Package leaflet: Information for the user

Silkis 3 micrograms per gram ointment

Calcitriol
Read this entire leaflet carefully before using this medicine because it contains important information for you

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Silkis is and what it is used for
What you need to know before using Silkis
How to use Silkis
Possible side effects
How to store Silkis
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 moderate plaque psoriasis affecting up to one-third of the body surface area.
It contains an active substance, calcitriol (a vitamin D derivative), which inhibits and normalizes uncontrolled cell growth in the skin affected by psoriasis.

2. What you should know before using Silkis

Do not use Silkis

if you are receiving systemic (oral) treatment for calcium deficiency
if you have kidney or liver disease
if you have high levels of calcium in the blood or suffer from abnormalities in 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.
Apply the ointment cautiously to the face, as the risk of irritation in this area is higher. Avoid contact with the eyes.
Wash your hands after each use to avoid inadvertently applying the ointment to other unaffected areas of the body.
Due to the potential effect on calcium metabolism, do not cover the ointment with occlusive dressings.
In case of severe irritation or hypersensitivity reaction, you must stop treatment and contact your doctor.
Although clinically significant cases of hypercalcemia (elevated calcium levels in the blood) have not been reported during clinical studies with this ointment, calcitriol is partially absorbed through the skin. This entails a risk of increased calcium levels in the blood or urine. The risk is minimal if you follow your doctor's instructions.

Children
There is limited data on the use of Silkis in children. Therefore, use in children should be avoided.
Other medicines and Silkis
Silkis may interact with other medicines, such as:

thiazide diuretics, since their concomitant use with this medicine may increase calcium levels in the blood.
medicines whose action may be altered by changes in blood calcium levels, such as digoxin.
calcium supplements or high doses of vitamin D.
exfoliating agents, astringents, or irritating products, as they may cause additional irritant effects.

Before starting this therapy, inform your doctor if you are using or may have used any other topical treatment for psoriatic lesions.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
Silkis must not be used if you are breastfeeding.
Driving and using machines
This treatment does not affect the ability to drive or operate machinery.

3. How to use Silkis

Silkis is an ointment for use on the skin only (cutaneous use).
Always use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or
pharmacist.
Instructions for application

First, wash and dry the affected areas of skin.
Apply a thin layer of Silkis to the affected areas twice daily, in the morning and in the evening before going to bed, or follow your doctor's instructions.
Wash your hands after each application to avoid contact with unaffected areas.
Do not apply more than 30 g of ointment per day, and do not treat more than one-third of the body surface area with the medicine (this area corresponds approximately to one entire arm and one entire leg). Do not swallow this product. In case of accidental ingestion, consult your doctor immediately. Follow the treatment regularly, strictly adhering to your doctor's instructions.

If you feel that the effect of this medicine is too strong or too weak, discuss it with your doctor or
pharmacist.
If you use more Silkis than you should

Applying the product in excessive amounts will not produce better or faster results, but may cause marked redness, peeling, or skin irritation.
If you apply an excessive amount of Silkis, always contact your doctor to determine whether treatment adjustments or discontinuation are necessary.
Excessive use of calcitriol may cause hypotonia (decreased muscle tone), nausea, vomiting, loss of appetite, constipation, and depression. Therefore, consult your doctor if you experience any of these symptoms.

If you forget to use Silkis
Do not apply a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If severe irritation or contact allergy (redness, itching) occurs, treatment must be discontinued and the patient should contact their doctor. If contact allergy is confirmed, treatment must be stopped.
This medicine may cause side effects at the site of application:

Common (may affect up to 1 in 10 people)
skin itching
skin discomfort
skin irritation
erythema (skin redness)
Uncommon (may affect up to 1 in 100 people)
dry skin
worsening of psoriasis
Not known (frequency cannot be estimated from the available data)
skin edema
contact dermatitis

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Silkis

Keep out of the sight and reach of children.
Discard the tube 8 weeks after first opening.
Do not use this medicine after the expiry date stated on the carton after "Expiry". The expiry date refers to the last day of that month.
No special precautions for storage required.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Silkis contains

The active substance is Calcitriol (3 micrograms per gram).
The other ingredients are liquid paraffin, white soft paraffin, and alpha-tocopherol.

Description of the appearance of Silkis and contents of the pack
Silkis is a white, translucent ointment.
This ointment is available only on prescription and comes in tubes of 15 g, 30 g or 100 g (not all pack sizes may be marketed).

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GALDERMA Italia S.p.A.
Registered Office – Via dell’Annunciata, 21 – Milan,
Commercial and Administrative Offices – Centro Direzionale Colleoni – Agrate Brianza (MB)
Manufacturer
Laboratoires Galderma
ZI - Montdésir
74 540 Alby sur Chéran
France

This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic: Silkis mast
Germany: SILKIS 3 μg/g Salbe
Spain: SILKIS 3 microgramos/g pomada
Finland: Silkis 3 mikrog/g voide
France: SILKIS 3 microgrammes/g, pommade
Ireland: SILKIS 3 micrograms per g ointment
Netherlands: SILKIS, zalf 3 microgram/gram
Norway: Silkis 3 mikrogram per g salve
Portugal: SILKIS 3 microgramas por grama de pomada
United Kingdom: SILKIS 3 micrograms per g ointment

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