NOTICE
ANSM - Updated on: 20/07/2017
Name of the medicinal product
BETADINE DERMIQUE 10 PER CENT, solution for local application
Povidone iodine
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, 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 IS BETADINE DERMIC 10 PERCENT, solution for local application AND WHAT IT IS USED FOR?
2. BEFORE YOU USE BETADINE DERMIQUE 10%, solution for local application?
3. HOW TO USE DERMIC BETADINE 10 PER CENT, solution for local application?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE BETADINE DERMIQUE 10 PER CENT, solution for local application?
6. ADDITIONAL INFORMATION
1. WHAT IS BETADINE DERMIC 10 PERCENT, solution for local application AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
ANTISEPTICS AND DISINFECTANTS
Therapeutic indications
This medication is an antiseptic containing iodine, it is indicated for:
· the antisepsis of the wounds or burns superficial and small extent,
· supplementary local treatment of skin and mucous membrane infections that are infected or at risk of becoming infected.
· the antisepsis of the skin of the operative field.
2. BEFORE YOU USE BETADINE DERMIQUE 10%, solution for local application?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not use BETADINE DERMIQUE 10 PER CENT, solution for local application in the following cases:
· in the case of repeated use, from the 2nd trimester of pregnancy and in case of breastfeeding.
· for the newborn less than 1 month,
· for the disinfection of medical and surgical equipment,
· antecedent of allergy to one of the constituents, in particular povidone. There are no cross-reactions with iodinated contrast media.
Reactions of intolerance (anaphylactoid reactions) to iodinated contrast media or anaphylaxis to seafood do not constitute a contraindication to the use of BETADINE DERMIQUE 10 PER CENT.
This medication MUST NOT BE USED, unless otherwise directed by your doctor, in combination with mercury-derived antiseptics.
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 BETADINE DERMIQUE 10 PER CENT, solution for local application:
Special warnings
The iodine contained in this medicinal product may pass through the skin, particularly in the case of repeated use or on certain fragile or fragile skin and pass into the general circulation (undesired and troublesome effects).
Special attention is required for regular applications on injured skin in patients with renal insufficiency, especially in patients with severe burns ( see What are the possible side effects? ).
Special attention is required during regular applications on injured skin in patients with renal insufficiency.
In the preparation of the operation, avoid sagging and maceration between the patient and the table cloth. Prolonged contact with undried solution may cause irritation and rarely severe burn-type skin reactions.
Precautions for use
Use in children under 30 months requires prior advice from your doctor or pharmacist.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Interaction with other medicines
Taking or using other medicines
Avoid simultaneous or sequential use of different antiseptics.
IN ORDER TO AVOID INTERACTIONS BETWEEN SEVERAL MEDICINES, INCLUDING mercury-derived antiseptics, YOU MUST SIGNAL SYSTEMATICALLY ANY OTHER PROCESSING IN PROGRESS TO YOUR DOCTOR OR YOUR PHARMACIST.
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
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
Due to the presence of iodine, the use of this drug, in the case of repeated use , is contraindicated during the last 6 months of pregnancy.
It will only be used occasionally on the advice of your doctor.
feeding
Breast-feeding is contraindicated if repeated use of this medication is used.
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
Not applicable.
3. HOW TO USE DERMIC BETADINE 10 PER CENT, solution for local application?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Use pure or diluted.
· Pure use: brushing on the skin.
· Diluted use:
o washing of wounds: diluted 1/10 with water or sterile saline, that is to say by mixing 1 volume of solution with 10 volumes of water or sterile saline.
o wound irrigation: diluted to 2 per cent in sterile saline, ie by mixing 2 volumes of solution with 100 volumes of sterile water or sterile saline
Administration mode
Dermal.
Symptoms and Instructions for Overdose
In case of massive oral ingestion, contact a doctor immediately.
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, BETADINE DERMIQUE 10 PER CENT, solution for local application is likely to have undesirable effects, although everyone is not subject to it:
· In case of repeated and prolonged use, there may be an iodine overload which can modify the functioning of the thyroid gland, especially in premature infants and infants.
· Local skin reactions may occur: burning-type caustic dermatitis in case of maceration and contact dermatitis.
· Possibility of skin irritation and local allergic reaction,
· Reversible and transient staining may appear on the skin,
· Exceptionally general allergic reactions: urticaria, angioedema, anaphylactic shock, anaphylactoid reaction have been described with products containing povidone including 10% DERMIC BETADINE.
· When used on large surfaces and in large burners general effects such as impaired renal function have been observed.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. 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 BETADINE DERMIQUE 10 PER CENT, solution for local application?
Keep out of the reach and sight of children.
Expiration date
Do not use BETADINE DERMIQUE 10%, solution for local application after the expiry date stated on the vial after {EXP}. The expiry date refers to the last day of that month
After first opening the vial, this medication should be stored for up to 6 months at room temperature.
Storage conditions
Before opening, keep at a temperature not exceeding 25 ° C.
If necessary, warnings against visible signs of deterioration
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What is BETADINE DERMIQUE 10 PERCENT, solution for local application?
Povidone iodine ................................................ .................................................. ................................... 10 g
For 100 ml.
The other components are:
Glycerol, macrogol lauryl ether (9), disodium phosphate dihydrate, citric acid monohydrate, sodium hydroxide, purified water.
Pharmaceutical form and content
What is BETADINE DERMIQUE 10%, solution for local application and contents of the outer packaging?
This medication is in the form of a solution for local application.
Bottle of 8 ml, 125 ml, 250 ml, 500 ml, 2 l or 5 l.
Bottle of 10 ml or 20 ml. Box of 50.
Bottle of 50 ml. Box of 1, 10, 20 or 50.
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
MEDA PHARMA
40-44 WASHINGTON STREET
75008 PARIS
exploiting
MYLAN MEDICAL SAS
40-44 Washington Street
75008 PARIS
Maker
MEDA MANUFACTURING
Avenue JF Kennedy
33700 MERIGNAC
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.