K-FENAK Film-coated tablet Ref.[115344] Active ingredients: Diclofenac

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2021  Publisher: CIPLA MEDPRO (PTY) LTD, Building 9, Parc du Cap, Mispel Street, Bellville, 7530, RSA

Therapeutic indications

K-FENAK OTC is indicated for:

  • The emergency treatment of acute gout attacks, for a maximum treatment period of 3 days.
  • The treatment of fever or mild to moderate pain of inflammatory origin, for a maximum period of 5 days.

Posology and method of administration

USE THE LOWEST EFFECTIVE DOSE FOR THE SHORTEST POSSIBLE DURATION OF TREATMENT.

Adults

For the emergency treatment of acute gout attacks:

100 to 150 mg (2-3 tablets) in two to three divided doses, with a maximum daily dose of 150 mg (3 tablets).

THE MAXIMUM TREATMENT PERIOD OF 3 DAYS SHOULD NOT BE EXCEEDED.

For the treatment of fever or mild to moderate pain of inflammatory origin:

75 mg (1,5 tablets) daily.

THE MAXIMUM TREATMENT PERIOD OF 5 DAYS SHOULD NOT BE EXCEEDED.

Overdose

K-FENAK OTC overdosage does not result in a typical clinical picture. Overdosage can cause symptoms such as gastrointestinal haemorrhage, vomiting, diarrhoea, tinnitus, dizziness or convulsions. Acute renal failure and liver damage are possible in the event of significant poisoning (see ʺWARNINGS AND SPECIAL PRECAUTIONSʺ and ʺSIDE EFFECTSʺ).

Therapeutic measures

Treatment is symptomatic and supportive, especially for convulsions, hypotension, gastrointestinal irritation, renal failure, and respiratory depression.

Absorption should be prevented with activated charcoal as soon as possible after a potentially toxic overdose, or by means of gastric lavage and vomiting (gastric decontamination) following a potentially life-threatening overdose.

Specific therapies such as forced diuresis, dialysis or haemoperfusion are of little value in eliminating K-FENAK OTC because of its high protein binding and extensive metabolism.

Special precautions for storage

Store in a dry place at or below 25°C.

KEEP OUT OF THE REACH OF CHILDREN.

Nature and contents of container

Aluminium blister strip-packed cartons of 9 tablets.

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