Fusidic acid 2% cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fusidic acid

Available from:

A A H Pharmaceuticals Ltd

ATC code:

D06AX01

INN (International Name):

Fusidic acid

Dosage:

20mg/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13100102; GTIN: 5025903012627 5025903012634

Patient Information leaflet

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FUSIDIC ACID 2% CREAM
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU
• Keep this leaflet. You may need to
read it again.
• If you have any further questions, ask
your doctor or pharmacist.
• This medicine has been prescribed for
you only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours.
• 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.
1. What Fusidic Acid is and what it is
used for
2. What you need to know before you use
Fusidic Acid
3. How to use Fusidic Acid
4. Possible side effects
5. How to store Fusidic Acid
6. Contents of the pack and other
information
WHAT FUSIDIC ACID IS AND WHAT IT
IS USED FOR
The active substance of Fusidic Acid is
fusidic acid. This is an antibiotic (this
means that it kills bacteria that cause
infections).
Fusidic Acid should be used on the skin.
The cream is used for the local treatment
of skin infections caused by bacteria that
are sensitive to fusidic acid (especially
staphylococcus infections) such as
impetigo (a weeping, crusty and swollen
patch of skin), folliculitis (inflammation
of one or more hair follicles), sycosis
barbae (infection of the bearded skin),
paronychia (infection of the tissue
surrounding a fingernail or toenail) and
erythrasma (infection with brown, scaly
skin patches, especially in the folds of
the body). It is also used to treat infected
dermatitis (inflammation of the skin),
spots, cuts and grazes.
WHAT YOU NEED TO KNOW BEFORE
YOU USE FUSIDIC ACID
DO NOT USE FUSIDIC ACID
• if you are allergic to fusidic acid or any
of the other ingredients of this
medicine (listed in section 6).
Therefore, always tell your doctor
which medicines or other substances
you are allergic to.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before
using FUSIDIC ACID
• if you use Fusidic Acid on the face. The
crea

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fusidic Acid 2% Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
2 % cream. Each gram contains 20 mg fusidic acid.
Excipient(s) with known effect: Butylhydroxyanisole 0.04 mg/gram,
Cetyl alcohol
111.00 mg/gram, and Potassium sorbate 2.70 mg/gram.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cream
White, homogenous cream.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of non-severe, superficial, non-extensive, primary and
secondary skin
infections caused by microorganisms that are sensitive to fusidic
acid, especially of
infections caused by Staphylococcus (see section 5.1).
Primary skin infections that may be expected to respond to treatment
with fusidic acid
applied topically include: impetigo contagiosa, superficial
folliculitis, sycosis barbae,
paronychia and erythrasma. Also such secondary skin infections as
infected
eczematoid dermatitis, infected contact dermatitis and infected
cuts/abrasions.
Consideration should be given to official guidance on the appropriate
use of
antibacterial agents._ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS AND PAEDIATRIC POPULATION:
Uncovered lesions: apply gently three or four times daily.
Covered lesions: less frequent applications may be adequate.
METHOD OF ADMINISTRATION
Cutaneous use
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Bacterial resistance among staphylococcus aureus has been reported to
occur with the
use of topical fusidic acid. As with all antibiotics, extended or
recurrent use may
increase the risk of developing antibiotic resistance.
Fusidic acid should not be used in infections caused by
non-susceptible organisms, in
particular, Pseudomonas aeruginosa, see section 5.1.
Extended or recurrent use may increase the risk of developing contact
sensitisation.
Extended treatment of very large surfaces should be avoided, in
particular