Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Betamethasone dipropionate, Calcipotriol may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for
Wynzora is used on the skin to treat mild to moderate psoriasis vulgaris, including scalp psoriasis in adults. Psoriasis is caused by your skin cells being produced too quickly. This causes redness, scaling and thickness of your skin. Wynzora contains calcipotriol and betamethasone. Calcipotriol helps to bring the rate of skin cell growth back to normal and betamethasone acts to reduce inflammation. Corticosteroid creams, ointments and other topical preparations come in four different potencies or strenghts. These are known as mild, moderately potent, potent or very potent. Healthcare professionals will usually refer to topical corticosteroid potency rather than strength. A potent or strong coticosteroid has a much stronger effect than a mild corticosteroid when using the same amount. Be aware the percentage of active ingredient that is sometimes included on product packaging does not indicate potency. Betamethasone is classed as a strong corticosteroid. Your healthcare professional will prescribe or advise a steroid of the appropriate potency for your condition. 2.
e Wynzora
Do not 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 problems with calcium levels in your body (ask your doctor) • if you have certain types of psoriasis: these are erythrodermic, exfoliative and pustular (ask your doctor).
As Wynzora contains a bethamethasone, a strong steroid, do NOT use it on skin affected by: • skin infections caused by viruses (e.g. cold sores or chicken pox) • skin infections caused by a fungus (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, easily damaged veins, stretch marks • ichthyosis (dry skin with fish-like scales) • acne (pimples) • rosacea (severe flushing or redness of the skin on the face) • ulcers or broken skin. Warnings and precautions Talk to your doctor, pharmacist or nurse before using Wynzora if: • you have diabetes mellitus (diabetes) as your blood sugar/glucose level may be affected by the steroid • you are using other medicines that contain steroids as you may get side effects • you have a certain type of psoriasis called guttate psoriasis. Talk to your doctor, pharmacist or nurse during treatment if: • you have used this medicine for a long time and plan to stop (as there is a risk your psoriasis will get worse or 'flare up' when steroids are stopped suddenly) • your skin becomes infected as you may need to stop your treatment • the calcium level in your blood changes (see section 4 for further information) • you experience blurred vision or other visual disturbances. Special precautions • Avoid use on more than 30% of your body or using more than 15 grams per day; • Avoid using under a bathing cap, bandages or dressings as it increases the absorption of the steroid; • Avoid use on large areas of damaged skin, on mucous membranes, or in skin folds (groin, armpits, under breasts) as it increases the absorption of the steroid; • Avoid use on your face or genitals (sex organs) as they are very sensitive to steroids; • Avoid excessive sunbathing, excessive use of solarium and other forms of light treatment. Do not smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
Children Wynzora is not recommended for the use in children below the age of 18 years. Other medicines and Wynzora Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. Pregnancy Use of Wynzora during pregnancy should only take place as directed by a doctor. Breast-feeding Use of Wynzora during breast-feeding should only take place as directed by a doctor. Do not apply Wynzora to the breast if you are breast-feeding.
Driving and using machines This medicine has no or negligble effect on your ability to drive or use machines. Wynzora contains butylhydroxyanisole (E320) and macrogolglycerol hydroxystearate Butylhydroxyanisole (E320) may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes. Macrogolglycerol hydroxystearate may cause local skin reactions.
3.
Wynzora
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Wynzora is for cutaneous use (on the skin). Instructions for proper use When used on the body • Use only on your psoriasis and do not use on skin which does not have psoriasis. • Squeeze the cream onto a clean finger or directly onto the area affected by psoriasis. • Apply the cream to the affected area with your fingertips, and rub in the cream thoroughly in a thin layer. • Do not bandage, tightly cover or wrap the treated skin area. • Wash your hands well after using Wynzora. This will avoid accidentally spreading the cream to other parts of your body (especially the face, mouth and eyes). • Do not worry if some cream accidentally gets on normal skin near your psoriasis, but wipe it off if it spreads too far. • In order to achieve optimal effect, it is recommended not to take a shower or bath immediately after application of Wynzora Cream. It is recommended to allow 8 hours between the application and showering to avoid washing it off. • After applying the cream, avoid contact with textiles which are easily stained by grease (e.g. silk).
When used on the scalp • Before applying Wynzora to the scalp, comb the hair to remove any loose scales. • It may help to part your hair before you use Wynzora. • Washing your hair before application of Wynzora is not necessary. • Apply Wynzora Cream to fingertip, and then apply directly to the areas where you can feel the raised plaques. Rub in the cream thoroughly in a thin layer.
