Xamiol 50mcg/0.5mg/g gel

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Ingredient activ:

BETAMETHASONE DIPROPIONATE, CALCIPOTRIOL

Disponibil de la:

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

Codul ATC:

D05AX52

INN (nume internaţional):

BETAMETHASONE DIPROPIONATE 0.5 mg/g CALCIPOTRIOL 50 µg/g

Forma farmaceutică:

GEL

Compoziție:

BETAMETHASONE DIPROPIONATE 0.5 mg/g CALCIPOTRIOL 50 µg/g

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

ANTIPSORIATICS

Statutul autorizaţiei:

Withdrawn

Data de autorizare:

2010-08-10

Prospect

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
XAMIOL 50 MICROGRAMS/0.5 MG/G GEL
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 Xamiol is and what it is used for
2.
What you need to know before you use Xamiol
3.
How to use Xamiol
4.
Possible side effects
5.
How to store Xamiol
6.
Contents of the pack and other information
1.
WHAT XAMIOL IS AND WHAT IT IS USED FOR
Xamiol is used as topical treatment of scalp psoriasis in adults.
Psoriasis is caused by your
skin cells being produced too quickly. This causes redness, scaling
and thickness of your skin.
Xamiol 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 XAMIOL
DO NOT USE XAMIOL:

if you_ _are allergic (hypersensitive)_ _to calcipotriol,
betamethasone or any of the other
ingredients of Xamiol (listed in section 6)_ _

if you have problems with calcium levels in your body (ask your
doctor)

if you_ _have certain types of psoriasis: these are erythrodermic,
exfoliative and pustular
(ask your doctor).
As Xamiol contains a strong steroid, do NOT use it 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 parasites (e.g. scabies)

tuberculosis (TB)

perioral de

Caracteristicilor produsului

Page 1 of 9
1.
NAME OF THE MEDICINAL PRODUCT
Xamiol 50 micrograms/0.5 mg/g gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of gel contains 50 micrograms of calcipotriol (as
monohydrate) and 0.5 mg of
betamethasone (as dipropionate).
_ _
Excipient with known effect
Butylhydroxytoluene (E321) 160 micrograms/g gel
_ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gel.
An almost clear, colourless to slightly off-white gel.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Topical treatment of scalp psoriasis in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Xamiol gel should be applied to affected areas once daily. The
recommended treatment period
is 4 weeks. If it is necessary to continue or restart treatment after
this period, 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).
All the affected scalp areas may be treated with Xamiol gel. Usually
an amount between 1 g
and 4 g per day is sufficient for treatment of the scalp (4 g
corresponds to one teaspoon).
Special populations
_Renal and hepatic impairment _
The safety and efficacy of Xamiol gel in patients with severe renal
insufficiency or severe
hepatic disorders have not been evaluated._ _
_Paediatric population _
The safety and efficacy of Xamiol gel 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.
Page 2 of 9
Method of administration
The bottle should be shaken before use and Xamiol gel applied to the
affected area. Xamiol
gel should not be applied directly to the face or eyes. The hands
should be washed after use.
In order to achieve optimal effect, it is not recommended to wash the
hair immediately after
app