Active Ingredient and Strength	DICLOFENAC POTASSIUM - 50 MG
Dosage Form	TABLET, SUGAR COATED
Manufacturer and Country	NOVARTIS SAGLIK, GIDA VE TARIM URUNLERI SAN. VE TIC. A.S. - TURKEY
Registration Number	SIN05664P
Licence Holder	NOVARTIS (SINGAPORE) PTE LTD
Forensic Classification	PRESCRIPTION ONLY MEDICINES
Anatomical Therapeutic Chemical (ATC) code	M01AB05

INDICATIONS

Short-term treatment in the following acute conditions:

Post-traumatic pain, inflammation and swelling, e.g., due to sprains.
Post-operative pain, inflammation and swelling, e.g., following dental or orthopaedic surgery.
Painful and/or inflammatory conditions in gynecology, e.g., primary dysmenorrhoea or adnexitis.
Migraine attacks.
Painful syndromes of the vertebral column.
Non-articular rheumatism.
As an adjuvant in severe painful inflammatory infections of the ear, nose or throat, e.g., pharyngotonsillitis, otitis. In keeping with general therapeutic principles, the underlying disease should be treated with basic therapy, as appropriate. Fever alone is not an indication.

DOSAGE REGIMEN AND ADMINISTRATION

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 section WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

General target population

Adults

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 50mg 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.

Special populations

Renal impairment

Cataflam is contraindicated in patients with renal failure (GFR <15 mL/min/1.73 m²) (see section 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 section WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment

Cataflam is contraindicated in patients with hepatic failure (see section 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 WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pediatric patients (below 18 years)

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 use of Cataflam (all forms) in migraine attacks has not been established in children and adolescents.

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. Although the pharmacokinetics of Cataflam are not impaired to any clinically relevant extent in elderly patients, Cataflam should be used with particular caution in such patients who generally are more prone to adverse reactions (see section WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Established cardiovascular disease or significant cardiovascular risk factors

The use of high dose diclofenac (150mg/day) for more than 4 weeks is contraindicated in patients with established cardiovascular disease (congestive heart failure, established ischemic heart disease, peripheral arterial disease) or uncontrolled hypertension. If diclofenac treatment is needed, patients with established cardiovascular disease, uncontrolled hypertension or significant cardiovascular risk factors (e.g. hypertension, hyperlipidaemia, diabetes mellitus and smoking) should be treated only after careful consideration and at doses ≤100 mg daily when treatment continues for more than 4 weeks. As the cardiovascular risks of diclofenac may increase with dose and duration of exposure, diclofenac should always be prescribed at the lowest effective daily dose and for the shortest duration possible (see section WARNINGS AND PRECAUTIONS – CARDIOVASCULAR EFFECTS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of administration

The tablets should be swallowed whole with liquid, preferably before meals, and must not be divided or chewed.

CONTRAINDICATIONS

Known hypersensitivity to the active substance or any of the other excipients.
Active gastric or intestinal ulcer, bleeding or perforation (see section WARNINGS AND PRECAUTIONS and also section ADVERSE DRUG REACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Last trimester of pregnancy (see section PREGNANCY, LACTATION, FEMALES AND MALES OF REPRODUCTIVE POTENTIAL – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Hepatic failure.
Renal failure (GFR <15 mL/min/1.73 m²).
Severe cardiac failure (see section WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Like other non-steroidal anti-inflammatory drugs (NSAIDs), Cataflam is also contraindicated in patients in whom the use of acetylsalicylic acid or other NSAIDs can precipitate asthma, angioedema, urticaria, or acute rhinitis (i.e., NSAID-induced cross-reactivity reactions) (see section WARNINGS AND PRECAUTIONS and also section ADVERSE DRUG REACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
The use of high dose diclofenac (150mg/day) for more than 4 weeks is contraindicated in patients with established cardiovascular disease (congestive heart failure, established ischemic heart disease, peripheral arterial disease) or uncontrolled hypertension (see sections DOSAGE AND ADMINISTRATION – SPECIAL POPULATIONS and WARNINGS AND PRECAUTIONS – CARDIOVASCULAR EFFECTS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).