• •
In order to achieve optimal effect, it is recommended that the hair is not washed immediately after application of Wynzora. It is recommended to allow 8 hours between the application and showering to avoid washing it off.
Duration of treatment • Use the cream once a day. It may be more convenient to use the cream in the evening. • The normal initial treatment period is 8 weeks. • Your doctor may decide on a different treatment period. • Your doctor may decide on repeated treatment. • Do not use more than 15 grams in one day. If you use other calcipotriol containing medicines, the total amount of calcipotriol medicines must not exceed 15 grams per day, and the area treated should not exceed 30% of the total body surface. What should I expect when I use Wynzora? Most patients see obvious results after 1 week, even if the psoriasis is not yet cleared at that point.
If you use more Wynzora than you should Contact your doctor if you have used more than 15 grams in one day. Excessive use of Wynzora may also cause a problem with calcium in your blood, which usually normalises when discontinuing treatment. Your doctor may need to carry out blood tests to check that using too much cream has not caused a problem with calcium in your blood. Excessive prolonged use can also cause your adrenal glands to stop working properly (the adrenal glands are found near the kidneys and produce hormones). If you forget to use Wynzora Do not take a double dose to make up for a forgotten dose. If you stop using Wynzora The use of Wynzora should be stopped as indicated by your doctor. It may be necessary for you to stop this medicine gradually, especially if you have used it for a long time. If you have any further questions on 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.
that have been observed with Wynzora: Uncommon (may affect up to 1 in 100 people): • Inflammation or swelling of the hair root at application site (folliculitis) • Sleeplessness (Insomnia) • Itchiness (Pruritus) • Rash • Hives (Urticaria) • Skin irritation at application site • Pain at application site • Eczema at application site • Peeling at application site (exfoliation) • Application site spider veins (telangiectasia) Frequency not known (frequency cannot be estimated from the available data): • Blurred vision. Wynzora contains betamethasone and calcipotriol. You may therefore experience the following side effects. These side effects are more likely to happen if Wynzora is used for a long time, if used under dressings or in skin folds (e.g. groin, armpits or under breasts), or if used on large skin areas: •
allergic reactions with swelling of the face or other parts of the body such as the hands or feet. Swelling of the mouth/throat and trouble breathing may also occur
• • • • • • •
calcium levels in your blood or urine may increase so much that you get symptoms. Signs are frequent urination, constipation, muscle weakness, and confusion. When the treatment is stopped, the calcium levels return to normal your adrenal glands may stop working properly. Signs are tiredness, depression, anxiety cloudy vision, difficulty seeing at night, sensitivity to light (this could be a sign of cataracts) eye pain, red eye, decreased or cloudy vision (this could be a sign of increased pressure inside the eye) infections (because your immune system is weakened) pustular psoriasis (a red area of psoriasis with yellowish pustules (pimples)) you may experience fluctuations in blood sugar levels.
If you experience any of the above side effects you should contact your doctor immediately. Less serious side effects known to be caused by calcipotriol or betamethasone include the following: • thinning of the skin • stretch marks • blood vessels under your skin may become more noticeable • changes in hair growth • red rash around the mouth (perioral dermatitis) • worsening of your psoriasis • sensitivity of the skin to light resulting in a rash • itchy skin rash (eczema) • white or grey hair can transiently change to a yellowish colour at the application site when used on the scalp. Steroid withdrawal reaction: If used over prolonged periods a withdrawal reaction, which might appear to be different from the previous condition, may occur in some patients during treatment or within days to weeks after stopping treatment, with some or all of the following features: redness of the skin which can extend beyond the initial area treated, a burning or stinging sensation, intense itching, peeling of the skin, oozing open sores. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5.
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 carton or tube after EXP. The expiry date refers to the last day of that month. Do not store above 25°C. Do not freeze. Discard the tube with any remaining cream 6 months after first opening.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6.
What Wynzora contains –
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The active substances are: calcipotriol and betamethasone. One gram of cream contains 50 micrograms of calcipotriol and betamethasone dipropionate equivalent to 0.5 mg betamethasone. The other ingredients are: isopropyl myristate, paraffin liquid, medium-chain triglycerides, isopropyl alcohol, macrogol lauryl ether , poloxamer, macrogolglycerol hydroxystearate, carbomer interpolymer, butylhydroxyanisole, trolamine, sodium phosphate dibasic 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 filled in aluminium tubes coated with epoxyphenol and with polyethylene screw cap. Pack size: 1 tube of 60 g, 2 x tube of 60 g Marketing Authorisation Holder Almirall, S.A. Ronda General Mitre 151 08022 Barcelona Spain Manufacturer Laboratoires Chemineau 93 route de Monnaie Vouvray, 37210 France
This leaflet was last revised in 11/2024.
