PEVISONE 1MG/G + 10MG/G CREAM

Χώρα: Κύπρος

Γλώσσα: Ελληνικά

Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Δραστική ουσία:

TRIAMCINOLONE ACETONIDE; ECONAZOLE NITRATE

Διαθέσιμο από:

JANSSEN-CILAG INTERNATIONAL NV (0000003494) TURNHOUTSEWEG 30, BEERSE, B-2340

Φαρμακολογική κατηγορία (ATC):

D01AC20

INN (Διεθνής Όνομα):

IMIDAZOLES/TRIAZOLES IN COMBINATION WITH CORTICOSTEROIDS

Φαρμακοτεχνική μορφή:

CREAM

Σύνθεση:

TRIAMCINOLONE ACETONIDE (0000076255) 0.11g; ECONAZOLE NITRATE (0024169026) 1g

Οδός χορήγησης:

TOPICAL USE (X-EXTERNAL USE)

Τρόπος διάθεσης:

Εθνική Διαδικασία

Θεραπευτική περιοχή:

COMBINATIONS

Περίληψη προϊόντος:

Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 1 TUBE X 15 g (980050401) 15 gram(s) - Εγκεκριμένο - Με Ιατρική Συνταγή

Φύλλο οδηγιών χρήσης

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PEVISONE 1 MG/G + 10 MG/G CREAM
triamcinolone acetonide, econazole nitrate
READ 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 have any further questions, ask your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Pevisone is and what it is used for
2.
What you need to know before you use Pevisone cream
3.
How to use Pevisone cream
4.
Possible side effects
5.
How to store Pevisone cream
6.
Contents of the pack and other information.
1.
WHAT PEVISONE IS AND WHAT IT IS USED FOR
Pevisone cream is used as an initial medical treatment of fungal skin
infections. Pevisone cream
contains triamcinolone acetonide, which relieves inflammatory
symptoms. Econazole nitrate
prevents the growth of fungus.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PEVISONE CREAM.
DO NOT USE PEVISONE:
-
if you are allergic to triamcinolone acetonide, econazole nitrate or
any of the other
ingredients of this medicine (listed in section 6)
-
if you have perioral dermatitis (skin inflammation around the mouth)
-
if you have a bacterial or viral skin infection, such as cutaneous
tuberculosis, varicella or
herpes
-
do not use Pevisone cream on a recently vaccinated skin area.
WARNINGS AND PRECAUTIONS
Pevisone cream is meant for external use only.
Keep this cream away from your eyes and mouth.
Discontinue using the product if you develop symptoms suggesting a
hypersensitivity or a
chemical reaction.
This cream contains a corticosteroid (triamcinolone acetonide), so
special caution is advised
-
when this cream is used to treat children, as it is not recommended
for children under the
age o

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
PEVISONE 1 mg/g + 10 mg/g cream
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Triamcinolone acetonide 1 mg/g, econazole nitrate 10 mg/g.
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Cream
_Product description._
A white-coloured cream.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mycotic eczema
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For local skin treatment
Adults and children: Pevisone cream should be applied as a thin layer
to inflamed parts of the
skin in the morning and evening for up to two weeks. Follow-up
treatment can be provided using
an econazole nitrate product, for example. To avoid recurrence, after
the disappearance of visible
symptoms this latter treatment should be continued for a period of no
less than two weeks.
4.3 CONTRAINDICATIONS
Hypersensitivity to one of the active substances or one of the
excipients listed in section 6.1.
Rosacea and perioral dermatitis.
The use of Pevisone cream and other skin products which contain
corticosteroids is contraindicated with
certain skin conditions such as tuberculosis infection, chickenpox,
_herpes simplex_ infection and other
virus infections of the skin, or if applied onto an area of the skin
into which a vaccine has just been
administered.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use only. Pevisone cream must not be used internally.
If considerable irritation or hypersensitivity occurs during
treatment, treatment must be discontinued.
Pevisone Cream_SPC
- 1 -
Strong corticoids should be used only temporarily to treat the
axillas, anogenital and other intertriginous
areas and areas around the eyes.
Corticosteroids that are applied to the skin are absorbed in a
capacity sufficient to cause systemic effects,
such as suppression of the adrenal gland. Systemic absorption may
increase due to multiple alternative
reasons, such as when the cream is used to treat large skin regions,
damaged skin regions, regions under
occlusion dressings, or when