Fucicort Cream, 20mg/g + 1mg/g

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BETAMETHASONE VALERATE; FUSIDIC ACID

Available from:

LEO Pharma A/S

ATC code:

D07CC01

INN (International Name):

BETAMETHASONE VALERATE; FUSIDIC ACID

Pharmaceutical form:

CREAM

Composition:

BETAMETHASONE VALERATE; FUSIDIC ACID

Prescription type:

POM

Therapeutic area:

CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS

Authorization status:

Authorised

Authorization date:

2005-08-01

Patient Information leaflet

FUCICORT
®
CREAM
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your
pharmacist.
• This medicine has been prescribed for you personally and you
should not pass it on to others. It may
harm them, even if their symptoms are the same as yours.
_In this leaflet: _
1. What Fucicort® cream is and what it is used for
2. Before you use Fucicort® cream
3. How to use Fucicort® cream
4. Possible side effects
5. How to store Fucicort® cream
FUCICORT
®
CREAM
Active substance: Fusidic acid 20 mg/g and Betamethasone 1 mg/g (as
valerate ester)
Other ingredients: Macrogol cetostearyl ether, cetostearyl alcohol,
chlorocresol, liquid paraffin, purified
water, sodium dihydrogen phosphatedihydrate, white soft paraffin,
sodium hydroxide and all-rac--
tocopherol.
PRESENTATION AND CONTENTS
Tubes containing 15 g of cream
MARKETING AUTHORISATION HOLDER
LEO Pharma A/S
Industriparken 55, DK-2750 Ballerup, Denmark
MANUFACTURER
LEO Laboratories Ltd.
285 Cashel Road, IRL-Dublin 12, Ireland
1. WHAT FUCICORT
®
CREAM IS AND WHAT IT IS USED FOR
Fucicort® cream is a combination of an antibiotic and a
corticosteroid. Fucicort® cream is used for initial
treatment of bacterially induced eczemas or dermatitis caused by
bacteria which are sensitive to fusidic
acid.
2. BEFORE YOU USE FUCICORT
®
CREAM
FUCICORT
®
CREAM MUST NOT BE USED
• if you have a hypersensitivity to one of the ingredients.
• if you have a skin infection primarily caused by bacteria, fungi
or virus (such as herpes or varicella).
• if you have skin manifestations in relation to tuberculosis or
syphilis.
• if you have perioral dermatitis.
• if you have rosacea.
•if you have foot ulcer (ulcus cruris).
SPECIAL CARE SHOULD BE TAKEN WHEN USING FUCICORT
®
CREAM:
Due to the content of corticosteroid, use of Fucicort® cream should
not be applied in the case of skin
atrophy, cutaneous ulcers, acne vulgaris, fragility of skin veins

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
Page 1 of 5
1.
NAME OF THE MEDICINAL PRODUCT
Fucicort
®
Cream, 20 mg/g + 1 mg/g
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fusidic acid 20 mg/g and betamethasone (as the valerate ester) 1 mg/g.
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Cream.
White water-miscible cream.
4.
CLINICAL PARTICULARS
4.1
Therapeutic Indications
Fucicort
®
Cream is indicated for the treatment dermatitis infected with bacteria
susceptible to
fusidic acid.
4.2 Posology and Method of Administration
Adults and children: A thin layer should be applied 2-3 times daily.
4.3 Contraindications
Known hypersensitivity to one of the constituents of Fucicort
®
Cream.
Due to the content of corticosteroid Fucicort
®
Cream is contraindicated in the following
conditions: Skin infections primarily caused by bacteria, fungi or
virus (such as herpes or
varicella), skin manifestations in relation to tuberculosis or
syphilis, perioral dermatitis and
rosacea.
4.4 Special Warning and Precautions for Use
Long-term continuous corticosteroid treatment should be avoided,
particularly in infants and
children. The adrenocortical inhibition may occur even without using
an occlusive dressing.
Due to the content of corticosteroid use of Fucicort
®
Cream should be avoided in the follow-
ing conditions: Atrophic skin, cutaneous ulcers, acne vulgaris,
fragility of skin veins and
perianal and genital pruritus.
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 5
Fucicort
®
Cream must be used with caution in the treatment of large areas of the
body, face
and cutaneous folds. Contact with open wounds and mucous membranes
should be avoided.
Adequate precautions should be taken when the product is used near the
eyes as penetration
into the eyes might produce glaucoma.
Visual disturbance may be reported with systemic and topical
corticosteroid use. If a patient
presents with symptoms such as blurred vision or other visual
disturbances, the patient should
be considered for referral to an ophthalmologist for evaluation of
possible causes w