Source: Medicines Authority (MT) Revision Year: 2019 Publisher: Novartis Ireland Limited, Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4, Ireland
Short-term treatment in the following acute conditions:
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 and precautions for use).
The recommended initial daily dose is 100 to 150 mg. In milder cases, 50 to 100 mg daily are usually sufficient. The daily dose should generally be divided in up to 3 separate doses.
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 total 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.
In migraine, an initial dose of 50 mg should be taken at the first signs of an impending attack. In cases where pain relief within 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 to 6 hours, not exceeding a total dose of 200 mg per day.
Catafast 50 mg powder for oral solution is not recommended for use in children and adolescents below 14 years of age. For treatment in children and adolescents below 14 years of age, oral drops and suppositories of diclofenac 12.5 mg and 25 mg are available.
For adolescents aged 14 years and over, 50 to 100 mg daily are usually sufficient, given as 1 to 2 divided doses.
The maximum daily dose of 150 mg should not be exceeded.
The use of Catafast 50 mg powder for oral solution in migraine attacks has not been established in children and adolescents.
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 (see section 4.4 Special warnings and precautions for use). 186
Patients with congestive heart failure (NYHA-I) or significant risk factors for cardiovascular disease should be treated with Catafast only after careful consideration and only at doses ≤100mg daily if treated for more than 4 weeks (see section 4.4 Special warnings and precautions for use).
Catafast is contraindicated in patients with renal failure (GFR<15mL/min./1.73m²) (see section 4.3 Contraindications).
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 Catafast to patients with renal impairment (see section 4.4 Special warnings and precautions for use).
Catafast is contraindicated in patients with hepatic failure (see section 4.3 Contraindications).
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 Catafast to patients with mild to moderate hepatic impairment (see section 4.4 Special warnings and precautions for use).
The contents of the sachet should be dissolved with stirring in a glass of natural (noncarbonated) water. The solution may remain slightly opalescent, but this should not influence the efficacy of the preparation. The solution should be swallowed preferably before meals.
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 lifethreatening overdose.
2 years.
Protect from moisture and heat.
Store below 25°C.
Catafast must be kept out of the reach and sight of children.
Sachet hermetically sealed in four directions made of coupled paper/aluminium/polyethylene in an outer carton box.
Pack sizes of 3,9,21 and 30 sachets.
Not all pack sizes may be marketed.
No special requirements.
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