Quinoderm 10 cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Benzoyl peroxide; Potassium hydroxyquinoline sulfate

Available from:

Alliance Pharmaceuticals Ltd

ATC code:

D10AE51

INN (International Name):

Benzoyl peroxide; Potassium hydroxyquinoline sulfate

Dosage:

100mg/1gram ; 5mg/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13060100; GTIN: 5012916000017 5012916000024

Patient Information leaflet

Quinoderm Cream 10% PIL UK 005
“DUAL ACTION” LOGO
QUINODERM
®
10% / 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.
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)
Quinoderm Cream 10% PIL UK 005
•
you have acne rosacea, a skin condition of the face where the nose and
cheeks are usually red.
WARNINGS AND PRECAUTIONS
•
Avoid contact with eyes, mouth and mucous membranes (such as nose or
throat).
•
Caution is required when applying to the neck and other sensitive
areas.
May bleach hair or dyed fabrics. If accidental contact occurs, rinse
thoroughly
with warm water.
•
Quinoderm Crea

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Quinoderm 10% / 0.5% w/w Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Benzoyl Peroxide, hydrous
10.0% w/w
Potassium Hydroxyquinoline Sulfate
0.5% w/w
Excipients with known effect:
Cetostearyl alcohol, approx 0.825% w/w
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Cream.
A creamy white astringent vanishing cream
.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acne vulgaris, acneform eruptions, folliculitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration
For topical use only.
Adults, children and the elderly
By gentle massage over all the affected area two or three times daily.
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. Caution is
required when
applying to the neck and other sensitive areas. May bleach hair or
dyed fabrics.
As Quinoderm Cream may cause increased sensitivity to sunlight,
sunlamps should
not be used and deliberate or prolonged exposure to sunlight should be
avoided or
minimised. When exposure to strong sunlight cannot be avoided,
patients should be
advised to use a sunscreen product and wear protective clothing.
In a 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 12 hours. If severe irritation or pronounced redness occurs, do
not proceed with
treatment.
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. Quinoderm
Cream 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 rash occur treatment shoul