Dovobet 50 microgram/g + 0.5 mg/g Ointment

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Calcipotriol; Betametasone dipropionate

Pieejams no:

B & S Healthcare

ATĶ kods:

D05AX52

SNN (starptautisko nepatentēto nosaukumu):

Calcipotriol; Betametasone dipropionate

Deva:

50 Micrograms/g

Zāļu forma:

Ointment

Receptes veids:

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

Ārstniecības joma:

calcipotriol, combinations

Autorizācija statuss:

Authorised

Autorizācija datums:

2007-01-05

Lietošanas instrukcija

PACKAGE LEAFLET: INFORMATION FOR THE USER
DOVOBET
®
50MICROGRAM/G + 0.5MG/G OINTMENT
(calcipotriol/betamethasone
)
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. 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.
The name of your medicine is Dovobet
®
50microgram/g+0.5mg/g
ointment but will be referred to as Dovobet throughout this leaflet.
WHAT IS 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 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 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 infections caused by a fungus (e.g. athlete’s foot or ringworm)
skin infections

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dovobet 50 microgram/g + 0.5 mg/g Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of ointment contains 50 micrograms of calcipotriol (as
monohydrate), and 0.5 mg of betametasone (as
dipropionate).
Excipient with known effect: butylhydroxytoluene (E321).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment
_Product imported from Italy:_
Off-white to yellow ointment.
4 CLINICAL PARTICULARS
As per PA 1025/001/001.
5 PHARMACOLOGICAL PROPERTIES
As per PA 1025/001/001.
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
liquid paraffin
polyoxypropylene-15-stearyl ether
all-rac-alpha-tocopherol
white soft paraffin
butylhydroxytoluene (E321)
6.2 INCOMPATIBILITIES
In the absence of compatibility studies, this medicinal product must
not be mixed with other medicinal products.
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on
the market in the country of origin.
After first opening of container: 1 year
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
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6.5 NATURE AND CONTENTS OF CONTAINER
The product is presented in a tube with a screw cap contained in an
over-labelled carton.
Tube sizes: 30g and 120 g.
Not