SILKIS 3 MICROGRAMMI/G Ointment

Зміст інструкції

1. Silkis 3 micrograms per gram ointment
   1. What is Silkis and what is it 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

Silkis 3 micrograms per gram ointment

Calcitriol
Read this leaflet carefully before you start using this medicine as 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 pass it on to others even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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 is Silkis and what is it used for

Silkisis used for the topical treatment of mild to moderately severe plaque psoriasis with
involvement of up to one-third of the body surface area.
It contains an active ingredient, calcitriol (a vitamin D derivative), which inhibits and normalizes the growth
of uncontrolled cells in the skin affected by psoriasis.

2. What you need to know before you use 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 your blood or if you suffer from calcium metabolism abnormalities
• if you are allergic to calcitriol or 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 to the face with caution, as the risk of irritation in this area is greater. Avoid contact with the eyes.
• Wash your hands after each use, to avoid unintentionally applying the ointment to other non-affected parts of the body.
• Given the potential effect on calcium metabolism, do not cover the ointment with occlusive bandages.
• In case of severe irritation or hypersensitivity reaction, you must stop treatment and contact your doctor .
• Although no significant cases of hypercalcemia (high levels of calcium in the blood) associated with this ointment have been reported during clinical studies, calcitriol is partially absorbed by the skin. This carries a risk of increased levels of calcium in the blood or urine. The risk is minimal if you follow your doctor's instructions.

Children
There are limited data on the use of Silkisin children. Therefore, use in children should be avoided.

Other medicines and Silkis
Silkismay interfere with other medicines, such as:

• thiazide diuretics, as their concomitant use with this medicine would increase calcium levels in the blood.
• medicines whose action may be altered by a change in calcium levels in the blood, such as digoxin.
• calcium supplements or high doses of vitamin D.
• exfoliating, astringent or irritating agents, as they may lead to additional irritating effects.

Before starting this therapy, tell your doctor if you are using or may have used any other
topical treatment for psoriasis lesions.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.

Silkisshould not be used if you are breastfeeding.

Driving and using machines
Treatment does not affect the ability to drive or operate machinery.

3. How to use Silkis

Silkisis an ointment for use only on the skin (cutaneous use).
Use this medicine following exactly the instructions of your doctor. If you have any doubts, consult your doctor or
pharmacist.

Instructions for application

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

If you feel that the effect of this medicine is too strong or too weak, talk to your doctor or
pharmacist.

If you use more Silkis than you should

• If the product is applied in excessive quantity, you will not obtain better or faster results, while marked redness, scaling or skin discomfort may occur.
• If you apply an excessive amount of Silkis, always contact your doctor to ascertain the need to modify or interrupt the treatment.
• The use of an excessive amount of calcitriol can cause hypotonia (decreased muscle tension), nausea, vomiting, loss of appetite, constipation and depression. Therefore, consult your doctor if you notice the appearance of these symptoms.

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

4. Possible side effects

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

• 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)
• skin dryness
• worsening of psoriasis
• Not known (frequency cannot be estimated from available data)
• skin edema
• contact dermatitis

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor
or pharmacist. You can also report side effects directly through 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.
• Dispose of the tube 8 weeks after first opening
• Do not use this medicine after the expiry date that is stated on the pack after “Expiry”. The expiry date refers to the last day of that month.
• No special storage precautions.

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

6. Contents of the pack and other information

What Silkis contains

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

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

Marketing Authorisation Holder and Manufacturer

MAH
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 Member States of the European Economic Area with the following
names:
Czech Republic: Silkis mast
Germany: SILKIS 3 μg/g Salbe
Spain: SILKIS 3 micrograms/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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