Dovonex Psoriasis 50 microgram/g ointment

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Calcipotriol, anhydrous

Saadav alates:

Leo Laboratories Limited

ATC kood:

D05AX; D05AX02

INN (Rahvusvaheline Nimetus):

Calcipotriol, anhydrous

Annus:

50 microgram per gram

Ravimvorm:

Ointment

Retsepti tüüp:

Product not subject to medical prescription

Terapeutiline ala:

Other antipsoriatics for topical use; calcipotriol

Volitamisolek:

Authorised

Loa andmise kuupäev:

2016-04-08

Infovoldik

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DOVONEX
® PSORIASIS 50 MICROGRAM/G OINTMENT
CALCIPOTRIOL
WHAT IS IN THIS LEAFLET
1.
What Dovonex
®
Psoriasis is and what
it is used for
2.
What you need to know before you
use Dovonex
®
Psoriasis
3.
How to use Dovonex
®
Psoriasis
4.
Possible side effects
5.
How to store Dovonex
®
Psoriasis
6.
Contents of the pack and other
information
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START USING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described
in this leaflet or as your 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.

In this leaflet Dovonex
®
Psoriasis
50 microgram/g ointment will be called
Dovonex Psoriasis.

YOU MUST TALK TO YOUR DOCTOR IF YOU DO
NOT SEE ANY IMPROVEMENT IN YOUR
PSORIASIS AFTER 4 WEEKS.
1. WHAT DOVONEX
® PSORIASIS IS AND WHAT IT IS USED FOR
Dovonex Psoriasis contains the active substance calcipotriol. This
medicine belongs to a group of
medicines called anti-psoriatics. It is a type of vitamin D_._ Vitamin
D controls how the cells in your skin
grow.
THIS MEDICINE IS USED IN ADULTS TO TREAT:
Mild or moderate plaque psoriasis (psoriasis vulgaris) which has been
previously diagnosed by a
doctor. Psoriasis is mild or moderate when it affects an area of skin
no bigger than the skin surface on
one of your arms.
If the cells in your skin grow too much you may get psoriasis.
Psoriasis is a condition where your skin
develops raised red patches and silver coloured scaly patches. The
scaly patches are dead cells that
would normally fall off your skin without you noticing.
Dovonex Psoriasis works by reducing the amount of cells your skin
makes. This means your skin
symptoms will reduce too.
These diagrams explain how your skin may improve

Toote omadused

Health Products Regulatory Authority
30 June 2020
CRN009Q0J
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dovonex Psoriasis 50 microgram/g ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of ointment contains 50 micrograms of calcipotriol.
Excipient with known effect
Contains propylene glycol 100 mg/g.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment
Off-white to yellowish-white translucent ointment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dovonex Psoriasis 50 microgram/g ointment is indicated for topical
treatment of adults with mild to moderate plaque psoriasis
which has been previously diagnosed by a doctor.
Plaque psoriasis (well defined, thickened, scaly, red lesions on trunk
and/or limbs) is mild to moderate when the area affected
does not exceed 10% of body surface area (for guidance purposes, the
body surface area of an arm is approximately 9%).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults (18 years or older):
Dovonex Psoriasis 50 microgram/g ointment should be applied to the
affected area once daily. The maximum weekly dose
should not exceed 100 g.
Dovonex Psoriasis 50 microgram/g ointment should not be used in
children and adolescents aged less than 18 years as
supervision by a doctor is needed in these age‑groups (see section
4.4 for further information).
Method of administration
Topical use.
Dovonex Psoriasis 50 microgram/g ointment should not be applied to the
face, scalp, flexures or genital area.
The patient must be instructed in correct use of the product to avoid
accidental transfer to the face and eyes. Hands must be
washed after each application to avoid accidental transfer to these
areas.
It is not recommended to take a shower or bath immediately after
application of Dovonex Psoriasis 50 microgram/g ointment.
For advice about duration of treatment, see section 4.4.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Health Products Regulat