Wynzora

Package leaflet: Information for the user

Wynzora, (50 micrograms + 0.5 mg)/g, cream
Calcipotriol + Betamethasone
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for possible future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Wynzora is and what it is used for
2. What you need to know 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 Wynzora is and what it is used for

Wynzora is a topical medicine used to treat mild to moderate plaque psoriasis, including mild to moderate scalp psoriasis, in adults. Psoriasis is caused by the skin cells growing too quickly. This leads to redness, scaling, and thickening of the skin.
Wynzora contains calcipotriol and betamethasone. Calcipotriol helps restore normal skin cell growth, while betamethasone reduces inflammation.

2. Important information before using Wynzora

When not to use Wynzora

• if the patient is allergic to calcipotriol, betamethasone, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has disorders of calcium levels in the body (consult a doctor);
• if the patient has been diagnosed with a specific type of psoriasis – erythrodermic psoriasis, pustular psoriasis, or impetigo psoriasis (consult a doctor).

Wynzora contains a potent steroid; therefore, it should NOT be used on skin affected by the following conditions:

• viral skin infections (e.g. cold sores or chickenpox);
• fungal skin infections (e.g. athlete’s foot or fungal skin infection);
• bacterial skin infections;
• parasitic skin infections (e.g. scabies);
• tuberculosis;
• perioral dermatitis (red rash around the mouth);
• thin skin, fragile veins, stretch marks;
• ichthyosis (dry, scaly skin resembling fish scales);
• acne (pimples);
• rosacea (severe flushing or redness of the facial skin);
• ulcerated or damaged skin.

Warnings and precautions
Before starting treatment with Wynzora, discuss with your doctor, pharmacist, or nurse if:

• the patient has diabetes, as steroids may affect blood sugar (glucose) levels;
• the patient is using other steroid-containing medicines, as adverse effects may occur;
• the patient has been diagnosed with guttate psoriasis.

Consult your doctor, pharmacist, or nurse during treatment if:

• the patient has used this medicine for a prolonged period and plans to discontinue treatment (as there is a risk that psoriasis may worsen or flare up due to sudden steroid withdrawal);
• a skin infection develops, as treatment may need to be stopped;
• blood calcium levels change (additional information, see section 4);
• the patient experiences blurred vision or other visual disturbances.

Special precautions

• Avoid using the medicine on areas larger than 30% of the body surface and avoid using more than 15 grams per day.
• Avoid using the medicine under a shower cap, bandages, or dressings, as this increases steroid absorption.
• 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 steroid absorption.
• Avoid using the medicine on the face and genital organs (genitalia), as these areas are highly sensitive to steroids.
• Avoid excessive sun exposure, use of sunbeds, and other forms of phototherapy.

Children
Wynzora should not be used in children under 18 years of age.
Wynzora with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
Pregnancy
Wynzora should be used during pregnancy only as directed by a doctor.
Breastfeeding
Wynzora should be used during breastfeeding only as directed by a doctor. Wynzora must not be applied to the breasts if the patient is breastfeeding.
Driving and operating machinery
This medicine has no effect or has a negligible effect on the ability to drive and operate machinery.
Wynzora contains butylhydroxyanisole (E320) and macrogol glycerol hydroxystearate (40) (polyoxyl 35 hydrogenated castor oil)
Butylhydroxyanisole (E320) may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
Polyoxyl 35 hydrogenated castor oil may cause skin reactions.

3. How to use Wynzora

This medicine should always be used as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Wynzora is for topical use only.

Instructions for proper use

When applying to the skin:

• Apply only to skin affected by psoriasis. Do not apply to unaffected skin.
• Squeeze the cream onto a clean fingertip or directly onto the psoriatic area.
• Apply the cream with the fingertip to the affected area and rub in a thin layer thoroughly.
• Do not cover treated skin areas with bandages, occlusive dressings, or wraps.
• Wash hands thoroughly after applying Wynzora. This helps prevent accidental transfer of the cream to other parts of the body (especially face, mouth, and eyes).
• Do not be concerned if a small amount of cream accidentally spreads to healthy skin near the psoriatic area; wipe off any cream applied too far from the target area.
• To achieve optimal effect, avoid showering or bathing immediately after applying Wynzora. Wait eight hours after application before showering to avoid washing the medicine off the skin.
• After applying the cream, avoid contact with fabrics that are easily stained by oily substances (e.g., silk).

