Source: Υπουργείο Υγείας (CY) Revision Year: 2023 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
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 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 75-100mg in two or three divided doses.
Areston is not recommended for children under 14 years of age. The use of diclofenac potassium 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 diclofenac potassium 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 section 4.4) and the patient should be monitored for GI bleeding during NSAID therapy.
Diclofenac is contraindicated in patients with renal failure (GFR <15 mL/min/1.73 m²) (see section 4.3).
No specific studies have been carried out in patients with renal impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering diclofenac to patients with renal impairment (see section 4.4).
Diclofenac is contraindicated in patients with hepatic failure (see section 4.3).
No specific studies have been carried out in patients with hepatic impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering diclofenac to patients with mild to moderate hepatic impairment (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.
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 haemo-perfusion are probably of no help in eliminating NSAIDs, including diclofenac, due to 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.
24 months.
Store below 25°C in the original package, in order to protect from light.
PVC-Al blisters. Boxes of 10, 20, 30, 50 or 100 tablets.
Not all pack sizes may be marketed.
No special requirements.
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