NOTICE
ANSM - Last updated: 21/05/2015
Name of the medicinal product
CORTAPAISYL 0.5%, cream
hydrocortisone
framed
Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist after 3 days, consult your doctor.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT CORTAPAISYL 0.5%, cream AND IN WHAT CASES IS IT USED?
2. BEFORE YOU USE CORTAPAISYL 0.5%, cream?
3. HOW TO USE CORTAPAISYL 0.5%, cream?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE CORTAPAISYL 0.5%, cream?
6. ADDITIONAL INFORMATION
1. WHAT CORTAPAISYL 0.5%, cream AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group
This medicine contains a corticosteroid.
Therapeutic indications
This medication is indicated for adults and children over 6 years of age in the following cases:
· stings of nettles
· Insect bites
· localized sunburns
2. BEFORE YOU USE CORTAPAISYL 0.5%, cream?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use CORTAPAISYL 0.5%, cream:
· in case of allergy to hydrocortisone or any of the components of the formula, 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.
If in doubt, it is essential to seek the advice of your doctor or pharmacist.
Precautions for use; special warnings
Take special care with CORTAPAISYL 0.5%, cream:
Warnings
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 .
This medicinal product contains cetostearyl alcohol and may cause local skin reactions (eg eczema).
It also contains sodium parahydroxybenzoate (E219) and soda propyl parahydroxybenzoate (E217), which can cause skin allergies (urticaria, eczema).
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
Ask your doctor or pharmacist for advice before taking any medicine. |
If needed, this medication may be used during pregnancy.
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 known effect : cetostearyl alcohol, sodium methyl parahydroxybenzoate (E 219), sodium propyl parahydroxybenzoate (E 217).
3. HOW TO USE CORTAPAISYL 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 Mode / 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.
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, CORTAPAISYL 0.5%, cream is likely to have undesirable 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, particularly during prolonged treatment, under occlusive dressing or in folds, have been reported,
Declaration of side effects
If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr . By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE CORTAPAISYL 0.5%, cream?
Keep out of the reach and sight of children.
Expiration date
Do not use CORTAPAISYL 0.5%, cream after the expiry date which is stated on the carton.
Storage conditions
No special storage conditions.
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 does CORTAPAISYL 0.5% contain, cream?
The active substance is:
Hydrocortisone base ................................................ .................................................. ....................... 0.500 g
In the form of hydrocortisone acetate .......................................... .................................................. ... 0.558 g
For 100 g.
The other components are:
Sorbitan stearate, polysorbate 60, synthetic whale white, cetyltearyl alcohol, octyldodecanol, sodium methyl parahydroxybenzoate (E 219), sodium propyl parahydroxybenzoate (E 217), imidurate, anhydrous citric acid, purified water.
Pharmaceutical form and content
What is CORTAPAISYL 0.5%, cream and contents of the pack?
This medication is in the form of a cream. Box of 1 tube of 15 g or 3 tubes of 5 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
MERCK MEDICATION FAMILIALE SAS
37, rue Saint-Romain
69379 Lyon Cedex 08
exploiting
MERCK MEDICATION FAMILIALE
18 C Winston Churchill Boulevard
21000 DIJON
(Registered office: 37, rue Saint Romain - 69008 LYON)
Maker
MERCK SANTE SAS
LACASSAGNE Production Center
115, avenue Lacassagne
69003 LYON
or
FAMAR LYON
29, avenue Charles de Gaulle
69230 SAINT GENIS LAVAL
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 Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.