ASCAL Effervescent tablet Ref.[11012] Active ingredients: Carbasalate calcium

Source: European Medicines Agency (EU) 

4.1. Therapeutic indications

Ascal Brisper Cardio-Neuro is indicated for secondary prevention after a first myocardial or cerebrovascular event linked to atherosclerosis:

  • Myocardial infarction
  • Unstable and stable angina pectoris
  • Stroke and transient ischaemic attack provided that intracranial haemorrhages are excluded.
  • Graft occlusion after aorta-coronary bypass.

4.2. Posology and method of administration

Secondary prevention of myocardial infarction:

In acute cases a loading dose of an initial 2 effervescent tablets (200 mg carbasalate calcium, corresponding to 156 mg acetylsalicylic acid) per day should be taken on the first day, followed by 1 to 2 effervescent tablets (100 mg carbasalate calcium, corresponding to 78 mg acetylsalicylic acid, to 200 mg carbasalate calcium, corresponding to 156 mg acetylsalicylic acid) per day. In acute cases, the first dose must be taken as soon as possible after the diagnosis.

Secondary prevention of unstable and stable angina pectoris:

In acute cases a loading dose of an initial 2 effervescent tablets (200 mg carbasalate calcium, corresponding to 156 mg acetylsalicylic acid) per day should be taken on the first day, followed by 1 to 2 effervescent tablets (100 mg carbasalate calcium, corresponding to 78 mg acetylsalicylic acid, to 200 mg carbasalate calcium, corresponding to 156 mg acetylsalicylic acid) per day. In acute cases, the first dose must be taken as soon as possible after the diagnosis.

Secondary prevention of stroke and transient ischaemic attack provided that intracranial haemorrhages are excluded:

In acute cases a loading dose of an initial 2 effervescent tablets (200 mg carbasalate calcium, corresponding to 156 mg acetylsalicylic acid) per day should be taken on the first day, followed by 1 effervescent tablet (100 mg carbasalate calcium, corresponding to 78 mg acetylsalicylic acid) per day. In acute cases, the first dose must be taken as soon as possible after the diagnosis.

Secondary prevention of graft occlusion after aorta-coronary bypass:

In acute cases a loading dose of an initial 2 effervescent tablets (200 mg carbasalate calcium, corresponding to 156 mg acetylsalicylic acid) per day should be taken on the first day, followed by 1 to 2 effervescent tablets (100 mg carbasalate calcium, corresponding to 78 mg acetylsalicylic acid, to 200 mg carbasalate calcium, corresponding to 156 mg acetylsalicylic acid) per day. In acute cases, the first dose must be taken as soon as possible after the aorta-coronary bypass.

Paediatric population

Ascal Brisper Cardio-Neuro should not be used in patients aged under 16 years (see section 4.4).

Method of administration

Ascal Brisper Cardio-Neuro 100 mg must be taken disintegrated in water. Disintegrate the effervescent tablet in a glass of lukewarm water (15-25°C), stir if necessary.

4.9. Overdose

The following are associated with moderate intoxication: dizziness, headache, tinnitus, confusion and gastrointestinal symptoms (nausea, vomiting and gastric pain). With severe intoxication, serious disturbances of the acid-base equilibrium occur. Initial hyperventilation leads to respiratory alkalosis. Subsequently a respiratory acidosis occurs as a result of a suppressive effect on the respiratory centre. A metabolic acidosis also arises due to the presence of salicylate. Given that children, infants and toddlers are often only seen at a late stage of intoxication, they will usually have already reached the acidosis stage.

The following can also arise: hyperthermia and perspiration, leading to dehydration, restlessness, convulsions, hallucinations and hypoglycaemia. Depression of the nervous system can lead to coma, cardiovascular collapse and respiratory arrest. The lethal dose of acetyl salicylic acid is 25-30 gram. Plasma salicylate concentrations above 300 mg/l (1,67 mmol/l) suggest intoxication.

If a toxic dose has been ingested then admission to hospital is necessary. With moderate intoxication an attempt can be made to induce vomiting; if this fails, gastric lavage is indicated. Activated charcoal (adsorbent) and sodium sulphate (laxative) are then administered. Alkalising of the urine (250 mmol NaHCO3 for 3 hours) while monitoring the urine pH is indicated. Haemodialysis is the preferred treatment for severe intoxication. Treat other signs of intoxication symptomatically

6.3. Shelf life

Shelf life of the medicinal product as packaged for sale (30 effervescent tablets): 3 years,
Shelf life after first opening the container: 1 month.

Shelf life of the medicinal product as packaged for sale (90 effervescent tablets): 3 years,
Shelf life after first opening the container: 3 months.

Shelf life of the medicinal product as packaged for sale (100 effervescent tablets): 3 years,
Shelf life after first opening the container: 100 days.

6.4. Special precautions for storage

Do not refrigerate or freeze.

Store in the original packaging, in order to protect from moisture.

Keep the container tightly closed.

Do not store above 30°C.

6.5. Nature and contents of container

30, 90 or 100 effervescent tablets in a polypropylene tablet container with polyethylene cap (containing a desiccant cartridge), packed in a cardboard outer box.

Not all pack sizes may be marketed

6.6. Special precautions for disposal and other handling

No special requirements

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