Source: Υπουργείο Υγείας (CY) Revision Year: 2020 Publisher: Novartis Ireland Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland <u>Marketing License Holder Representative in Cyprus:</u> Novartis Pharma Services Inc., Methonis Tower, 73 Arch. Makarios ...
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.
The tablets should be swallowed whole with liquid, preferably before meals, and must not be chewed or divided.
The recommended daily dose is 100-150 mg in two or three divided doses. For milder cases, 75-100 mg daily in two or three divided doses is usually sufficient.
In migraine an initial dose of 50 mg should be taken at the first signs of an impending attack. In cases where relief 2 hours after the first dose is not sufficient, a further dose of 50 mg may be taken. If needed, further doses of 50 mg may be taken at intervals of 4-6 hours, not exceeding a total dose of 200 mg per day.
For children over 14 years of age, the recommended daily dose is 75-100 mg in two or three divided doses. Cataflam tablets are not recommended for children under 14 years of age.
The use of Cataflam (all forms) in migraine attacks has not been established in children.
No adjustment of the starting dose is generally required for elderly patients. However, caution is indicated on basic medical grounds, especially for frail elderly patients or those with a low body weight. Although the pharmacokinetics of Cataflam are not impaired to any clinically relevant extent in elderly patients, nonsteroidal anti-inflammatory drugs should be used with particular caution in such patients who generally are more prone to adverse reactions. In particular it is recommended that the lowest effective dosage be used in frail elderly patients or those with a low body weight (also see precautions) and the patient should be monitored for GI bleeding during NSAID therapy.
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.
36 months.
Store in original packaging below 30°C and protect from moisture.
PVC/PE/PVDC blister strips containing 20 tablets.
(PVC 190-275 micron, PE20-40 micron, PVDC 32-59 micron, aluminium foil 26-34 micron).
Medicines should be kept out of the reach of children.
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