AUSTIFEN Film-coated tablet Ref.[115143] Active ingredients: Ibuprofen

Posology

Use the lowest effective dose for the shortest possible duration of treatment.

Adults

The recommended dosage of AUSTIFEN is 1 200 mg daily in divided doses. Some patients can be maintained on 600 to 1 200 mg daily. In severe conditions, it can be advantageous to increase the dosage until the acute phase has been brought under control. To relieve early morning stiffness, the first dose of the day can be given immediately after the patient awakes.

For the relief of mild to moderate pain, the following doses are recommended:

• dysmenorrhoea – 1 200 mg per day in three divided doses
• in cases of dental or post-episiotomy pain an initial dose of 800 mg may be given.

The total daily dose of AUSTIFEN should not exceed 2 400 mg. Once the acute phase has been brought under control, a maintenance dosage should be reverted to.

Acute gout

2 400 mg daily either as 800 mg 8 hourly or 600 mg 6 hourly until the acute symptoms have been relieved. If the acute symptoms do not resolve within three days, consult a health professional.

Children

In Juvenile Rheumatoid Arthritis, the total daily dosage of AUSTIFEN is 20 mg/kg of body mass given in divided doses. Safety in children under one year of age has not been proven (see section 4.3).

Pain

Initial dose 5 mg/kg of body weight. A second dose of 5 mg/kg may be given after 2 hours if pain is not controlled. Thereafter 5 mg/kg every 4 – 6 hours.

DO NOT EXCEED 20 mg/kg of bodyweight per day. If pain persists for more than 7 days, consult a medical professional.

Fever

5 mg/kg of bodyweight every 4 – 6 hours.

DO NOT EXCEED 20 mg/kg of bodyweight per day.

If fever persists for more than 3 days, consult a medical professional.

Method of administration

For oral use.

To minimize gastrointestinal side-effects or if gastrointestinal disturbances occur, AUSTIFEN should be given with food or milk.

Paediatric population

This formulation is not suitable for children under 12 years of age.

Toxicity

Signs and symptoms of toxicity have generally not been observed at doses below 100 mg/kg in children or adults. However, supportive care may be needed in some cases. Children have been observed to manifest signs and symptoms of toxicity after ingestion of 400 mg/kg or greater.

Symptoms

Most patients who have ingested significant amounts of ibuprofen will manifest symptoms within 4 to 6 hours. The most likely symptoms of overdosage are epigastric pain, nausea, vomiting, lethargy and drowsiness.

Central nervous system (CNS) effects include headache, tinnitus, dizziness, convulsion, and loss of consciousness. Nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnoea, diarrhoea and depression of the CNS and respiratory system have also been rarely reported.

In serious poisoning metabolic acidosis may occur and the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Disorientation, excitation, fainting and cardiovascular toxicity, including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose, renal failure and liver damage are possible. Large overdoses are generally well tolerated when no other medicines are being taken.

Prolonged use at higher than recommended doses may result in severe hypokalaemia and renal tubular acidosis. Symptoms may include reduced level of consciousness and generalised weakness (see section 4.4 and section 4.8). Exacerbation of asthma is possible in asthmatics.

Management

Patients should be treated symptomatically as required. Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Electrolytes may be corrected by intravenous infusions if necessary.

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. There is no specific antidote for AUSTIFEN.

36 months.

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

Keep blister packs in the outer carton until required for use.

Keep the HDPE containers well closed.

AUSTIFEN-200 tablets:

Opaque Aluminium/PVC blister packs of 1 × 12, 2 × 12, 4 × 12, 7 × 12, 1 × 15, 1 × 16 and 3 × 14 tablets.

Bulk pack (White HDPE jars) of 1000 tablets.

AUSTIFEN-400 tablets:

Opaque Aluminium/PVC blister packs of 1 × 12, 2 × 12, 4 × 12, 7 × 12, 1 × 15, 1 × 16 and 3 × 14 tablets.

Bulk pack (White HDPE jars) of 1000 tablets.

AUSTIFEN-600 tablets:

Opaque Aluminium/PVC blister packs of 1 × 12, 2 × 12, 4 × 12, 7 × 12, 1 × 15, 1 × 16 and 3 × 14 tablets.

Bulk pack (White HDPE jars) of 1000 tablets.

No special requirements.