SILKIS 3 MICROGRAMS/G OINTMENT

Active substance: CALCITRIOL

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Ref: 1337/150313/1/F

Silkis 3 micrograms/g ointment
(calcitriol)
Patient Information Leaflet
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.
Your medicine is called Silkis 3 micrograms/g ointment but will be referred to
as Silkis throughout the leaflet.

*

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.

In this leaflet:
1

What Silkis is and what it is used for

2

Before you use Silkis

3

How to use Silkis

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

4

Possible side effects

5

How to store Silkis

6

Further information

1

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.

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.

3
2

Before you use Silkis

How to use Silkis

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

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).

Ref: 1337/150313/1/B

Silkis® 3 micrograms/g ointment
(calcitriol)
Patient Information Leaflet (continued)
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.

4

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.

5

How to store Silkis

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Discard the tube 8 weeks after first opening.
Do not use Silkis after the expiry date shown on the carton or tube label.
The expiry date refers to the last day of that month.
If your doctor tells you to stop using the medicine, take any remaining
medicine back to the pharmacist for safe disposal.
Only keep this medicine if your doctor tells you to.
If your medicine becomes discoloured or shows any signs of deterioration,
ask your pharmacist who will advise you what to do.
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.

6

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
100g.
Manufacturer and Licence Holder
Manufactured by Laboratories Galderma, ZI-Montdesir, 74 540 Alby sur
Cheran, France and is procured from within the EU and repackaged by the
Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.

This medicine may cause some unwanted effects at the site of application:

POM
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.

PL 15184/1337 Silkis 3 micrograms/g ointment.

Silkis is a registered trademark of GALDERMA, S.A.
Revision date: 15/03/13

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Phone Lexon (UK) Limited, Tel: 01527 505414

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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