SILKIS OINTMENT

Active substance: CALCITRIOL

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3 micrograms/g
calcitriol
OINTMENT

PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
2.
3.
4.
5.
6.

What Silkis is and what it is used for
Before you use Silkis
How to use Silkis
Possible side effects
How to store Silkis
Further information

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 is used for the topical treatment of mild to
moderately severe plaque psoriasis with up to one third
of body surface area involvement.

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.

It contains an active ingredient, calcitriol (a vitamin D
derivate), which inhibits and normalizes the unrestrained
cell growth in psoriasis affected skin.

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

2. BEFORE YOU USE SILKIS
Do not use Silkis:

Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including medicines
obtained without a prescription.

1. WHAT SILKIS IS AND WHAT IT IS USED FOR

• 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

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. 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.

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.
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.

5. 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.

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 15g, 30g or 100g (not all pack
sizes may be marketed).

Marketing Authorisation Holder and Manufacturer
Holder
Galderma (UK) Ltd.
Meridien House
3rd Floor
69-71 Clarendon Road
Watford
Herts. WD17 1DS
UK
PL 10590/0047
PA 590/21/1
Manufacturer
Laboratoires Galderma
ZI - Montdésir
74 540 Alby sur Chéran
France
This leaflet was last approved in November 2009.

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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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