Dovobet® 50 microgram/g + 0.5 mg/g ointment

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Calcipotriol; Betamethasone

Available from:

LEO Pharma A/S

ATC code:

D05AX; D05AX52

INN (International Name):

Calcipotriol; Betamethasone

Dosage:

50 mcg/g +0.5 milligram(s)/gram

Pharmaceutical form:

Ointment

Prescription type:

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

Therapeutic area:

Other antipsoriatics for topical use; calcipotriol, combinations

Authorization status:

Not marketed

Authorization date:

2002-02-08

Patient Information leaflet

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 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 Dovobet® is and what it is 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 IT IS 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 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 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 caused by bacteria

skin infections caused by par

Summary of Product characteristics

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 0.5mg 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
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.
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