Wynzora 50 micrograms/g + 0.5 mg/g cream comes as cream containing 50mcg / 0.5mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Wynzora 50 micrograms/g + 0.5 mg/g cream is betamethasone dipropionate, calcipotriol.
This leaflet reproduces the patient information leaflet approved for Wynzora 50 micrograms/g + 0.5 mg/g cream, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Wynzora is indicated for topical treatment of mild to moderate psoriasis vulgaris, including scalp psoriasis, in adults.
Posology
Wynzora Cream should be applied to affected areas once daily. Rub in the cream thoroughly in a thin layer. The recommended treatment period is up to 8 weeks. Treatment should be discontinued when control is achieved. If it is necessary to continue or restart treatment after this period, treatment should be continued only after medical review and under regular medical supervision.
When using calcipotriol containing medicinal products, the maximum daily dose should not exceed 15 g. The body surface area treated with calcipotriol containing medicinal products should not exceed 30% (see section 4.4).
If used on the scalp
All the affected scalp areas may be treated with Wynzora Cream.
Special populations
Renal and hepatic impairment
The safety and efficacy of Wynzora Cream in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated.
Paediatric population
The safety and efficacy of Wynzora Cream in children below 18 years have not been established.
Currently available data in children aged 12 to 17 years are described in sections 4.8, 5.1 and 5.2.
Method of administration
Wynzora Cream should not be applied directly to the face or eyes. In order to achieve optimal effect, it is not recommended to take a shower or bath, immediately after application of Wynzora Cream. It is recommended to allow 8 hours between the application and showering to avoid washing it off.
Hands must be washed after use.
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Wynzora Cream is contraindicated in erythrodermic, exfoliative and pustular psoriasis.
Due to the content of calcipotriol, Wynzora Cream is contraindicated in patients with known disorders of calcium metabolism (see section 4.4).
Due to the content of corticosteroid, Wynzora Cream is contraindicated in the following conditions: Viral (e.g. herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers and wounds (see section 4.4).
Effects on endocrine system
Adverse reactions found in connection with systemic corticosteroid treatment, such as adrenocortical suppression or impact on the metabolic control of diabetes mellitus may occur also during topical corticosteroid treatment due to systemic absorption.
Application under occlusive dressings should be avoided since it increases the systemic absorption of corticosteroids. Application on large areas of damaged skin or on mucous membranes or in skin folds should be avoided since it increases the systemic absorption of corticosteroids (see section 4.8).
HPA (hypothalamic–pituitary–adrenal) axis suppression was evaluated in adult subjects (N=27) with extensive psoriasis (including scalp). Adrenal suppression was seen in 1 out of 27 subjects (3.7%) after 4 weeks of treatment, and in one additional patient after 8 weeks of treatment.
Visual disturbance
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for a referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Effects on calcium metabolism
Due to the content of calcipotriol in Wynzora Cream, hypercalcaemia may occur. Serum calcium is normalised when treatment is discontinued. The risk of hypercalcaemia is minimal when the maximum daily dose of Wynzora Cream (15 g) is not exceeded (see section 4.2).
Local adverse reactions
In a vasoconstrictor trial in healthy subjects, the skin blanching response of Wynzora Cream was consistent with a moderate (class II) corticosteroid when compared with other topical corticosteroids. Concurrent treatment with other steroids on the same treatment area must be avoided.
Skin of the face and genitals are very sensitive to corticosteroids. The medicinal product should not be used in these areas.
The patient must be instructed in correct use of the medicinal product to avoid application and accidental transfer to the face, mouth and eyes. Hands must be washed after each application to avoid accidental transfer to these areas.
Concomitant skin infections
When lesions become secondarily infected, they should be treated with antimicrobiological therapy. However, if infection worsens, treatment with corticosteroids should be stopped (see section 4.3).
Discontinuation of treatment
When treating psoriasis with topical corticosteroids, there may be a risk of generalised pustular psoriasis or of rebound effects when discontinuing treatment. Medical supervision should therefore continue in the post-treatment period.
Long-term use
Long-term use of corticosteroids may increase the risk of local and systemic adverse reactions. Treatment should be discontinued in case of adverse reactions related to long-term use of corticosteroid (see section 4.8).
Topical steroid withdrawal syndrome
Long term use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advise is recommended in these cases or other treatment options should be considered.
Unevaluated use
There is no experience with the use of Wynzora Cream in guttate psoriasis.
