Vinzora

PATIENT INFORMATION LEAFLET

Enclosed leaflet: information for the user

Wynzora, (50 micrograms + 0.5 mg)/g, cream

Calcipotriol + Betamethasone

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Wynzora and what is it used for

Wynzora is used on the skin to treat psoriasis, including scalp psoriasis, with a mild to moderate course, in adults. Psoriasis is caused by the skin cells being produced too quickly. This leads to redness, scaling, and thickening of the skin.
Wynzora contains calcipotriol and betamethasone. Calcipotriol helps to restore the normal rate of skin cell growth, and betamethasone reduces inflammation.

2. Important information before using Wynzora

When not to use Wynzora

• if you are allergic to calcipotriol, betamethasone, or any of the other ingredients of this medicine (listed in section 6);
• if you have disorders of calcium levels in the body (consult your doctor);
• if you have a certain type of psoriasis - erythrodermic psoriasis, pustular psoriasis, or psoriasis with pus-filled bumps (consult your doctor).

Wynzora contains a strong steroid, so it MUST NOT be used on skin with conditions such as:

• viral skin infections (e.g., cold sores or chickenpox);
• fungal skin infections (e.g., athlete's foot or ringworm);
• bacterial skin infections;
• parasitic skin infections (e.g., scabies);
• tuberculosis;
• perioral dermatitis (red rash around the mouth);
• thin skin, fragile blood vessels, stretch marks;
• ichthyosis (dry skin with scales resembling fish scales);
• acne (pimples);
• rosacea (severe redness or flushing of the skin on the face);
• broken or damaged skin.

Warnings and precautions

Before startingtreatment with Wynzora, you should discuss it with your doctor, pharmacist, or nurse if:

• you have diabetes, as the steroid may affect your blood sugar levels;
• you are using other medicines that contain steroids, as side effects may occur;
• you have been diagnosed with guttate psoriasis.

You should consult your doctor, pharmacist, or nurse during treatmentif:

• you have been using this medicine for a long time and plan to stop using it (as there is a risk that your psoriasis may worsen or flare up when steroid use is stopped suddenly);
• you have a skin infection, as treatment may need to be interrupted;
• your blood calcium levels have changed (see section 4 for more information);
• you experience blurred vision or other vision problems.

Special precautions

• Avoid using the medicine on an area larger than 30% of the body surface and avoid using more than 15 grams per day.
• Avoid using the medicine under a bathing cap, bandages, or dressings, as this increases the absorption of the steroid.
• Avoid using the medicine on large areas of damaged skin, mucous membranes, or skin folds (e.g., groin, armpits, skin under the breasts), as this increases the absorption of the steroid.
• Avoid using the medicine on the face and genital areas, as they are very sensitive to steroids.
• Avoid excessive sunbathing, using sunbeds, and other forms of phototherapy.

Children

Wynzora should not be used in children under 18 years of age.

Wynzora and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and any you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before using this medicine.
Pregnancy
Use of Wynzora during pregnancy should only be done under medical supervision.
Breastfeeding
Use of Wynzora during breastfeeding should only be done under medical supervision. Do not use Wynzora on the breast if you are breastfeeding.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines.

Wynzora contains butylhydroxyanisole (E320) and macrogolglycerol hydroxystearate

• (40) (hydrogenated polyoxyethylene castor oil)Butylhydroxyanisole (E320) may cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation. Hydrogenated polyoxyethylene castor oil may cause skin reactions.

3. How to use Wynzora

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Wynzora is for use on the skin.

Instructions for proper use

When using on the skin

• Use only on skin affected by psoriasis and avoid using on unaffected skin.
• Squeeze the cream onto a clean finger or directly onto the affected area.
• Apply the cream with the fingertip to the affected area and gently rub in a thin layer.
• Do not cover the treated skin areas with bandages, tight dressings, or binders.
• Wash your hands thoroughly after using Wynzora to avoid accidentally transferring the cream to other parts of the body (especially the face, mouth, and eyes).
• Do not worry if a small amount of cream accidentally gets on healthy skin near the affected area; wipe off any cream that has been applied too far.
• To achieve optimal effect, it is not recommended to take a shower or bath immediately after applying Wynzora. It is recommended to wait eight hours after applying the cream before taking a shower to avoid washing the medicine off the skin.
• After applying the cream, avoid contact with fabrics that may be easily stained by greasy substances (e.g., silk).

When using on the scalp

• Before using Wynzora on the scalp, comb out your hair to remove any scales.
• It may be helpful to part your hair before applying Wynzora.
• Washing your hair before applying Wynzora is not necessary.
• Apply Wynzora to the fingertip, then apply it directly to the area where you can feel the raised patches on the skin. Gently rub in a thin layer of cream.

• To achieve optimal effect, it is not recommended to wash your hair immediately after applying Wynzora.
• It is recommended to wait eight hours after applying the cream before taking a shower to avoid washing the medicine off the skin.

