Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 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
Oruvail is recommended in the management of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute articular and peri-articular disorders, (bursitis, capsulitis, synovitis, tendinitis), cervical spondylitis, low back pain (strain, lumbago, sciatica, fibrositis), painful musculo-skeletal conditions, acute gout, dysmenorrhoea and control of pain and inflammation following orthopaedic surgery.
Oruvail reduces joint pain and inflammation and facilitates increase in mobility and functional independence. As with other non-steroidal anti-inflammatory agents, it does not cure the underlying disease.
Adults: 100–200 mg once daily, depending on patient weight and on severity of symptoms.
The maximum daily dose is 200 mg. The balance of risks and benefits should be carefully considered before commencing treatment with 200 mg daily, and higher doses are not recommended (see also section 4.4).
Elderly: 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.
Paediatric dosage not established.
Oruvail capsules are 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).
Cases of overdose have been reported with doses up to 2.5 g of ketoprofen. In most instances the symptoms observed have been benign and limited to lethargy, drowsiness, nausea, vomiting and epigastric pain. Headache, rarely diarrhoea, disorientation, excitation, coma, dizziness, tinnitus, fainting, occasionally convulsions may also occur. Adverse effects seen after overdose with propionic acid derivatives such as hypotension, bronchospasm and gastro-intestinal haemorrhage should be anticipated.
In cases of significant poisoning, acute renal failure and liver damage are possible.
If renal failure is present, haemodialysis may be useful to remove circulating medicinal product.
There are no specific antidotes to ketoprofen overdosages. In cases of suspected massive overdosages, a gastric lavage is recommended, and symptomatic and supportive treatment should be instituted to compensate for dehydration, to monitor urinary excretion and to correct acidosis, if present.
Owing to the slow-release characteristics of Oruvail, it should be expected that ketoprofen will continue to be absorbed for up to 16 hours after ingestion.
Within one hour of ingestion, consideration should be given to administering activated charcoal in an attempt to reduce absorption of slowly-released ketoprofen.
Alternatively, in adults, gastric lavage, aimed at recovering pellets that may still be in the stomach, should be considered if the patient presents within 1 hour of ingesting a potentially toxic amount.
It should be possible to identify the pellets in the gastric contents. Correction of severe electrolyte abnormalities may need to be considered.
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.
The benefit of gastric decontamination is uncertain.
Other measures may be indicated by the patient’s clinical condition.
36 months.
Securitainer / HDPE bottle: Store below 30°C in a dry place.
Blister pack: Store below 25°C in a dry place and protect from light.
Securitainer or HDPE bottle containing 100 capsules.
UPVC/Aluminium foil blister or UPVC coated with PVDC aluminium foil blister containing either 8, 28, 30 or 56 capsules.
Not all pack sizes may be marketed.
None stated.
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