Concurrent treatment and UV exposure
During Wynzora Cream treatment, physicians are recommended to advise patients to limit or avoid excessive exposure to either natural or artificial sunlight. Topical calcipotriol should be used with ultra-violet radiation (UVR) only if the physician and patient consider that the potential benefits outweigh the potential risks (see section 5.3).
Wynzora Cream contains butylhydroxyanisole (E320) and macrogolglycerol hydroxystearate
Wynzora Cream contains butylhydroxyanisole (E320) as an excipient, which may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.
Wynzora Cream contains macrogolglycerol hydroxystearate which may cause skin reactions.
Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
The label will state moderate steroid.
No interaction studies have been performed with Wynzora Cream.
Pregnancy
There are no adequate data from the use of calcipotriol/betamethasone products in pregnant women. When administered orally in animals, studies of calcipotriol have not shown teratogenic effects, though reproductive toxicity has been shown (see section 5.3). Studies in animals with glucocorticoids have shown reproductive toxicity (see section 5.3), but a number of epidemiological studies (less than 300 pregnancy outcomes) have not revealed congenital anomalies among infants born to women treated with corticosteroids during pregnancy. The potential risk for humans is uncertain. Therefore, during pregnancy, Wynzora Cream should only be used when the potential benefit justifies the potential risk.
Breastfeeding
Betamethasone is excreted in human milk, but risk of an adverse effect on the infant seems unlikely with therapeutic doses. There are no data on the excretion of calcipotriol in human milk. Caution should be exercised when prescribing Wynzora Cream to women who breast-feed. The patient should be instructed not to use Wynzora Cream on the breast when breast-feeding.
Fertility
Studies in rats with oral doses of calcipotriol or betamethasone dipropionate demonstrated no impairment of male and female fertility (see section 5.3).
Wynzora Cream has no or negligible influence on the ability to drive and use machines.
The estimation of the frequency of adverse reactions is based on a pooled analysis of data from clinical studies.
All reported adverse reactions were seen at a frequency below 1%. The most frequently reported adverse reactions were “Application site reactions” including application site irritation, pain, pruritus, eczema, exfoliation, telangiectasia and folliculitis.
Adverse reactions are displayed by system organ class and frequency in Table 1 below. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. The frequency of the adverse reactions is expressed according to the following categories: uncommon (≥1/1,000 to <1/100); not known (cannot be estimated from available data).
Table 1: Adverse reactions reported for Wynzora
System Organ Class
Uncommon
Not known
Infections and infestations
Application site folliculitis
Nervous system disorders
Insomnia
Eye disorders
Vision, blurred*
Skin and subcutaneous tissue disorders
Pruritus
Rash
Urticaria
General disorders and administration site conditions
Application site irritation
Application site pain
Application site pruritus
Application site eczema
Application site exfoliation
Application site telangiectasia
* See section 4.4
Paediatric population
In an uncontrolled clinical trial with 7 subjects aged 12 to 17 years no adverse reactions were reported. See section 5.1 for further details regarding the trial.
In this limited sample, no clinically relevant differences have been observed between the safety profiles of Wynzora cream in adult and adolescent populations.
The following adverse reactions are considered to be related to the pharmacological classes of calcipotriol and betamethasone, respectively:
Calcipotriol
Adverse reactions include application site reactions, pruritus, skin irritation, burning and stinging sensation, dry skin, erythema, rash, dermatitis, eczema, psoriasis aggravated, photosensitivity and hypersensitivity reactions including very rare cases of angioedema and facial oedema.
Systemic effects after topical use may appear very rarely causing hypercalcaemia or hypercalciuria (see section 4.4).
Betamethasone (as dipropionate)
Local reactions can occur after topical use, especially during prolonged application, including skin atrophy, telangiectasia, striae, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation and colloid milia.
When treating psoriasis with topical corticosteroids, there may be a risk of generalised pustular psoriasis.
Systemic reactions due to topical use of corticosteroids are rare in adults, however they can be severe. Adrenocortical suppression, cataract, infections, impact on the metabolic control of diabetes mellitus and increase of intra-ocular pressure can occur, especially after long-term treatment. Systemic reactions occur more frequently when applied under occlusion (plastic, skin folds), when applied on large areas and during long-term treatment (see section 4.4).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Usage above the recommended dose may cause elevated serum calcium which subsides when treatment is discontinued. The symptoms of hypercalcaemia include polyuria, constipation, muscle weakness, confusion, and coma.
Excessive prolonged use of topical corticosteroids may result in adrenocortical suppression which is usually reversible. Symptomatic treatment may be indicated.
In case of chronic toxicity the corticosteroid treatment must be discontinued gradually.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Wynzora 50 micrograms/g + 0.5 mg/g cream. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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