In this manual :
1. WHAT IS CORTISEDERMYL 0.5% cream AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE USING CORTISEDERMYL 0.5% cream?
3. HOW DO I USE CORTISEDERMYL 0.5% cream?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE CORTISEDERMYL 0.5% cream?
6. ADDITIONAL INFORMATION
1. WHAT IS CORTISEDERMYL 0.5% cream AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
This medicine contains a corticosteroid.
It is indicated in adults and children over 6 years of age in the case of:
- nettle stings,
- insect bites,
- localized sunburn.
2. WHAT YOU SHOULD KNOW BEFORE USING CORTISEDERMYL 0.5% cream
List of information needed before taking the medicine
Not applicable.
Do not use CORTISEDERMYL 0.5% cream for yourself (or your child):
- if you are allergic to hydrocortisone or any of the components of the cream(see What does CORTISEDERMYL 0.5%, cream contain?),
- on wounds,
- on acne,
- on rosacea,
- on infected skin, whether bacterial (e.g. impetigo), viral (herpes, shingles, chickenpox), mycotic (due to microscopic fungi) or parasitic.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use; special warnings
Be careful with CORTISEDERMYL 0.5% cream:
KEEP THIS MEDICINE OUT OF THE REACH OF CHILDREN.
If blisters appear after sunburn, consult your doctor before applying the product.
Precautions for use
This medicine contains a corticoid, respect the instructions for use. Indeed, an increase in the quantity applied and/or the number of applications would not improve either the activity or the speed of action of the product but could cause undesirable effects.
- Do not treat large areas,
- do not cover with a closed bandage (occlusive bandage), as this could lead to the passage of part of the active ingredient into the bloodstream,
- do not apply other dermatological products to the treated area,
- do not use more than twice a day,
- do not exceed the recommended duration of use (3 days).
If symptoms persist beyond 3 days of treatment, take the advice of your doctor.
In case of:
- local intolerance,
- irritation, skin superinfection,
Stop the treatment and consult your doctor.
Interactions with other medicines
Taking or using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, especially dermatological treatments.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and lactation
Pregnancy
If necessary, this medicine can be used during pregnancy.
Ask your doctor or pharmacist for advice before taking any medication.
Breastfeeding
Breastfeeding is possible when taking this medicine.
Do not apply to the breasts while breast-feeding, because of the risk of ingestion of the product by the newborn.
Ask your doctor or pharmacist for advice before taking any medication.
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
List of excipients with a known effect:wool fat.
3. HOW TO USE CORTISEDERMYL 0.5% cream
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage/Frequency of administration
- Apply the cream twice a day, morning and evening.
- Apply the product in a thin layer, then spread it by massaging lightly until it is completely absorbed.
- Wash your hands after application.
Duration of treatment
|
The duration of use is limited to 3 days.
|
If symptoms persist beyond 3 days, medical advice should be sought.
Method of administration
Dermal route.
Symptoms and instructions in case of overdose
Not applicable.
Instructions in case of omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, CORTISEDERMYL 0.5% cream may have undesirable effects, although not everyone is susceptible:
- risk of skin thinning, dilation of small blood vessels, stretch marks, acne flare-ups, redness and irritation around the mouth;
- cases of exaggerated development of the hair system, disturbance of skin colouring, secondary infection, particularly in the case of prolonged treatment, under occlusive dressing or in the folds, have been reported;
- due to the presence of wool fat, risk of eczema (allergic skin reaction).
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW DO I USE CORTISEDERMYL 0.5% cream?
Keep out of the reach and sight of children.
Do not use CORTISEDERMYL 0.5% cream after the expiry date stated on the box.
Store at a temperature not exceeding +30°C.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of the medicine in the sewage system or in your household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does CORTISEDERMYL 0.5% cream contain?
The active substance is:
Hydrocortisone .................................................................................................................................. 0.50 g
For 100 g of cream.
Other components are:
Stearyl alcohol, cetyl alcohol, isopropyl alcohol, wool fat, macrogol 1000 stearate, macrogol 4000 stearate, macrogol 6000 stearate, cherry laurel distilled water
Pharmaceutical form and content
What CORTISEDERMYL 0.5% cream is and what it contains
This medicine is in the form of a cream. Tube of 15 g.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
Coopération Pharmaceutique Française
Place Lucien-Auvert
77020 Melun Cedex
Operator
COOPERATION PHARMACEUTIQUE FRANCAISE
Place Lucien-Auvert
77020 MELUN CEDEX
Manufacturer
COOPERATION PHARMACEUTIQUE FRANCAISE
Place Lucien-Auvert
77020 MELUN CEDEX
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
Not applicable.
Français
English
