Dovonex 50micrograms/g ointment

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Calcipotriol

Tilgjengelig fra:

LEO Pharma

ATC-kode:

D05AX02

INN (International Name):

Calcipotriol

Dosering :

50microgram/1gram

Legemiddelform:

Cutaneous ointment

Administreringsrute:

Cutaneous

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 13050200; GTIN: 5702191004298 5702191004304 5702191008395

Informasjon til brukeren

Creation Date:
Revision Date:
Sign:
Sign:
Scale:
OMA
12/09/2016
Ref. No.:
Size:
Material:
Type:
100%
IIE042-00
610 x 350 mm
Insert
PACKAGING COMPONENT SPECIFICATION
Daivonex
®
range - 10 g, 15 g, 30 g, 60 g
Daivobet
®
range - 10 g, 15 g, 30 g, 60 g
Fucidin
®
range - 15 g, 30 g, 60 g
Fucicort
®
range - 15 g, 30 g, 60 g
FRONT OF LEAFLET
IIE042-00 - 13/09/2016 - OMA - New leaflet based on trial 99991530
with new supplier drawing
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IIE042-00 - 610 x 350 mm - page 1
Only to be used together with CIE093 37 x 32 x 120 mm, CIE094 44 x 32
x 140 mm, CIE095 47 x 38 x 160 mm,
PACKAGE LEAFLET: INFORMATION FOR THE USER
DOVONEX
® OINTMENT
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
®
Ointment will 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 yo

Preparatomtale

OBJECT 1
DOVONEX OINTMENT
Summary of Product Characteristics Updated 03-Mar-2015 | Leo
Laboratories Limited
1. Name of the medicinal product
Dovonex
®
* Ointment
2. Qualitative and quantitative composition
Each gram of ointment contains 50 micrograms of calcipotriol.
For excipients, see section 6.1
3. Pharmaceutical form
Ointment
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)
amenable to topical therapy.
4.2 Posology and method of administration
Adults:
Dovonex
®
* Ointment should be applied to the affected area once or twice
daily. For maximum benefit use the ointment twice daily. Maximum
weekly dose should not exceed 100 g.
Children over 12 years:
Dovonex®* Ointment should be applied to the affected area twice
daily.
Maximum weekly dose should not exceed 75 g.
Children aged 6 to 12 years:
Dovonex®* Ointment should be applied to the affected area twice
daily.
Maximum weekly dose should not exceed 50 g.
Children 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.
These dose recommendations are based on extensive experience in
adults. In respect of children, clinical
experience in children has shown Dovonex
®
* to be safe and effective over eight weeks at a mean dose of
15 g per week but with wide variability in dose among patients.
Individual dose requirement depends on
the extent of psoriasis but should not exceed the above
recommendations. There is no experience of use
of Dovonex
®
* in combination with other therapies in children.
4.3 Contraindications
Hypersensitivity to the active substance or 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
Effects on calcium metabolism
Due to th