Calmiox 5 mg/g cream
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Calmiox 5 mg/g cream
hydrocortisone
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for use of this medicine provided in this leaflet or those given 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 adverse effects, consult your doctor or pharmacist, even if they are adverse 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 the 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 as the active substance hydrocortisone, a corticosteroid that relieves itching, inflammation, and skin irritation.
It is indicated for the temporary local symptomatic relief of skin itching due to minor skin irritations that respond to corticosteroids, such as allergic reactions to soaps, detergents, metals, insect bites, and stings from nettles.
2. What you need to know before using Calmiox
Do not use Calmiox
- if you are allergic to hydrocortisone or to any of the other ingredients of this medicine (listed in section 6).
- if you have infected or injured skin, acne, athlete's foot (tinea pedis), pressure ulcers in bedridden patients, or diaper rash and irritation.
- Do not apply this medicine to the eyes or to anal, genital, or oral mucous membranes, as it is intended for external use on the skin only.
- Do not apply in cases of itching without inflammation.
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Calmiox.
Contact your doctor if you experience blurred vision or other visual disturbances.
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 necessary.
- if you have fragile skin, such as on the face, or if you bruise easily, as this medicine may increase skin thinning.
- if you have any liver problems.
- when applying to large areas of skin or when using occlusive dressings, as side effects may occur, especially in children.
- if used in children, as the risk of adverse effects is higher, particularly when used over large areas or with occlusive dressings.
- you must avoid any contact with the eyes or nearby areas. Application to 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 irritation occurs, 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 thoroughly after use.
Children
Children and infants are especially sensitive, and corticosteroids are more likely to cause adverse effects and to be absorbed through the skin into the body, potentially causing systemic effects. In general, they require shorter treatment durations than adults.
Interference with diagnostic tests
Calmiox may interfere with diagnostic tests of adrenal function, which may be reduced, as well as with blood and urine glucose levels, which may be increased if systemic absorption of the medicine occurs.
Other medicines and Calmiox
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take 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.
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.
Pregnancy
Calmiox should only be used during pregnancy if your doctor considers that the potential benefit justifies the potential risk to the fetus.
Pregnant women should not use this medicine over large areas of skin, for prolonged periods, or with occlusive dressings.
Breastfeeding
Do not use Calmiox during breastfeeding unless instructed by your doctor.
Do not apply the medicine to the breasts, and avoid contact between treated areas and the infant.
Driving and using machines
No effects affecting the ability to drive or operate machinery have been reported.
Calmiox contains benzoic acid (E-210), bronopol, and butylhydroxyanisole (E-320)
This medicine 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 medicine may cause local skin reactions (e.g., 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 butylhydroxyanisole (E-320).
3. How to use Calmiox
Follow exactly the instructions for administration provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
For topical use (external use only).
- 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.
Use in children
-
Children under 12 years of age: consult your doctor.
-
Use in individuals 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 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 the amount ingested.
If you forget to use Calmiox
Do not use a double dose to make up for missed doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
At the administered doses, adverse effects are rare and usually occur only after use beyond 7 days, over very large areas, or under occlusive dressings. These effects typically disappear when treatment is discontinued or the frequency of administration is reduced.
The following adverse effects may occur:
Rare adverse 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 hair follicles), acne, telangiectasias (fine red blood vessels visible on the skin that disappear under 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 people)
- Cushing's syndrome (a disease caused by elevated cortisol levels, manifested among others by obesity, moon face, increased blood pressure, acne), increased blood and urine glucose levels, hypothalamic-pituitary disorders (of the brain glands).
- Tachyphylaxis (loss of drug effect) and rebound phenomenon (reappearance of symptoms after prolonged treatment).
Adverse effects of unknown frequency (cannot be estimated from available data):
- Blurred vision
In children receiving 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.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the package and other information
Composition of Calmiox
- The active substance is hydrocortisone.
Each gram of cream contains 5 mg of hydrocortisone (5 mg/g).
- The other components are: ethylene palmitostearate and polyethylene glycol, polyethylene glycolated glycerides, liquid paraffin, benzoic acid (E-210), disodium edetate, butylhydroxyanisole (E-320), bronopol and purified water.
Appearance of the medicinal product and contents of the container
Calmiox is a homogeneous white cream; it is presented in lacquered aluminum tubes (internally coated with epoxy resin) with a polypropylene cap and plug, 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 most recent review of this leaflet: November 2022.
Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/