ASPIRIN KRKA 75 mg Gastro-resistant tablet Ref.[116530] Active ingredients: Acetylsalicylic acid

Posology

Adults

Secondary prevention of myocardial infarction:

The recommended dose is 75-160 mg once daily.

Prevention of cardiovascular morbidity in patients suffering from stable angina pectoris:

The recommended dose is 75-160 mg once daily.

History of unstable angina pectoris, except during the acute phase:

The recommended dose is 75-160 mg once daily.

Prevention of graft occlusion after Coronary Artery Bypass Grafting (CABG):

The recommended dose is 75-160 mg once daily.

Coronary angioplasty, except during the acute phase:

The recommended dose is 75-160 mg once daily.

Secondary prevention of transient ischaemic attacks (TIA) and ischaemic cerebrovascular accidents (CVA), provided intracerebral haemorrhages have been ruled out:

The recommended dose is 75-325 mg once daily.

Aspirin Krka should not be used at higher doses unless advised by a doctor, and the dose should not exceed 325 mg a day. For dosage, national and local treatment guidelines should be taken into account.

Elderly

In general, acetylsalicylic acids should be used with caution in elderly patients who are more prone to adverse events. The usual adult dose is recommended in the absence of severe renal or hepatic insufficiency (see sections 4.3 and 4.4). Treatment should be reviewed at regular intervals.

Paediatric population

Acetylsalicylic acid should not be used in children and adolescents younger than 16 years, except on medical advice where the benefit outweighs the risk (see section 4.4).

Method of administration

For oral use.

The tablets should be swallowed whole with sufficient fluid (½ glass of water). Due to the gastro resistant coating the tablets should not be crushed, broken or chewed because coating prevents irritant effects on the gut.

Duration of administration

Long-term treatment with the lowest possible dose.

Although considerable inter-individual variations are involved, it can be considered that the toxic dose is about 200 mg/kg in adults and 100 mg/kg in children. The lethal dose of acetylsalicylic acid is 25‑30 grams. Plasma salicylate concentrations above 300 mg/l indicate intoxication. Plasma concentrations above 500 mg/l in adults and 300 mg/l in children generally cause severe toxicity.

Overdose may be harmful for elderly patients and particularly for small children (therapeutic overdose or frequent accidental intoxications may be fatal).

Symptoms of moderate intoxications

Tinnitus, hearing disorders, headache, vertigo, confusion and gastrointestinal symptoms (nausea, vomiting and abdominal pain).

Symptoms of severe intoxications

Symptoms are related to severe disruption of the acid-base balance. In the first instance hyperventilation occurs, which results in respiratory alkalosis. Respiratory acidosis ensues due to suppression of the respiratory centre. In addition, metabolic acidosis occurs as a result of the presence of salicylate.

Since younger children are often not seen until they have reached a late stage of intoxication, they are usually in the stage of acidosis.

Furthermore, the following symptoms may occur: hyperthermia and perspiration, resulting in dehydration: feelings of restlessness, convulsions, hallucinations and hypoglycaemia. Depression of the nervous system may lead to coma, cardiovascular collapse or respiratory arrest.

Management

If a toxic dose has been ingested, hospital admission is required. In the event of moderate intoxication, inducing the patient to vomit should be attempted.

If this fails, gastric lavage may be attempted during the first hour after ingestion of a substantial amount of the medicine. Afterwards, administer activated carbon (adsorbent) and sodium sulphate (laxative).

Activated charcoal may be given as a single dose (50 g for an adult, 1 g/kg body weight for a child up to 12 years). Alkalisation of the urine (250 mmol NaHCO³, for three hours) whilst checking urine pH levels.

In the event of severe intoxication, haemodialysis is to be preferred.

Other symptoms to be treated symptomatically.

3 years.

Do not store above 25°C.

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

Blister (PVC/Aluminium).

Pack sizes:

Blisters: 28, 30, 50, 56, 60, 84, 90 and 100 gastro-resistant tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.