CALMIOX 5 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Calmiox5 mg/gcream

hydrocortisone

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

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

Contents of the Package Leaflet

1. What is Calmiox and what is it 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. Package Contents and Additional Information

1. What is Calmiox and what is it used for

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 symptomatic relief of skin itching due to minor skin irritations that respond to corticosteroids, such as contact allergy to soaps, detergents, metals, insect bites, and nettles.

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

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, wounded, acne-prone, or fungal-infected skin (also known as athlete's foot), or if you have ulcers in bedridden patients, as well as diaper rash or skin irritation.
• Do not apply this medication to the eyes or mucous membranes, as it is for external use on the skin only.
• Do not apply in cases 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 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 medication.
• if you have very fragile skin, such as on the face, or if you bruise easily, as this medication 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 ocular 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 irritation, consult your doctor as soon as possible.
• consult your doctor if symptoms worsen or persist for more than 7 days.
• avoid contact with mucous membranes and wash your hands well after use.

Children

Children and infants are especially sensitive, and it is more likely that the corticosteroid will produce side effects and pass into the body through the skin, having side effects in other areas of the body. In general, they require shorter treatments than adults.

Interference with Laboratory Tests

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

Other Medications and Calmiox

Inform your doctor or pharmacist if you are using, have recently used, 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 on the same area, unless prescribed by a doctor.

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 medication.

Pregnancy

Calmiox should only be 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 use Calmiox during breastfeeding unless your doctor advises you to do so.

Do not apply the medication to the breasts; do not let the child come into contact with treated areas.

Driving and Using Machines

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

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 (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

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).

3. How to use Calmiox

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

Topical use (external).

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

Use in Children

• Children under 12 years old: consult a doctor.

• Use in people over 65 years old: 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 application to large areas may increase the manifestation of its side effects.

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 medication and the amount ingested.

If you forget to use Calmiox

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

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

At the administered doses, side effects are rare, usually occurring with use beyond 7 days and in very extensive areas or with occlusive dressings, disappearing when treatment is discontinued or the frequency of administration is reduced.

The following side effects may occur:

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

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

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

• Cushing's syndrome (disease caused by increased cortisol, which manifests, among other ways, with obesity, moon face, increased blood pressure, acne), increased blood and urine glucose levels, hypothalamic-pituitary disorders.
• Tachyphylaxis (loss of the medication'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 package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Calmiox

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

Store below 25°C.

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

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

6. Package Contents and Additional Information

Calmiox Composition

• The active ingredient is hydrocortisone.

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

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

Product Appearance and Package Contents

Calmiox is a cream, homogeneous white in color; it is presented in aluminum tubes with an interior epoxy resin coating and a polypropylene cap with a punch, 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

Date of the Last Revision of this Package Leaflet:November 2022.

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