Dovobet 50 microgram/g + 0.5 mg/g ointment

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Calcipotriol; BETAMETHASONE DIPROPIONATE

Dostopno od:

Imbat Limited

Koda artikla:

D05AX; D05AX03

INN (mednarodno ime):

Calcipotriol; BETAMETHASONE DIPROPIONATE

Odmerek:

50 Micrograms/g

Farmacevtska oblika:

Ointment

Tip zastaranja:

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

Terapevtsko območje:

Other antipsoriatics for topical use; calcitriol

Status dovoljenje:

Authorised

Datum dovoljenje:

2008-01-18

Navodilo za uporabo

_Page 1 of 2 _
PACKAGE LEAFLET: INFORMATION FOR THE USER
DOVOBET
® 50 MICROGRAM/G + 0.5 MG/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.
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 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

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

infections caused by viruses (e.g. cold sores or chicken pox)

infections caused by a fungus (e.g. athlete’s foot or
ringworm)

infections caused by bacteria

infections caused by parasites (e.g. scabies)

tuberculosis (TB) or

Lastnosti izdelka

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 Dovobet contains 50microgram calcipotriol (as hydrate) and
0.5mg betamethasone (as dipropionate).
Excipient with known effects:
Butylhydroxytoluene (E321) 50 micrograms/g ointment
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment
_Product imported from the United Kingdom:_
Off-white to yellow ointment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Topical treatment of stable plaque psoriasis vulgaris amenable to
topical therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dovobet ointment should be applied to the affected area once daily.
The recommended treatment period is 4 weeks.
There is experience with repeated courses of Dovobet up to 52 weeks.
If it is necessary to continue or restart treatment
after 4 weeks, treatment should be continued after medical review and
under regular medical supervision.
When using calcipotriol containing medicinal products, the maximum
daily dose should not exceed 15 g. The body
surface area treated with calcipotriol containing medicinal products
should not exceed 30 % (see section 4.4).
Special populations
_Renal and hepatic impairment_
The safety and efficacy of Dovobet ointment in patients with severe
renal insufficiency or severe hepatic disorders have
not been evaluated.
Paediatric population
The safety and efficacy of Dovobet ointment in children below 18 years
have not been established.
Currently available data in children aged 12 to 17 years are described
in section 4.8 and 5.1 but no recommendation on
a posology can be made.
Method of administration
Dovobet ointment should be applied to the affected area. In order to
achieve optimal effect, it is not recommended to
take a shower or bath immediately after application of Dovobet
ointment.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients.
Dovobet ointment is contraindicated in erythrod