NOTICE
ANSM - Updated on: 23/06/2016
Description of the Medicine
MITOSYL IRRITATIONS, ointment
Fish liver oil - Zinc oxide
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AT· This medication is a specialty of AUTOMEDICATION intended to be used without consultation or prescription of a doctor.
AT· The persistence of the symptoms, the aggravation or the appearance of new disorders, require to take a medical opinion.
AT· Please read this manual carefully as it contains important information for you. Keep this leaflet, you may need to read it again.
AT· If you need more information and advice, ask your pharmacist.
What is in this leaflet?
1. What is MITOSYL IRRITATIONS, Ointment and in which cases is it used?
2. What should be known before using MITOSYL IRRITATIONS, ointment?
3. How to use MITOSYL IRRITATIONS, Ointment?
4. What are the possible undesirable effects?
5. How to keep MITOSYL IRRITATIONS, ointment?
6. Contents of the package and other information.
1. WHAT IS MITOSYL IRRITATIONS, ointment AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: Emollients and protectors
This medication is indicated for skin irritation, especially in the case of the buttocks (red buttocks) of the infant.
2. WHAT TO DO ABOUT BEFORE USING MITOSYL IRRITATIONS, ointment?
Never use MITOSYL IRRITATIONS, Ointment:
This medication should not be used if:
AT· allergy known to any of the components, especially salicylates, wool fat (or lanolin), or other constituents of the ointment,
AT· oozing lesions,
AT· surinfected lesions.
Warnings and Precautions
This medication is not a preventive treatment for the red buttocks of the infant. Due to the risk of passing vitamin A in the blood and therefore the risk of hypervitaminosis, it is imperative to respect the dosage and not to apply the ointment:
AT· over a large area,
AT· under occlusive dressing,
AT· on a mucous membrane,
AT· on a deeply damaged skin,
AT· in the premature.
Skin irritation : if symptoms persist beyond 5 days, consult a physician or ask the pharmacist for advice.
Red buttocks of the infant : in case the infantile rhythm of the infant persists beyond 3 days consult a physician or ask the pharmacist for advice.
This medication contains wool fat (or lanolin) and can cause skin reactions (eg eczema).
This medicine contains butylhydroxyanisole and may cause local skin reactions (eczema) or irritation of eyes and mucous membranes.
Other medicines and MITOSYL IRRITATIONS, ointment
Do not use this medication with or after an antiseptic with oxidising properties.
MITOSYL IRRITATIONS, ointment with food, drink and alcohol
Not applicable.
Pregnancy, breastfeeding
This medication will only be used during pregnancy on the advice of your doctor.
Do not apply to the breasts during breastfeeding because of the risk of ingestion of the product by the newborn.
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medication.
Sport
Not applicable.
Driving and using machines
Not applicable.
MITOSYL IRRITATIONS, ointment contains wool fat (or lanolin) and butylhydroxyanisole.
3. HOW TO USE MITOSYL IRRITATIONS, ointment?
Skin irritation: applied several times a day by gently massaging on the irritated area.
Infant diaper rash: applied 1 to 3 times per day on the irritated area.
If you feel that the effect of this medication is too strong or too weak, consult your doctor or pharmacist.
Cutaneous route.
Skin irritation: The duration of use is limited to 5 days. Red buttocks of the infant: the duration of use is limited to 3 days. |
If you have used more MITOSYL IRRITATIONS, ointment than you should have:
Not applicable.
If you forget to use MITOSYL IRRITATIONS, Ointment:
Not applicable.
If you stop using MITOSYL IRRITATIONS, ointment:
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medication can cause side effects, although not everybody gets them.
THIS MEDICINE MAY, IN CERTAIN PERSONS, CAUSE MORE OR LESS GENERAL EFFECTS, in particular the risk of allergy to one of the components (salicylates, wool fat or lanolin, etc.) requiring the discontinuation of the treatment .
Declaration of side effects
If you experience any undesirable effects, talk to your doctor or pharmacist. This also applies to any undesirable effects not mentioned in this leaflet. You can also report undesirable effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (NSAH) and network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting adverse effects, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE MITOSYL IRRITATIONS, pommadE?
Keep this medication out of the reach and sight of children.
Do not use this medication after the expiration date stated on the package. The redemption date refers to the last day of the month.
For the aluminum tube :
Keep at a temperature not exceeding 25 ° C.
For the alumino-plastic tube :
Keep at a temperature not exceeding 25 ° C.
Shelf life after opening: do not store above 6 months.
Do not throw any medicines into the sewer or the household garbage. Ask your pharmacist to discontinue the medications you are no longer using. These measures will help to protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What MITOSYL IRRITATIONS contains, ointment
The active substances are:
Fish liver oil ............................................. .................................................. .............. 20 g
Zinc oxide............................................... .................................................. .......................... 27 g
For 100 g.
This ointment contains 12,000 IU of vitamin A per 100 g.
The other components are: essential oil of geranium, methyl salicylate, butylhydroxyanisole, vaseline, wool fat (or lanolin), purified water.
What is MITOSYL IRRITATIONS, Ointment and Contents of Outer Packaging
This medication is in the form of an ointment. Tube of 20 g, 65 g, 135 g or 150 g.
Not all presentations may be marketed.
Holder of the marketing authorization
SANOFI AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
Operator of the marketing authorization
SANOFI AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
Maker
DELPHARM DIJON
6 BOULEVARD OF EUROPE
21800 QUETIGNY
Names of medicines in the Member States of the European Economic Area
Not applicable.
The last day on which this notice was revised is as follows:
[To be completed subsequently by the Contractor]
Other
Health Education Council:
In order to limit the risks of the appearance of an infantile gluteus of the infant, it is necessary to:
AT· change the baby frequently, at least 6 times a day,
AT· At each change, clean the buttocks of the baby with soap by insisting on the folds and then rinse thoroughly with water,
AT· sprinkle carefully with a clean absorbent towel, without rubbing to avoid the risk of irritation.
In case of infant gluteal rhythm, it is recommended to leave the buttocks of the baby in the air more often and for as long as possible.