Patient leaflet - Calcipotriol 50 micrograms / ml Scalp solution
1) WHAT CALCIPOTRIOL 50 MICROGRAMS/ML SCALP SOLUTION IS AND WHAT IT IS USED FOR
Calcipotriol 50 micrograms/ml Scalp Solution is used for the local treatment of mild to moderate scalp psoriasis.
Psoriasis is when your skin cells are being produced too quickly.
This causes scaling and redness. This solution helps bring the rate at which your skin cells are produced back to normal.
2) WHAT YOU NEED TO KNOW BEFORE YOU USE CALCIPOTRIOL 50 MICROGRAMS/ML SCALP SOLUTION
Do not use Calcipotriol 50 micrograms/ml Scalp Solution:
- if you are allergic to calcipotriol or to any of the other ingredients of this medicine (listed in section 6).
- if you have severe liver or kidney impairment.
- if you have a problem with your calcium metabolism or if the level of calcium in your body is too high. This solution can increase calcium levels in the blood.
- if you concomitantly use treatment with other medicinal products which increase your calcium level.
Warnings and precautions
Talk to your doctor or pharmacist before using Calcipotriol
50 micrograms/ml Scalp Solution:
- the solution may cause irritation of the skin. If the scalp solution accidentally gets on your face, wash it off immediately. If it gets in your eye, bathe the eye with water. Wash your hands after you have applied the solution.
- if you use more than 60 ml of Calcipotriol Scalp Solution in a week as you may develop high blood calcium levels. This may cause e.g. weakness, nausea, loss of appetite, and constipation (please see also Section 3).
- if you are exposed to sunlight when using this solution. Any use of it with artificial UV light therapy (including sunbeds) should be discussed with your doctor first.
- if you know you have a type of psoriasis called generalised pustular psoriasis or erythrodermic exfoliative psoriasis. Ask your doctor if you are unsure.
Do not apply it on your face as it may cause skin irritation.
Do not cover the treated area with waterproof wrap.
You should avoid excessive exposure to sunlight when using this solution.
Use Calcipotriol 50 micrograms/ml Scalp Solution with care in skin folds, as this may increase the risk of side effects.
Calcipotriol 50 micrograms/ml Scalp Solution should not be used for guttate psoriasis, erythrodermic and pustular psoriasis because there is no experience.
Other medicines and Calcipotriol 50 micrograms/ml Scalp Solution
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
If you are using this cutaneous solution with other treatments for psoriasis, your doctor will tell you when to use it.
Concomitant use with systemic vitamin D products, calcium supplements, or other agents that can increase serum calcium concentrations such as thiazide diuretics, oestrogens, anabolic steroids, and parathyroid hormone or parathyroid hormone analogs may increase the risk of clinically significant hypercalcemia.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Calcipotriol 50 micrograms/ml Scalp Solution should not be used during pregnancy unless clearly necessary.
Breast feeding
It is not known if calcipotriol is excreted in breast milk. Your doctor will decide whether you can be given Calcipotriol 50 micrograms/ml Scalp Solution during pregnancy and breast-feeding.
Fertility
There are no data on the effect of calcipotriol therapy on human fertility.
Driving and using machines
No effect on the ability to drive and use machines is to be expected.
Calcipotriol 50 micrograms/ml Scalp Solution contains 30 mg propylene glycol per ml of solution
Propylene glycol may cause skin irritation.
3) HOW TO USE CALCIPOTRIOL 50 MICROGRAMS/ML SCALP SOLUTION
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Dose:
Adults
You should not apply more than 60 ml of this cutaneous solution in one week.
If you apply it together with cream or ointment containing calcipotriol, the total weekly amount of calcipotriol should not be more than 5 mg (for example 60 ml scalp solution plus 40 g of cream or ointment).
Method and route of administration:
Calcipotriol 50 micrograms/ml Scalp Solution is intended for use on the skin (cutaneous use). It should be used on parts of scalp that are affected by psoriasis.
When you use the solution, tilt your head to make sure the solution does not run on to your face. It may help to part your hair before you use the solution. Remove the cap and place the nozzle through the hair on to an affected area of the scalp. Squeeze the bottle gently and apply a few drops. Rub in gently. One or two drops should cover an area about the size of a postage stamp. If you accidentally get the solution on your face, wash it off straight away.
If you get the solution in your eyes rinse it out immediately with water.
If you have any sterile saline, you could use it to bathe your eye afterwards. If your eye stays sore, you should see your doctor.