When applying to hairy scalp:

• Before applying Wynzora to the hairy scalp, comb the hair to remove all loose, flaking skin.
• Creating a parting may be helpful before application.
• Shampooing before applying Wynzora is not necessary.
• Apply Wynzora to the fingertip, then directly to the area where raised skin lesions are felt. Rub in a thin layer thoroughly.

• To achieve optimal effect, avoid washing the hair immediately after applying Wynzora.
• Wait eight hours after applying Wynzora before showering to avoid washing the medicine off the skin.

Duration of treatment

• Apply the cream once daily. It may be more convenient to apply it in the evening.
• The initial treatment period is usually eight weeks.
• Your doctor may determine a different treatment duration.
• Your doctor may decide on repeat treatment.
• Do not use more than 15 grams per day (within a 24-hour period).

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

What to expect during treatment with Wynzora?
In most patients, noticeable treatment results will be visible after one week, even if psoriasis has not completely cleared by that time.

Use of more than the recommended dose of Wynzora
If more than 15 grams per day (within a 24-hour period) is used, contact your doctor.
Using more than the recommended dose of Wynzora may cause disturbances in blood calcium levels, which usually resolve after stopping treatment. Blood tests ordered by your doctor may be necessary to check whether excessive use of the cream has caused abnormal calcium levels in the blood.
Long-term use of more than the recommended dose may also cause disturbances in adrenal gland function (adrenal glands are located near the kidneys and produce hormones).

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

Stopping treatment with Wynzora
Treatment with Wynzora should be discontinued as directed by your doctor. Gradual discontinuation may be necessary, especially if the medicine has been used for a long time.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions observed during treatment with Wynzora:
Uncommon (may affect less than 1 in 100 people):

• inflammation or swelling at the hair root at the application site (folliculitis);
• insomnia;
• itching (pruritus);
• rash;
• urticaria;
• 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;
• blood vessels visible on the skin at the application site (telangiectasia).

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

• blurred vision.

Wynzora contains betamethasone and calcipotriol. Therefore, patients may experience the following adverse reactions. The likelihood of these adverse reactions is greater if Wynzora is used for a prolonged period, under occlusive dressings, in skin folds (e.g. groin, armpits, or under the breasts), or over large areas of skin:

• allergic reactions including swelling of the face or other body parts such as hands or feet. Swelling of the mouth/throat and breathing difficulties may also occur;
• increased calcium levels in blood or urine, which may cause symptoms. Objective symptoms include: frequent urination, constipation, muscle weakness, and confusion. After discontinuation of treatment, calcium levels return to normal;
• adrenal gland function disorders. Objective symptoms include: fatigue, depression, and anxiety;
• blurred vision, difficulty seeing at night, light sensitivity (may be a sign of cataract);
• eye pain, eye redness, worsening or blurred vision (may be a sign of increased intraocular pressure);
• infections (due to immune system suppression);
• pustular psoriasis (red, psoriatic-appearing area with yellowish pustules [pimples]);
• fluctuations in blood glucose (sugar) levels may occur.

If any of the above adverse reactions occur, contact a doctor immediately.
Less serious adverse reactions caused by calcipotriol or betamethasone include:

• skin thinning;
• stretch marks;
• visible blood vessels under the skin;
• changes in hair growth rate;
• red rash around the mouth (perioral dermatitis);
• worsening of psoriasis;
• skin sensitivity to light resulting in rash;
• itchy rash on the skin (eczema);
• when applied to hairy scalp, white or grey hair may temporarily turn yellowish.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Wynzora medicine

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging
(carton) or tube after: "Expiry date" or "EXP". The expiry date refers to the last day of the stated month. The batch number is marked on the tube with the abbreviation "Lot".
Do not store above 25°C.
Do not freeze.
Shelf life after first opening the tube: 6 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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.
• Other ingredients are: isopropyl myristate, liquid paraffin, medium-chain triglycerides, isopropyl alcohol, macrogol lauryl ether (4), poloxamer (407), polyoxyl 40 hydrogenated castor oil, carbomer (interpolymer type A), butylhydroxyanisole, trometamol, disodium hydrogen 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 aluminium tube internally coated with epoxy-phenolic lacquer, with an HDPE cap, packed in a cardboard box.
Pack sizes: 1 tube containing 60 g or a multiple pack of 120 g (2 tubes in a cardboard box, each containing 60 g).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Almirall, S.A.
Ronda General Mitre 151
08022 Barcelona
Spain
Importer
Laboratoires Chemineau
93 route de Monnaie
37210 Vouvray
France
For further information, contact the representative of the Marketing Authorisation Holder:
Almirall Sp. z o.o.
Tel.: 22 330 02 57
This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: