- Approval Id
- 953caa73081ecd2d
- Drug Name
- CLOFENAC SR TABLET 100 mg
- Product Name
- CLOFENAC SR TABLET 100 mg
- Approval Number
- SIN11814P
- Approval Date
- 2002-02-21
- Registrant
- GOLDPLUS UNIVERSAL PTE LTD
- Licence Holder
- GOLDPLUS UNIVERSAL PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- **DOSAGE AND ADMINISTRATION**
- **Adults:**
Oral, one 100 mg tablet a day. Tablets should be swallowed whole preferably with food.
- **Elderly:**
Care should be used when treating patients who are frail or have a low body weight as they will in general be more susceptible to adverse reactions. The lowest effective dose should be used in these patients. The standard adult dose may be used for other elderly patients.
- **Children:**
Not suitable for use in children.
**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.
Note: The information given here is limited. For further information, consult your doctor or pharmacist.
- Route Of Administration
- ORAL
- Indication Info
- **INDICATIONS**
Used for relief of pain and inflammation in conditions such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout and following some surgical procedures.
- Contraindications
- **CONTRAINDICATIONS**
- Contraindicated in patients known to be hypersensitive to Diclofenac sodium.
- Contraindicated in patients who when taking aspirin or other non-steroidal anti-inflammatory drugs suffer attacks of asthma, urticaria or acute rhinitis.
- Should not be used in patients with active or suspected peptic ulcer or gastrointestinal bleeding.
- Contraindicated in patients with bone marrow depression.
- 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.
- Atc Code
- M01AB05
- Atc Item Name
- diclofenac
- Pharma Manufacturer Name
- GOLDPLUS UNIVERSAL PTE LTD
- Company Detail Path
- /organization/goldplus-universal-pte-ltd
