Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Silkis 3 micrograms per g ointment
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Calcitriol may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for you need to know before you use Silkis Silkis is an ointment for use on the skin only (cutaneous).
How to take it
Silkis Always use this medicine exactly as your doctor has told you.
Possible side effects
Check with your doctor or pharmacist if you are not sure. 5. How to store Silkis Dosage instructions 6. Contents of the pack and other information 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, Silkis is and what it is used for morning and evening before retiring, or as advised by your doctor. Silkis is used for the topical treatment of mild to moderately severe plaque Wash your hands after each application in order to avoid any contact with other psoriasis with up to one third of body surface area involvement. non lesional areas. It contains an active ingredient, calcitriol (a vitamin D derivate), which inhibits and Do not use more than 30 g of ointment per day and do not cover more than one normalizes the unrestrained cell growth in psoriasis affected skin. third of your skin area (approximately one full arm and one full leg). so, seek Immediate you accidentally do So, not swallow this product. If yOu Do immediate medical VO NOt you need to know before you use Silkis advice. Do not use Silkis: Regularly follow your treatment, according strictly to your instructions. are treated by systemic (oral) route for a calcium deficiency weak, you strong or feel the effect of this medicine is too too that talk to your If you kidney or liver disease if have a if you have high blood calcium levels or if you suffer from abnormal calcium doctor or pharmacist. If you use more Silkis than you should: if you are allergic to calcitriol or to any of the other ingredients of this the product is applied excessively, no more rapid or better results will be (listed in section 6). obtained and marked redness, peeling or discomfort may occur. Always contact your physician to hear whether treatment or discontinuation is Warnings and precautions necessary if too much Silkis is Talk to your doctor or pharmacist before using Silkis. Hypotonia (decreased tension in muscles), nausea, lack of appetite, Carefully apply the ointment to the face, since it has a greater risk of constipation and depression may occur after using too much calcitriol. Avoid contact with the eyes. contact your physician if these symptoms appear. After using the ointment, wash your hands to prevent unintentional spread non-affected zones. If you forget to use Silkis: Due to a potential effect on calcium metabolism, the ointment may not be applied Do not apply a double dose to make up for forgotten individual doses. under an occlusive wound dressing. In case of severe irritation or allergic reaction occur, the treatment should be 4. Possible side effects discontinued and the doctor contacted. Like all medicines, this medicine can cause side effects, although not everybody Although no significant hypercalcaemia (high blood calcium levels) was observed them. this there is during absorption of calcitriol by In case of severe irritation or contact allergy (redness, itching), the treatment risk of an increase of or calcium levels. should be stopped and the patient should seek medical attention. If contact This risk is minimal if you follow your allergy is confirmed, the treatment should be discontinued. Do not smoke or go near naked flames risk of severe burns. Fabric (clothing, medicine may cause some unwanted effects at the site of application: bedding, dressings etc) that has been in contact with this product burns more © to in 10 people) easily and is a serious fire hazard. Washing clothing and bedding may reduce Common (may affect up to pruritus (itching skin) product build-up but not totally remove it.' skin discomfort SKIN Children There is limited data on the use of Silkis in children. Therefore, use in erythema (skin redness) should be avoided. Uncommon (may af affect up to 1 in 100 people) Other medicines and Silkis -dry dry skin Silkis might interfere with other medicines such as: diuretics as their use jointly with this medicine would increase your psoriasis aggravation (frequency cannot be estimated from the available data) Not known (freque blood calcium levels. skin oedema Medications whose action can be modified by a change in calcium blood contact dermatitis such as digoxin 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. –
–
–
–
metabolism
clinical studieswith ointment, some the skin.This gives a blood
advice.
–
1
–
Children
–
skin
–
–
Uncommon skin
–
–
Galderma Laboratories
Printing Colors
Product code: P27889-4 Product description: SILKIS POM 100 GBR Market: GBR Article: Leaflet Font size: 9 pt Flat size: 180×315 Fold size: 180×26,25 Pharmacode: 2637 GRAPHIC DESIGNER: Guillaume ANDRE
GALDERMA
INDUSTRIALIZATION DEPARTMENT LABORATOIRES GALDERMA
–
Galderma 74540 ALBY-SUR-CHERAN FRANCE –
–
EST.
