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HSA Approval

PROCTOSEDYL SUPPOSITORY

SIN01717P

PROCTOSEDYL SUPPOSITORY

PROCTOSEDYL SUPPOSITORY

June 8, 1988

OPELLA HEALTHCARE SINGAPORE PTE. LTD.

OPELLA HEALTHCARE SINGAPORE PTE. LTD.

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

NEOMYCIN B SULPHATE

10 mg

Neomycin

ESCULOSIDE

10 mg

Esculin

DIBUCAINE HCl

5 mg

Cinchocaine

HYDROCORTISONE

5 mg

Hydrocortisone

Documents

Package Inserts

Proctosedyl Suppository PI.pdf

Approved: October 7, 2019

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