XYLOPROCT SUPPOSITORY

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

ALUMINIUM SUBACETATE; LIGNOCAINE/LIDOCAINE; HYDROCORTISONE ACETATE; Zinc oxide

Available from:

Aspen Medical Products Malaysia Sdn Bhd

INN (International Name):

ALUMINIUM SUBACETATE; LIGNOCAINE/LIDOCAINE; HYDROCORTISONE ACETATE; Zinc oxide

Units in package:

10Units Units

Manufactured by:

RECIPHARM KARLSKOGA AB

Summary of Product characteristics

Xyloproct
Xyloproct ointment
Xyloproct suppository
Composition
1 g rectal ointment contains: Lidocaine 50 mg, hydrocortisone acetate 2.5 mg, aluminium diacetate 35
mg and zinc oxide 180 mg.
1 suppository contains: Lidocaine 60 mg, hydrocorti sone acetate 5 mg, aluminium diacetate 50 mg and
zinc oxide 400 mg.
For a full list of excipients, see “List of excipients”
Pharmaceutical Form
Rectal ointment
Suppository
Rectal ointment: W hite to slightly yellow homogenous ointment.
Suppositories: W hit e to slightly yellow suppositories.
Therapeutic indications
Xyloproct is intended for the treatment of pain, itching and discomfort, arising from irritated anorectal
tissues e.g., haemorrhoids, pruritus ani, proctitis, milder forms of anal fissures, post operative pain
relief.
Xyloproct suppositories should be used in preference to ointment for treatment of proctitis or internal
haemorrhoids.
Posology and method of administration
Rectal ointment The rectal ointment is applied in and around the rectum one or more times daily in a
thin layer. Up to 6 g rectal ointment per day may be applied. The treatment period can vary between
ten days and three weeks. If an extension of the treatment period is intended, a treatment -free interval
is recommended.
Suppositories One suppository is inserted into the rectum morning and evening, and as required after
each bowel action. Up to 5 suppositories per day may be administered.
In cases of painful bowel actions the suppository is inserted a few minutes before. It is important that
the suppository is retained until it has melted. The treatment period can vary between ten days and
three weeks. If an extension of the treatment period is intended, a treatment -free interval is
recommended.
The treatment period should not exceed 3 weeks, see “Special warnings and special precautions for
use”.
Contraindications
Hypersensitivity to active substance or other ingredients in the product.
Special warnings and special precautions for use
Before prescription the patient shoul d be investigate