Active Ingredient and Strength	DICLOFENAC SODIUM - 50 MG
Dosage Form	ENTERIC COATED TABLET
Manufacturer and Country	NOVARTIS SAGLIK, GIDA VE TARIM ÜRÜNLERI SAN. VE TIC. A.S. - TURKEY
Registration Number	SIN05662P
Licence Holder	NOVARTIS (SINGAPORE) PTE LTD
Forensic Classification	PRESCRIPTION ONLY MEDICINES
Anatomical Therapeutic Chemical (ATC) code	M01AB05

INDICATIONS

Treatment of:

Inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and spondylarthritis, painful syndromes of the vertebral column, non-articular rheumatism.
Acute attacks of gout.
Post-traumatic and post-operative pain, inflammation and swelling, e.g., following dental or orthopaedic surgery.
Painful and/or inflammatory conditions in gynaecology, e.g., primary dysmenorrhoea or adnexitis.
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, as well as for long-term therapy, 75 to 100 mg daily is usually sufficient.

The total daily dose should generally be divided into 2 to 3 doses. To suppress nocturnal pain and morning stiffness, treatment with tablets during the day can be supplemented by the administration of a suppository at bedtime (up to a total maximum daily dose of 150 mg).

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 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.

Special populations

Renal impairment

Voltaren 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 Voltaren 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

Voltaren 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 Voltaren to patients with mild to moderate hepatic impairment (see 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)

Children aged 1 year or over and adolescents should be given 0.5 to 2 mg/kg body weight daily in 2 to 3 separate doses, depending on the severity of the disorder. For treatment of juvenile rheumatoid arthritis, the daily dose can be raised up to a maximum of 3 mg/kg daily, given in separate doses.

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 Voltaren are not impaired to any clinically relevant extent in elderly patients, Voltaren 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 if the treatment is 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 to any of the excipients.
Active gastric or intestinal ulcer, bleeding or perforation (see section WARNINGS AND PRECAUTIONS and 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), Voltaren 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 ADVERSE DRUG REACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Treatment of peri-operative pain in setting of coronary artery bypass graft (CABG) surgery.
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).