Daivonex

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CALCIPOTRIOL

Available from:

LEO Pharma A/S Industriparken 55, 2750-DK Ballerup, Denmark

ATC code:

D05AX02

INN (International Name):

CALCIPOTRIOL 50 µg/g

Pharmaceutical form:

CREAM

Composition:

CALCIPOTRIOL 50 µg/g

Prescription type:

POM

Therapeutic area:

ANTIPSORIATICS

Authorization status:

Withdrawn

Authorization date:

2005-09-07

Patient Information leaflet

10 mm (minimum 5 mm)
145 mm
148 mm
10 mm
10 mm (minimum 5 mm)
LEO
Pharma-
code
10 mm
50 mm
80 mm
000000-00
DAIVONEX
®
CREAM
In this leaflet:
1. What Daivonex
®
cream is and what it is
used for
2. Before you use Daivonex
®
cream
3. How to use Daivonex
®
cream
4. Possible side effects
5. How to store Daivonex
®
cream
DAIVONEX
®
CREAM
Active substance: Calcipotriol 50 micrograms/g
Other ingredients: Disodium edetate, disodium
phosphate dihydrate, liquid paraffin, white soft
paraffin, glycerol (85 per cent), macrogol
cetostearyl ether, cetostearyl alcohol, chloro-
allylhexaminium chloride, sodium hydroxide
and purified water
PRESENTATION AND CONTENTS
Tubes containing 30 g of cream
MARKETING AUTHORISATION HOLDER
LEO Pharmaceutical Products
Industriparken 55, DK-2750 Ballerup, Denmark
MANUFACTURER
LEO Laboratories Ltd.
285 Cashel Road, IRL-Dublin 12, Ireland
1. WHAT DAIVONEX
®
CREAM IS AND WHAT IT IS
USED FOR
You use the cream on your skin to treat a 
certain type of psoriasis (plaque psoriasis).
Psoriasis is when your skin cells are being
produced too quickly. This causes scaling and
redness. Daivonex
®
cream helps bring the rate
at which your skin cells are produced back to
normal.
2. BEFORE YOU USE DAIVONEX
®
CREAM
DAIVONEX
®
CREAM MUST NOT BE USED
• if you have a hypersensitivity to one of the
ingredients.
• if you or your doctor knows you have
problems with your calcium levels.
SPECIAL CARE SHOULD BE TAKEN WHEN USING 
DAIVONEX
®
CREAM:
Wash your hands after you have used the
cream, unless you are using the cream to treat
psoriasis on your hands.
Try not to transfer the cream from the areas
you have treated to other areas of your body,
especially your face.
Use should be avoided if you have severe kid-
ney or liver problems.
PREGNANCY AND BREAST-FEEDING
Ask your doctor or pharmacist for advice 
before taking any medicine.
DRIVING AND USING MACHINES
Daivonex“ cream has no influence on the 
ability to drive and to use machines.
IMPORTANT INFORMATION ABOUT SOME OF THE
INGREDIENTS OF DAIVONEX
�

Summary of Product characteristics

Page 1 of 5 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. NAME OF THE MEDICINAL PRODUCT 
Daivonex
®
, 50 micrograms per gram cream. 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
Calcipotriol, 50 micrograms per gram (as hydrate). 
For excipients, see 6.1. 

3. PHARMACEUTICAL FORM 
Cream. 
A white homogeneous cream. 

4. CLINICAL PARTICULARS 

4.1 Therapeutic Indications 
Treatment of psoriasis vulgaris. 

4.2 Posology and Method of Administration  
Adults 
The cream should be applied to the affected area once
to twice daily. Twice daily 
application is often preferred initially. Application of
the cream can be reduced to once 
daily when appropriate. 

The maximum weekly dose should not exceed 100 g of cream. When
cream, ointment or scalp 
solution are used together, the total dose of calcipotriol
should not exceed 5 mg per 
week. 

Children 
There is no experience of the use of Daivonex
®
 cream in children. 

4.3 Contraindications  
Known hypersensitivity to any of the ingredients.  

Due to the content of calcipotriol, Daivonex
®
 is contraindicated in patients with known disorders of 
calcium metabolism.   

4.4 Special Warning and Precautions for Use  
The cream should not be used on the face. The
patient must be instructed on the correct 
use of the product to avoid application and accidental transfer
to the face. Hands must be 
washed after each application. Use of Daivonex
®
 should be avoided in patients with  
Page 2 of 5 
severe renal insufficiency or severe hepatic disorders. 

The risk of hypercalcaemia is minimal
when the dosage recommendations are followed.  
Hypercalcaemia may occur if the maximum weekly dose (100g of
cream) is exceeded. 
This is, however, quickly normalised when treatment is
discontinued. 

4.5 Interaction with Other Medicinal Products and Other Forms of
Interaction  
None known. 

4