Patient Information Leaflet

SILKIS 3 micrograms/g Cream

Calcitriol

Read this patient information leaflet carefully before you start using this medicine because 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 for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Silkis is used for the topical treatment of psoriasis plaques that are mild to moderately severe, affecting up to one-third of the body surface.

It contains calcitriol (a derivative ofvitamin D), the active ingredient, which inhibits and normalizes excessive cellular growthin the skin affected by psoriasis.

No use Silkis:

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

Warnings and precautions:

Consult your doctor or pharmacist before starting to use Silkis

- Apply the ointment carefully on the face, as there is a greater risk of irritation on the face. Avoid contact with the eyes.

- After using the ointment, wash your hands to avoid accidentally carrying the ointment to other unaffected areas.

- Due to a potential risk in calcium metabolism, the ointment should not be applied with occlusive dressings.

- In case of severe irritation or allergic reaction, treatment should be interrupted and your doctor should be contacted.

-Although significant hypercalcemia (high levels of calcium in the blood) was not observed in clinical trials with this ointment, there is some absorption of calcitriol through the skin. This may lead to a risk of increased calcium levels in the blood or urine. This risk is minimal if you follow your doctor's instructions.

Children:

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

Other medications and Silkis:

Silkis may interact with other medications such as:

• Thiazide diuretics, as the use of these with this medication may increase their calcium levels in the blood.
• Medications whose action may be modified by a change in calcium levels in the blood, such as digoxin.
• Calcium supplements or high doses of vitamin D.
• Exfoliating agents, astringent agents, or irritating agents, as they may produce additional irritative effects.

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

Inform your doctor or pharmacist if you are using, or have recently used, or may need to use any other medication.

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Silkis should not be used during breastfeeding.

Driving and operating machinery:

The treatment does not affect the ability to drive or operate machinery.

Silkis is a topical cream for use only on the skin (cutaneous).

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

Application Instructions

• First, wash and dry the affected skin areas.
• Applya thin layer of Silkis to the affected skin areas to be treated twice a day, in the morning and at night before going to bed, or as indicated by your doctor.
• Wash your hands carefully after each application to avoid any contact with other areas without lesions.
• Do not use more than30 gof cream per day and do not cover more than one-third of your skin surface (approximately one entire arm and one entire leg)

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

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

If you estimate that the effect of this medication is too strong or too weak, inform your doctor or pharmacist.

If you use more Silkis than you should:

• If the medication is applied excessively, there will be no better or faster results, and instead, it may cause intense redness, peeling, or skin discomfort.
• Contact your doctor to know if you need to continue or interrupt treatment if you have used too much Silkis.
• After using too much calcitriol, hypotonia (muscle tension decrease), nausea, vomiting, loss of appetite, constipation, and depression may appear. Therefore, if these symptoms appear, contact your doctor.

If you forgot to use Silkis.

Do not take a double dose to compensate for the missed doses.

Like all medications, this medication may have adverse effects, although not everyone will experience them.

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

This medication may occasionally cause unwanted effects at the application site such as:

• Frequent Adverse Effects (may affect up to 1 in 10 people)

Pruritus (itching on the skin)

Dermatological discomfort

Skin irritation

Erythema (skin redness)

• Rare Adverse Effects (may affect up to 1 in 100 people)

Dry skin

Worsening of psoriasis

• Adverse Effects of Unknown Frequency (cannot be estimated from available data)

Cutaneous edema

Contact dermatitis

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

• Keep out of sight and reach of children.
• Discard the tube 8 weeks after first opening.
• Do not use this medication after the expiration date shown on the box. The expiration date is the last day of the month indicated.
• No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of containers and medications that you no longer need. This will help protect the environment.

Composition of Silkis

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

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

Appearance of the product and content of the container

Silkis is a white, translucent ointment.

This ointment is available by prescription from your doctor in tubes with15 g,30 gor100 gof ointment. (Not all packaging may be marketed).

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

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

Last review date of this leaflet:

“Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/