Anusol Ointment

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

מרכיב פעיל:

BALSAM PERU, BISMUTH OXIDE, BISMUTH SUBGALLATE, ZINC OXIDE

זמין מ:

Church & Dwight UK Limited Premier House, Shearway Business, Park, Pent Road, Folkestone, Kent, CT194RJ, United Kingdom

קוד ATC:

C05AX

INN (שם בינלאומי):

BALSAM PERU 1.875 % (W/V) BISMUTH OXIDE 0.875 % (W/V) BISMUTH SUBGALLATE 2.25 % (W/V) ZINC OXIDE 10.75 % (W/V)

טופס פרצבטיות:

OINTMENT

הרכב:

BALSAM PERU 1.875 % (W/V) BISMUTH OXIDE 0.875 % (W/V) BISMUTH SUBGALLATE 2.25 % (W/V) ZINC OXIDE 10.75 % (W/V)

סוג מרשם:

OTC

איזור תרפויטי:

VASOPROTECTIVES

מצב אישור:

Withdrawn

תאריך אישור:

2006-08-10

מאפייני מוצר

Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
PRODUCT SUMMARY
1.
NAME OF THE MEDICINAL PRODUCT
Anusol Ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100g ointment contains:
Zinc Oxide
10.75 g
Bismuth Subgallate
2.25 g
Balsam Peru
1.875 g
Bismuth Oxide
0.875 g
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
A light buff coloured ointment.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Symptomatic relief of uncomplicated internal and external
haemorrhoids,
pruritus ani, proctitis and fissures. Also indicated post operatively
in ano-
rectal surgical procedures and after incision of thrombosed or
sclerosed ano-
rectal veins.
Anusol Ointment provides antiseptic, astringent and emollient
properties
which help to relieve discomfort associated with minor ano-rectal
conditions.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Topical.
ADULTS AND ELDERLY (OVER 65 YEARS): Apply to the affected area at
night, in
the morning and after each evacuation until the condition is
controlled.
Thoroughly cleanse the affected area, dry and apply ointment. Anusol
Ointment should be applied on a gauze dressing. For internal
conditions use
rectal nozzle provided. Remove the nozzle cap. Clean the nozzle after
each
Page 2 of 6
use. Not to be taken orally.
CHILDREN: Not recommended
4.3.
CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in
section 6.1
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients with rectal bleeding or blood in the stool should talk to
their doctor
before using this product as these conditions may be the symptom of a
more
serious underlying disorder.
If symptoms persist or worsen, patients should be instructed to stop
use and
consult a physician.
4.5.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.6.
FERTILITY, PREGNANCY AND LACTATION
Whilst formal studies on the effect of this product during pregnancy
have not
been conducted, there is no epidemiological evidence of adverse
effects either
to the pr