Silkis 3 micrograms per g ointment

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Calcitriol

Tersedia dari:

Galderma (UK) Ltd

Kode ATC:

D05AX; D05AX03

INN (Nama Internasional):

Calcitriol

Dosis:

3 microgram(s)

Bentuk farmasi:

Ointment

Jenis Resep:

Product subject to prescription which may be renewed (B)

Area terapi:

Other antipsoriatics for topical use; calcitriol

Status otorisasi:

Marketed

Tanggal Otorisasi:

2006-07-07

Selebaran informasi

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.
WHAT IS 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 allergic to calcitriol or to any of the other
ingredients of this medicine (listed in section 6).
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 allergic reaction occur, the
treat

Karakteristik produk

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_
There is no experience of the use of Silkis in children (see 4.4.
Special Warnings and Precautions for Use).
_Special population_
Patients with kidney or liver dysfunction should not use Silkis (see
also 4.3. Contra-indications).
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section 6.1.
Patients on systemic treatment of calcium homeostasis.
Patients with kidney or liver dysfunction.
Patients with hypercalcaemia and patients known to suffer from
abnormal calcium metabolism.
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 body
surface should be exposed to daily treatment. Not
more than 30g of ointment should be used per day.
Due to potential effects on calcium metabolism