Eumovate

Package leaflet: Information for the patient

EUMOVATE 0.5 mg/g cream

clobetasone butyrate
Please read this leaflet carefully before using this medicine because 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What EUMOVATE is and what it is used for

EUMOVATE contains the active substance clobetasone butyrate, which belongs to a group of medicines called corticosteroids. Corticosteroids have an anti-inflammatory action and help reduce redness, swelling, and skin irritation.
EUMOVATE is used to treat:

• atopic eczema (a skin inflammation causing redness and blisters)
• seborrhoeic eczema (skin inflammation appearing red and scaly, affecting the face, scalp, and occasionally other skin areas)
• nappy rash (diaper dermatitis)
• skin disorders (dermatoses) localized in more sensitive areas, such as face, neck, and skin folds
• mild forms of eczema (mild skin inflammations)
• first-degree burns and sunburn

EUMOVATE is also indicated for maintenance therapy and treatment of large skin areas.

2. What you need to know before using EUMOVATE

DO NOT use EUMOVATE

• if you are allergic to clobetasone butyrate or to any of the other ingredients of this medicine (listed in section 6);
• in the eyes (it is not for ophthalmic use);
• if you have a skin infection caused by viruses (herpes, chickenpox, etc.), fungi, or bacteria, unless you are already treating the infection with a specific medicine;
• if you have rosacea (a skin condition affecting the face where the nose, cheeks, chin, forehead, or entire face appear unusually red, with or without visible fine blood vessels, small bumps, or pustules);
• if you have acne;
• if you have itching without skin inflammation;
• if you are pregnant (read the section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before using EUMOVATE.
Be especially careful with EUMOVATE and consult your doctor:

• if during treatment you experience or worsening symptoms such as redness or skin rash, itching, hives, local burning sensation, or skin inflammation at the application site: these symptoms may resemble those of your condition, but could actually be due to an allergic reaction to the medicine;
• if you notice fat accumulation, especially in the neck, abdomen, and face, fluid retention, and increased blood pressure (Cushing's syndrome). Your doctor will decide whether to gradually reduce the frequency of application or discontinue EUMOVATE and switch to another medicine. Do not stop treatment abruptly;
• if one of the inflamed areas becomes infected. Your doctor will instruct you to stop using the medicine and will prescribe a specific treatment.

Be especially careful with EUMOVATE:

• when treating warm, moist areas such as skin folds, or when covering the treated area with plastic film after applying the medicine (occlusive dressing), as bacterial infections may develop. Clean the skin thoroughly each time before reapplying the dressing;
• when treating large skin areas; use occlusive dressing technique only on a limited body area at a time, because occlusive dressings may enhance absorption of the medicine through the skin and cause disturbances in body temperature regulation;
• when using the medicine on the face; avoid prolonged use as it may cause skin thinning;
• when using the medicine on moist areas; avoid prolonged use as it may cause skin thinning;
• when applying the medicine to the eyelids, as it may enter the eyes and cause problems such as cataract (loss of transparency of a part of the eye called the lens) and glaucoma (increased eye pressure);
• if you have inflammation near chronic leg lesions (chronic ulcers), as this may increase the risk of local allergic reactions and infections;
• if you use EUMOVATE for a long time or with occlusive dressings, as prolonged or repeated use and the dressings themselves may cause allergic reactions.

Contact your doctor if you experience blurred vision or other visual disturbances.
Wash your hands after applying EUMOVATE, unless the treatment area includes the hands themselves.
Prolonged or repeated use of this product may lead to sensitization (allergic reaction).

Children and adolescents
In newborns and children under 12 years of age, EUMOVATE should be used only if strictly necessary and under medical supervision. Newborns and children under 12 years are more susceptible to the medicine's side effects. Be especially cautious, as in newborns, diapers act like an occlusive dressing and increase the absorption of the medicine.

Other medicines and EUMOVATE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may affect the activity of EUMOVATE, for example:

• ritonavir (a medicine used to treat HIV);
• itraconazole (a medicine used to treat fungal infections).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
This medicine should not be used during pregnancy. In cases of actual medical necessity, your doctor will evaluate the potential risks and benefits and prescribe the minimum amount for the shortest possible duration.

Breastfeeding
It has not been established whether the use of this medicine is safe during breastfeeding.
Consult your doctor before using EUMOVATE while breastfeeding: your doctor will assess the potential risks and benefits for you and your baby.
If you use EUMOVATE while breastfeeding, do not apply it to the breast area, as the baby could ingest it during breastfeeding.

