Fucidin H cream

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Fusidic acid; Hydrocortisone acetate

Tersedia dari:

LEO Pharma

Kode ATC:

D07CA01

INN (Nama Internasional):

Fusidic acid; Hydrocortisone acetate

Dosis:

20mg/1gram ; 10mg/1gram

Bentuk farmasi:

Cutaneous cream

Rute administrasi :

Cutaneous

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 13040000; GTIN: 5702191001020 5702191005004

Selebaran informasi

FOR AN ADULT:
FOR A CHILD UNDER 11 YEARS:
IF YOU FORGET TO USE FUCIDIN H CREAM
If you forget to use this medicine, use it as soon as you remember.
Then
next use this medicine at the usual time.
If you have any further questions on the use of this medicine, please
ask
your doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Fucidin H Cream can cause side effects, although
not
everybody gets them.
IMPORTANT SIDE EFFECTS TO LOOK OUT FOR:
YOU MUST GET URGENT MEDICAL HELP IF YOU HAVE ANY OF THE FOLLOWING
SYMPTOMS. YOU MAY BE HAVING AN ALLERGIC REACTION:
●
YOU HAVE DIFFICULTY BREATHING
●
YOUR FACE OR THROAT SWELL
●
YOUR SKIN DEVELOPS A SEVERE RASH.
OTHER POSSIBLE SIDE EFFECTS:
Any of the problems listed below are more likely if the medicine is
used
for a long time, in large amounts or on skin folds (such as armpits or
under breasts).
These problems are more likely in babies and children.
They are also more likely if the skin is covered with a dressing,
bandage
or nappy.
SKIN PROBLEMS
COMMON SIDE EFFECTS (MAY AFFECT UP TO 1 IN 10 PEOPLE)
●
Application site reaction (including itching, burning and irritation).
UNCOMMON SIDE EFFECTS (MAY AFFECT UPTO 1 IN 100 PEOPLE)
●
Itchy rash and skin inflammation in the area where the medicine is
used
●
Worsening of your eczema.
●
Skin rash
FREQUENCY NOT KNOWN (CANNOT BE ESTIMATED FROM THE AVAILABLE DATA.
●
Blurred vision
Some side effects are known to be caused by hydrocortisone (steroid),
one of the ingredients in Fucidin H Cream. You should tell your doctor
if
any of the side effects occur:
●
Adrenal glands may stop working properly. Signs are tiredness,
depression and anxiety.
●
Glaucoma
●
Thinning of the skin
●
Red spotty rash around the mouth or chin
●
Stretch marks
●
Small veins near the surface of the skin become visible
●
Skin redness
●
Lightening of your skin colour
●
Changes in the growth of your body hair
●
Excessive sweating
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor, pharmacist or nurse.
T

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fucidin H cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fucidin
H cream contains fusidic acid Ph.Eur.2% and hydrocortisone acetate
Ph.Eur.1%.
Excipients with known effect
Butyl hydroxyanisole E320 (40 microgram/g), cetyl alcohol (111 mg/g)
and
potassium sorbate E202 (2.7 mg/g).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream for topical administration
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fucidin H cream is indicated in eczema and dermatitis with secondary
bacterial
infections, including atopic eczema, primary irritant dermatitis and
allergic and
seborrhoeic dermatitis where the organisms responsible are known to be
or
believed to be sensitive to fusidic acid.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and Children:
Uncovered lesions - a small quantity should be applied to the affected
area
twice daily until a satisfactory response is obtained. A single
treatment course
should not normally exceed 2 weeks.
Covered lesions - less frequent applications may be adequate.
4.3
CONTRAINDICATIONS
Hypersensitivity to fusidic acid/sodium fusidate, hydrocortisone
acetate or to any
of the excipients listed in section 6.1.
Due to the content of corticosteroid, Fucidin H cream is
contraindicated in the
following conditions:
Primary skin infections caused by fungi, virus or bacteria, either
untreated or
uncontrolled by appropriate treatment (see section 4.4).
Skin manifestations in relation to tuberculosis, either untreated or
uncontrolled
by appropriate therapy.
Perioral dermatitis and rosacea.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Long-term continuous topical therapy with Fucidin
H cream should be avoided.
Depending on the application site, possible systemic absorption of
hydrocortisone acetate should always be considered during treatment
with
Fucidin
H cream.
Due to the content of corticosteroid, Fucidin H cream should be used
with care
near the eyes. Avoid getting Fucidin H cream into the eyes (see
s