Product Information for the User

Wynzora 50micrograms/g + 0.5mg/g Cream

calcipotriol/betamethasone

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

• Keep this product information, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse,evenif they do not appearin this product information. See section4.

1.What is Wynzora and how is it used

2.What you need to know before starting to use Wynzora

3.How to use Wynzora

4.Possible adverse effects

5.Storage of Wynzora

6.Contents of the package and additional information

This medication is used on the skin to treat mild to moderate vulgar psoriasis, including scalp psoriasis, in adults.Psoriasis is caused because your skin cells are produced too quickly. This causes redness, peeling, and thickening of the skin.

This medication contains calcipotriol and betamethasone. Calcipotriol helps the rate of skin cell growth return to normal and betamethasone acts by reducing inflammation.

Do not use Wynzora

• if you are allergic to calcipotriol, betamethasone, or any of the other ingredients in this medication (listed in section6)
• if you have problems with calcium levels in your body (consult your doctor)
• if you have other types of psoriasis such as erythrodermic, exfoliative, or pustular (consult your doctor).

Since this medication contains a potent corticosteroid, DO NOT use it on the skin affected by:

• skin infections caused by viruses (e.g., cold sores or chickenpox)
• skin infections caused by fungi (e.g., athlete's foot or ringworm)
• skin infections caused by bacteria
• skin infections caused by parasites (e.g., scabies)
• tuberculosis (TB)
• perioral dermatitis (red rash around the mouth)
• thin skin, fragile veins, striae
• ichthyosis (dry skin with scales similar to fish)
• acne (pimples)
• rosacea (intense redness or flushing of the face)
• ulcers or cracked skin.

Warnings and precautions

Consult your doctor, pharmacist, or nursebefore starting to useWynzora:

• if you have diabetes mellitus (diabetes), as the level of sugar/glucose in the blood may be affected by the corticosteroid
• if you are using other medications that contain corticosteroids, as you may experience side effects
• if you have a certain type of psoriasis called guttate psoriasis.

Consult your doctor, pharmacist, or nurseduring treatment:

• if you have used this medication for a long time and plan to stop (as there is a risk that your psoriasis may worsen or relapse if corticosteroids are stopped suddenly)
• if a skin infection appears, as you may need to interrupt treatment
• if the level of calcium in the blood changes (see section4 for more information)
• if you experience blurred vision or other visual disturbances.

Special precautions

• Avoid using it on more than 30% of the body or more than 15grams per day;
• Avoid using it with bathing caps, bandages, or dressings, as this increases the absorption of the corticosteroid;
• Avoid using it on large areas of damaged skin, mucous membranes, or skin folds (groin, armpits, under the breasts) as this increases the absorption of the corticosteroid;
• Avoid using it on the face or genitals (sexual organs), as they are very sensitive to corticosteroids;
• Avoid excessive sun exposure, excessive use of tanning beds, and other forms of light treatment or exposure.

Children and adolescents

This medication is not recommended for use in children and adolescents under 18years.

Other medications and Wynzora

Inform your doctor, pharmacist, or nurse if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

This medication should only be used during pregnancy if your doctor advises it.

Breastfeeding

If your doctor agrees that you can continue breastfeeding, be careful and do not apply this medication to the breast area.

Driving and operatingmachinery

This medication has no or negligible effect on your ability to drive or operate machinery.

Wynzora contains butylhydroxyanisole (E320) and macrogolglycerol hydroxystearate

This medication may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes because it contains butylhydroxyanisole (E320) and macrogolglycerol hydroxystearate.

Follow exactly the administration instructionsofthismedication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

This medication is for topical use (on the skin).

Proper Use Instructions

When used on the body

• Use only on the skin with psoriasis and not on skin without psoriasis.
• Apply the cream on a clean finger or directly on the affected area by psoriasis.
• Apply the cream to the affected area with the tip of the fingers and spread thinly.
• Do not cover, wrap, or sell the treated skin area.
• Wash your hands thoroughly after using this medication. This will prevent accidental spreading of the cream to other parts of the body (especially the face, mouth, and eyes).
• Do not worry if a little cream is accidentally applied to normal skin near the psoriasis, but clean it if it spreads too much.
• To achieve optimal effect, it is recommended not to shower or bathe immediately after applying this medication. It is recommended to wait 8hours between application and shower for avoiding cream removal.
• Avoid contact with textiles as they can easily stain with the grease it contains (e.g., silk).

When used on the scalp

• Before applying this medication to the scalp, brush the hair to remove any loose scales.
• It may be helpful to separate the hair before using this medication.
• No need to wash the hair before applying this medication.
• Apply cream on the tip of the finger, apply directly to areas where you can notice plaques and massage well a thin layer.

• To achieve optimal effect, it is recommended not to wash the hair after applying this medication.
• It is recommended to wait 8hours between application and shower for avoiding cream removal.

