ORUDIS SR Capsule Ref.[50303] Active ingredients: Ketoprofen

After assessing the risk/benefit ratio in each individual patient, the lowest effective dose for the shortest possible duration should be used (see Section 4.4 Special warnings and precautions for use). Patients on long term treatment should be reviewed regularly with regards to efficacy, risk factors and ongoing need for treatment.

Orudis SR (Sustained Release) Capsules: 100 to 200 mg once daily depending on the patient’s weight and on the severity of symptoms. Orudis SR should be taken with food.

Use in the Elderly: It is generally advisable in the elderly to begin ketoprofen therapy at the lower end of the dosage range and to maintain such patients on the lowest effective dosage.

Use in Pregnancy: see Section 4.3 Contraindications and Section 4.6 Fertility, pregnancy and lactation.

Signs and symptoms following acute NSAID overdose are usually limited to lethargy, drowsiness, abdominal pain, nausea and vomiting, which are generally reversible with supportive care. Respiratory depression, coma or convulsions have occurred following large ketoprofen overdoses. Gastrointestinal bleeding, hypotension, hypertension, or acute renal failure may occur, but are rare.

Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. Gut decontamination may be indicated in patients with symptoms seen within 4 hours (longer for sustained release products) or following a large overdose (5 to 10 times the usual dose). Administration of activated charcoal in an attempt to reduce absorption of ketoprofen should be considered. Forced diuresis, alkalinization of the urine, haemodialysis or haemoperfusion would probably not be useful due to ketoprofen’s high protein binding.

Due to the sustained release characteristics of Orudis SR, it should be expected that ketoprofen will continue to be absorbed for up to 16 hours after ingestion.

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

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

Orudis SR 200 mg Capsules are available in the following presentations: Blister pack of 4*, 28, 30* and 100* capsules.

^* non-marketed pack sizes.

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.