Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
ENTERIC COATED TABLET
**DOSAGE AND ADMINISTRATION:** Administration as 25 mg and 75mg, patients should be generally maintained on the lowest dosage, consistent with achieving satisfactory and therapeutic response. Encourage to take with food or just after food. Osteoarthritis : 100 – 150 mg/day in divided doses, 50 mg b.i.d or t.i.d. or 75 mg b.i.d. Rheumatoid arthritis: 150–200 mg/day, in divided doses, 50 mg t.i.d or q.i.d or 75 mg b.i.d. Ankylosing spondylitis: 100–125 mg/day, or 25 mg q.i.d with an extra 25 mg extra dose at bed time if necessary. **Special populations** **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.
ORAL
Medical Information
**INDICATIONS AND USES:** Acute and chronic treatment of the signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.
**CONTRAINDICATIONS:** Diclofenac is contraindicated in patients with history of Hypersensitivity, or active or suspected peptic ulcer or GI bleeding, and in those who are known to develop asthma, urticarial or other allergic reactions with aspirin or other NSAIDs. Acute porphyria is a contraindication for diclofenac. Hepatic and Renal insufficiency. Not recommended in pregnancy. 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.
M01AB05
diclofenac
Manufacturer Information
NAINA MOHAMED & SONS PRIVATE LIMITED
MICRO LABS LTD
Active Ingredients
Documents
Package Inserts
Neodol-50 Tablet PI.pdf
Approved: September 29, 2022