Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: Merck Serono Ltd, Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, UK
Rheumatoid arthritis, osteoarthritis, low back pain, and post-operative pain and inflammation.
For oral administration.
To be taken preferably with or after food.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).
The recommended starting dose is 120mg/day in divided doses, increasing to 180mg/day in divided doses, depending on patient response.
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.
The safety in children and adolescents is not established.
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.
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.
5 years.
Store below 25°C.
White polypropylene bottles with polypropylene screw caps.
Pack sizes: 90, 56, 60 and 30 capsules.
PVC/PVDC foil blister packs in cartons:
Pack sizes: 90, 60, 56, 30, 10, and 6 capsules.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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