Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
SUPPOSITORY
**Dosage and Administration:** **Adult**: 100mg, usually to be used at night. Maximum total daily dose is 150mg. **Children**: 0.5 – 2mg/kg body weight daily, in 2 – 3 divided doses. **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 ≤100mg 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. To be inserted deep into the rectum. To be dispensed by the physician's prescription.
RECTAL
Medical Information
**Indication(s):** Chronic rheumatic arthritis, degenerative osteoarthritis and painful post-operative inflammation.
**Contraindication(s):** 1. Voren suppository should not be used in patients who have shown hypersensitivity to Diclofenac Sodium. 2. It is contraindicated in patients with any inflammatory lesions of the rectum or anus, and in patients with recent history of rectal and anal bleeding. 3. It should not be given to children under 12 months of age. 4. It is contraindicated in patients with active or suspected peptic ulcer or gastric-intestinal bleeding. 5. It is contraindicated in patients in whom attack of asthma, urticaria or acute rhinitis are precipitated by aspirin or other NSAIDs. 6. 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
YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD
Y S P INDUSTRIES (M) SDN BHD
Active Ingredients
Documents
Package Inserts
Voren Suppositories PI.pdf
Approved: June 28, 2022