Fucidin H Cream, 20mg/g + 10mg/g

Country: Մալթա

language: անգլերեն

source: Medicines Authority

active_ingredient:

FUSIDIC ACID; HYDROCORTISONE ACETATE

MAH:

LEO Pharma A/S

ATC_code:

D07CA01

INN:

FUSIDIC ACID; HYDROCORTISONE ACETATE

pharmaceutical_form:

CREAM

composition:

FUSIDIC ACID; HYDROCORTISONE ACETATE

prescription_type:

POM

therapeutic_area:

CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS

authorization_status:

Authorised

authorization_date:

2005-08-01

PIL

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FUCIDIN
® H 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 Fucidin
®
H is and what it is used for
2.
Before you use Fucidin
®
H cream
3.
How to use Fucidin
®
H cream
4.
Possible side effects
5.
How to store Fucidin
®
H cream
FUCIDIN
® H CREAM
Active substance: Fusidic acid 20 mg/g and Hydrocortisone acetate 10
mg/g
Other ingredients: Butylhydroxyanisole, cetyl alcohol, glycerol 85%,
liquid paraffin, polysorbate 60,
potassium sorbate, purified water, hydrochloric acid and white soft
paraffin.
PRESENTATION AND CONTENTS
Tubes containing 15 g of cream
MARKETING AUTHORISATION HOLDER
LEO Pharmaceutical Products
Industriparken 55, DK-2750 Ballerup, Denmark
MANUFACTURER
LEO Laboratories Ltd.
285 Cashel Road, IRL-Dublin 12, Ireland
1.
WHAT FUCIDIN
® H CREAM IS AND WHAT IT IS USED FOR
Fucidin
®
H cream is a combination of an antibiotic and a corticosteroid.
Fucidin
®
H cream is used for the local treatment of bacterially induced eczemas
or dermatitis caused
by bacteria which are sensitive to fusidic acid.
2.
BEFORE YOU USE FUCIDIN
® H CREAM FUCIDIN
® H CREAM MUST NOT BE USED
DO NOT USE FUCIDIN
® H:
-
If you are allergic (hypersensitive) to fusidic acid or hydrocortisone
acetate.
-
If you are allergic (hypersensitive) to any of the other ingredients
in your medicine. You can find a list
of these ingredients in section 6 of this leaflet.
-
To treat a skin condition called acne rosacea. This is redness and
inflammation over your nose and
cheeks. Ask your doctor if you are unsure.
-
To treat a skin condition called perioral dermatitis. This is a red
spotty rash around your mouth or
chin.
-
To treat skin conditions caused by tuberculosi

SPC

Page 1 of 5
1.
NAME OF THE MEDICINAL PRODUCT
Fucidin H, 20 mg/g + 10 mg/g Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fusidic acid 20 mg/g and hydrocortisone acetate 10 mg/g.
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Cream
White water-miscible cream
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fucidin
®
H cream is indicated in treatment of infected eczema and atopic
dermatitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children:
Uncovered lesions: apply gently three times daily for up to 2 weeks.
Covered lesions: less frequent applications may be adequate.
4.3
CONTRAINDICATIONS
Known hypersensitivity to any of the ingredients of Fucidin
®
H Cream.
Due to content of corticosteroid Fucidin
®
H 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 Fucidin
®
H Cream should be avoided in the following
conditions: Atrophic skin, cutaneous ulcer, acne vulgaris, fragility
of skin veins and perianal and
genital pruritus.
Due to the content of corticosteroid any contact with open wounds and
mucous membranes should
be avoided.
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 which may include
cataract, glaucoma or rare diseases such as central serous
chorioretinopathy (CSCR) which have
been reported after use of systemic and topical corticosteroids.
2
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERA