Xamiol gel

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Betamethasone dipropionate; Calcipotriol monohydrate

Beschikbaar vanaf:

LEO Pharma

ATC-code:

D05AX52

INN (Algemene Internationale Benaming):

Betamethasone dipropionate; Calcipotriol monohydrate

Dosering:

500microgram/1gram ; 50microgram/1gram

farmaceutische vorm:

Cutaneous gel

Toedieningsweg:

Cutaneous

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 13050200; GTIN: 5702191007473

Bijsluiter

3. HOW TO USE XAMIOL
®
Always use Xamiol
®
exactly as your doctor has told
you. You should check with your doctor or pharmacist
if you are not sure.
How to put on Xamiol
®
: Cutaneous use. Medicine
only to be used on scalp.
Instructions for proper use
• Use only on your psoriasis on the scalp and do not
use on skin which does not have psoriasis
• Washing your hair before application of Xamiol
®
is
not necessary
• Shake the bottle before use and remove the cap
• Before applying Xamiol
®
to the scalp, comb the
hair to remove any loose scales. Tilt your head to
make sure Xamiol
®
does not run onto your face. It
may help to part your hair before you use Xamiol
®
.
Apply Xamiol
®
to the affected area with your
fingertips, and rub it in gently
• Usually an amount between 1 g and 4 g per day is
sufficient for treatment of the scalp (4 g corresponds
to one teaspoon)
• Do not bandage, tightly cover or wrap the treated
skin area
• Wash your hands well after using Xamiol
®
. This
will avoid accidentally spreading the gel to other
parts of your body (especially the face, mouth and
eyes)
• Do not worry if some gel accidentally gets on normal
skin near your psoriasis, but wipe it off if it spreads
too far
• In order to achieve optimal effect, it is recommended
that the hair is not washed immediately after
application of Xamiol
®
. Let Xamiol
®
remain on the
scalp during the night or during the day.
• After applying the gel, avoid contact with textiles
which are easily stained by grease (e.g. silk).
Duration of treatment
• Use the gel once a day. It may be more convenient
to use the gel in the evening
• The normal initial treatment period is 4 weeks
• Your doctor may decide on a different treatment
period
• Your doctor may decide on repeated treatment
• Do not use more than 15 grams in one day.
All the affected areas may be treated with Xamiol
®
.
However, if you also use other calcipotriol containing
medicines, the total amount of calcipotriol medicines
must not exceed 15 grams per day

Productkenmerken

OBJECT 1
XAMIOL GEL
Summary of Product Characteristics Updated 16-Apr-2012 | Leo
Laboratories Limited
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Xamiol 50 microgram/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: 160 micrograms butylated hydroxytoluene/g gel
For a 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 contain