Candiplas H 2%w/w / 1%w/w cream

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Dostupné z:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

ATC kód:

D01AC20

INN (Medzinárodný Name):

MICONAZOLE NITRATE 20 mg HYDROCORTISONE 10 mg

Forma lieku:

CREAM

Zloženie:

MICONAZOLE NITRATE 20 mg HYDROCORTISONE 10 mg

Typ predpisu:

OTC

Terapeutické oblasti:

ANTIFUNGALS FOR DERMATOLOGICAL USE

Prehľad produktov:

Licence number in the source country: NOT APPLICAPABLE

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2022-11-15

Príbalový leták

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CANDIPLAS H CREAM
miconazole nitrate / hydrocortisone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told
you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
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.
-
You must talk to a doctor if you do not feel better or if you feel
worse 3-4 days.
WHAT IS IN THIS LEAFLET
1.
What Candiplas H is and what it is used for
2.
What you need to know before you use Candiplas H
3.
How to use Candiplas H
4.
Possible side effects
5.
How to store Candiplas H
6.
Contents of the pack and other information
1.
WHAT CANDIPLAS H IS AND WHAT IT IS USED FOR
The name of your medicine is Candiplas H cream. Candiplas H cream is a
medicine which is used to
treat inflamed conditions of the skin such as eczema and dermatitis
which may be caused by infection
with certain fungi and bacteria.
The cream contains the following ingredients:
•
Miconazole nitrate - an antifungal which works by destroying both the
fungus that causes the
infection and some of the associated bacteria which may also be
present.
•
Hydrocortisone - a mild ‘topical steroid’ which reduces
inflammation, swelling, redness and
itching of the skin.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CANDIPLAS H
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DO NOT USE CANDIPLAS H
•
If you are allergic to miconazole nitrate, hydrocortisone, any of the
other ingredients of this
medicine (listed in section 6) or to other similar antifungal
medicines.
•
If you have any other skin problems such as cold sores, herpes,
chicken pox or shingles. Only use
it for the skin problem that you showed the doctor.
Do not use this medicine if any of the above applies to you. If you
are not sure,

Súhrn charakteristických

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Candiplas H 2%w/w / 1%w/w cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 g of cream contains miconazole nitrate 2% w/w, equivalent to 20
mg, and hydrocortisone 1%
w/w, equivalent to 10 mg.
Excipients with known effect:
- Cetostearyl alcohol. Each 1 g of Candiplas H cream contains 77 mg
cetostearyl alcohol.
- Chlorocresol. Each 1g of Candiplas H cream contains 1 mg
chlorocresol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream.
White, soft, homogeneous, smooth, odourless cream.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
•
For the topical treatment of inflamed dermatoses where infection by
susceptible organisms and
inflammation co-exist, e.g. intertrigo and infected eczema.
•
Moist or dry eczema or dermatitis including atopic eczema, primary
irritant or contact allergic
eczema or seborrhoeic eczema including that associated with acne.
•
Intertriginous eczema including inflammatory intertrigo, perianal and
genital dermatitis.
Organisms which are susceptible to miconazole are dermatophytes and
pathogenic yeasts (e.g.
_Candida_
spp.). Also many Gram-positive bacteria including most strains of
_Streptococcus_
and
_Staphylococcus_
.
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4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Apply the cream two or three times a day to the affected area, rubbing
in gently until the cream has
been absorbed by the skin.
The properties of Candiplas H cream indicate it particularly for the
initial stages of treatment. Because
of
its
corticosteroid
content
avoid
long-term
treatment
with
Candiplas
H
cream.
Once
the
inflammatory symptoms have disappeared (after about 7 days), treatment
can be continued where
necessary with miconazole nitrate 20 /g cream or powder. Treatment
should be continued without
interruption until the lesion has completely disappeared (usually
after 2 to 5 weeks).
If after about 7 days' application, no improvement has occurred,
cultural isolation of the offending
orga