Quinoderm 10% w/w + 0.5% w/w Cream

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Benzoyl peroxide hydrous; Potassium Hydroxyquinoline Sulphate

Disponible des:

Alliance Pharma (Ireland) Limited

Codi ATC:

D10AE; D10AE01

Designació comuna internacional (DCI):

Benzoyl peroxide hydrous; Potassium Hydroxyquinoline Sulphate

Dosis:

10 %w/w + 0.5 percent weight/weight

formulario farmacéutico:

Cream

Área terapéutica:

Peroxides; benzoyl peroxide

Estat d'Autorització:

Not marketed

Data d'autorització:

2012-05-25

Informació per a l'usuari

Quinoderm Cream 10% PIL ROI 007
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
“DUAL ACTION” LOGO
QUINODERM
®
10% W/W + 0.5% W/W CREAM
benzoyl peroxide, hydrous /
potassium hydroxyquinoline sulfate
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
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).
2. WHAT YOU NEED TO KNOW BEFORE YOU USE QUINODERM CREAM
DO NOT USE QUINODERM CREAM IF:
•
you are allergic to benzoyl peroxide or potassium hydroxyquinoline
sulfate or any of
the other ingredients of this medicine (listed in section 6)
•
you have acne rosacea, a skin condition of the face where the nose and
cheeks are
usually red.
WARNINGS AND PRECAUTIONS
Quinoderm Cream 10% PIL ROI 007
•
Avoid contact with eyes, mouth and mucous membranes (such as nose or
throat)
•
Caution is required when applying to thin or

Fitxa tècnica

Health Products Regulatory Authority
26 February 2019
CRN008KJV
Page 1 of 5
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.
Health Products Regulatory Authority
26 February 2019
CRN008KJV
Page 2 of 5
Benzoyl Peroxide should not be used in patients with fair or sensitive
skin if there is extensive exposure to sunlight or
ultraviolet light.
Where local irritation or inflammation may result, use should be
interrupted or frequency reduced. If itch or