FUCIDIN H CREAM

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

FUSIDIC ACID; HYDROCORTISONE ACETATE

Available from:

DKSH SINGAPORE PTE. LTD.

ATC code:

D07CA01

Dosage:

20 mg/g

Pharmaceutical form:

CREAM

Composition:

FUSIDIC ACID 20 mg/g; HYDROCORTISONE ACETATE 10 mg/g

Administration route:

TOPICAL

Prescription type:

Prescription Only

Manufactured by:

LEO Laboratories Limited

Authorization status:

ACTIVE

Authorization date:

1999-03-24

Patient Information leaflet

145 mm
280 mm
80 mm
Item-number: 
font: OCR-B, 8 pt., 
kerning +10., 
rotate 90%   
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FUCIDIN
®
H cream
COMPOSITION
Active ingredients:
Fusidic acid 20 mg/g, Hydrocortisone acetate 10 mg/g.
Inactive ingredients:
Butylated hydroxyanisole, Cetyl alcohol, Glycerol 85%, Liquid
paraffin, Polysorbate, 
Potassium sorbate, White soft paraffin, Purified water.
PROPERTIES
Fucidin
®
H Cream combines the antibacterial action of fusidic acid with the
anti-inflammatory
effect of hydro cortisone acetate.
INDICATIONS
Fucidin
®
H Cream is indicated for the treatment of dermatitis, including atopic
dermatitis and
contact dermatitis, where an infection with bacteria sensitive to
fusidic acid is suspected or
confirmed.
Because of its hydrocortisone content, Fucidin
®
H Cream is particularly appropriate in cases
where a milder  corticosteroid is indicated, including milder
inflammatory dermatoses - on
the face and on children’s skin.
Fucidin
®
H Cream is cosmetically acceptable for use on the face and hands and
convenient
for use in the armpits.
DOSAGE
Apply the cream  three times daily for up to 2 weeks.
CONTRAINDICATIONS
Known hypersensitivity to any component. 
Primary bacterial, viral and fungal skin infections.
PRECAUTIONS
Long-term continuous therapy should be avoided. Caution should be
exercised when the
product is used near the eye, since hydrocortisone acetate can cause
glaucoma if the 
preparation gets into the eye. 
INTERACTIONS
Doping test: Athletes are not allowed to use corticosteroids, except
for locally used
cream/ointment/solution  containing steroids. If such a
cream/ointment/solution is used, the
athlete is to write a notification (Medical  Certificate) about this
before contest start.
PREGNANCY AND LACTATION
Topical corticosteroids should not be used extensively, in large
amounts or for prolonged
periods in pregnant patients, as fetal abnormalities have been seen in
animals due to
systemic absorption.
It is not known whether topical corticosteroids are excreted in breast
milk, pr

Summary of Product characteristics

FUCIDIN® H CREAM
COMPOSITION
Active ingredients:
Fusidic acid 20 mg/g, Hydrocortisone acetate 10 mg/g.
Inactive ingredients:
Butylated hydroxyanisole, Cetyl alcohol, Glycerol 85%, Liquid
paraffin, Polysorbate,
Potassium sorbate, White soft paraffin, all-rac-α-tocopherol,
hydrochloric acid, Purified water.
PROPERTIES
Fucidin
®
H Cream combines the antibacterial action of fusidic acid with the
anti-inflammatory
effect of hydrocortisone acetate.
INDICATIONS
Fucidin
®
H Cream is indicated for the treatment of dermatitis, including atopic
dermatitis and
contact dermatitis, where an infection with bacteria sensitive to
fusidic acid is suspected or
confirmed.
Because of its hydrocortisone content, Fucidin
®
H Cream is particularly appropriate in cases
where a milder corticosteroid is indicated, including milder
inflammatory dermatoses – on
the face and on children’s skin.
Fucidin
®
H Cream is cosmetically acceptable for use on the face and hands and
convenient
for use in the armpits.
DOSAGE
Apply the cream three times daily for up to 2 weeks.
CONTRAINDICATIONS
Hypersensitivity to fusidic acid/sodium fusidate, hydrocortisone
acetate or to any of the
excipients listed above (see Composition).
Due to the content of corticosteroid, Fucidin
®
H is contraindicated in the following conditions:
Primary skin infections caused by fungi, virus or bacteria, either
untreated or uncontrolled
by appropriate treatment (see Special warnings and precautions for
use)
Skin manifestations in relation to tuberculosis, either untreated or
uncontrolled by
appropriate therapy.
Perioral dermatitis and rosacea.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Long-term continuous therapy with Fucidin
®
H should be avoided. Depending on the
application site, possible systemic absorption of hydrocortisone
acetate should always be
considered during treatment with Fucidin
®
H.
Due to the content of corticosteroid, Fucidin
®
H should be used with care near the eyes.
Avoid getting Fucidin
®
H into the eyes (see Undesirable effects).
Visual distu