Details for: SILKIS
Company: GALDERMA CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02338572 | SILKIS | CALCITRIOL | 3 MCG / G | OINTMENT | TOPICAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
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 D- like 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,.
- Have liver problems.
What the medicinal ingredient is
Calcitriol
What the non-medicinal ingredients are
Vitamin E (dl-α tocopherol) added as an antioxidant, mineral oil, and white petrolatum.
What dosage form 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.
It is not recommended to use Silkis® with an occlusive dressing, such as a bandage, or to cover the treated area(s) tightly.
In case of severe irritation or an allergic reaction, stop using Silkis® and contact your healthcare provider.
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.
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 Silkis® in your eyes, on your lips or face. 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. Other side effects reported for Silkis® include: skin swelling and skin irritation (rash, redness or flaky skin). Silkis® may affect the results of certain laboratory tests or the level of calcium in your urine (hypercalciuria).
In case of severe irritation or an allergic reaction, stop using
Silkis® and contact your healthcare provider.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Very rarely: hypercalcaemia (high blood calcium levels) | |||
| Nausea, vomiting, excessive thirst, excessive urination | ✔ | Ϭ | |
This is not a complete list of side effects. For any unexpected effects while taking Silkis®, contact your doctor or pharmacist.
How to store
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 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:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- 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 1908C
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
This leaflet was prepared by Galderma Canada Inc.
Last revised: October 17, 2017