VOLTAREN 50 TABLET 50 MG

NOVARTIS SAGLIK, GIDA VE TARIM ÜRÜNLERI SAN. VE TIC. A.S. (TURKEY)🇸🇬 Health Sciences Authority

Approval Date: Apr 8, 1991
Approval ID: ec11b739b87dbb5d
Company: NOVARTIS SAGLIK, GIDA VE TARIM ÜRÜNLERI SAN. VE TIC. A.S. (TURKEY)
Type: Therapeutic

Approval Details

Approval Id: ec11b739b87dbb5d
Drug Name: VOLTAREN 50 TABLET 50 MG
Product Name: VOLTAREN 50 TABLET 50 MG
Approval Number: SIN05662P
Approval Date: 1991-04-08
Registrant: NOVARTIS (SINGAPORE) PTE LTD
Licence Holder: NOVARTIS (SINGAPORE) PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: ENTERIC COATED TABLET
Dosage: 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.
Route Of Administration: ORAL
Indication Info: INDICATIONS Treatment of: <ul> <li>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.</li> <li>Acute attacks of gout.</li> <li>Post-traumatic and post-operative pain, inflammation and swelling, e.g., following dental or orthopaedic surgery.</li> <li>Painful and/or inflammatory conditions in gynaecology, e.g., primary dysmenorrhoea or adnexitis.</li> <li>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.</li> </ul>
Contraindications: CONTRAINDICATIONS <ul> <li>Known hypersensitivity to the active substance or to any of the excipients.</li> <li>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).</li> <li>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).</li> <li>Hepatic failure.</li> <li>Renal failure. (GFR <15 mL/min/1.73 m2).</li> <li>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).</li> <li>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).</li> <li>Treatment of peri-operative pain in setting of coronary artery bypass graft (CABG) surgery.</li> <li>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).</li> </ul>
Atc Code: M01AB05
Atc Item Name: diclofenac
Pharma Manufacturer Name: NOVARTIS (SINGAPORE) PTE LTD

Active Ingredients

DICLOFENAC SODIUM

50 mg

DICLOFENAC SODIUM

50 mg

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Apr 8, 1991

Approval ID

ec11b739b87dbb5d

Type

Therapeutic

Back to HSA Approvals