Regulatory Information
OPELLA HEALTHCARE SINGAPORE PTE. LTD.
OPELLA HEALTHCARE SINGAPORE PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
SUPPOSITORY
**Dosage and direction for use:** A suppository is inserted morning and evening and after each stool.
RECTAL
Medical Information
**Indications:** 1. For the treatment of internal and external haemorrhoids 2. Haemorrhoids in pregnancy and post-partum 3. Anal pruritus, peri-anal eczema, anal fissures and proctitis 4. Post-haemorrhoidectomy application to relieve pain and discomfort
**Contra-indications:** Known hyper-sensitivity to any of the ingredients. In pregnant animals administration of corticosteroid can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established. However, topical steroids should not be used extensively in pregnancy, ie in large amounts of for long periods. Hydrocortisone may pass into human breast milk. This product should not be used in pregnancy or lactation unless considered essential by the physician. Topical corticosteroid preparations are contra-indicated in the presence of untreated infections of viral, bacterial, tuberculous, parasitic or fungal origin.
C05AA01
hydrocortisone
Manufacturer Information
OPELLA HEALTHCARE SINGAPORE PTE. LTD.
HANDOK PHARMACEUTICALS CO LTD
PT Aventis Pharma
Active Ingredients
Documents
Package Inserts
Proctosedyl Suppository PI.pdf
Approved: October 7, 2019