Silkis ointment

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Calcitriol

Beszerezhető a:

Waymade Healthcare Plc

ATC-kód:

D05AX03

INN (nemzetközi neve):

Calcitriol

Adagolás:

3microgram/1gram

Gyógyszerészeti forma:

Cutaneous ointment

Az alkalmazás módja:

Cutaneous

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 13050200

Betegtájékoztató

O I
N T M E N T
C A L
C I
T R I
O L
3 M I C RO G R A M S / G
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 or pharmacist.
•
This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
IN THIS LEAFLET:
1.
What SILKIS is and what it is used for
2.
What you need to know before you use SILKIS
3.
How to use SILKIS
4.
Possible side effects
5.
How to store SILKIS
6.
Contents of the pack and other information
1.
WHAT SILKIS IS AND WHAT IT IS USED FOR
SILKIS is used for the topical treatment of mild to moderately
severe plaque psoriasis with up to one third of body surface
area involvement.
It contains an active ingredient, calcitriol (a vitamin D derivate),
which inhibits and normalizes the unrestrained cell growth
in psoriasis affected skin.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SILKIS
DO NOT USE SILKIS:
•
if you are treated by systemic (oral) route for a calcium deficiency
•
if you have a kidney or liver disease
•
if you have high blood calcium levels or if you suffer from
abnormal calcium metabolism
•
if you are hypersensitive (allergic) to calcitriol or to any of
the other ingredients of Silkis
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Silkis.
•
Carefully apply the ointment to the face, since it has a
greater risk of irritation. Avoid contact with the eyes.
•
After using the ointment, wash your hands to prevent
unintentional spread to non-affected zones.
•
Due to a potential effect on calcium metabolism, the ointment
may not be applied under an occlusive wound dressing.
•
In case of severe irritation or hypersensitive reaction occur,
the treatment should be

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Silkis 3 micrograms per g ointment
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of ointment contains 3 micrograms of calcitriol (INN).
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Ointment
White, translucent ointment
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Silkis is indicated in topical treatment of mild to moderately severe
plaque
psoriasis
(psoriasis
vulgaris)
with
up
to
35%
of
body
surface
area
involvement.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Silkis Ointment should be applied to the psoriasis affected areas
twice per day, once
in the morning and once in the evening before retiring and after
washing. It is
recommended that not more than 35% of the body surface be exposed to
daily
treatment. Not more than 30 g of ointment should be used per day.
There is limited
clinical experience available for the use of this dosage regimen of
more than 6 weeks.
_Paediatric population _
The safety and efficacy of Silkis in children less than 18 years have
not been
established. Currently available data are described in sections 4.4,
5.1 and 5.3 but no
recommendation on a posology can be made.
_Special population _
Patients with kidney or liver dysfunction should not use Silkis (see
also 4.3.
Contraindications).
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance(s) or to any of the
excipients
listed in section 6.1.
•
Patients with kidney or liver dysfunction.
•
Patients with hypercalcaemia and patients known to suffer from
abnormal calcium metabolism.
•
Patients with known hypersensitivity to the active substance or to any
of the excipients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The ointment can be applied to the face with caution, as there is an
increased risk of
irritation in this area. Contact with the eyes should be avoided. The
hands should be
washed after applying the ointment in order to avoid unintentional
application to non
lesional areas. Not more than 35% of the bod