Duration of treatment

• The cream should be used once a day. It may be more convenient to apply the cream in the evening.
• Usual initial treatment period is eight weeks.
• Your doctor may decide on a different treatment period.
• Your doctor may decide to repeat the treatment.
• Do not use more than 15 grams per day (in one day).

If you are using other medicines that contain calcipotriol, the total amount of calcipotriol-containing medicines should not exceed 15 grams per day, and the treated area should not exceed 30% of the total body surface.

What to expect when using Wynzora?

In most patients, noticeable treatment results will be visible after one week, even if the psoriasis has not cleared up by then.

Using more than the recommended dose of Wynzora

If you use more than 15 grams per day (in one day), contact your doctor.
Using more than the recommended dose of Wynzora may also cause disturbances in blood calcium levels, which usually disappear after treatment is stopped. Your doctor may need to order blood tests to check if using too much cream has caused disturbances in blood calcium levels.
Long-term use of more than the recommended dose may also cause adrenal gland problems (adrenal glands are located near the kidneys and produce hormones).

Missing a dose of Wynzora

Do not use a double dose to make up for a missed dose.

Stopping treatment with Wynzora

Use of Wynzora should be stopped as advised by your doctor. It may be necessary to gradually stop using the medicine, especially if it has been used for a long time.
If you have any further questions about using 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.

Side effects seen with Wynzora:

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

• inflammation or swelling of the hair follicle at the application site (folliculitis);
• insomnia;
• itching (pruritus);
• rash;
• hives;
• skin irritation at the application site;
• pain at the application site;
• itchy rash on the skin (eczema) at the application site;
• skin peeling at the application site;
• spider veins at the application site (telangiectasias).

Frequency not known (cannot be estimated from the available data):

• blurred vision.

Wynzora contains betamethasone and calcipotriol. As a result, the following side effects may occur in patients. The likelihood of these side effects is higher if Wynzora is used for a long time, under dressings, or on skin folds (e.g., groin, armpits, or skin under the breasts) or if it is used on large areas of skin:

• allergic reactions including swelling of the face or other parts of the body, such as hands or feet. Swelling of the mouth and throat, and difficulty breathing may also occur;
• blood or urine calcium levels may increase to a level that causes symptoms. Symptoms include: frequent urination, constipation, muscle weakness, and confusion. After stopping treatment, calcium levels return to normal;
• adrenal gland problems may occur. Symptoms include: fatigue, depression, and anxiety;
• blurred vision, difficulty seeing at night, sensitivity to light (may be a sign of cataracts);
• eye pain, redness of the eyes, decreased vision, or blurred vision (may be a sign of increased eye pressure);
• infections (related to a weakened immune system);
• psoriasis with pus-filled bumps (pustular psoriasis);
• fluctuations in blood sugar levels.

If you experience any of the above side effects, contact your doctor immediately.
Less serious side effects caused by calcipotriol or betamethasone include:

• skin thinning;
• stretch marks;
• visible blood vessels under the skin;
• change in hair growth rate;
• red rash around the mouth (perioral dermatitis);
• psoriasis worsening;
• skin sensitivity to light resulting in a rash;
• itchy rash on the skin (eczema);
• when used on the scalp, white or gray hair may temporarily turn yellow.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website:
https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Wynzora

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 outer packaging (carton) or tube after "EXP". The expiry date refers to the last day of the month.
Store below 25°C.
Do not freeze.
Shelf-life after first opening the tube: 6 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Wynzora contains

• The active substances are calcipotriol and betamethasone. One gram of cream contains 50 micrograms of calcipotriol and betamethasone dipropionate, equivalent to 0.5 mg of betamethasone.
• The other ingredients are: isopropyl myristate, liquid paraffin, medium-chain triglycerides, isopropyl alcohol, laureth-4, poloxamer 407, macrogolglycerol hydroxystearate (40), carbomer (interpolymer Type A), butylhydroxyanisole, tromethamine, disodium phosphate heptahydrate, sodium dihydrogen phosphate monohydrate, all-rac-α-tocopherol, and purified water.

What Wynzora looks like and contents of the pack

Wynzora is a white cream in an aluminum tube with an internal epoxy-phenolic coating, with an HDPE cap, in a cardboard box.
Pack sizes: 1 tube containing 60 g or a collective pack of 120 g (2 tubes in a cardboard box, each containing 60 g).
Not all pack sizes may be marketed.

Marketing authorization holder

Almirall, S.A.
Ronda General Mitre 151
08022 Barcelona
Spain

Importer

Laboratoires Chemineau
93 route de Monnaie
37210 Vouvray
France
To obtain more detailed information, please contact the representative of the marketing authorization holder:
Almirall Sp. z o. o.
tel.: 22 330 02 57

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet: