Dovonex 50 microgram/g Ointment

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Calcipotriol, anhydrous

Available from:

Leo Laboratories Limited

ATC code:

D05AX; D05AX02

INN (International Name):

Calcipotriol, anhydrous

Dosage:

50 microgram per gram

Pharmaceutical form:

Ointment

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:

1991-02-25

Patient Information leaflet

IIE007-01 - 175 x 280 mm
175 mm
280 mm
Calcipotriene. Conoptal
®
,
Daivonex
®
,
Dovonex
®
, Daivobet
®
, Dovobet
®
Taclonex
®
,
Psorcutan
®
, Token
®
,
Fucidin
®
, Fucidin
®
H, Fucicort
®
,
Fucibet
®
, Fucithalmic
®
, Isathal
®
,
Isathalmic
®
, Verutex
®
, Verutex
®
B
1 column and 2 columns
PackRat approved
Comments:
INS007-00 - 22/09/2017 DVR - Moved details about itemnumber
IIE007-01 - 03/06/2018 - OMA - Updated for CI project (CAPA 173674),
changed reference from INS005 to IIE005-01
Revision info:
Used for:
OMA
11/06/2018
Insert
175 x 280mm
IIE007-01
20/01/2004
PSR
100%
065931-XX
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
®
50 microgram/g Ointment will sometimes be called Dovonex.
PACKAGE LEAFLET: INFORMATION FOR THE USER
DOVONEX
® 50 MICROGRAM/G OINTMENT
calcipotriol
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.
Dovonex is used to treat:
• Plaque psoriasis (psoriasis vulgaris).
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

Summary of Product characteristics

Health Products Regulatory Authority
25 May 2020
CRN009Q0D
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dovonex 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.
An off-white to yellowish white translucent ointment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dovonex Ointment is indicated for the topical treatment of plaque
psoriasis (psoriasis vulgaris). Dovonex Ointment may also
be used in combination with acitretin, ciclosporin or topical
corticosteroids.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS:
The ointment should be applied to the affected area once to twice
daily. Twice daily application of the ointment is often
preferred initially. Application of the ointment can be reduced to
once daily when appropriate. Maximum weekly dose should
not exceed 100g.
Twice daily application of Dovonex in combination with ciclosporin or
acitretin and once daily application of Dovonex in
combination with corticosteroids (e.g. administration of Dovonex in
the morning and steroid in the evening) is effective and
well tolerated.
The addition of Dovonex twice daily will enhance the efficacy and
reduce the dosage of ciclosporin and acitretin.
_PAEDIATRIC POPULATION _
OVER 12 YEARS: Dovonex Ointment should be applied to the affected area
twice daily. Maximum weekly dose should not
exceed 75 g.
AGED 6 TO 12 YEARS: Dovonex Ointment should be applied to the affected
area twice daily. Maximum weekly dose should not
exceed 50 g.
UNDER 6 YEARS: There is limited experience of the use of Dovonex
Ointment in this age group. A maximum safe dose has not
been established.
METHOD OF ADMINISTRATION
For cutaneous use.
Health Products Regulatory Authority
25 May 2020
CRN009Q0D
Page 2 of 6
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the ex