Source: Υπουργείο Υγείας (CY) Revision Year: 2014 Publisher: HEXAL AG, Industriestraße 25, D-83607 Holzkirchen, Telephone: +49 (0) 80 24 / 908-0, Telefax: +49 (0) 80 24 / 908-1290, e-mail: service@hexal.de <u>Distributor in Cyprus:</u> P.T.Hadjigeorgiou Co Ltd, ...
Relief of all grades of pain and inflammation in a wide range of conditions, including:
As a general recommendation, the dose should be individually adjusted and the lowest effective dose given for the shortest possible duration.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4 Special warnings andprecautions for use).
The recommended initial daily dose is 100 to 150 mg. In milder cases, as well as for long-term therapy, 75 to 100 mg daily is usually sufficient.
The total daily dose should generally be divided into 2 to 3 separate doses. To suppress nocturnal pain and morning stiffness, treatment with tablets during the day can be supplemented by the administration of a suppository at bedtime (up to a total maximum daily dose of 150 mg).
In primary dysmenorrhoea, the daily dose should be individually adjusted and is generally 50 to 150 mg. A dose of 50 to 100 mg should be given initially and, if necessary, increased over the course of several menstrual cycles up to a maximum of 200 mg/day. Treatment should be started on appearance of the first symptoms and, depending on the symptomatology, continued for a few days.
Children aged 1 year or over and adolescents should be given 0.5 to 2 mg/kg body weight daily in 2 to 3 divided doses, depending on the severity of the disorder. For treatment of juvenile rheumatoid arthritis, the daily dose can be raised up to a maximum of 3 mg/kg daily, divided into 2 to 3 separate doses.
The maximum daily dose of 150 mg should not be exceeded.
Because of their dosage strength, diclofenac 50 mg gastro-resistant tablets are not recommended for use in children and adolescents below 14 years of age; diclofenac 25 mg gastro-resistant tablets could be used in these patients.
No adjustment of the starting dose is required for elderly patients (see section 4.4 Special warnings and precautions for use).
No adjustment of the starting dose is required for renally impaired patients (see section 4.4 Special warnings and precautions for use).
No adjustment of the starting dose is required for hepatically impaired patients (see section 4.4 Special warnings and precautions for use).
The tablets should be swallowed whole with liquid, preferably before meals, and must not be divided or chewed.
There is no typical clinical picture resulting from diclofenac overdosage. Overdosage can cause symptoms, such as vomiting, gastrointestinal haemorrhage, diarrhoea, dizziness, tinnitus or convulsions. In the event of significant poisoning acute renal failure and liver damage are possible.
Management of acute poisoning with NSAIDs, including diclofenac, essentially consists of supportive measures and symptomatic treatment. Supportive measures and symptomatic treatment should be given for complications, such as hypotension, renal failure, convulsions, gastrointestinal disorder and respiratory depression.
Special measures, such as forced diuresis, dialysis or haemoperfusion are probably of no help in eliminating NSAIDs, including diclofenac, due to the high protein binding and extensive metabolism.
Activated charcoal may be considered after ingestion of a potentially toxic overdose and gastric decontamination (e.g. vomiting, gastric lavage) after ingestion of a potentially life-threatening overdose.
The shelf life is 18 months.
The medication should not be used after the expiry date printed on the package.
Do not store at temperatures above +25°C (77°F).
Protect from moisture!
Original package containing 10, 20, 30, 50 and 60 enteric-coated tablets.
None.
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