VOLTAREN 50MG TAB; diclofenac sodium, anti inflammatory agents .
ACTIVE-INGREDIENT OF VOLTAREN 50MG TAB
one enteric coated tablet contains 25 mg or 50 mg of diclofenac sodium .
INDICATION OF VOLTAREN 50MG TAB
Treatment of : Inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and spondylarthritis, painful syndroms of the vertebral column, non-articular rheumatism. Acute attacks of gout. Post-traumatic and post-operative pain, inflammation, and sweeling, e.g. following dental or orthopaedic surgery. Painful and/or inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea or adnexitis. Migraine attacks. 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 OF VOLTAREN 50MG TAB
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
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 ). 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 gerenrally be divided into 2 to 3 separate 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: pediatric patients (below 18 years of age): Children aged 1 year or over and adolescents should be given 0.5 to 2 mg/kg body weight daily divided into 2 to 3 separate doses, depending on the severity of the disorder. For treatment of juvenile rheumatoid arthritis, the dose can be raised up to a maximum of 3 mg/kg daily, given in separated doses. The maximum daily dose of 150 mg should not be exceeded. Voltaren 12.5 mg or 25 mg suppositories are recommended for use in children and adolescents below 14 years of age. Because of their dosage strength, Voltaren 50 mg suppositories are not recommended for children and adolescents below 14 years of age; Voltaren 25 mg enteric coated tablets could be used in these patients . Geriatric patients ( aged 65 years or above ): No adjustment of the starting dose is generally required for elderly patients. However, caution is indicated on basic medical grounds, especially for frial elderly patients or those with a low body weight ( see section Warnings and Precautions ). Established cardiovascular disease or significant cardiovascular risk factors: Treatment with Voltaren is generally not recommended in patients with established cardiovascular disease, uncontrolled hypertension, if needed , patients with established cardiovascular disease ,uncontrolled hypertension , or significant risk factors for cardiovascular disease should be treated with Voltaren only after careful consideration and only at doses = 100 mg daily if treated for more than 4 weeks ( see section Warnings and Precautions ). Renal impairment : Voltaren is contraindicated in patients with renal failure (GFR OVER-DOSAGE OF VOLTAREN 50MG TAB
symptoms : There is no typical clinical picture resulting from diclofenac overdosage . Overdosage can cause symptoms such as vomiting, gastrointestinal hemorrhage, diarrhea, dizziness, tinnitus or convulsions. In the event of significant poisoning, acute renal failure and liver damage are possible. Therapeutic measures: Management of acute poisoning with NSAIDs , including diclofenac, essentially consists of supportive measures and symptomatic treatment. Supportive measures and symptomatic treatment should be given for complications such as hypotension, renal failure, convulsions, gastrointestinal disorder, and respiratory depression. Special measures such as forced diuresis, dialysis, or haemoperfusion are probably of no help in eliminating NSAIDs, including diclofenac, due to the high protein-binding and extensive metabolism. activated charcoal may be considered after ingestion of a potentially toxic overdose , and gastric decontamination (e.g. vomiting , gastric lavage ) after ingestion of a potentially life-threatening overdose .
CONTRA-INDICATION OF VOLTAREN 50MG TAB
Known hypersensitivity to the active substance or to any of the excipients. Active gastric or intestinal ulcer, bleeding or perforation ( see section Wawnings and Precautions and Adverse Drug Reactions ). Last trimester of pregnancy ( see section Women of Child-Bearing-Potential, Pregnancy, Breast-feeding and Fertility). Hepatic failure. Renal failure (GFR STORAGE OF VOLTAREN 50MG TAB
protect from moisure and heat ( store below 30 C ) .
PACK OF VOLTAREN 50MG TAB
20 enteric coated tablets .
VOLTAREN 50MG TAB MANUFACTURED BY
Novartis Pharma AG,Basel, Switzerland.