Cataflam Dosage/Direction for Use

Dosage regimen: 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 Precautions).
General target population: Adults: Sugar-coated tablets: 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 dysmenorrhea, 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 to 6 hours, not exceeding a total dose of 200 mg per day.
Oral drops: Specific pharmaceutical forms (e.g. tablets, suppositories, solution for injection) are available for use in adults. The initial daily dose is 100 to 150 mg diclofenac sodium equivalent. In milder cases, 75 to 100 mg diclofenac sodium equivalent daily is usually sufficient.
The total daily dose should generally be divided into 2 to 3 separate doses.
Special populations: Renal impairment: Cataflam is contraindicated in patients with renal failure (GFR <15 mL/min/1.73 m²) (see 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 renal impairment (see Precautions).
Hepatic impairment: Cataflam is contraindicated in patients with hepatic failure (see 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 Precautions).
Pediatric patients (below 18 years): Sugar-coated tablets: Cataflam tablets are 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 or suppositories of diclofenac 12.5 mg and 25 mg could be used. 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 to 3 separate doses, as applicable.
The use of Cataflam (all forms) in migraine attacks has not been established in children and adolescents.
Oral drops: Cataflam oral drops are particularly suitable for pediatric use, because they enable the dose to be adapted individually to the child's body weight in accordance with the dosage schedule recommended for children (1 drop=0.5 mg).
Children aged 1 year or over and adolescents should be given the diclofenac sodium equivalent of 0.5 to 2 mg/kg body weight (1 to 4 drops) daily, depending on the severity of the disorder. For adolescents aged 14 or over, 75 to 100 mg daily is usually sufficient. The total daily dose should generally be divided into 2 to 3 separate doses.
The maximum daily dose of 150 mg diclofenac sodium equivalent should not be exceeded.
Geriatric patients (65 years of age or above): 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 Precautions).
Established cardiovascular disease or significant cardiovascular risk factors: Treatment with Cataflam is generally not recommended in patients with established cardiovascular disease (congestive heart failure, established ischemic heart disease, peripheral arterial disease) or uncontrolled hypertension. If needed, patients with established cardiovascular disease, uncontrolled hypertension or significant risk factors for cardiovascular disease (e.g. hypertension, hyperlipidemia, diabetes mellitus and smoking) should be treated with Cataflam only after careful consideration and only at doses ≤100 mg daily if treated for more than 4 weeks (see Precautions).
Method of administration: Sugar-coated tablets: The tablets should be swallowed whole with liquid, preferably before meals, and must not be divided or chewed.
Oral drops: It is recommended to hold the bottle containing the suspension in the hands for at least 2 minutes to bring the suspension to room temperature. Then the bottle should be shaken well for 1 minute before opening. The required number of drops should be counted into a spoon and the content of the spoon should be swallowed, preferably during meals.