PMS 432U
DIELINES
NOTICE VERSO 180×315 PLAN n° Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. Ln
How to store it
Silkis out of the sight and reach of children. Discard the tube 8 weeks after first opening. 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. special precautions for storage. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
Contents of the pack and other information
What Silkis contains The active substance is Calcitriol (3 micrograms per 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 (U.K.) Limited, Evergreen House North, Grafton Place, London, England, PL 10590/0047 Manufacturer Laboratoires Galderma Z| Montdésir Alby sur Chéran France This medicinal product is authorised in the Member States of the EEA under the following names: Czech Republic: Silkis mast Germany: SILKIS 3 Salbe Spain: SILKIS 3 microgramos/g pomada Finland: Silkis 3 mikrog/g voide France: SILKIS 3 microgrammes/g, pommade SILKIS 3 micrograms per g ointment Italy: SILKIS 3 microgrammi per grammo di unguento Netherlands: SILKIS, zalf microgram/gram Norway: Silkis 3 mikrogram per g salve Portugal: SILKIS 3 microgramas por grama de pomada For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Galderma (UK) Ltd. Tel: +44 (0)300 3035674 This leaflet was last revised in May 2024. –
GALDERMA Galderma Laboratories Product code: P27889-4 Product description: SILKIS POM 100 GBR Market: GBR Article: Leaflet Font:size: 9 pt Font Flat size: Fold size: 180×26,25 Pharmacode: 2637 GRAPHIC DESIGNER: Guillaume ANDRE
–
GALDERMA
INDUSTRIALIZATION DEPARTMENT LABORATOIRES GALDERMA
Galderma 74540 ALBY-SUR-CHERAN FRANCE –
–
Printing Colors PMS 432U
DIELINES
P27889-4
3
Frequently asked questions about Silkis 3 micrograms per g ointment
How do I take Silkis 3 micrograms per g ointment?
Silkis 3 micrograms per g ointment comes as ointment containing 3mcg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Silkis 3 micrograms per g ointment?
The active substance in Silkis 3 micrograms per g ointment is calcitriol.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Silkis 3 micrograms per g ointment, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Silkis 3 micrograms per g ointment without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: calcitriol
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Silkis is indicated in topical treatment of mild to moderately severe plaque psoriasis (psoriasis vulgaris) with up to 35% of body surface area involvement.
4.2. Posology and method of administration
Posology
Silkis Ointment should be applied to the psoriasis affected areas twice per day, once in the morning and once in the evening before retiring and after washing. It is recommended that not more than 35% of the body surface be exposed to daily treatment. Not more than 30 g of ointment should be used per day. There is limited clinical experience available for the use of this dosage regimen of more than 6 weeks.
Paediatric population
The safety and efficacy of Silkis in children less than 18 years have not been established. Currently available data are described in sections 4.4, 5.1 and 5.3 but no recommendation on a posology can be made.
Special population
Patients with kidney or liver dysfunction should not use Silkis (see also 4.3. Contraindications).
4.3. Contraindications
• Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
• Patients on systemic treatment of calcium homeostasis.
• Patients with kidney or liver dysfunction.
• Patients with hypercalcaemia and patients known to suffer from abnormal calcium metabolism.
4.4. Special warnings and precautions for use
The ointment can be applied to the face with caution, as there is an increased risk of irritation in this area. Contact with the eyes should be avoided. The hands should be washed after applying the ointment in order to avoid unintentional application to non lesional areas. Not more than 35% of the body surface should be exposed to daily treatment. Not more than 30g of ointment should be used per day.
Due to potential effects on calcium metabolism, substances which stimulate absorption must not be added to the ointment, and the ointment must not be covered with an occlusive dressing.
