Posology : מינונים

4.2       Posology and method of administration
As a general recommendation, the dose should be individually adjusted. Adverse effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4 Special warnings and precautions for use).

General target population
The recommended initial daily dose is 100 to 150 mg. In milder cases, 75 to 100 mg daily is usually sufficient.
The total daily dose should generally be divided into 2 or 3 separate doses, as applicable.
In primary dysmenorrhoea, the daily dose should be individually adjusted and is generally 50 to 150 mg. An initial dose of 50 mg is usually sufficient. If necessary, an initial dose of 100 mg can be prescribed with a maximum of 200 mg/day reached over the course of several menstrual cycles. 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 4-6 hours, not exceeding a total dose of 200 mg per day.


Special populations
Paediatrics
Cataflam® tablets are not recommended for use in children and adolescents below 14 years of age.
For adolescents aged 14 years and over, a daily dose of 75 to 100 mg is usually sufficient.
The maximum daily dose of 150 mg should not be exceeded. The total daily dose should generally be divided into 2 or 3 separate doses, as applicable.
The use of Cataflam in migraine attacks has not been established in children and adolescents.



CAT API 02JUN24                                                                      UK SmPC Feb2023 

Elderly
No adjustment of the starting dose is required for elderly patients (see section 4.4 Special warnings and precautions for use).

Cardiovascular disease or significant cardiovascular risk factors
Cataflam is contraindicated in patients with established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease (see section 4.3 Contraindications).

Patients with congestive heart failure (NYHA-I) or significant risk factors for cardiovascular disease should only be treated with diclofenac after careful consideration. Since cardiovascular risks with diclofenac may increase with dose and duration of exposure, the lowest effective daily dose should be used and for the shortest duration possible (see section 4.4 Special warnings and precautions for use).

Renal impairment
Cataflam is contraindicated in patients with renal failure (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 Cataflam to patients with mild to moderate renal impairment (see section 4.3 Warnings and precautions for use).

Hepatic impairment
Cataflam 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 Cataflam to patients with mild to moderate hepatic impairment (see section 4.4 Special warnings and precautions for use).
Mode of administration
The tablets should be swallowed whole with liquid, preferably with or after food, and must not be divided or chewed.