Driving and using machines
No negative effect on the ability to drive or use machinery is expected.

EUMOVATE contains cetostearyl alcohol and chlorocresol
EUMOVATE contains cetostearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis).
EUMOVATE contains chlorocresol, which may cause allergic reactions.
Attention for athletes: The product contains substances prohibited in doping. Any use differing from the therapeutic indications, dosage regimen, or route of administration specified is prohibited.

3. How to use EUMOVATE

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply a thin layer sufficient to cover the entire affected area once or twice daily, until symptoms improve.
Gently apply EUMOVATE and allow it to be absorbed before applying any other skin softening products (emollients).
Wash your hands after use, unless the hands are the area being treated.
Once symptoms have improved, consult your doctor, who will reduce the frequency of applications or modify the treatment. Be careful not to stop using the medicine abruptly, as this may cause a relapse of the disease symptoms.
When the condition is under control, your doctor will advise you to use an emollient cream as maintenance therapy.

Atopic eczema
If your condition worsens or does not improve within 4 weeks, consult your doctor, who will reassess the treatment.

Use in children and adolescents
Consult your doctor before using EUMOVATE.
Children are more susceptible to adverse effects from the medicine; therefore, your doctor will determine the minimum amount of medicine to use and the shortest treatment duration necessary to achieve the desired benefit.

Use in the elderly
Consult your doctor before using EUMOVATE.
Your doctor will determine the minimum amount of medicine to use and the shortest treatment duration necessary to achieve the desired benefit.

Use in patients with kidney or liver problems
Consult your doctor before using EUMOVATE.
Your doctor will determine the minimum amount of medicine to use and the shortest treatment duration necessary to achieve the desired benefit.

If you use more EUMOVATE than you should
If you use more EUMOVATE than recommended or for longer than instructed, you may experience weight gain, increased blood pressure, and abnormal hair growth. In such cases, stop using the medicine and consult your doctor immediately.
This medicine is for external use only. In case of accidental ingestion or overdose, contact your doctor immediately, go to the nearest hospital, or contact a poison control center without delay.

If you forget to use EUMOVATE
If you forget to apply EUMOVATE, apply it as soon as you remember, then continue as before. Do not apply a double dose to make up for the missed dose.

If you stop using EUMOVATE
Do not stop treatment with EUMOVATE without consulting your doctor, as symptoms may relapse.
Treatment with EUMOVATE should always be gradually reduced. When the condition is under control, your doctor will advise you to use an emollient cream as maintenance therapy.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects not known (frequency cannot be determined from available data):

• blurred vision

Very rare side effects (may affect up to 1 in 10,000 people):

• infections due to reduced immune defenses
• allergy (in this case, stop using the medicine immediately and contact your doctor)
• reversible reduction in the production of certain hormones
• moon face, central obesity
• delayed weight gain / delayed growth in children
• reduced mineral content in bones (osteoporosis)
• increased pressure in the eyes (glaucoma)
• high blood sugar levels (hyperglycaemia) / sugar in urine (glycosuria)
• blurred vision caused by clouding of the lens (cataract)
• high blood pressure (hypertension)
• weight gain / obesity
• decreased levels of cortisol produced by the body, detected by specific tests
• skin inflammation caused by contact allergy
• hives
• thinning of the skin
• changes in skin pigmentation
• local skin burning
• increased hair growth and number of hairs
• appearance of spots and/or bumps on the skin (rash)
• itching
• redness of the skin
• worsening of pre-existing or latent symptoms at the application site

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following address: 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 EUMOVATE

Keep this medicine out of the sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the tube and the carton after "Exp". The expiry date refers to the last day of that month. The expiry date applies to the product in its original, unopened packaging, correctly stored.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What EUMOVATE contains

• The active substance is clobetasone butyrate. 1 g of cream contains 0.5 mg of clobetasone butyrate. The other components are: glyceryl monostearate, cetyl alcohol, mixture of paraffins and natural waxes, self-emulsifying glyceryl monostearate, dimethicone, glycerol, chlorocresol, sodium citrate, citric acid, purified water.

Description of the appearance of EUMOVATE and package contents
EUMOVATE is a cream for topical use contained in a 30 g tube.
Marketing Authorization Holder
Haleon Italy S.r.l. - Via Monte Rosa 91 - 20149 Milan, Italy
Manufacturer
Haleon Germany GmbH - Barthstrasse 4 - 80339 Munich - Germany