Silkis 3 micrograms per g ointment

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Calcitriol

Beszerezhető a:

Galderma International

ATC-kód:

D05AX; D05AX03

INN (nemzetközi neve):

Calcitriol

Adagolás:

3 microgram per gram

Gyógyszerészeti forma:

Ointment

Terápiás terület:

Other antipsoriatics for topical use; calcitriol

Engedélyezési státusz:

Marketed

Engedély dátuma:

2006-07-07

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE USER
SILKIS 3 MICROGRAMS/G OINTMENT
Calcitriol
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.
-
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. 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
treatment

Termékjellemzők

Health Products Regulatory Authority
11 January 2023
CRN00DCRX
Page 1 of 5
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 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 lesi