Anusol HC Suppositories

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

HYDROCORTISONE ACETATE; Benzyl benzoate; Bismuth oxide; Balsam peru; Zinc oxide; Bismuth subgallate

Available from:

SOFIBEL

ATC code:

C05AA; C05AA01

INN (International Name):

HYDROCORTISONE ACETATE; Benzyl benzoate; Bismuth oxide; Balsam peru; Zinc oxide; Bismuth subgallate

Dosage:

2.8 mg percent weight/weight

Pharmaceutical form:

Suppository

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Corticosteroids; hydrocortisone

Authorization status:

Marketed

Authorization date:

1990-03-30

Summary of Product characteristics

Health Products Regulatory Authority
21 March 2019
CRN008XRC
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anusol HC Suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.8g suppository contains:
Hydrocortisone Acetate
10 mg
Benzyl Benzoate
33 mg
Bismuth oxide
24 mg
Balsam Peru
49 mg
Zinc Oxide
296 mg
Bismuth Subgallate
59 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suppository
Off white suppositories.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Anusol HC Suppositories are indicated for the symptomatic relief of
external and internal haemorrhoids, proctitis, cryptitis, anal
fissures, pruritus ani and perianal sinuses. Also indicated
post-operatively in ano-rectal surgical procedures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Intrarectal.
ADULTS:
Remove wrapper and insert one suppository into the anus at night, in
the morning and after each evacuation, up to a
maximum of three a day.
Not to be taken orally.
ELDERLY (OVER 65 YEARS):
As for adults.
CHILDREN:
Not recommended.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section 6.1
Tubercular, fungal, bacterial and viral lesions including herpes
simplex, vaccinia and varicella.
Health Products Regulatory Authority
21 March 2019
CRN008XRC
Page 2 of 5
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.
As with all products containing topical steroids the possibility of
systemic absorption should be borne in mind.
Prolonged or excessive use may produce systemic corticosteroid effects
and use for periods longer than seven days is not
recommended unless under the direction of a doctor.
The product should be discontinued and the patient advised to consult
a medical practitioner if symptoms do not improve,
worsen or if rectal bleeding occurs.
Continuous application