In case of severe irritation or contact allergy, the treatment with Silkis should be discontinued and the patient should obtain medical advice. If contact allergy is demonstrated this discontinuation is definitive.
Although no clinically significant hypercalcaemia was observed in clinical studies with a dosage under 30 g/day of Silkis ointment, some absorption of calcitriol through the skin does occur and excessive use of the ointment can lead to systemic side-effects, such as an increase in urine and serum calcium levels, which is a known class effect for calcitriol.
There is no information about the use of Silkis in other clinical forms of psoriasis (other than plaque psoriasis) i.e. Psoriasis guttata acuta, pustular psoriasis, psoriasis erythrodermica and rapid progressive plaque psoriasis.
Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc.) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
Paediatric population
There is limited amount of clinical data supporting the use of Silkis in the paediatric population (See section 5.1).
In view of the particular sensitivity of neonates versus adult rodents to the toxic effects of calcitriol, exposure of children to calcitriol ointment should be avoided (see section 5.3).
4.5. Interaction with other medicinal products and other forms of interaction
Silkis must be used with caution in patients receiving medications known to increase the serum calcium level, such as thiazide diuretics or medications with pharmacological effects impacted by a change in calcium levels such as digoxin. Caution must also be exercised in patients receiving calcium supplements or high doses of vitamin D. There is no experience of the concurrent use of calcitriol and other medications for the treatment of psoriasis.
Information on interaction of systemic medications after the use of calcitriol ointment is limited.
Silkis Ointment has a slight irritant potential, and therefore, it is possible that concomitant use of peeling agents, astringents or irritants products may produce additive irritant effects.
4.6. Fertility, pregnancy and lactation
Pregnancy:
There are no or limited amount of data from the use of Calcitriol in pregnant women. Studies in animals have shown developmental toxicity at doses which caused maternal toxicity (see section 5.3). The potential risk for humans is unknown. Silkis should only be used during pregnancy in restricted amounts when clearly necessary. Calcium levels should be monitored.
Breastfeeding:
Calcitriol has been found in milk of lactating dams. Due to the lack of human data, it should not be used during breastfeeding.
4.7. Effects on ability to drive and use machines
Silkis has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Between 10% and 20% of patients can be expected to experience adverse reactions. Adverse reactions are usually localised to the application site and mild to moderate in nature.
Very common adverse reactions: Adverse reactions occurring in ≥1/10 of patients.
Common adverse reactions: Adverse reactions occurring in ≥1/100, <1/10 of patients.
Uncommon adverse reactions: Adverse reactions occurring in ≥1/1000, <1/100 of patients.
Rare adverse reactions: Adverse reactions occurring in ≥1/10000; <1/1000 of patients.
Very rare adverse reactions: Adverse reactions occurring in <1/10000 of patients
Adverse reactions reported by more than two patients in the clinical studies are included.
Not known: cannot be estimated from the available data
MedDRA System Organ Class
Frequency
Preferred term
Skin and Subcutaneous disorders
Common
Pruritus, Skin discomfort, Skin irritation, Erythema
Uncommon
Dry skin, Psoriasis (aggravated)
Not known*
Skin oedema, Contact dermatitis
*Adverse reactions reported from post marketing surveillance
In case of severe irritation or contact allergy, the treatment with Silkis should be discontinued and the patient should obtain medical advice. If contact allergy is demonstrated this discontinuation is definitive.
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
4.9. Overdose
The most common symptoms which may occur after accidental administration are anorexia, nausea, vomiting, constipation, hypotonia and depression. Lethargy and coma are occasionally observed. If hypercalcaemia or hypercalciuria occurs, the use of Silkis should be discontinued until the serum or urinary calcium levels have returned to normal.
If the medication is applied excessively no more rapid or better results will be obtained and marked redness, peeling or discomfort may occur.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- DECOSTRIOL 0,25 micrograme prescriptionCALCITRIOLUM · taken by mouth
- DECOSTRIOL 0,50 micrograme prescriptionCALCITRIOLUM · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- DetriolCalcitriolum
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Silkis 3 micrograms per g ointment. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.