Leaflet: information for the user

Calmiox5 mg/gcream

hydrocortisone

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

Followexactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 7 days.

1. What is Calmiox and what it is used for

2. What you need to know before starting touse Calmiox

3. How to use Calmiox

4. Possible side effects

5. Storage of Calmiox

6. Contents of the pack andadditional information

It is a topical medication that contains hydrocortisone as its active ingredient, a corticosteroid that relieves itching, inflammation, and skin irritation.

It is indicated for the temporary local symptomatic relief of skin itching due to small skin irritations that respond to corticosteroids, such as contact dermatitis caused by soaps, detergents, metals, insect bites, and nettle stings.

Do not use Calmiox

• if you are allergic to hydrocortisone 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 burns or irritations of diapers.
• Do not apply this medication to the eyes or mucous membranes, such as the anal, genital, or oral areas, as it is only for external use on the skin.
• Do not apply in case of itching without inflammation.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Calmiox.

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

Be especially 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.
• if the area to be treated is infected as it will be necessary to treat with another medication.
• if you have very fragile skin, such as on the face, or if you easily get bruises as this medication may increase skin thinning.
• if you have any liver problems.
• when applying to large areas and using occlusive dressings as it may cause side effects, especially in children.
• if you are using it 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. Application to the eye may increase eye pressure, especially if you have open-angle glaucoma.
• Do not exceed the recommended dose, or use it on areas other than the intended one.
• Consult your doctor as soon as possible if irritation occurs.
• Consult your doctor if symptoms worsen or persist for more than 7 days.
• Avoid contact with mucous membranes and wash your hands thoroughly after use.

Children

Children and infants are especially sensitive and it is morelikelythat the corticosteroid will cause adverse effects and pass through the skin and have adverse effects in other areas of the bodyand in general need shorter treatments than adults.

Interference with analytical tests

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

Other medications and Calmiox

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,do not use simultaneously with other preparations in the same area, unless prescribed by a doctor.

Pregnancy and breastfeeding

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

Pregnancy

Calmiox will onlybe used during pregnancy if your doctor considers that the potential benefit of its use justifies the potential risk to the fetus.

Pregnant women should not use this medication on large areas of the skin, for prolonged periods, or use occlusive dressings.

Breastfeeding

Do not useCalmioxunless your doctor tells you to.

Do not apply the medication to the breasts; do not put the baby in contact with treated areas.

Driving and operating machinery

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

Calmiox contains benzoic acid (E-210), bronopol, and butylhydroxyanisole (E-320)

This medication contains 2 mg of benzoic acid (E-210) per gram of cream.

Benzoic acid may cause local irritation.

Benzoic acid may increase the risk of jaundice (yellow discoloration of the skin and eyes) in newborns (up to 4 weeks old).

This medication may cause local skin reactions (e.g. 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 butylhydroxyanisole (E-320).

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

Topical (external) use.

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

Use in children

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

-Use in individuals 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 surfaces, the manifestation of adverse reactions increases.

In case of 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.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

At the administered doses, adverse effects are rare, generally occurring in uses beyond 7 days and in very extensive areas or with occlusive dressings, disappearing upon abandoning treatment or reducing the frequency of administration.

The following adverse effects may occur:

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

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

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

• Cushing's Syndrome (disease caused by increased cortisol, manifesting in various ways, including obesity, moon face, increased blood pressure, acne), increased glucose (sugar) in the 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.

Store below 25°C.

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

Do not dispose of medications through drains or trash.Dispose of packaging and

medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Calmiox Composition

- The active principle is hydrocortisone.

Cada gram of cream contains 5 mg of hydrocortisone (5mg/g).

- The other components are: ethylene palmitoestearate and polyethylene glycol, polyoxietylenated glycerides, liquid paraffin, benzoic acid(E-210), disodium edetate, butylhydroxyanisole(E-320), bronopol and purified water.

Product appearance and packaging contents

Calmiox is a homogeneous white cream; it is presented in aluminum tubesinternally coated with epoxy resin and a polypropylene cap with a striker, containing 30 g and 50 g of cream.

Marketing authorization holder and manufacturer

Marketing authorization holder

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Spain

Manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Ind.Colón II

08228 Terrassa- Barcelona

Spain

Last review date of this leaflet:November 2022.

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