50 micrograms/ml cutaneous solution
calcipotriol
What Zoriaxiol is and what it is used for
Zoriaxiol is used for local treatment of mild to moderately severe scalp psoriasis.
Psoriasis is a disease where your skin cells are produced too quickly. This causes skin flaking and redness. This solution helps restore the skin’s production rate of new cells to normal.
Calcipotriol found in Zoriaxiol may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Zoriaxiol
Do not use Zoriaxiol
- if you are allergic to calcipotriol or any of the other ingredients of this medicine (listed in section 6).
- if you have severe liver or kidney failure.
- if you have problems with your calcium metabolism or if the calcium level in your body is too high. This solution can increase the level of calcium in the blood.
- if you simultaneously use other medicines that increase calcium levels.
Warnings and precautions
Talk to your doctor or pharmacist before using Zoriaxiol.
- this solution may cause skin irritation. If the solution accidentally gets on your face, wash it off immediately. If it gets in the eye, rinse the eye with water. Wash your hands after applying the solution.
- if you use more than 60 ml of Zoriaxiol cutaneous solution during a week because you can develop high levels of calcium in the blood. This can lead to e.g. weakness, nausea, loss of appetite, and constipation (see also section 3).
- if you are exposed to sunlight while using this solution. All treatment with artificial UV radiation (including solarium) should first be discussed with your doctor.
- if you know you have a type of psoriasis called generalized pustular or erythrodermic exfoliative psoriasis. Ask your doctor if you are unsure.
Do not apply the solution to the face, as it may cause skin irritation.
Do not cover the treated area with a waterproof bandage.
Avoid excessive exposure to sunlight when using the solution.
Use Zoriaxiol with caution in skin folds, as this may increase the risk of side effects.
Zoriaxiol should not be used for guttate psoriasis, erythrodermic psoriasis, or pustular psoriasis as there is no experience.
Other medicines and Zoriaxiol
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
If you use this cutaneous solution together with other treatments for psoriasis, your doctor will tell you when to use the solution.
Concomitant use with systemic vitamin D preparations, calcium supplements, or other substances that can increase serum calcium concentration such as thiazide diuretics, estrogens, anabolic steroids, and parathyroid hormone or parathyroid hormone analogs may increase the risk of you getting too high levels of calcium in the blood (clinically significant hypercalcemia ).
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Zoriaxiol should not be used during pregnancy unless necessary.
Breast-feeding
It is not known whether calcipotriol passes into breast milk. Your doctor will decide if you can use Zoriaxiol during pregnancy and breastfeeding.
Fertility
There are no data on the effect of calcipotriol treatment on human fertility.
Driving ability and use of machinery
No effect on the ability to drive or use machines can be expected. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Zoriaxiol contains 30 mg of propylene glycol per ml of solution.
Propylene glycol can cause skin irritation.
How to use Zoriaxiol
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Dose
Adults
You should not use more than 60 ml of this cutaneous solution in one week.
If you use it together with a cream or ointment containing calcipotriol, the total amount of calcipotriol per week should not exceed 5 mg (eg 60 ml of scalp solution plus 40 g of cream or ointment).
Method of use
Zoriaxiol is intended for use on the scalp ( cutaneous use). Zoriaxiol should be used on the areas of the scalp affected by psoriasis.
When using the solution, tilt your head so that the solution does not run down your face. It may help to part the hair before using the solution. Remove the cap and run the nozzle down through the hair so that it reaches an affected area of the scalp. Gently press the bottle and apply a few drops. Massage the solution 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 immediately. If you get the solution in your eyes, immediately rinse it out with water. If you have access to some sterile saline solution, you can use it to rinse your eyes with afterward. If the eyes still sting, you should consult a doctor.
Wash your hands after applying this solution.
How often should the application take place?
For best results, you should apply this solution twice daily, once in the morning and once in the evening.
Duration of treatment
Your doctor decides how long the treatment should last, but normally it should not last longer than 22 weeks.
Use for children and adolescents (under 18 years)
Zoriaxiol is not recommended for children and adolescents (under 18 years of age) due to the lack of sufficient experience in the use of the solution among these patients.
If you have used too much Zoriaxiol
If you have used more solution than you should (more than 60 ml in a week), you should contact your doctor. Such use can lead to high levels of calcium in the blood, which e.g. can cause nausea, loss of appetite, constipation, vomiting, muscle weakness, weakness, fatigue, and unconsciousness.
If you have ingested too much medicine or if, for example, a child accidentally ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to use Zoriaxiol
If you forget to use this solution at the right time, apply it as soon as you remember. Then continue as before. Do not apply more solutions than usual to make up for a missed dose.
If you stop using Zoriaxiol
Always ask your doctor for advice if you are considering stopping treatment.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using this cutaneous solution and consult a doctor or go to the nearest emergency department immediately if you experience any of the following symptoms:
- Signs of allergy (less common side effect ) such as hives, swelling of the face, eyelids, hands, feet, or throat, or difficulty breathing.
Other possible side effects:
Very common side effects ( may affect more than 1 in 10 users):
- skin irritation
Common side effects ( may affect up to 1 in 10 users):
- itching
- burning sensation in the skin
- contact dermatitis
- skin redness
- worsened psoriasis
- skin inflammation
- flaky skin
- skin rash (incl. scaly rash, papules and persistent pustules)
- pain in the area where the drug is used.
Uncommon side effects ( may affect up to 1 in 100 users):
- dry skin
- hypersensitivity reaction
- eczema, rash
- changed skin color in the area where the medicine is used
- folliculitis
- hypercalciuria (too much calcium in the urine)
- hypercalcemia (too much calcium in the blood)
- dandruff (e.g. dandruff or milk scab )
- transiently increased sensitivity to sunlight.
Rare side effects ( affects less than 1 in 1,000 users):
- You may experience nausea, vomiting, loss of appetite, constipation, stomach pain, excessive thirst, muscle weakness, drowsiness, or confusion.
- itchy raised rash ( hives ).
If you accidentally get the cutaneous solution on your face, it may cause redness or irritation on the face or around the mouth.
How to store Zoriaxiol
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the bottle and carton after EXP. The expiration date is the last day of the specified month.
Store at a maximum of 25 °C. Store protected from cold. Do not freeze.
Store the bottle in the outer carton. Light sensitive.
Do not use or store the cutaneous solution near open flames or flames (alcohol content is flammable).
Shelf life after first opening: 3 months.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is calcipotriol.
One ml of cutaneous solution contains 0.05 mg (corresponding to 50 micrograms) of calcipotriol.
Other ingredients are sodium citrate, hypromellose, propylene glycol, isopropyl alcohol, levomenthol, and purified water.
Appearance and package sizes of the medicine
The clear, colorless solution that smells of menthol.
The cutaneous solution is supplied in polyethylene bottles of 30 ml, 60 ml, 100 ml, and 120 ml. The bottles have a polyethylene spout and are closed with polypropylene screw caps.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Sandoz A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer:
Lek Pharmaceuticals dd, Verovškova 57, 1526 Ljubljana, Slovenia
or
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany