Mitosyl EYE OINTMENT TUBE 65G

3400935062376

Sanofi Aventis Sanofi Aventis

Mitosyl irritation ointment is indicated in case of irritation of the skin, especially in case of diaper dermatitis (red buttocks) of infants.

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For warnings, the precautions and cons-indications, please see the instructions.

Description

Mitosyl irritation ointment is indicated in case of skin irritation, especially in case of diaper rash (red butt) of infants.  

Ointment: 65g tube

  • This medicine is a specialty SELF-MEDICATION to be used without consultation or prescription of a physician
  • Persistent symptoms, worsening or onset of new disorders impose seek medical advice
  • Please read this leaflet carefully because it contains important information for you. Keep this leaflet, you may need to read it again
  • If you need more information and advice, please contact your pharmacist.


The active substances are:   oil foir fish 20g, 27g zinc oxide per 100 g.
This ointment contains 12,000 IU of vitamin A per 100g
The other ingredients are:   the essential oil of geranium, of methyl salicylate, the butylhydroxyyanisole, petrolatum, wool fat, purified water


NECCESSAIRES INFORMATION BEFORE USING Mitosyl IRRITATIONS, ointment:


This medication should not be used if:

  • known to one of the components, including salicylates, wool grease (lanolin or), or other components of the ointment allergy,
  • oozing lesions,
  • superinfected lesions

Take special care with Mitosyl Irritations, ointment:  
This medicine is not a preventive treatment red buttocks of the infant. Due to the risk of passage of the vitamin A in the blood and therefore the risk of hypervitaminosis,   it is imperative   respect the dosage and did not apply the ointment:

  • on a large surface,
  • under occlusive dressings,
  • on mucous membranes,
  • a deeply damaged skin,
  • in premature infants.

Irritation:   if symptoms persist beyond 5 days, consult a doctor or pharmacist for advice

Red buttocks infant:   where infant diaper rash persists beyond 3 days, consult a doctor or pharmacist for advice

This medicine contains wool fat (or lanolin) and can cause skin rections (eg eczema)

This medicine contains butylated and may cause local skin reactions (dermatitis) or irritation of the eyes and mucous membranes

Pregnancy:  
This drug should be used during pregnancy only on the advice your doctor dee.
Ask your or your pharmacist before taking any medications

Breastfeeding:  
Do not apply on the breasts during lactation because of risue of ingestion by the newborn
Ask your doctor or pharmacist before taking any medicine.

List of excipients known effect:  
Wool grease (or lanolin), butylated


HOW TO USE Mitosyl IRRITATIONS, ointment?


Skin irritation:  
Application several times a day lightly massaging the irritated area.

Erythema rash infant:  
under 1 to 3 times per day on the irritated area

If you have the impression that the effect of this médicamant is too strong or too weak, talk to your doctor or pharmacist.  

Dermal.

Skin Irritation: The duration of use is limited to 5 days.
Red buttocks infant: the duration of use is limited to 3 days


WHAT ARE THE POSSIBLE SIDE EFFECTS?


THIS MEDICINE MAY IN SOME PEOPLE CAUSE MORE OR LESS bothersome effects, including risue allergies to any component (salicylates, wool grease or lanolin, ...) require discontinuation of treatment.

If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


HOW TO STORE Mitosyl IRRITATIONS, ointment?


KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
No special precautions for storage.

After opening the tube:   not retained after 6 months
Do not use after the expiry date stated on the box


HEALTH EDUCATION COUNCIL


To reduce the risk of occurrence of diaper rash, it is necessary to:

  • Frequently change the baby, at least 6 times a day
  • each change, clean baby's bottom with soap stressing at the folds then rinse well with water,
  • Dry thoroughly with a clean, absorbent towel, without rubbing to avoid the risk of irritation

In case of diaper rash, it is recommended, in addition, let the baby's buttocks in the air more often and for as long as possible.

 

DATE OF REVISION OF THE NOTICE


December 2010


Summary of Product Characteristics (MSNA)

Warnings on drugs

Warning, the drug is not a product like any other. Read the package leaflet before ordering. Do not leave medicines out of reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Attention to incompatibilities on products in your.

