Calcipotriol Sandoz

Package leaflet: Information for the patient

Calcipotriol Sandoz 50 micrograms/g ointment

Calcipotriol
Generic medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Calcipotriol Sandoz is and what it is used for
2. What you need to know before using Calcipotriol Sandoz
3. How to use Calcipotriol Sandoz
4. Possible side effects
5. How to store Calcipotriol Sandoz
6. Contents of the pack and other information

1. What Calcipotriol Sandoz is and what it is used for

Calcipotriol Sandoz is used on the skin for the local treatment of mild to moderate forms of psoriasis ( psoriasis
vulgaris ).
Psoriasis is a condition that occurs when skin cells are produced too quickly.
This causes scaling and redness. This ointment helps restore the rate of skin cell production to normal levels.

2. What you need to know before using Calcipotriol Sandoz

Do not use Calcipotriol Sandoz:

• 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 failure.
• If you have a problem with calcium metabolism or if your calcium levels are too high. This ointment may increase calcium levels in the blood.
• If you are being treated concurrently with other medicines that increase calcium levels.

Warnings and precautions
Talk to your doctor or pharmacist before using Calcipotriol Sandoz:

• if the patient is under 18 years of age, as there is insufficient experience with the use of this ointment in children and adolescents.
• the ointment may cause skin irritation. Wash your hands after applying the ointment. Also remove any product that may have spread to healthy areas of skin.
• if you use more than 60 ml of Calcipotriol Sandoz in one week, as this may lead to increased calcium levels in the blood. This may cause, for example, fatigue, nausea, loss of appetite, and constipation (see also section 3).
• if you are exposed to sunlight while using this ointment. Any use of artificial UV light therapy (including sunbeds) must be discussed with your doctor beforehand.
• if you know you have a type of psoriasis called generalized pustular psoriasis or exfoliative erythrodermic psoriasis. Consult your doctor if you are unsure. Do not apply it to the face, as it may cause skin irritation.

Do not cover the treated area with an airtight dressing.
You must avoid excessive exposure to light while using this ointment.
Use Calcipotriol Sandoz with caution in skin folds, as this may increase the risk of
adverse effects.
Calcipotriol Sandoz must not be used for guttate, erythrodermic, or pustular psoriasis, as there is no experience regarding its use in these conditions.
Other medicines and Calcipotriol Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are using this ointment concurrently with other psoriasis treatments (e.g. topical corticosteroids), your doctor will advise you on when to use the ointment.
Concomitant use with systemic vitamin D products, calcium supplements, or other agents that may increase serum calcium levels—such as thiazide diuretics, estrogens, anabolic steroids, and parathyroid hormone or parathyroid hormone analogs—may significantly increase the risk of hypercalcemia in a clinically relevant manner.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Calcipotriol Sandoz must not be used during pregnancy unless strictly necessary.
Breastfeeding
It is not known whether calcipotriol is excreted in breast milk. Your doctor will decide whether Calcipotriol Sandoz can be used during pregnancy and breastfeeding.
Fertility
There are no data on the effect of calcipotriol therapy on human fertility.
Driving and using machines
No effects on the ability to drive or operate machinery are expected.
Calcipotriol Sandoz contains 10 mg of propylene glycol per gram of ointment.
Propylene glycol may cause skin irritation.

3. How to use Calcipotriol Sandoz

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Dose:
For adults
Do not apply more than 100 g of this ointment per week. If you are using it concurrently with a cream or solution containing calcipotriol, the total weekly amount of calcipotriol should not exceed 5 mg (for example, 40 ml of scalp solution plus 60 g of cream or ointment).

Method and route of administration:
Calcipotriol Sandoz is intended for use on the skin (cutaneous use).
Before applying this ointment, wash your hands. Then remove the cap and check that the seal is intact before first use. For a 30 g or 120 g tube, break the seal using the protrusion on the back of the cap. Squeeze the ointment onto a finger or directly onto the affected area of skin. Apply a thin layer of ointment to the affected skin areas and gently rub in until the entire area is covered. Do not apply this ointment to the face (see also section 4).

After applying this ointment, wash your hands, unless you are treating psoriasis on the hands themselves. Avoid transferring the ointment from treated areas to other parts of the body, especially the face.

If you are using a moisturizer, apply it first and wait for complete absorption before applying this ointment.

Frequency of administration:
As monotherapy:
For optimal results, apply this ointment twice daily, once in the morning and once in the evening. Depending on your response to treatment, your doctor may advise you to use the ointment once daily.

