acid are recommended. The first tablet should be crushed or chewed and swallowed in order to achieve fast absorption.

For the prevention of transient ischemic attacks and cerebral infarction after the onset of precursor stages:

Daily doses to 30–300 mg acetylsalicylic acid are recommended.

For the prevention of thrombosis of the coronary blood vessels in patients with multiple risk factors:

Doses of 100–200 mg daily or 300 mg every other day are recommended.

4.2.2 Method of administration

The tablets should preferably be taken at least 30 minutes before meals, swallowed whole with plenty of water. Tablets should not be crushed, broken or chewed to ensure a release in the alkaline milieu of the intestine (see section “Gastro-resistant tablets (enteric-coated)” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

When using this product in acute myocardial infarction, the first tablet should be crushed or chewed and swallowed in order to achieve fast absorption.

4.2.3 Additional information on special populations

4.2.3.1 Pediatric patients

The safety and efficacy of Aspirin Cardio in children below 18 years of age has not been established. No data are available. Therefore, Aspirin Cardio is not recommended for use in pediatric patients below 18 years

4.2.3.2 Patients with hepatic impairment

Aspirin Cardio is contraindicated in patients with severe hepatic failure (see section “Contraindications”). Aspirin Cardio should be used with particular caution in patients with impaired hepatic function (see section “Special warnings and precautions for use” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2.3.3 Patients with renal impairment

Aspirin Cardio is contraindicated in patients with severe renal failure (see section “Contraindications”). Aspirin Cardio should be used with particular caution in patients with impaired renal function since acetylsalicylic acid may further increase the risk of renal impairment and acute renal failure (see section “Special warnings and precautions for use” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).