Tell your pharmacist online treatments underway to identify possible incompatibilities. The checkout form contains a custom message field provided for this purpose.

Click here to find record of the drug at the site of the National Security Agency of Medicines and Health Products.

Pharmacovigilance : Report or a related adverse event (s) (s) (s) the use of a drug

VIDAL OF THE FAMILY

MITOSYL IRRITATIONS

Skin Protector

zinc oxide, fish liver oil

. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS Â (summary)

MITOSYL irritations: ointment; 2 tubes of 20 g.
-

MITOSYL irritations: ointment; 65 g tube.
-

MITOSYL irritations: ointment; 150 g tube.
-

MITOSYL irritations: ointment; 2 tubes of 150 g.
-

Laboratory Sanofi-Aventis France

COMPOSITION Â (summary)
AT p 100 g
Zinc oxide 27 g
Fish liver oil 20 g
or Vitamin A 12,000 IUs
Lanoline  +
Methyl Salicylate  +

INDICATIONS Â (summary)
It is a protective and healing ointment containing zinc oxide and fish liver oil rich in vitamin A.
It is used to treat skin irritations, including redness of the infant's buttocks.
CONTRAINDICATIONS Â (summary)
This medication should not be used in the following cases:
CAUTION Â (Contents)
Due to the presence of vitamin A, avoid applying this ointment, particularly in children, on a prolonged basis and on extended or deeply injured surfaces, without the advice of your pharmacist or your doctor. For the same reasons, do not use it as a prolonged treatment of the red buttocks of the infant.
PREGNANCY AND BREASTFEEDING (summary)
Pregnancy :
The passage of vitamin A in the blood when applied to the skin is negligible. Nevertheless, do not use this ointment prolonged during pregnancy without medical advice.

Breastfeeding:
Due to the risk of ingestion by the newborn , the ointment should not be applied to the nipple of the breastfeeding woman.
DIRECTIONS FOR USE AND DOSAGE (summary)
Clean the area to be treated before application of the ointment.

Usual dosage:

  • Skin irritation: Apply to the irritated area several times a day, by gently massaging to penetrate the ointment.
  • Redness of infant buttocks: 1 to 3 applications per day.
TIPS (summary)
This medication may be freely available in some pharmacies; nevertheless, do not hesitate to ask your pharmacist for advice.
The redness of the infant's buttocks is often due to the impregnation of the skin by the urine, under the layer. It is therefore necessary to clean and rinse the skin abundantly with water before applying the medication.
The tube must not be stored for more than 6 months after opening.
POSSIBLE ADVERSE EFFECTS (summary)
Eczema (presence of lanolin).


GLOSSARY Â (summary)


allergy
Skin reactions (thirst, pimples, swelling) or general discomfort occurring after contact with a particular substance, use of a medication, a food. The main forms of allergy are eczema, urticaria, asthma, angioedema and allergic shock (anaphylactic shock). Food allergy can also result in digestive disorders.


Ecza © my
Skin disease manifested by pimples and sharp discomfort. Eczema may be due to contact with an allergenic substance (contact eczema) or be linked to a genetic predisposition (atopic eczema).


infant
Child from one to 30 months. A child under one month is a newborn.


© new-born
Child less than one month old.


salicylà © s
Family of medicines of which the best known is acetylsalicylic acid (aspirin).


vitamin
Essential to the growth and proper functioning of the body. Vitamin requirements are normally covered by a varied diet. In developed countries, only vitamin D deficiency, in young children or the elderly with little exposure to the sun, justifies systematic supplementation. Excessive intake, especially medicines, can lead to overdose and various disorders (mainly vitamins A and D).

Cliquez ici pour retrouver la notice de ce médicament sur le site de l'Agence Nationale de Sécurité du Médicament et des produits de santé.

Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

NOTICE

ANSM - Updated on: 23/06/2016

Description of the Medicine

MITOSYL IRRITATIONS, ointment

Fish liver oil - Zinc oxide

© framed

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.

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Mitosyl is a drug indicated in case of irritation of the skin, especially in case of diaper dermatitis (red buttocks) in infants.

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