DERMOVATE SCALP APPLICATION

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

CLOBETASOL PROPIONATE

Dostupné z:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC kód:

D07AD01

Forma lieku:

SOLUTION - EXTERNAL

Zloženie:

CLOBETASOL PROPIONATE 0.05 %W/W

Spôsob podávania:

TOPICAL- SCALP

Typ predpisu:

Required

Výrobca:

ASPEN BAD OLDESLOE GMBH, GERMANY

Terapeutické skupiny:

CLOBETASOL

Terapeutické oblasti:

CLOBETASOL

Terapeutické indikácie:

For the topical treatment of inflammatory conditions of the scalp responsive only to corticosteroids.

Dátum Autorizácia:

2015-01-31

Príbalový leták

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a physician’s prescription only
DERMOVATE SCALP APPLICATION
CLOBETASOL PROPIONATE (0.05% W/W)
Each 1 gram contains 0.5 mg clobetasol propionate (0.05% w/w).
The list of additional ingredients is detailed in section 6.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This
leaflet contains concise information about the medicine. If you have
further
questions, refer to the physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them even if it seems to you that their medical condition is
similar.
The medicine is not intended for children under 1 year of age.
1. WHAT IS THE MEDICINE INTENDED FOR?
Dermovate
Scalp
Application
is
used
to
treat
inflammatory
conditions
responsive only to corticosteroids.
It contains a medicine called clobetasol propionate. It belongs to a
group of
medicines called steroids.
THERAPEUTIC GROUP
Corticosteroids
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE:
•
if
you are sensitive (allergic) to clobetasol propionate or to any of the
additional ingredients contained in the medicine, as listed in section
6.
•
if you have a skin infection on the scalp.
•
on ch
ildren under 1 year of age.
Do not use if any of the above apply to you. If you are not sure, talk
to your
physician or pharmacist before using Dermovate Scalp Application.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE TREATMENT WITH DERMOVATE SCALP APPLICATION, TELL THE PHYSICIAN
IF:
•
You experience newly developed bone pain or worsening of previous bone
symptoms during treatment with Dermovate especially if you have been
using Dermovate for a long time or have used it repeatedly.
•
You
use
other
oral/topical
medication
containing
corticosteroids
or
medication intended to regulate your immune system (e.g., for
autoimmune
disease
or
after
a
transplantation).
Combining
Dermovate
with
these
medicines may cause seriou

Súhrn charakteristických

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DERMOVATE SCALP APPLICATION
1.
NAME OF THE MEDICINAL PRODUCT
Dermovate Scalp Application
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 g contains 0.5 mg of clobetasol propionate (0.05% w/w)
3.
PHARMACEUTICAL FORM
Scalp application
4. CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For the topical treatment of inflammatory conditions of the scalp
responsive only to corticosteroids.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
CLOBETASOL PROPIONATE BELONGS TO THE MOST POTENT CLASS OF TOPICAL
CORTICOSTEROIDS (GROUP IV) AND
PROLONGED USE MAY RESULT IN SERIOUS UNDESIRABLE EFFECTS (SEE SECTION
4.4). IF TREATMENT WITH A LOCAL
CORTICOSTEROID IS CLINICALLY JUSTIFIED BEYOND 4 WEEKS, A LESS POTENT
CORTICOSTEROID PREPARATION SHOULD
BE CONSIDERED. REPEATED BUT SHORT COURSES OF CLOBETASOL PROPIONATE MAY
BE USED TO CONTROL
EXACERBATIONS (SEE DETAILS BELOW).
Route of administration: Topical, on the scalp.
Owing to the flammable nature of the product, Dermovate Scalp
Application should be kept away from
open fire and flames and all sources of ignition, including smoking,
during and immediately after use.
ADULTS, ELDERLY AND CHILDREN OVER 1 YEAR
A small quantity of clobetasol should be applied to the scalp night
and morning until improvement is
noticeable. It may then be possible to sustain improvement by applying
once a day, or less frequently.
PAEDIATRIC POPULATION
Children are more likely to develop local and systemic side effects of
topical corticosteroids and, in
general, require shorter courses and less potent agents than adults.
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Care should be taken when using clobetasol propionate to ensure the
amount applied is the minimum
that provides therapeutic benefit.
DURATION OF TREATMENT FOR CHILDREN AND INFANTS
Courses should be limited if possible to a few days and reviewed
weekly.
ELDERLY
Clinical studies have not identified differences in responses between
the elderly and younger patients.
The greater frequency of decreased hepatic or renal function in the
elderly may delay elimination if
systemic