Silkis 3 micrograms/g
c a l c i t r i o l
O I N T M E N T
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Silkis is and what it is used for
2. Before you use Silkis
3. How to use Silkis
4. Possible side effects
5. How to store Silkis
6. Further information
What Silkis Is And What It Is Used For
Silkis is used for the topical treatment of mild to moderately severe plaque psoriasis with up to one third of body surface area involvement.
It contains an active ingredient, calcitriol (a vitamin D derivate), which inhibits and normalizes the unrestrained cell growth in psoriasis affected skin.
Before You Use Silkis
Do not use Silkis:
- if you are hypersensitive (allergic) to calcitriol or to any of the other ingredients of Silkis
- if you are treated by systemic (oral) route for a calcium deficiency
- if you have high blood calcium levels or if you suffer from abnormal calcium metabolism
- if you have a kidney or liver disease
Take special care with Silkis:
- Carefully apply the ointment to the face, since it has a greater risk of irritation. Avoid contact with the eyes.
- After using the ointment, wash your hands to prevent unintentional spread to non-affected zones.
- Due to a potential effect on calcium metabolism, the ointment may not be applied under an occlusive wound dressing.
- In case of severe irritation or hypersensitive reaction occur, the treatment should be discontinued and the doctor contacted.
- There is no experience with the use of Silkis in children. Therefore, use in children should be avoided.
- Although no significant hypercalcaemia (high blood calcium levels) was observed during clinical studies with this ointment, there is some absorption of calcitriol by the skin. This gives a risk of an increase of blood or urine calcium levels. This risk is minimal if you follow your doctor’s advice.
Taking other medicines:
Silkis might interfere with other medicines such as:
- Thiazide diuretics as their use jointly with this medicine would increase your blood calcium levels.
- Calcium supplements or high doses of vitamin D.
- Peeling agents, astringent agents or irritant agents, because additional irritant effects might occur.
Inform your doctor of any other topical treatment you may have used or you are using for your psoriasis lesions, before starting this treatment.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
During pregnancy, Silkis should only be used if your doctor deems necessary. Treatment may be initiated or continued during pregnancy under the advice of your doctor.
Silkis should not be used if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines:
The treatment does not affect the ability to drive and use machines.
How To Use Silkis
Silkis is an ointment for use on the skin only (cutaneous).
Always use this product exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Dosage instructions
- First wash and dry the affected areas of your skin.
- Apply a thin layer of Silkis over the affected areas to be treated twice a day, morning and evening before retiring, or as advised by your doctor.
- Wash your hands after each application in order to avoid any contact with other non lesional areas.
- Do not use more than 30 g of ointment per day and do not cover more than one third of your skin area (approximately one full arm and one full leg).
Do not swallow this product. If you accidentally do so, seek immediate medical advice.
Regularly follow your treatment, according strictly to your 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 excessively, no more rapid or better results will be obtained and marked redness, peeling or discomfort may occur.
- Always contact your physician to hear whether treatment or discontinuation is necessary if too much Silkis is used.
- Hypotonia (decreased tension in muscles), nausea, vomiting, lack of appetite, constipation and depression may occur after using too much calcitriol. Therefore, contact your physician if these symptoms appear.
If you forget to use Silkis:
Do not apply a double dose to make up for forgotten individual doses.
Possible Side Effects
Like all medicines, Silkis can cause side effects, although not everybody gets them.
In case of severe irritation or contact allergy (redness, itching), the treatment should be stopped and the patient should seek medical attention. If contact allergy is confirmed, the treatment should be discontinued.
This medicine may cause some unwanted effects at the site of application:
- Common side effects (occur in less than 1 in every 10 people)
- pruritus (itching skin)
- skin discomfort
- skin irritation
- erythema (skin redness)
- Uncommon side effects (occur in less than 1 in every 100 people)
- dry skin
- psoriasis aggravation
- Unknown frequency of occurrence (frequency cannot be estimated from the available data):
- skin oedema
- contact dermatitis
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Silkis
- Keep out of the reach and sight of children.
- Discard the tube 8 weeks after first opening.
- Do not use Silkis after the expiry date which is stated on the carton after Exp. date. The expiry date refers to the last day of that month.
- No special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further Information
What Silkis contains:
Silkis contains the active ingredient Calcitriol (3 micrograms per g).
The ointment also contains liquid paraffin, white soft paraffin and alpha-tocopherol.
What Silkis looks like and contents of the pack
Silkis is a white, translucent ointment.
This ointment is available on prescription from your doctor in tubes containing 15g, 30g or 100g (not all pack sizes may be marketed).
Marketing Authorisation Holder and Manufacturer
Holder
Herts
PL 10590/0047
PA 590/21/1
Manufacturer
This leaflet was last approved in November 2009.
P22842-7
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