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 because it contains important information for you.
• 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 only. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
In this leaflet:
1. What Silkis is and what it is used for
2. What you need to know before you use Silkis
3. How to use Silkis
4. Possible side effects
5. How to store Silkis
6. Contents of the pack and other 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.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE SILKIS
Do not use Silkis:
• if you are treated by systemic (oral) route for a calcium deficiency
• if you have a kidney or liver disease
• if you have high blood calcium levels or if you suffer from
abnormal calcium metabolism
• if you are hypersensitive (allergic) to calcitriol or to any of
the other ingredients of Silkis
Warnings and precautions
Talk to your doctor or pharmacist before using 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.
• 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.
Children
There is no experience with the use of Silkis in children.
Therefore, use in children should be avoided.
Other medicines and Silkis
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.
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
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 medicine 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.

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 (may affect up to 1 in 10 people)
- pruritus (itching skin)
- skin discomfort
- skin irritation
- erythema (skin redness)
• Uncommon (may affect up to 1 in 100 people)
- dry skin
- psoriasis aggravation
• Not known (frequency cannot be estimated from the
available data)
- skin oedema
- contact dermatitis
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effect not listed in this leaflet.
You can also report side effects directly (see details below).
By reporting side effects you can help provide more
information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

Ireland
Pharmacovigilance Section
Irish Medicines Board
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie

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 this medicine 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. CONTENTS OF THE PACK AND OTHER INFORMATION
What Silkis contains
The active ingredient is Calcitriol (3 micrograms per g).
The other excipients are 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
Marketing Authorisation 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 revised in July 2013.

P2XXXX-X

- 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).

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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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