DOVOBET OINTMENT 50 Microgram Ointment

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

CALCIPOTRIOL, BETAMETHASONE

Prieinama:

IMED Healthcare Ltd.

ATC kodas:

D05AX52

INN (Tarptautinis Pavadinimas):

CALCIPOTRIOL, BETAMETHASONE

Dozė:

50 Microgram

Vaisto forma:

Ointment

Recepto tipas:

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

Gydymo sritis:

Other antipsoriatics for topical use

Autorizacija statusas:

Authorised

Leidimo data:

2009-05-08

Pakuotės lapelis

PACKAGE LEAFLET INFORMATION FOR THE USER
: 
DOVOBET 50 
MICROGRAMS/G + 0.5 MG/G OINTMENT

Calcipotriol/betamethasone 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. 


Keep this leaflet. You may need to read it again. 


If you have any further questions, ask your doctor or
pharmacist. 


This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if 
their symptoms 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: 
1. WHAT DOVOBET IS AND WHAT IS IT USED FOR? 
2. WHAT YOU NEED TO KNOW BEFORE YOU USE DOVOBET 
3. HOW TO USE DOVOBET 
4. POSSIBLE SIDE EFFECTS 
5. HOW TO STORE DOVOBET 
6. CONTENTS OF THE PACK AND OTHER INFORMATION 

1. WHAT DOVOBET IS AND WHAT IS IT USED FOR?  
Dovobet ointment is used on the skin to treat plaque
psoriasis (psoriasis vulgaris) in adults. Psoriasis is 
caused by your skin cells being produced too
quickly. This causes redness, scaling and thickness of your 
skin. 
Dovobet ointment contains calcipotriol and betamethasone.
Calcipotriol helps to bring the rate of skin cell 
growth back to normal and betamethasone acts to reduce
inflammation. 

2. WHAT YOU NEED TO KNOW BEFORE YOU USE DOVOBET 
DO NOT USE DOVOBET: 


If you are allergic (hypersensitive) to calcipotriol, betamethasone
or any of the other ingredients of 
Dovobet. (listed in section 6) 


If you have problems with calcium levels in the body (ask your
doctor) 


If you have certain types of psoriasis: these are erythrodermic,
exfoliative and pustular (ask your 
doctor). 

AS DOVOBET CONTAINS A STRONG STEROID DO NOT USE ON SKIN
AFFECTED BY:  


Skin infections caused by viruses (e.g. cold sores or chicken
pox) 


Skin i

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dovobet 50 microgram/g + 0.5 mg/g ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of ointment contains 50 micrograms calcipotriol (as monohydrate), and 0.5mg of betamethasone (as
dipropionate).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment
_Product imported from the UK:_
Off-white to yellow.
4 CLINICAL PARTICULARS
As per PA1025/001/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1025/001/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Liquid paraffin
Polyoxypropylene stearyl ether
All-rac- -tocopherol
White soft paraffin
Butylhydroxytoluene (E321)
6.2 INCOMPATIBILITIES
In the absence of compatability studies, this medicinal product must not be mixed with other medicinal products.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the container and outer package of the product on the
market in the country of origin.
Shelf life after first opening is 1 year.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25
°
C.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 17/05/2016_
_CRN 2175045_
_page number: 1_
6.5 NATURE AND CONTENTS OF CONTAINER
Aluminium/epoxyphenol tubes with polyethylene screw cap in an over labelled outer container
Tube size: 120g
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
iMed Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/022/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE