Dovonex 50 micrograms/g Cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Calcipotriol hydrate

Available from:

Leo Laboratories Limited

ATC code:

D05AX; D05AX02

INN (International Name):

Calcipotriol hydrate

Dosage:

50 microgram per gram

Pharmaceutical form:

Cream

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other antipsoriatics for topical use; calcipotriol

Authorization status:

Marketed

Authorization date:

1994-03-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DOVONEX
® 50 MICROGRAMS/G CREAM
calcipotriol
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, pharmacist or
nurse.

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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.

In this leaflet, Dovonex
®
cream will sometimes be called Dovonex.
WHAT IS IN THIS LEAFLET
1.
What Dovonex
®
is and what it is used for
2.
What you need to know before you use Dovonex
®
3.
How to use Dovonex
®
4.
Possible side effects
5.
How to store Dovonex
®
6.
Contents of the pack and other information
1.
WHAT DOVONEX
® IS AND WHAT IT IS USED FOR
Dovonex contains the active substance calcipotriol. Dovonex 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.
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 works by reducing the amount of cells your skin makes. This
means your symptoms
will reduce too. You may begin to see an improvement in two to four
weeks.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DOVONEX
®
DO NOT USE DOVONEX:

If you are allergic (hypersensitive) to calcipotriol or any of the
other ingredients of this
medicine (listed in section 6).

If you have been told by your doctor that you may have high or low
levels of a substance
called calcium in your body (calcium metabolism disorders).
WARNINGS AND PRECAUTIONS:
Talk to your doctor, pharmacist or

Summary of Product characteristics

Health Products Regulatory Authority
15 November 2019
CRN009G88
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dovonex 50 micrograms/g Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 50 micrograms of calcipotriol (as the
hydrate).
Excipient(s) with known effect:
Contains cetostearyl alcohol.
Contains diazolidinyl urea 3 mg/g.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
Soft, white cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dovonex Cream is indicated for the topical treatment of plaque
psoriasis (psoriasis vulgaris). Dovonex Cream may also be used
in combination with topical corticosteroids.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS:
The cream should be applied to the affected area once to twice daily.
Twice daily application of the cream is often preferred
initially.
Application of the cream can be reduced to once daily when
appropriate. Maximum weekly dose shouldnot exceed 100g.
Dovonex Cream in combination with corticosteroids (e.g.administration
of Dovonex in the morning and steroid in the evening)
is effective and well tolerated.
PAEDIATRIC POPULATION
OVER 12 YEARS:
Dovonex Cream should be applied to the affected area twice daily.
Maximum weekly dose should not exceed 75g.
AGED6TO12YEARS:
Dovonex Cream should be applied to the affected area twice daily.
Maximum weekly dose should not exceed 50g.
UNDER6YEARS:
There is limited experience of the use of Dovonex Cream in this age
group. A maximum safe dose has not been established.
There is no experience of use of Dovonex in combination with other
psoriasis therapies in children.
Health Products Regulatory Authority
15 November 2019
CRN009G88
Page 2 of 6
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Due to the content of calcipotriol Dovonex is contraindicated in
patients with known disorders of calcium metabolism (see
section 4.4).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Effe