Daivobet 50 micrograms/0.5 mg/g ointment

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BETAMETHASONE DIPROPIONATE, CALCIPOTRIOL MONOHYDRATE

Available from:

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

ATC code:

D05AX52

INN (International Name):

BETAMETHASONE DIPROPIONATE 0.5 mg/g CALCIPOTRIOL MONOHYDRATE 50 µg/g

Pharmaceutical form:

OINTMENT

Composition:

BETAMETHASONE DIPROPIONATE 0.5 mg/g CALCIPOTRIOL MONOHYDRATE 50 µg/g

Prescription type:

POM

Therapeutic area:

ANTIPSORIATICS

Authorization status:

Authorised

Authorization date:

2005-10-11

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
DAIVOBET 50 MICROGRAMS/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 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.
WHAT IS IN THIS LEAFLET
1.
What Daivobet
is and what it is used for
2.
What you need to know before you use Daivobet
3.
How to use Daivobet
4.
Possible side effects
5.
How to store Daivobet
6.
Contents of the pack and other information
1.
WHAT DAIVOBET IS AND WHAT IT IS USED FOR
Daivobet 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.
Daivobet 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 DAIVOBET
DO NOT USE DAIVOBET
•
If you are allergic (hypersensitive) to calcipotriol, betamethasone or
any of the other
ingredients of this medicine (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 Daivobet 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 and
ringworm)
•
Skin infections caused by bacteria
•
Skin infections caus

Summary of Product characteristics

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1.
NAME OF THE MEDICINAL PRODUCT
Daivobet 50 micrograms/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
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.
Off-white to yellow.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Topical treatment of stable plaque psoriasis vulgaris amenable to
topical therapy in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Daivobet ointment should be applied to the affected area once daily.
The recommended treatment
period is 4 weeks. There is experience with repeated courses of
Daivobet 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 Daivobet ointment in patients with severe
renal insufficiency or severe
hepatic disorders have not been evaluated.
Paediatric population
The safety and efficacy of Daivobet 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
Daivobet 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
Daivobet ointment.
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4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
Daivobet is contraindicated in erythrodermic, e