Wash your hands after you have applied this solution.
Frequency of administration
For the best results you should apply this solution twice a day, once in the morning and once in the evening.
Duration of treatment
Duration of treatment will be decided by your physician, but should not normally be longer than 22 weeks.
Use in children and adolescents (under 18 years)
Calcipotriol 50 micrograms/ml Scalp Solution is not recommended for children and adolescents (under 18 years), because there is not enough experience with the use of this solution in these patients.
If you use more Calcipotriol 50 micrograms/ml Scalp Solution than you should
If you have applied more solution than you should (more than 60 ml in a week), you should consult your doctor. Such usage may lead to high blood calcium levels, which may cause e.g. nausea, loss of appetite, constipation, vomiting, muscle weakness, lack of energy, tiredness, and loss of consciousness.
If you forget to use Calcipotriol 50 micrograms/ml Scalp Solution
If you forget to use this solution at the right time, apply it as soon as you remember. Then go on as before. Do not apply more solution than usual to make up for a forgotten dose.
If you stop using Calcipotriol 50 micrograms/ml Scalp Solution
Always consult your doctor if you are thinking about stopping the treatment. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using this ointment and contact a doctor or go to your nearest emergency department immediately if you experience any of the following symptoms:
- Signs of allergy (uncommon side effect) such as hives, swelling of the face, eyelids, hands, feet or throat, difficulty breathing.
Very common (may affect more than 1 in 10 people):
- skin irritation
Common side effects (may affect up to 1 in 10 people):
- itching
- burning sensation
- contact dermatitis
- redness
- aggravated psoriasis
- skin inflammation
- skin peeling
- skin rash (incl. scaling, papules, pustules)
- pain in the area where the medicine is used
Uncommon side effects (may affect up to 1 in 100
people):
- dry skin
- hypersensitivity reactions
- eczema, rash
- changes in skin colour where the medicine is used
- infection in the hair follicle (folliculitis)
- hypercalciuria (too much calcium in the urine)
- seborrheic dermatitis (such as dandruff or cradle cap) temporary increased sensitivity to sunlight
- hypercalcaemia (too much calcium in the blood)
Rare side effects (may affect up to 1 in 1,000 people):
- You may feel or be sick, lose your appetite, have constipation, stomach ache, feel very thirsty, have muscle weakness, drowsiness or confusion.
- itchy raised rash (hives)
If you accidentally get the cutaneous solution on your face, it can cause redness or irritation on your face or around your mouth.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5) HOW TO STORE CALCIPOTRIOL 50 MICROGRAMS/ML SCALP SOLUTION
- Keep out of the sight and reach of children.
- Do not use Calcipotriol 50 micrograms/ml Scalp Solution after the expiry date which is stated on the bottle and carton after EXP. The expiry date refers to the last day of that month.
- Do not store above 25oC.
- Keep the bottle in the outer carton in order to protect from light.
- Do not refrigerate or freeze.
- Keep the cutaneous solution away from fire or flames (the alcohol base is flammable).
- Discard the opened bottle with any remaining solution after 3 months.
- If your medicine becomes discoloured or shows any sign of deterioration, return it to your pharmacist.
- 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 Calcipotriol 50 micrograms/ml Scalp Solution contains
The active substance in Calcipotriol 50 micrograms/ml Scalp Solution is calcipotriol. One ml of calcipotriol cutaneous solution contains 50 micrograms of calcipotriol.
The other ingredients are: Sodium citrate, Hypromellose, Propylene glycol, Isopropyl alcohol, Levomenthol and Purified water.
What Calcipotriol 50 micrograms/ml Scalp Solution looks like and contents of the pack
The cutaneous solution is a clear, colourless solution with an odour of menthol.
The cutaneous solution comes in bottles of 30ml. The bottles are fitted with a nozzle and closed with screw caps.
Calcipotriol 50 micrograms/ml Scalp Solution is supplied in cartons containing either 1 bottle of 30ml, 2 bottles of 30ml or 4 bottles of 30ml.
Manufactured by
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia.
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben,
Germany.
Procured from within the EU by Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall, WS9 8ER, UK.
Repackaged by MPT Pharma Ltd.
PL: 33532/0458
Leaflet dated 11th December 2020
Leaflet coded XXXXXXXXXX
To request a copy of this leaflet in Braille, large print or audio please call 01922 745645 and ask for the Regulatory Department.
POM