What Silkis is used for and how to use it
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Silkis - Consumer Medicine Information

Manufacture: Galderma Laboratories
Country: Canada
Condition: Psoriasis
Class: Antipsoriatics, Topical non-steroidal anti-inflammatories
Form: Cream, gel, liniment or balm, lotion, ointment, etc
Ingredients: Calcitriol, vitamin E (dl-α tocopherol) added as an antioxidant, mineral oil, and white petrolatum

About This Medication

What the Medication is Used For

Silkis is used for the topical treatment of mild to moderate psoriasis on your body.

What it Does

Silkis contains the active ingredient calcitriol, a vitamin Dlike agent.

Psoriasis results from skin cells growing and multiplying too quickly, causing plaques (scaly, red patches) to form on your skin. Calcitriol acts in a way that aims to return the growth of skin cells to normal.

When it Should not be Used

Silkis should not be used if you:

  • Are allergic to calcitriol, or any medications that contain a vitamin D-like agent (vitamin D derivative), or any of the other ingredients in Silkis.
  • Have high blood calcium levels (hypercalcemia);
  • Are being treated for conditions affecting normal calcium levels (abnormal calcium metabolism).
  • Have severely reduced kidney function or end-state kidney disease.

Silkis should not be used in or near your eyes or on your face. Silkis should not be used internally (e.g. orally or intravaginally).

What the Medicinal Ingredient Is

Calcitriol

What the Important Nonmedicinal Ingredients Are

Vitamin E (dl-α tocopherol) added as an antioxidant, mineral oil, and white petrolatum.

What Dosage Forms it Comes In

Silkis is available as an ointment at a concentration of 3 μg/g.

Warnings and Precautions

The ointment component of Silkis may increase the risk of developing skin tumours caused by ultraviolet radiation (UVR). Silkis ointment alone does not cause cancer. Avoid excessive exposure of areas being treated with Silkis to either natural or artificial sunlight, including tanning booths and sun lamps.

BEFORE you use Silkis talk to your doctor or pharmacist if:

  • You have severe extensive psoriasis or other forms of psoriasis (the use of Silkis is not recommended).
  • You receive other treatments for psoriasis or other skin conditions.
  • You have liver or kidney disease.
  • You are pregnant or planning to become pregnant
  • You are breastfeeding or plan to breastfeed an infant.
  • You are using sun tanning beds or sun lamps

Silkis is not recommended for use in patients under 18 years of age.

It is not recommended to use Silkis with an occlusive dressing, such as a bandage, or to cover the treated area(s) tightly

Interactions With This Medication

Before using Silkis, tell your doctor or pharmacist about your other medications, including non-prescriptions, vitamin or mineral supplements. Drugs that may interact with Silkis include:

  • Medications that may increase blood calcium levels, such as thiazide (water pill) and calcium supplements.
  • Medications that may change blood calcium levels, such as digoxin.
  • High doses of vitamin D.

Silkis has a slight irritant potential, and therefore it is possible that use of peeling agents, astringents, or other irritants at the same time may make the irritation worse.

Proper use of this Medication

Usual Dose

Apply Silkis to the skin areas affected with psoriasis twice a day (morning and evening) after washing and gentle drying. Rub the ointment in carefully until you can no longer see it.

Do not apply Silkis to more than 35% of your body area each time. Do not use more than 30 grams of Silkis ointment per day. After applying the ointment, wash your hands thoroughly with soap and water. Do not bandage or cover the treated area tightly.

You will not get better or faster results by applying Silkis more often. If more than the recommended amount of medication is used, marked redness, peeling or discomfort may occur.

Once your psoriasis improves your doctor may ask you to stop using Silkis. If your psoriasis returns, treatment may be re-started.

Overdose

Excessive use or accidental ingestion of Silkis may result in signs of high blood calcium levels such as upset stomach, excessive thirst, and increased urination. If you have overdosed, contact your local poison control centre or contact your physician or pharmacist.

Missed Dose

If you miss a dose, apply it as soon as you remember. Then go back to your usual dosing schedule at the next dose.

Side Effects and What to do About Them

The most common side effects with Silkis are skin discomfort, itching, psoriasis, flu syndrome and skin infection. Silkis may affect the results of certain laboratory tests or the level of calcium in your urine (hypercalciuria).

Serious Side Effects, how Often They happen and what to do about Them

Symptom / effect Talk with your doctor or pharmacist Stop taking
drug and
call your
doctor or
pharmacist
Only
if severe
In all
cases
Very rarely:
hypercalcaemia
(high blood
calcium levels)
Nausea, vomiting,
excessive thirst,
excessive urination
Χ Χ

This is not a complete list of side effects. For any unexpected effects while taking Silkis, contact your doctor or pharmacist.

How to Store It

Store at room temperature (15° - 30°C).

Do not use past the expiry date stamped on the tube.

Keep out of the reach of children.

Reporting Suspected Side Effects

To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance.

You can report any suspected adverse reactions associated with the use of health products in the Canada Vigilance Program by one of the following 3 ways:

  1. Report online at www.healthcanada.gc.ca/medeffect
  2. Call toll-free at 1-866-234-2345
  3. Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
                      Health Canada
                     Postal Locator 0701E
                     Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada website at:
www.healthcanada.gc.ca/medeffect

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice..

More Information

This document plus the full product monograph, prepared for health professionals can be found at:
http://www.galderma.ca
or by contacting the sponsor, Galderma Canada Inc., at: 1-800-467-2081