SILKIS 3 micrograms/g OINTMENT

Introduction

Patient Information Leaflet

SILKIS 3 micrograms/g Ointment

Calcitriol

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Silkis is and what it is used for
2. What you need to know before using Silkis
3. How to use Silkis
4. Possible side effects
5. Storage of Silkis
6. Package contents and additional information

1. What Silkis is and what it is used for

Silkis is used for the topical treatment of plaque psoriasis of mild to moderate severity, affecting up to one-third of the body surface area.

It contains the active ingredient calcitriol (a vitamin D derivative), which inhibits and normalizes excessive cell growth in affected psoriatic skin.

2. What you need to know before using Silkis

Do not use Silkis:

• if you are being treated systemically (orally) for a calcium deficiency.
• if you have kidney or liver disease.
• if you have high blood calcium levels or suffer from abnormal calcium metabolism.
• if you are allergic to calcitriol or any of the other components of this medicine listed in section 6.

Warnings and precautions:

Consult your doctor or pharmacist before starting to use Silkis

• Apply the ointment carefully to the face, as there is a higher risk of irritation. Avoid contact with the eyes.
• After using the ointment, wash your hands to avoid accidentally transferring the ointment to unaffected areas.
• Due to a potential risk of calcium metabolism, the ointment should not be applied with occlusive dressings.
• In case of severe irritation or allergic reaction, treatment should be discontinued and your doctor contacted.
• Although significant hypercalcemia (high blood calcium levels) was not observed in clinical trials with this ointment, some absorption of calcitriol through the skin may occur. This may lead to a risk of increased blood or urine calcium levels. This risk is minimal if you follow your doctor's instructions.

Children

There is limited data on the use of this medicine in children. Therefore, its use in children should be avoided.

Other medicines and Silkis:

Silkis may interact with other medicines such as:

• Thiazide diuretics, as the use of these with this medicine may increase blood calcium levels.
• Medicines whose action may be altered by a change in blood calcium levels, such as digoxin.
• Calcium supplements or high doses of vitamin D.
• Exfoliating agents, astringent agents, or irritant agents, as additional irritant effects may occur.

Inform your doctor of any other topical treatment you have used or are using for your psoriasis lesions before starting this treatment.

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Silkis should not be used during breastfeeding.

Driving and using machines:

The treatment does not affect the ability to drive or use machines.

3. How to use Silkis

Silkis is an ointment for use only on the skin (cutaneous).

Follow exactly the administration instructions for this medicine as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Application instructions

• First, wash and dry the affected areas of your skin.
• Apply a thin layer of Silkis to the affected areas to be treated twice a day, in the morning and at night before bedtime, or as instructed by your doctor.
• Wash your hands carefully after each application to avoid any contact with unaffected areas.
• Do not use more than 30g of ointment per day and do not cover more than one-third of your skin surface (approximately one entire arm and one entire leg)

This medicine is for use only on the skin. Do not swallow it. If you accidentally swallow it, go to the doctor immediately.

Remember to regularly monitor your treatment, strictly following your doctor's instructions.

If you think the action of this medicine is too strong or too weak, tell your doctor or pharmacist.

If you use more Silkis than you should:

• If the medicine is applied excessively, it will not produce better or faster results, and it may cause intense redness, scaling, or skin discomfort.
• Always contact your doctor to determine if treatment should be continued or discontinued if you have used too much Silkis.
• After using too much calcitriol, hypotonia (decreased muscle tension), nausea, vomiting, loss of appetite, constipation, and depression may occur. Therefore, if these symptoms appear, contact your doctor.

If you forget to use Silkis.

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

In case of severe irritation or contact allergy (redness and itching), treatment with Silkis should be discontinued, and your doctor should be consulted. If a contact allergy is confirmed, treatment should be suspended.

This medicine may occasionally cause unwanted side effects at the application site, such as:

• Common side effects (may affect up to 1 in 10 people)

Pruritus (itching on the skin)

Skin discomfort

Skin irritation

Erythema (redness of the skin)

• Uncommon side effects (may affect up to 1 in 100 people)

Dryness of the skin

Worsening of psoriasis

• Rare side effects (frequency cannot be estimated from the available data)

Edema of the skin

Contact dermatitis

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Silkis

• Keep out of sight and reach of children.
• Discard the tube 8 weeks after opening it for the first time.
• Do not use this medicine after the expiry date stated on the carton. The expiry date is the last day of the month indicated.
• No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Silkis

The active ingredient is calcitriol (3 micrograms per gram).

The other ingredients are liquid paraffin, light white paraffin, and alpha-tocopherol.

Appearance of the product and package contents

Silkis is a white, translucent ointment.

This ointment is available on prescription from your doctor in tubes containing 15g, 30g, or 100g of ointment. (Not all pack sizes may be marketed).

Marketing authorisation holder and manufacturer:

Marketing authorisation holder

Laboratorios Galderma, S.A.

Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Laboratoires Galderma

Z.I.- Montdésir

74540, Alby-sur-Chéran

France

or

Galderma Laboratorium GmbH

Toulouser Allee 23a40211 Düsseldorf

Germany

Date of the last revision of this leaflet:

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/