Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, low back pain, musculoskeletal disorders such as fibrositis, capsulitis, epicondylitis and other soft-tissue inflammatory conditions, sprains and strains, post-operative inflammation and pain and other soft tissue injuries.
600 mg daily in divided doses:
As for adults (see section 4.4). NSAIDs should be used with particular caution in older patients who are at increased risk of the serious consequences of adverse reactions.
In cases of renal, cardiac or hepatic impairment, the dosage should be kept as low as possible. It is suggested that in such cases, the dosage be reduced to 200 mg twice daily.
If an NSAID is considered necessary, elderly patients should receive the lowest effective dose for the shortest possible duration and be monitored regularly for gastrointestinal bleeding for following initiation of NSAID therapy.
There are insufficient data to recommend use of Surgam in children.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).
For oral administration.
To be swallowed whole.
To be taken preferably with or after food.
In the event of overdosage with Surgam, supportive and symptomatic therapy is indicated.
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.
36 months.
Store below 25°C. Protect from light.
Polyethylene bottles with screw cap, amber glass bottles with polyethylene caps or blister packs sealed with aluminium foil in a cardboard carton in packs of 10, 12, 14, 20, 28, 30, 56 or 60.
Not applicable.
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