CALMIOX 5 mg/g CUTANEOUS FOAM

2. What you need to know before using Calmiox

Do not use Calmiox

• if you are allergic to the active substance or to any of the other components of this medicine, listed in section 6.
• if you have infected, wounded, acne, fungal infections of the feet (also called athlete's foot), in the case of ulcers in bedridden patients, as well as in diaper rash or skin irritations.

Do not apply this medicine to the eyes or mucous membranes, as it is for external use on the skin only.

Warnings and precautions

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

Consult your doctor or pharmacist before starting to use Calmiox.

Be careful with Calmiox

• if you have diabetes, as it may alter your control.
• if you have tuberculosis, as it may worsen the infection or cause new infections to appear.
• if the area to be treated is infected, as it will be necessary to treat it with another medicine.
• if you have very fragile skin or if you bruise easily, as this medicine may increase skin thinning.
• if you have liver problems.
• when applied to large areas and occlusive dressings are used, as side effects may occur, especially in children.
• if used in children, as the risk of side effects is higher, especially if used on large areas and with occlusive dressings.
• avoid any contact with the eyes or surrounding areas. Application to the eye may increase eye pressure, especially if you have open-angle glaucoma.
• do not exceed the recommended dose, and do not use it on areas other than those intended.
• 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 well after use.

Using Calmiox with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

Interference with diagnostic tests

Calmiox may interfere with the results of diagnostic tests for adrenal function, which may decrease, as well as with blood and urine glucose concentrations, which may increase if the medicine has been absorbed.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

No effects have been described that affect driving or using machines.

Important information about some of the components of Calmiox

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

This medicine 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).

3. How to use Calmiox

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Calmiox is for topical use. Shake before use and keep in a vertical position during use.

• Adults and adolescents from 12 years: Apply a thin film to the affected area. The normal dose is 1 or 2 applications per day.

• Children under 12 years: consult a doctor.

• Use in patients over 65 years: consult a doctor.

Wash your hands well 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

Prolonged use or use on large surfaces increases the manifestation of its adverse reactions.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service, phone 91 562.04.20, indicating the medicine and the amount ingested.

If you forget to use Calmiox

Do not use a double dose to make up for forgotten doses.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. At the administered doses, the appearance of side effects is rare, usually occurring with use beyond 7 days and on very large areas or with occlusive dressings, disappearing when treatment is stopped or the frequency of administration is reduced.

The following side effects may occur:

Rare side effects(may affect up to 1 in 1,000 patients)

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

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

• Cushing's syndrome (disease caused by increased cortisol, which manifests, among other ways, with obesity, moon face, increased blood pressure, acne), increased glucose (sugar) in blood and urine, hypothalamic-pituitary disorders.
• Tachyphylaxis (loss of the medicine's effect) and rebound phenomenon (reappearance of symptoms with long-term treatment).

Side effects of unknown frequency(cannot be estimated from available data):

• Blurred vision

In children with chronic treatments, isolated cases of increased intracranial pressure and adrenal suppression have been described, which manifest with growth retardation and weight gain; chronic therapy may interfere with child development.

Reporting side effects:

If you experience any type of side effect, consult your doctor, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Calmiox

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

Warning: Contains 6% by weight 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 puncture or burn, even after use. Protect from sunlight. Do not expose to temperatures above 50°C/122°F.

Store below 30°C

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Calmiox composition

The active substance is hydrocortisone.

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

The other components are stearic acid, cetearyl octanoate, octyldodecanol, methylparaben (E218), propylparaben (E216), butylhydroxytoluene (E321), disodium edetate, sorbitan stearate, polysorbate 60, carbomer, sodium hydroxide, bronopol, purified water, and propane/isobutane.

Appearance of the product and package contents

Calmiox is presented in aluminum monobloc aerosol cans, with an interior epoxy coating, equipped with a valve and diffuser. Each can contains 50 g of foam.

Marketing authorization holder

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109 - 08038 Barcelona

Spain

Manufacturer

Meribel Pharma Parets, S.L.U. Ramón y Cajal, 2- 08150 Parets del Valles

Barcelona - Spain

Date of the last revision of this leaflet:09/2017

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