ALFOXAN Film-coated tablet Ref.[28108] Active ingredients: Mefenamic acid

Source: Υπουργείο Υγείας (CY)  Revision Year: 2018  Publisher: Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus

4.1. Therapeutic indications

  1. As an anti-inflammatory analgesic for symptomatic relief of mild to moderate pain associated with rheumatic, muscular or arthritic disorders (including rheumatoid arthritis and osteoarthritis), trauma, headache, dental pain, post-operative or post-partum states.
  2. In the management of dysfunctional menorrhagia.
  3. Primary dysmenorrhoea.
  4. Premenstrual syndrome.

4.2. Posology and method of administration

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4, Special warnings and precautions for use).

Posology

Adults

The usual total daily dosage is 1500 mg in divided doses.

Elderly

NSAIDs should be used with particular caution in elderly patients who are more prone to adverse events, especially with long-term use. Therefore, the risks versus the benefits of chronic therapy in the elderly should be carefully considered. The lowest dose compatible with adequate safe clinical control should be employed (see section 4.4,

Special warnings and precautions for use). Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or intolerance occurs.

Paediatric population

Not recommended for children under 12 years of age.

Do not exceed the stated dose.

Alfoxan should be taken preferably with or after food.

Method of administration

Oral administration.

4.9. Overdose

Gastric lavage in the conscious patient and intensive supportive therapy where necessary. Vital functions should be monitored and supported. Activated charcoal has been shown to be a powerful absorbent for mefenamic acid and its metabolites. Studies in experimental animals and humans have shown that a 5 to 1 ratio of charcoal to mefenamic acid results in considerable suppression of absorption of the drug. Haemodialysis is of little value since mefenamic acid and its metabolites are firmly bound to plasma proteins. Overdose has led to fatalities.

Mefenamic acid has a tendency to induce tonic-clonic (grand mal) convulsions in overdose. Acute renal failure and coma have been reported with mefenamic acid overdose. It is important that the recommended dose is not exceeded and the regime adhered to since some reports have involved daily dosage under 3 g.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Store below 25°C, protected from light and moisture.

6.5. Nature and contents of container

PVC/Aluminium blisters. Pack sizes of 20 and 100 film-coated tablets.

PP containers with PE closure. Pack sizes of 100 and 1000 film-coated tablets.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

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