CLOTAM RAPID Tablet Ref.[8274] Active ingredients: Tolfenamic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: A/S GEA Farmaceutisk Fabrik, Edvard Thomsens Vej 14, 2300, Copenhagen S, Denmark

Therapeutic indications

Acute migraine.

Posology and method of administration

Posology

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

Adults

Migraine – acute attacks: 200mg when the first symptoms of migraine appear. The treatment can be repeated once after 1-2 hours if a satisfactory response is not obtained.

Children

A paediatric dosage regimen has not yet been established.

Eldrerly

The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.

Method of administration

For oral administration.

To be taken preferably with or after food.

Overdose

Symptoms

Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting, occasionally convulsions. In cases of significant poisoning acute renal failure and liver damage are possible.

Therapeutic measure

Patients should be treated symptomatically as required. Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose. Good urine output should be ensured. Renal and liver function should be closely monitored. Patients should be observed for at least four hours after ingestion of potentially toxic amounts. Frequent or prolonged convulsions should be treated with intravenous diazepam. Other measures may be indicated by the patient’s clinical condition.

Shelf life

Five years.

Special precautions for storage

Store below 25°C.

Nature and contents of container

Blister card:

Cover foil: 20 μm Al foil.

Form foil: 250 μm PVC foil.

HDPE tablet container with LDPE closure.

Pack sizes: 3, 10 and 30 tablets.

Special precautions for disposal and other handling

None.

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