Source: Υπουργείο Υγείας (CY) Revision Year: 2019 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Relief of all grades of pain and inflammation in a wide range of conditions, including:
Almiral 25mg tablets: Treatment of juvenile chronic arthritis.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).
75-150mg daily in two or three divided doses.
The recommended maximum daily dose of diclofenac is 150mg.
Although the pharmacokinetics of diclofenac 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 (see also section 4.4) and the patient should be monitored for GI bleeding during NSAID therapy.
Almiral 25mg tablets only: 1mg-3mg/kg/day, in divided doses, by oral administration.
Diclofenac is contraindicated in patients with severe renal impairment (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 mild to moderate renal impairment (see section 4.3 and 4.4).
Diclofenac is contraindicated in patients with severe hepatic impairment (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 4.3 and 4.4).
For oral administration.
Almiral tablets should be swallowed whole, with a little water if desired, preferably before meals.
There is no typical clinical picture resulting from diclofenac over dosage. Over dosage can cause symptoms such as headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, diarrhoea, dizziness, disorientation, excitation, coma, drowsiness, tinnitus, fainting or convulsions. In the case 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.
5 years.
Almiral tablets 25 mg and 50 mg should be stored below 25oC, in the original package.
Almiral tablets 25 mg are presented in aluminium/polyvinylchloride blisters of ten tablets in packs of three or ten blisters.
Almiral tablets 50 mg are presented in aluminium/polyvinylchloride blisters of ten tablets in packs of two, three, ten or 100 blisters.
Not all pack sizes may be marketed.
No special requirements.
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