Anusol Cream

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Bismuth oxide; Balsam peru; Zinc oxide

Beszerezhető a:

SOFIBEL

ATC-kód:

C05AX; C05AX04

INN (nemzetközi neve):

Bismuth oxide; Balsam peru; Zinc oxide

Adagolás:

2.14/1.8/1 gram(s)

Gyógyszerészeti forma:

Cream

Recept típusa:

Product not subject to medical prescription

Terápiás terület:

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

Engedélyezési státusz:

Marketed

Engedély dátuma:

1990-04-03

Betegtájékoztató

ANUSOL® cream
ZINC OXIDE, BISMUTH OXIDE, BALSAM PERU
■
This medicine is used for the relief of internal and external piles
and other minor ano-rectal
conditions such as anal itching.
■
This medicine is for use in adults over the age of 18 years.
■
DO NOT USE THIS MEDICINE:
■
If you have had a BAD REACTION to Anusol Cream or any of the
ingredients in it. _See _
_section 6 _
■
SPEAK TO YOUR DOCTOR:
■
If you have RECTAL BLEEDING or blood in your stool which has not been
diagnosed as piles.
_See section 2 _
■
FOLLOW THE INSTRUCTIONS ON HOW TO USE THIS PRODUCT CAREFULLY. _See
section 3 _
NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE.
Keep the leaflet: you
might need it again.
1 WHAT THE MEDICINE IS FOR
Anusol Cream is a medicine which is used to relieve the pain,
swelling, itch and irritation of
internal and external piles (haemorrhoids) and other minor ano-rectal
conditions such as anal
itching and fissures as diagnosed by a doctor. It can be used
post-operatively following ano-
rectal surgery as advised by a doctor.
Anusol Cream has a vanishing base which means it is rapidly absorbed.
The cream can also
provide lubrication when used with suppositories. It contains the
following ingredients:
ZINC OXIDE which is an astringent which soothes and protects raw areas
and helps reduce
swelling. It also acts as an antiseptic.
BALSAM PERU which is mildly antiseptic and has a protective action on
sore areas and may
help healing.
BISMUTH OXIDE which is astringent and antiseptic and also protects
raw, irritated areas
around the anal area.
This product is for use by adults over the age of 18 years old.
2 BEFORE USING THIS MEDICINE
This medicine is suitable for most people but a few people should not
use it. If you are in any
doubt, talk to your doctor or pharmacist.
DO NOT USE THIS MEDICINE
■
If you are allergic to Anusol Cream or any of the other ingredients of
this medicine (listed
in section 6.1).
If the above applies to you, GET ADVICE FROM A DOCTOR OR PHARMACIST
WITHOUT USING ANUSOL
CREA

Termékjellemzők

Health Products Regulatory Authority
21 March 2019
CRN008XRC
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anusol Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 g of cream contains:
Active substances:
Bismuth oxide
2.14 g
Zinc Oxide
10.75 g
Balsam Peru
1.80 g
Excipients:
Propylene Glycol 8.00 g
Methyl Parahydroxybenzoate (E218) 0.11 g
Propy Parahydroxybenzoate (E216) 0.01 g
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
A smooth, homogeneous, buff coloured cream with the characteristic
odour of Balsam Peru.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Anusol Cream provides antiseptic, astringent and emollient properties
which help to relieve discomfort associated with minor
ano-rectal conditions. Anusol Cream also provides lubricating
properties for use with suppositories.
Indicated for the symptomatic relief of uncomplicated internal and
external haemorrhoids, pruritus ani, proctitis and fissures as
diagnosed by a doctor. Also indicated post-operatively in ano-rectal
surgical procedures and after incision of thrombosed
sclerosed ano-rectal veins as advised by a doctor.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN 12 YEARS AND OVER:
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 cream. Anusol Cream is
prepared in a vanishing cream base and may be gently
smoothed onto the affected area without the need to apply a gauze
dressing. For internal conditions use rectal nozzle
provided and clean it after each use. Not to be taken orally.
CHILDREN UNDER 12 YEARS:
Not recommended, except under medical advice.
THE ELDERLY:
As for adults.
4.3 CONTRAINDICATIONS
Health Products Regulatory Authority
21 March 2019
CRN008XRC
Page 2 of 5
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
Not to be taken orally.
Patients with rectal bl