Anusol Suppositories

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Bismuth oxide; Zinc oxide; Balsam peru; Bismuth subgallate

זמין מ:

SOFIBEL

קוד ATC:

C05AX; C05AX04

INN (שם בינלאומי):

Bismuth oxide; Zinc oxide; Balsam peru; Bismuth subgallate

כמות:

1

טופס פרצבטיות:

Suppository

סוג מרשם:

Product not subject to medical prescription

איזור תרפויטי:

Other agents for treatment of hemorrhoids and anal fissures for topical use; zinc preparations

מצב אישור:

Marketed

תאריך אישור:

1990-04-03

מאפייני מוצר

Health Products Regulatory Authority
21 March 2019
CRN008XRC
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anusol Suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Suppository contains:
Bismuth oxide anhydrous
24 mg
Zinc Oxide
296 mg
Balsam Peru
49 mg
Bismuth Subgallate
59 mg
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Suppository
White or off white suppositories having the characteristic odour of
Balsam Peru.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Indicated for the symptomatic relief of uncomplicated internal
haemorrhoids, or post-operatively after ano-rectal procedures
using surgical or sclerosing techniques.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN 12 YEARS AND OVER: Remove wrapper and insert into
the anus at night, in the morning and after each
evacuation. Not to be taken orally.
CHILDREN UNDER 12 YEARS: Not recommended, except under medical advice.
THE ELDERLY: As for adults.
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 stop use and consult
their doctor.
Health Products Regulatory Authority
21 March 2019
CRN008XRC
Page 2 of 6
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
None known.
4.6 FERTILITY, PREGNANCY AND LACTATION
There are no adequate and well-controlled clinical studies of fixed
combinations of balsam peru, bismuth oxide, bismuth
subgallate and zinc oxide in pregnant or breast-feeding women. This
product should not be used during pregnancy and
lactation unless the potential benefit of treatment to the mother
outweighs the possible risk to the developing foetus or
nursing infant.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES