QUINODERM

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

BENZOYL PEROXIDE HYDROUS ; POTASSIUM HYDROXYQUINOLIN SULFATE

Tilgængelig fra:

Alliance Pharmaceuticals Ltd.

ATC-kode:

D10AE01

INN (International Name):

BENZOYL PEROXIDE HYDROUS ; POTASSIUM HYDROXYQUINOLIN SULFATE

Dosering:

10 + 0.5 %w/w

Lægemiddelform:

Cream

Recept type:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

benzoyl peroxide

Autorisation status:

Not marketed

Autorisation dato:

1981-04-24

Indlægsseddel

Artwork Information
Product Title:
Quinoderm cream 10% IRE PIL
Date:
03-10-17
Product Size:
125mm x 160mm (Flat size) 125mm x 80mm (Finished size)
Label Number:
16-148
Colours Used:
Black
Fonts Used:
Arial Regular and Bold
Font size: (min)
7pt
Version:
2
1. WHAT QUINODERM CREAM IS AND WHAT IT IS USED FOR
Quinoderm Cream belongs to a group of medicines called peroxides.
It contains two active ingredients; benzoyl peroxide, which provides a
peeling action, and potassium hydroxyquinoline sulfate, which has
antimicrobial and antifungal properties.
Quinoderm Cream is used for the treatment of acne vulgaris
(common acne), acneform eruptions (an acne like rash) and
folliculitis (a mild infection of the hair follicles).
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist.
This
includes any possible side effects not listed in this leaflet. See
section 4.
• You must talk to a doctor if you do not feel better or if you feel
worse after 3 months. WHAT IS IN THIS LEAFLET
1. What Quinoderm Cream is and what it is used for
2. What you need to know before you use Quinoderm Cream
3.
How to use Quinoderm Cream
4.
Possible side effects
5. How to store Quinoderm Cream
6. Contents of the pack and other information
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
10% W/W + 0.5% W/W CREAM
BENZOYL PEROXIDE, HYDROUS /
POTASSIUM HYDROXYQUINOLINE SULFATE
XXXXXX
to use Quinoderm Cream whilst you are breast-feeding, you should
ensure that the infant’s skin does not come into direct contact with
the areas of skin that have been treated.
QUINODERM CREAM CONTAINS CETOSTEARYL ALCOHOL:
Quinoderm Cream contains cetostearyl alcohol, which may cause
local skin reactions (e.g. contact dermatit

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Quinoderm 10% w/w + 0.5% w/w Cream.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Benzoyl Peroxide, hydrous
10.0% w/w
Potassium Hydroxyquinoline Sulfate
0.5% w/w
Excipient(s) with known effect
Cetostearyl alcohol
5.25 % - 6.375 % w/w
Macrogol 40 castor oil
0.75 % - 1.5 %
w/w
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
White, astringent vanishing cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Acne vulgaris, acneform eruptions, folliculitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults, Children and the Elderly
By gentle massage over all the affected area two or three times daily.
A single course of treatment should not extend beyond three months
unless there is clear evidence of response.
Method of administration
For topical use only.
4.3 CONTRAINDICATIONS
Acne Rosacea.
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Avoid contact with eyes, mouth and mucous membranes. May bleach hair
or dyed fabrics. Avoid exposure to excessive
sunlight.
In the few isolated cases, overreaction to Quinoderm Cream may occur.
To minimise this possibility, select a small area
of skin behind the ear, apply the cream and leave for twelve hours. If
severe irritation or pronounced redness occurs, do
not proceed with treatment and a doctor or pharmacist should be
consulted_._
The product should only be used with caution in areas of thin or
sensitive skin. Fair skinned individuals are likely to be
particularly sensitive to irritation.
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