As combination therapy:
If you are using this ointment together with other psoriasis treatments, your doctor will instruct you on when and how often to use this ointment.

Duration of treatment:
You may notice improvement after approximately two weeks of using the ointment. Scaling or flaking usually improves first, making psoriatic patches feel thinner. Improvement in skin redness may take longer. Maximum effect is usually achieved after 4–8 weeks.

Use in children and adolescents
Calcipotriol Sandoz is not recommended for children and adolescents (under 18 years of age), as experience with the use of this ointment in these patients is limited.

If you use more Calcipotriol Sandoz than you should
If you have applied more ointment than recommended (more than 100 g per week), inform your doctor. Such use may cause increased calcium levels in the blood, which could lead to symptoms such as nausea, loss of appetite, constipation, vomiting, muscle weakness, loss of energy, fatigue, and loss of consciousness.

If you forget to use Calcipotriol Sandoz
If you forget to apply the ointment at the scheduled time, do so as soon as you remember, then continue treatment as before.
Do not apply a larger amount of ointment than normal to make up for a missed application.

If you stop using Calcipotriol Sandoz
If you intend to stop treatment, always consult your doctor.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop using the ointment and contact your doctor immediately or go to hospital 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.

Other possible side effects:
Very common side effects (may affect more than 1 in 10 people):

• skin irritation
  Common side effects (may affect up to 1 in 10 people):
  • itching sensation
  • burning sensation, contact dermatitis
  • redness
  • worsening of psoriasis
  • skin inflammation
  • skin peeling
  • skin rash (including desquamation, papules and pustules)
  • pain in the area where the medicine is applied

Uncommon side effects (may affect up to 1 in 100 people):

• dry skin
• hypersensitivity reactions
• eczema, skin rash
• change in skin colour where the medicine is applied
• hair follicle infection (folliculitis)
• hypercalciuria (excess calcium in urine)
• temporary seborrhoeic dermatitis (such as dandruff or cradle cap), increased sensitivity to sunlight
• hypercalcemia (excess calcium in blood)

Rare side effects (may affect up to 1 in 1,000 people):

• you may feel unwell, lose your appetite, become constipated, have stomach ache, feel very thirsty, experience muscle weakness, drowsiness or confusion
• itchy skin rash (urticaria)

If you accidentally apply the ointment to your face, it may cause redness or irritation of the facial skin or around the mouth.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Calcipotriol Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the tube and packaging after "Exp". The expiry date refers to the last day of that month.
Do not store above 25°C. Do not refrigerate or freeze. Store the product in its original packaging.
Shelf life after first opening: 3 months
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Calcipotriol Sandoz contains
The active substance is calcipotriol.
Each gram of ointment contains 0.05 mg (an amount equivalent to 50 micrograms) of
calcipotriol.
The other components are: macrogol stearil ether, disodium edetate, disodium phosphate dihydrate, alpha-
tocopheryl acetate, propylene glycol (E 490), light liquid paraffin, purified water and white soft paraffin.
Description of the appearance of Calcipotriol Sandoz and package contents
Colour: white to almost white.
The ointment is available in aluminium tubes with a polypropylene screw cap of 30 and 120 grams.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Sandoz S.p.A – Largo U. Boccioni, 1 – 21040 Origgio (VA)
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
Salutas Pharma GmbH, Lange Göhren 3, 39171 Osterweddingen, Germany
This medicinal product has been authorised in the European Economic Area countries and in the
United Kingdom (Northern Ireland) under the following names:
Belgium: Calcipotriol Sandoz 50 µg/g zalf
Czech Republic: Calcipotriol Sandoz 0.05 mg/g mast
Denmark: Calcipotriol Sandoz
Finland: Calcipotriol Sandoz
France: CALCIPOTRIOL Sandoz 50 microgrammes/gramme, pommade
Germany: Calcipotriol Sandoz 0.05 mg/g Salbe
Italy: CALCIPOTRIOLO Sandoz
Latvia: Calcipotriol Sandoz 50mcg/g ziede
Netherlands: Calcipotriol Sandoz zalf 0.05mg/g, zalf
Norway: Calcipotriol Sandoz
Poland: SOREL PLUS
Slovenia: SOREL mazilo 0.005%
Sweden: Calcipotriol Sandoz
United Kingdom (Northern Ireland): Calcipotriol Ointment 50 micrograms/g