Dermovate cream

Valsts: Armēnija

Valoda: angļu

Klimata pārmaiņas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktīvā sastāvdaļa:

clobetasol (clobetasol propionate)

Pieejams no:

Delpharm Poznan Spolka Akcyjna

ATĶ kods:

D07AD01

SNN (starptautisko nepatentēto nosaukumu):

clobetasol (clobetasol propionate)

Deva:

0,5mg/g

Zāļu forma:

cream

Vienības iepakojumā:

aluminium tube 25g

Receptes veids:

Prescription

Autorizācija statuss:

Registered

Autorizācija datums:

2023-06-21

Lietošanas instrukcija

PACKAGE LEAFLET: INFORMATION FOR THE USER
DERMOVATE CREAM
DERMOVATE OINTMENT
_Clobetasol propionate _
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.
WHAT IS IN THIS LEAFLET:
1 What Dermovate is and what it is used for
2 What you need to know before you use Dermovate
3 How to use Dermovate
4 Possible side effects
5 How to store Dermovate
6 Contents of the pack and other information
1.
WHAT DERMOVATE IS AND WHAT IT IS USED FOR
Dermovate contains a medicine called clobetasol propionate. It belongs
to a group of medicines called
steroids. It helps to reduce swelling and irritation.
Dermovate is used to help reduce the redness and itchiness of certain
skin problems. These skin
problems include:
•
frequently relapsing eczema
•
psoriasis (thickened patches of inflamed, red skin, often covered by
silvery scales), excluding
widespread plaque psoriasis
•
lichen planus (a skin disease that causes itchy, reddish-purple,
flat-topped bumps on the
wrists, forearms or lower legs)
•
discoid lupus erythematosus (a disease of the skin most often
affecting the face, ears and scalp
causing scarring and increased sensitivity of the affected skin to
sunlight)
•
dermatitis and other skin conditions that have not responded to milder
steroid creams or
ointments.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE DERMOVATE
Do not use Dermovate:
•
if you are allergic (hypersensitive) to clobetasol propionate or any
of the other ingredients of
this medicine (listed in Section 6)
•
on a child under 1 year of age
•
to treat any of the following skin pr

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dermovate Cream
Dermovate Ointment
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
CREAM:
Clobetasol propionate 0.0525% w/w
Excipients with known effect:
Cetosteryl alcohol
Clorocresol
Propylene glycol
OINTMENT:
Clobetasol 17-propionate 0.05375% w/w
Excipients with known effect:
Propylene Glycol
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Cream
Ointment
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clobetasol is a very potent topical corticosteroid indicated for
adults, elderly and children
over 1 year for the short term treatment only of more resistant
inflammatory and pruritic
manifestations of steroid responsive dermatoses unresponsive to less
potent corticosteroids.
These include the following:
•
Psoriasis (excluding widespread plaque psoriasis)
•
Recalcitrant dermatoses
•
Lichen planus
•
Discoid lupus erythematosus
•
Other skin conditions which do not respond satisfactorily to less
potent steroids.
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:
Cutaneous
Ointments are especially appropriate for dry, lichenified or scaly
lesions.
Creams are especially appropriate for moist or weeping surfaces.
ADULTS, ELDERLY AND CHILDREN OVER 1 YEAR
Apply thinly and gently rub in using only enough to cover the entire
affected area once or
twice a day until improvement occurs (in the more responsive
conditions this may be within a
few days), then reduce the frequency of application or change the
treatment to a less potent
preparation. Allow adequate time for absorption after each ap