Calmiox 5 mg/g cutaneous foam
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Calmiox 5 mg/g Cutaneous Foam
Hydrocortisone
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
This medicine is available without a prescription. However, to achieve the best results, it must be used correctly.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or does not improve after 7 days.
Contents of this leaflet
- What Calmiox is and what it is used for
- What you need to know before using Calmiox
- How to use Calmiox
- Possible side effects
- How to store Calmiox
- Contents of the pack and other information
1. What Calmiox is and what it is used for
It is a topical medication containing hydrocortisone, a corticosteroid that relieves itching of the skin.
It is indicated for the temporary local symptomatic relief of skin itching (but not pain) due to minor skin irritations, allergic contact with soaps, detergents, metals, insect bites, and stinging nettles.
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 ingredients of this medicine listed in section 6.
- if you have infected, damaged, or wounded skin, acne, athlete's foot (fungal infection of the feet), bedsores in bedridden patients, or diaper rash or irritation.
Do not apply this medicine to the eyes or mucous membranes (anal, genital, or oral), as it is intended for external use on the skin only.
Warnings and precautions
Contact your doctor if you experience blurred vision or any other visual disturbances.
Consult your doctor or pharmacist before starting to use Calmiox.
Take special care with Calmiox
- if you have diabetes, as it may affect your blood sugar control.
- if you have tuberculosis, as it may worsen the infection or lead to new infections.
- if the area to be treated is infected, as additional treatment with another medicine may be required.
- if you have very fragile skin or bruise easily, as this medicine may increase skin thinning.
- if you have any liver problems.
- when applying over large areas of skin, especially when using occlusive dressings, as side effects may occur, particularly in children.
- if used in children, as the risk of adverse effects is higher, especially when applied over large areas or under occlusive dressings.
- you must avoid any contact with the eyes or surrounding areas. Application near the eye may increase intraocular pressure, especially if you have open-angle glaucoma.
- do not exceed the recommended dose or use on areas other than those intended.
- if bleeding occurs, 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 medicines
Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.
Although no interactions between Calmiox and other medicines have been reported, it should not be used simultaneously with other topical preparations on the same area unless directed by a doctor.
Interference with diagnostic tests
Calmiox may interfere with adrenal function tests, potentially reducing their results, and may increase blood and urine glucose (sugar) levels if systemic absorption of the medicine occurs.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and use of machines
No effects on driving or operating machinery have been reported.
Important information about some of the ingredients 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 irritation of the eyes and mucous membranes because it contains butylhydroxytoluene (E321).
It may cause allergic reactions (possibly delayed) because it contains methylparahydroxybenzoate (E218) and propylparahydroxybenzoate (E216).
3. How to use Calmiox
Follow exactly the instructions for drug administration provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Calmiox is for cutaneous use. Shake well before use and keep in an upright position during application.
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Adults and adolescents from 12 years of age: Apply a thin film to the affected area. The usual dose is 1 or 2 applications per day.
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Children under 12 years of age: consult your doctor.
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Use in patients over 65 years of age: consult your doctor.
Wash your hands thoroughly after use.
Do not use for more than 7 consecutive days without consulting your doctor, under any circumstances.
If you use more Calmiox than you should
Prolonged use or application over large skin areas increases the likelihood of adverse reactions.
In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service at telephone number 91 562.04.20, indicating the medication and amount ingested.
If you forget to use Calmiox
Do not use a double dose to make up for missed doses.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them. Adverse effects are rare at the administered doses and usually occur only after use beyond 7 days or on very large areas or under occlusive dressings. They disappear upon discontinuation of treatment or reduction in the frequency of administration.
The following adverse effects may occur:
Rare adverse effects (may affect up to 1 in 1,000 patients)
- Allergic reaction
- Erythema (redness of the skin), rash, skin atrophy, skin fragility, foliculitis (inflammation of hair follicles), acne, telangiectasias (bright red lesions appearing on the skin that disappear upon pressure), reddish striae (stretch marks) on the skin, hypertrichosis (excessive growth of body and facial hair), hyperpigmentation of the skin (dark, raised freckles, especially if used on the face).
Very rare adverse effects (may affect up to 1 in 10,000 patients)
- Cushing's syndrome (a disease caused by increased cortisol levels, manifesting among others as obesity, moon face, increased blood pressure, acne), increased glucose (sugar) levels in blood and urine, hypothalamic-pituitary disorders (of the brain glands).
- Tachyphylaxis (loss of drug effect) and rebound phenomenon (reappearance of symptoms after long-term treatment).
Adverse effects of unknown frequency (cannot be estimated from available data):
- Blurred vision
In children undergoing chronic treatment, isolated cases of increased intracranial pressure and adrenal suppression have been reported, manifesting as growth retardation and weight gain; chronic therapy may interfere with a child's development.
Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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.
Caution: 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 source of ignition. Do not smoke. Do not pierce 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Calmiox
The active substance is hydrocortisone.
Each gram of Calmiox contains 5 mg of hydrocortisone (5 mg/g).
The other components are stearic acid, cetylstearyl octanoate, octyldodecanol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), butylhydroxytoluene (E321), disodium edetate, sorbitan stearate, polysorbate 60, carbomer, sodium hydroxide, bronopol, purified water and propane/isobutane.
Appearance of the product and contents of the container
Calmiox is supplied in single-block aluminium aerosol bottles with an internal epoxy lacquer coating, fitted with a valve and diffuser. Each bottle contains 50 g of foam.
Marketing Authorization Holder
EstevePharmaceuticals, 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 Vallès
Barcelona - Spain
Date of the most recent revision of this leaflet: 09/2017
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/