NOTICE
ANSM - Last updated: 14/11/2013
Name of the medicinal product
CORTISEDERMYL 0,5%, cream
framed
Read this manual carefully because it contains important information.
This medication is a specialty of AUTOMEDIZATION which can be used without consultation or prescription from a doctor.
The persistence of the symptoms beyond 3 days, the aggravation or the appearance of new disorders, require to take a medical opinion.
Keep this leaflet, you may need to read it again.
If you need more information and advice, ask your pharmacist or doctor.
Review summary
In this notice :
1. WHAT CORTISEDERMYL 0.5%, cream AND WHAT IT IS USED FOR?
2. BEFORE YOU USE CORTISEDERMYL 0.5%, cream?
3. HOW TO USE CORTISEDERMYL 0.5%, cream?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE CORTISEDERMYL 0.5%, cream?
6. ADDITIONAL INFORMATION
1. WHAT CORTISEDERMYL 0.5%, cream AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
This medicine contains a corticosteroid.
Therapeutic indications
It is indicated in adults and children over 6 years in case of:
· stings of nettles,
· Insect bites,
· localized sunburns.
2. BEFORE YOU USE CORTISEDERMYL 0.5%, cream?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not use for you (or your child) CORTISEDERMYL 0.5%, cream:
· in case of allergy to hydrocortisone or to any of the ingredients of the cream ( see What contains CORTISEDERMYL 0,5%, cream? ),
· on wounds,
· on an acne,
· on a rosacea,
· on an infected skin, whether the origin is bacterial (eg impetigo ...), viral (herpes, shingles, varicella), mycotic (due to microscopic fungi) or parasitic.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with CORTISEDERMYL 0,5%, cream:
DO NOT LEAVE THIS MEDICINE FOR CHILDREN.
If blistering occurs after sunburn, consult your doctor before applying the product.
Precautions for use
This medication contains a corticosteroid, follow the directions for use. Indeed, an increase in the applied amount and / or the number of applications would not improve the activity or the speed of action of the product but could cause undesirable effects.
· Do not deal with large areas,
· do not cover with a closed dressing (occlusive dressing), as this may cause some of the active ingredient to pass through the blood,
· do not apply other dermatological products to the treated surface,
· do not use more than 2 times a day,
· do not exceed the recommended service life (3 days).
If symptoms persist beyond 3 days of treatment, take the advice of your doctor.
In case of:
· intolerance,
· irritation, skin superinfection,
Discontinue treatment and see your doctor.
Interaction 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, including dermatologic treatment.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
Pregnancy
If needed, this medication may be used during pregnancy.
Ask your doctor or pharmacist for advice before taking any medicine.
feeding
Breast-feeding is possible when treated with this medication.
Do not apply on the breasts during breastfeeding, because of the risk of ingestion of the product by the newborn.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with 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, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage / Administration Frequency
· Apply cream 2 times 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 the treatment
The duration of use is limited to 3 days. |
Persistence of symptoms beyond 3 days requires medical advice.
Administration mode
Dermal.
Symptoms and Instructions for Overdose
Not applicable.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, CORTISEDERMYL 0.5%, cream is likely to have unwanted effects, although not everyone is subject to it:
· risk of thinning of the skin, dilation of small blood vessels, stretch marks, acne outbreak, redness and irritation around the mouth;
· cases of exaggerated development of the hair system, skin discoloration disorder, secondary infection especially during prolonged treatment, under occlusive dressing or in folds, have been reported;
· due to the presence of wool fat, risk of eczema (allergic reaction of the skin).
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE CORTISEDERMYL 0.5%, cream?
Keep out of the reach and sight of children.
Expiration date
Do not use CORTISEDERMYL 0.5%, cream after the expiry date which is stated on the carton.
Storage conditions
Store at a temperature not exceeding + 30 ° C.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What contains CORTISEDERMYL 0.5%, cream?
The active substance is:
Hydrocortisone ................................................. .................................................. ............................... 0.50 g
For 100 g of cream.
The other components are:
Stearyl Alcohol, Cetyl Alcohol, Isopropyl Alcohol, Wool Grease, Macrogol 1000 Stearate, Macrogol 4000 Stearate, Macrogol 6000 Stearate, Cherry Laurel Distilled Water
Pharmaceutical form and content
What is CORTISEDERMYL 0.5%, cream and contents of the pack?
This medication is in the form of a cream. Tube of 15 g.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
French Pharmaceutical Cooperation
Place Lucien-Auvert
77020 Melun Cedex
exploiting
FRENCH PHARMACEUTICAL COOPERATION
Place Lucien-Auvert
77020 MELUN CEDEX
Maker
FRENCH PHARMACEUTICAL COOPERATION
Place Lucien-Auvert
77020 MELUN CEDEX
Or
FRENCH PHARMACEUTICAL COOPERATION
RUE DE LA SAUSSAIE
77310 SAINT-FARGEAU PONTHIERRY
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 is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Ansm website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.