ANUSOL

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BISMUTH OXIDE ; ZINC OXIDE ; BALSAM PERU ; BISMUTH SUBGALLATE

Available from:

Church & Dwight UK Limited

ATC code:

C05AX04

INN (International Name):

BISMUTH OXIDE ; ZINC OXIDE ; BALSAM PERU ; BISMUTH SUBGALLATE

Pharmaceutical form:

Suppositories

Prescription type:

Product not subject to medical prescription

Therapeutic area:

zinc preparations

Authorization status:

Marketed

Authorization date:

1990-04-03

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anusol Suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Suppository contains:
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.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
Bismuth oxide anhydrous
24 mg
Zinc Oxide
296 mg
Balsam Peru
49 mg
Bismuth Subgallate
59 mg
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_3_
_1_
_/_
_0_
_7