CALCIPOTRIOLO 0.05 MG/G Maść

Treść ulotki

1. Calcipotriolo Sandoz 50 micrograms/g ointment
   1. What is Calcipotriolo Sandoz and what is it used for
   2. What you need to know before using Calcipotriolo Sandoz
   3. How to use Calcipotriolo Sandoz
   4. Possible side effects
   5. How to store Calcipotriolo Sandoz
   6. Contents of the pack and other information

Calcipotriolo Sandoz 50 micrograms/g ointment

Calcipotriol

Generic medicine
Read this leaflet carefully before using this medicine as 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 others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Calcipotriolo Sandoz is used on the skin for the local treatment of mild to moderately severe 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 to restore to normal the
rate at which skin cells are produced.

2. What you need to know before using Calcipotriolo Sandoz

Do not use Calcipotriolo Sandoz:

• 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 a problem with calcium metabolism or if the level of calcium in your body is too high. This ointment can increase calcium levels in the blood.
• If you are being treated with other medicines that increase calcium levels.

Warnings and precautions
Talk to your doctor or pharmacist before using Calcipotriolo 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 has spread to healthy skin areas.
• if you use more than 60 ml of Calcipotriolo Sandoz in a week, as this may cause an increase in calcium levels in the blood. This can cause, for example, fatigue, nausea, loss of appetite and constipation (see also section 3).
• if you are exposed to sunlight when using this ointment. Any use with artificial UV light therapy (including sunbeds) should be discussed with your doctor first.
• if you know you have a type of psoriasis called generalized pustular psoriasis or exfoliative erythrodermic psoriasis. Ask your doctor if you are not sure. Do not apply it to the face, as it may cause skin irritation.

Do not cover the treated area with a waterproof bandage.
You should avoid excessive exposure to light when using this ointment.
Use Calcipotriolo Sandoz with caution in skin folds, as this may increase the risk of
undesirable effects.
Calcipotriolo Sandoz should not be used for guttate, erythrodermic and pustular psoriasis because
there is no experience in this regard.

Other medicines and Calcipotriolo Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
If you are using this ointment in conjunction with other treatments for psoriasis (e.g. topical corticosteroids
), your doctor will tell you when to use the ointment.
Concomitant use with systemic vitamin D products, calcium supplements, or other agents that can
increase serum calcium concentrations such as thiazide diuretics, estrogens, anabolic steroids and
parathyroid hormone or parathyroid hormone analogues may increase the risk of hypercalcemia in a
clinically significant way.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Calcipotriolo Sandoz should not be used during pregnancy unless it is strictly
necessary.
Breastfeeding
It is not known whether calcipotriol is excreted in breast milk. The doctor will decide whether Calcipotriolo 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 and use machines are expected.

Calcipotriolo Sandoz contains 10 mg of propylene glycol per gram of ointment.
Propylene glycol may cause skin irritation.

3. How to use Calcipotriolo Sandoz

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.

Dosage:
For adults
You should not apply more than 100 g of this ointment per week. If you apply it in
conjunction 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:
Calcipotriolo 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 not
broken before using the ointment for the first time. In the case of a 30 gram or 120 gram tube,
you will need to break the seal using the tip on the back of the cap. Squeeze the ointment onto a finger or
onto an area of skin affected by psoriasis. Apply the ointment by spreading a thin layer over the
affected areas of the skin. Rub it in lightly to cover the entire area. Do not apply this ointment to the
face(see also section 4).
After applying this ointment, wash your hands, unless you are treating a form of
psoriasis that specifically affects the hands. Try not to transfer the ointment from the treated areas to other
parts of the body, especially the face.
If you are using a moisturizer, you should apply it first and wait for it to be fully absorbed before
applying this ointment.

Frequency of administration:
As monotherapy:
To achieve optimal results, apply this ointment twice a day, once in the morning and once in the
evening. Depending on the response to treatment, your doctor may suggest using the ointment once
a day.
As combination therapy:
If you are using this ointment together with other treatments for psoriasis, your doctor will tell you when and
how often to use this ointment.

Duration of treatment:
You may notice an improvement after about two weeks of using the ointment. Usually the first
symptoms to disappear are scaling or flaking. This will make the psoriasis patches thinner to the touch. Improvement of skin redness will take longer. The maximum
effect is usually achieved after 4-8 weeks.

Use in children and adolescents
Calcipotriolo 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 Calcipotriolo Sandoz than you should
If you have applied more ointment than you should (more than 100 grams per week), you should inform your doctor.
Such use may cause an increase in blood calcium levels, which in turn may cause
symptoms such as nausea, loss of appetite, constipation, vomiting, muscle weakness,
loss of energy, fatigue and loss of consciousness.

If you forget to use Calcipotriolo Sandoz
If you forget to use this ointment at the prescribed time, do so as soon as you remember, then
continue treatment as before.
Do not apply a dose of ointment more than usual to make up for the forgotten dose.

If you stop using Calcipotriolo Sandoz
If you intend to stop treatment, always consult your doctor.
If you have any doubts about 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 the ointment and contact your doctor or go to hospital 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.

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
• rash (including scaling, papules and pustules)
• pain in the area where the medicine is used

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

• skin dryness
• hypersensitivity reactions
• eczema, skin rash
• change in skin color where the medicine is used
• hair follicle infection (folliculitis)
• hypercalciuria (excess calcium in the urine)
• seborrheic dermatitis (like dandruff or cradle cap) temporary, increased sensitivity to sunlight
• hypercalcemia (excess calcium in the blood)

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

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

If you accidentally apply the ointment to the face, the ointment may cause redness or irritation of the skin of
the face or around the mouth.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 Calcipotriolo 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 the packaging after
“Exp”. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C. Do not refrigerate or freeze. Store the product in the
original packaging.
Period of validity after first opening: 3 months
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Calcipotriolo Sandoz contains
The active ingredient is calcipotriol.
Each gram of ointment contains 0.05 mg (an equivalent amount to 50 micrograms) of
calcipotriol.
The other components are: sterile macrogol ether, disodium edetate, disodium phosphate dihydrate, alpha-
tocopheryl acetate, propylene glycol (E 490), light liquid paraffin, purified water and soft
white paraffin.

Description of the appearance of Calcipotriolo Sandoz and contents of the pack
Colour from white to almost white.
The ointment is available in aluminium tubes with a propylene screw cap in 30 and 120 gram sizes.
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 Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) under the following denominations:
Belgium: Calcipotriol Sandoz 50 µg/g ointment
Czech Republic: Calcipotriol Sandoz 0.05 mg/g ointment
Denmark: Calcipotriol Sandoz
Finland: Calcipotriol Sandoz
France: CALCIPOTRIOL Sandoz 50 micrograms/ gram, ointment
Germany: Calcipotriol Sandoz 0.05 mg/g ointment
Italy: CALCIPOTRIOLO Sandoz
Latvia: Calcipotriol Sandoz 50mcg/g cream
Netherlands: Calcipotriol Sandoz zalf 0.05mg/g, cream
Norway: Calcipotriol Sandoz
Poland: SOREL PLUS
Slovenia: SOREL ointment 0.005%
Sweden: Calcipotriol Sandoz
United Kingdom (Northern Ireland): Calcipotriol Ointment 50 micrograms/g