Treatment Duration

• Use the cream once a day. It may be more comfortable to use the cream at night.
• The initial treatment period is usually 8weeks.
• Your doctor may decide on a different treatment period.
• Your doctor may decide if you should repeat the treatment.
• Do not use more than 15grams per day.

If you use other medications containing calcipotriol, the total amount of these should not exceed 15grams per day, and the treated area should not exceed 30% of the total body surface area.

What to Expect When Using Wynzora

Most patients observe results after 1week of treatment, even if the psoriasis has not yet faded at that time.

If You Use More Wynzora Than You Should

Consult your doctor if you have used more than 15grams per day.

Excessive use of this medication may also cause a calcium problem in the blood, which usually normalizes by stopping treatment. Your doctor may need you to have blood tests to check if excessive cream use causes calcium problems in the blood.

Excessive prolonged use may also make the adrenal glands stop working properly (adrenal glands are located above the kidneys and produce hormones).

IfyouusemoreWynzorathanyouhavebeeninstructed,consultyour doctor immediately or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount used.

If You Forget to Use Wynzora

Do not take a double dose to compensate for the misseddoses.

If You Stop Using Wynzora

You should stop using this medication as instructed by your doctor. You may need to stop using this medication gradually, especially if you have used it for a long time.

If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Side effects observed with Wynzora:

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

• Swelling or inflammation of the hair follicle at the application site (foliculitis)
• Insomnia (lack of sleep)
• Itching (pruritus)
• Skin rash (urticaria)
• Pruritus
• Skin irritation at the application site
• Pain at the application site
• Eczema at the application site (urticaria)
• Exfoliation at the application site (peeling)
• Spider veins at the application site (telangiectasia)

Unknown frequency (cannot be estimated from available data):

• Blurred vision.

This medicine contains betamethasone and calcipotriol. Therefore, you may experience the following side effects. It is more likely that these side effects will occur if this medicine is used for a long time, if it is used under dressings or in skin folds (e.g., groin, armpits, or under the breasts), or if it is used on large areas of skin:

• Allergic reactions with facial swelling or other parts of the body, such as the hands or feet. It may also cause swelling of the mouth/throat and breathing difficulties
• Calcium levels in the blood or urine may increase to the point where you experience secondary symptoms. The signs are frequent urination, constipation, muscle weakness, and confusion. When treatment is stopped, calcium levels return to normal
• The adrenal glands may stop functioning properly. The signs are fatigue, depression, and anxiety
• Blurred vision, difficulty seeing at night, light sensitivity (this could be a sign of cataracts)
• Eyeball pain, red eye, decreased vision, or blurred vision (could be a sign of increased eye pressure)
• Infections (because your immune system is weakened)
• Pustular psoriasis (a red area of psoriasis with yellowish pustules [grains])
• You may experience fluctuations in blood sugar levels.

If you experience any of the above side effects, you mustcontact your doctor immediately.

Among the less severe side effects that are known to be caused by calcipotriol or betamethasone are the following:

• Thinning of the skin
• Striae
• Visible blood vessels under the skin
• Changes in hair growth
• Red rash around the mouth (perioral dermatitis)
• Worsening of psoriasis
• Sensitivity of the skin to light that causes a skin rash
• Itchy skin rash (eczema)
• Temporary change in hair color from white or gray to yellowish in the application area when used on the scalp.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box or tube after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Do not freeze.

Dispose of the tube with remaining cream 6months after the first opening.

Medicines should not be thrown into the drains or trash. Deposit the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Wynzora

• The active principles are: calcipotriol and betamethasone.

One gram of cream contains 50 micrograms of calcipotriol and 0.5 mg of betamethasone (as dipropionate of betamethasone).

• The other components are: isopropyl myristate, liquid paraffin, medium-chain triglycerides, isopropanol, lauryl macrogol ether, poloxamer, macrogolglycerol hydroxystearate, carbomer interpolimer, butylhydroxyanisole (E320), trolamine, sodium heptahydrate phosphate dibasic, dihydrogen sodium phosphate monohydrate, all-rac-α-tocopherol, and purified water.

Appearance of the product and contents of the packaging

Wynzora is a white cream presented in an aluminum tube coated with epoxifenol and a polyethylene screw cap.

Packaging size: A 60 g tube, or a multiple pack with two packs (120 g), each containing a 60 g tube (2 x 60 g).

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Almirall, S.A.

Ronda General Mitre, 151

08022 Barcelona

Spain

Responsible manufacturer

Laboratoires Chemineau

93 route de Monnaie

Vouvray, 37210

France

This medicine is authorized in the member states of the European Economic Area with the following names:

Denmark, Czech Republic, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden, United Kingdom (Northern Ireland): Wynzora

Austria: Winxory

Last review date of this leaflet: June/2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es