Leaflet: information for the user

Calmiox 5 mg/g topical foam

Hydrocortisone

1. What is Calmiox and what it is used for

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

3. How to use Calmiox

4. Possible side effects

5. Storage of Calmiox

6. Contents of the pack and additional information

It is a topical medication that contains hydrocortisone, a corticosteroid that relieves skin itching.

It is indicated for the temporary local symptomatic relief of skin itching (but not pain) due to small skin irritations, contact allergy with soaps, detergents, metals, insect bites, and nettle stings.

Do not use Calmiox

• if you are allergic to the active ingredient or any of the other components of this medication listed in section 6.
• if you have infected skin, wounds, acne, fungal infections on the feet (also known as athlete's foot), in the case of bedsores in bedridden patients, as well as in scalds or irritations of diapers.

Do not apply this medication to the eyes or mucous membranes, including anal, genital, or oral mucous membranes, as it is only for external use on the skin.

Warnings and precautions

Consult your doctor if you experience blurred vision or other visual disturbances.

Consult your doctor or pharmacist before starting to use Calmiox.

Be especially careful with Calmiox

• if you have diabetes as it may affect your control.
• if you have tuberculosis as it may worsen the infection or cause new infections.
• if the area to be treated is infected as it will be necessary to treat with another medication.
• if you have very fragile skin or easily develop bruises as this medication may increase skin thinning.
• if you have any liver problems.
• when applied to large areas and also using occlusive dressings as they may cause side effects, especially in children.
• if used in children as the risk of adverse effects is higher, especially if used on large areas and with occlusive dressings.
• you should avoid any contact with the eyes or nearby areas. Eye application may increase intraocular pressure, especially if you have open-angle glaucoma.
• do not exceed the recommended dose, or use it on areas other than the intended one.
• in case of bleeding, consult your doctor as soon as possible.
• consult your doctor if symptoms worsen or persist for more than 7 days.
• do not insert this product into the rectum.
• avoid contact with mucous membranes and wash your hands thoroughly after use.

Use of Calmiox with other medications

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

Although no interactions have been described between Calmiox and other medications, it should not be used simultaneously with other preparations in the same area, unless prescribed by a doctor.

Interference with diagnostic tests

Calmiox may interfere with adrenal function diagnostic tests that may decrease, as well as blood and urine glucose concentrations that may be increased if the medication has been absorbed.

Pregnancy and lactation

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

Driving and operating machinery

No effects have been described that affect driving or operating machinery.

Important information about some of the components of Calmiox

• This medication may cause local skin reactions (such as contact dermatitis) because it contains bronopol.

This medication may cause local skin reactions (such as contact dermatitis) or eye and mucous membrane irritation because it contains butylhydroxytoluene (E321).

It may cause allergic reactions (possibly delayed) because it contains methylparaben (E218) and propylparaben (E216).

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Calmiox is for topical use.Shake before use and keep in an upright position during use.

-Adults and adolescents 12 years of age and older:Applya thin film to the affected area.The usual dose is 1 or 2 applications per day.

-Children under 12 years of age: consult a doctor.

-Use in patients 65 years of age and older: consult a doctor.

Wash your hands thoroughly after use.

Do not apply for more than 7 consecutive days without consulting a doctor, in any case.

If you use more Calmiox than you should

Due to prolonged use or on large skin areas, the manifestation of adverse reactions increases.

In caseof overdose or accidental ingestion, go immediately to a medical center or call the Toxicological Information Service, phone 91 562.04.20, indicating the medication and the amount ingested.

If you forgot to use Calmiox

Do not use a double dose to compensate for the missed doses.

Like all medications, this medication may produce adverse effects, although not all people will experience them. Adverse effects are rare at the administered doses, generally occurring in prolonged use beyond 7 days and in extensive areas or with occlusive dressings, disappearing upon discontinuation of treatment or reduction in administration frequency.

The following adverse effects may occur:

Rare Adverse Effects(may affect up to 1 in 1,000 patients)

• Allergic reaction
• Erythema (skin redness), eruption, skin atrophy, skin fragility, folliculitis (inflammation of hair follicles), acne, telangiectasias (bright red lesions on the skin that disappear with pressure), erythematous striae on the skin, hirsutism (excessive growth of body and facial hair), hyperpigmentation of the skin (dark, elevated spots, especially on the face if used there).

Very Rare Adverse Effects(may affect up to 1 in 10,000 patients)

• Cushing's Syndrome (disease caused by increased cortisol, manifesting in various ways, including obesity, moon face, increased blood pressure, acne), increased glucose (sugar) in blood and urine, hypopituitarism (disorders of the pituitary gland).
• Tachyphylaxis (loss of medication effect) and rebound phenomenon (reappearance of symptoms in long-term treatments).

Adverse Effects of Unknown Frequency(cannot be estimated from available data):

• Blurred vision

In childrenwith chronic treatments, isolated cases ofincreased intracranial pressure and adrenal suppression have been described, manifesting as delayed growth and increased weight; chronic therapy may interfere with child development.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Attention. Contains 6% by mass of flammable components. Pressurized container: May burst if heated. Keep away from heat, hot surfaces, sparks, open flames, and any other ignition source. Do not smoke. Do not pierce or burn, even after use. Protect from sunlight. Do not expose to temperatures above 122°F/50°C.

Store below 30°C

Do not use Calmiox after the expiration date appearing on the container after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and the

medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Calmiox Composition

The active principle is hydrocortisone.

Calmiox contains 5 mg of hydrocortisone per gram (5 mg/g).

The other components are stearic acid, cetearil octanoate, octyldodecanol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), butylhydroxytoluene (E321), disodium edetate, sorbitan estearate, polisorbate 60, carboxymethyl cellulose, sodium hydroxide, bronopol, purified water, and propano/isobutane.

Product appearance and packaging contents

Calmiox is presented in aluminum monobloc aerosol containers with epoxy-coated interiors, equipped with valves and diffusers. Each container contains 50 g of foam.

Marketing Authorization Holder

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109- 08038 Barcelona

Spain

Responsible for manufacturing

RECIPHARM PARETS, S.L.

Ramón y Cajal, 2- 08150 Parets del Valles

Barcelona - Spain

Last review date of this leaflet:09/2017

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