Xamiol 50 micrograms/g + 0.5 mg/g gel

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Calcipotriol; Betamethasone

Disponível em:

LEO Pharma A/S

Código ATC:

D05AX; D05AX52

DCI (Denominação Comum Internacional):

Calcipotriol; Betamethasone

Dosagem:

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

Forma farmacêutica:

Gel

Tipo de prescrição:

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

Área terapêutica:

Other antipsoriatics for topical use; calcipotriol, combinations

Status de autorização:

Not marketed

Data de autorização:

2008-09-12

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER XAMIOL
®
50 MICROGRAMS/G + 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 this medicine_ _(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)
■

Características técnicas

Health Products Regulatory Authority
21 November 2019
CRN0098YV
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xamiol 50 micrograms/g + 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.
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 op