FELDENE Capsule, FELDENE D Tablet Ref.[50782] Active ingredients: Piroxicam

Pregnancy: for patients in their third trimester of pregnancy or are breastfeeding, see Section 4.3 Contraindications and Section 4.6 Fertility, pregnancy and lactation.

Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis

After assessing the risk versus benefit for each patient, use the minimum effective dose for the shortest duration possible. The duration of treatment should preferably be limited to 14 days. If continued treatment is considered necessary, this should be accompanied by evaluation at 14 days and subsequent frequent review with regards to efficacy, risk factors and ongoing need for treatment.

The dose should be adjusted to each individual patient’s response and toleration. In studies to date, the optimal response generally has been achieved at a daily dose of 20 mg, given as a single dose. The recommended starting dose is 10 mg and administration of doses higher than 20 mg daily carries an increased risk of adverse effects and is not recommended.

FELDENE-D dispersible tablets should be dispersed in a minimum of 50 mL of water and then swallowed.

Insufficient human data are available to fully assess the toxicity following acute overdosage.

Signs and Symptoms

Mild symptoms of lethargy, drowsiness and gastrointestinal upset have been reported. Rarely severe overdose may cause hypotension, coma, respiratory depression, gastrointestinal bleeding or acute renal insufficiency. Low grade fever and sinus tachycardia have been reported following NSAID overdose. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following overdose.

Recommended Treatment

In the event of acute overdosage with piroxicam, supportive and symptomatic therapy is indicated. There are no specific antidotes. Emesis and/or gastric lavage and/or activated charcoal may be considered dependent upon amount ingested and time since ingestion. Studies indicate that administration of activated charcoal may result in reduced absorption and reabsorption of piroxicam thus reducing the total amount of active drug available. Activated charcoal is most effective when administered within 1-hour of ingestion. In patients who are not fully conscious or who have an impaired gag reflex, consideration should be given to administering activated charcoal via a nasogastric tube once the airway is protected. Haemodialysis, forced diuresis, or haemoperfusion are probably ineffective in enhancing elimination, since the drug is highly protein-bound. There appears to be no indication for alkalinisation of the urine.

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 30°C.

FELDENE 10 mg capsules are available in PVC/Al blister packs of 50 capsules.

FELDENE-D 20 mg dispersible tablets are available in PVC/Al blister packs of 25 tablets.

Not all pack sizes may be marketed.

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