Betadine 10 PERCENT TULLE DRESSING 5 is recommended for wounds or burns superficial and extended adjunctive treatment of diseases of the skin and primitive bacterial or may become secondarily infected mucous membranes.
For warnings, precautions for use and contraindications, please consult the instructions for use .
DO NOT LEAVE THIS MEDICINE IN THE REACH OF CHILDREN
Note : Antiseptic agents are not sterilizing. They temporarily reduce the number of microorganisms.
Wound disinfection .
A wound exposes cells which are usually protected by the screen that represents the most superficial part of the skin, the epidermis. These cells should remain alive as much as possible and the technique or product used should kill foreign microorganisms or prevent them from growing without damaging human cells.
DERMAL
The active substance is : povidone iodine 10.00 g per 100 ml.
The other ingredients are : Macrogol lauric ether (9), sodium hydroxide (qs ph = 2), purified water.
IN CASE OF DOUBT DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR PHARMACIST
This medication is in the form of medicated dressings. Bags of 10.
Attention, the drug is not a product like the others. Read the package leaflet carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.
All products of the MEDA PHARMA laboratory
All disinfectant antispetic products
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated on: 20/07/2017
BETADINE TULLE 10 PER CENT, medicated dressing
Povidone iodine
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 a physician.
· 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.
In this notice :
1. WHAT IS BETADINE TULLE 10 PER CENT, medicated dressing AND WHAT IT IS USED FOR?
2. WHAT TO DO ABOUT BEFORE USING BETADINE TULLE 10 PER CENT, medicated dressing?
3. HOW TO USE BETADINE TULLE 10 PER CENT, medicated dressing?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE BETADINE TULLE 10 PER CENT, medicated dressing?
6. ADDITIONAL INFORMATION
1. WHAT IS BETADINE TULLE 10 PER CENT, medicated dressing AND WHAT IT IS USED FOR?
ANTISEPTICS AND DISINFECTANTS
This medicine is an antiseptic (it combats the proliferation of microbes).
It is recommended:
· in the case of superficial wounds and burns.
· in the adjunct treatment of skin and mucosal disorders that are primarily bacterial or susceptible to superinfection.
2. WHAT TO DO ABOUT BEFORE USING BETADINE TULLE 10 PER CENT, medicated dressing?
List of information needed before taking the medication
Never use BETADINE TULLE 10 PER CENT, medicated dressing:
· for the newborn of less than 1 month especially in premature babies,
· in the case of repeated use, from the 2nd trimester of pregnancy and in case of breastfeeding.
· In case of history of allergy to any of the constituents, especially 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 TULLE 10 PER CENT.
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 TULLE 10 PER CENT, medicated dressing:
Special warnings
Iodine can pass through the skin (especially if used repeatedly or on some fragile skin).
Special attention is required for routine applications to injured skin in patients with renal insufficiency, especially in severe burns ( see Possible side effects ).
Precautions for use
Special care must be exercised in cases of "fragile" skin, in children, pregnant women.
Use in children from 1 to 30 months is not recommended. If it is necessary, apply it briefly and not very widely. Wash with sterile water after application.
Avoid the simultaneous or successive use of different antiseptics including mercury-derived antiseptics: formation of highly irritating derivatives.
IN CASE OF DOUBT DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST
Interaction with other medicines
Use of other medicines
Do not combine products containing mercury.
Interactions with food and beverages
Interactions with Herbal Medicines or Alternative Therapies
Use during pregnancy and lactation
Pregnancy and breast feeding
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.
Breast-feeding is contraindicated if repeated use of this medication is used.
Ask your doctor or pharmacist for advice before taking any medicine.
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Not applicable.
3. HOW TO USE BETADINE TULLE 10 PER CENT, medicated dressing?
Dosage
· This medicinal product is for external use only.
o Open the protective pouch
o Apply the impregnated pad to the wound
o Cover with a compress of gauze or hydrophilic cotton
o Maintain by means of a bandage
o Application every day or every other day.
If you feel that the effect of BETADINE TULLE 10 PER CENT, medicated dressing is too strong or too weak, talk to your doctor or pharmacist.
Method and route of administration
Dermal.
Symptoms and Instructions for Overdose
If you used more BETADINE TULLE 10 PER CENT, medicated dressing you should not have:
In case of overdose, there may be an iodine overload that may affect the functioning of the thyroid gland and cause impaired renal function. Quickly see a doctor.
Instructions for omission of one or more doses
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· In case of repeated and prolonged use, there may be an iodine overload which can modify the functioning of the thyroid gland on certain fragile or brittle skins, especially in the premature and the burned,
· possibility of skin irritation and local allergic reaction,
· Exceptionally general allergy reactions: urticaria, angioedema, anaphylactic shock, anaphylactoid reaction have been described with products containing povidone including BETADINE TULLE 10 PER CENT.
· 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 TULLE 10 PER CENT, medicated dressing?
Keep out of the reach and sight of children.
Do not use BETADINE TULLE 10%, medicated dressing after the expiry date stated on the outer packaging.
Store at a temperature not exceeding 30 ° C.
Keep away from heat.
Do not keep the sachet open.
If necessary, warnings against visible signs of deterioration
Full list of active substances and excipients
What does BETADINE TULLE 10 PERCENT, medicated dressing contain?
The active substance is :
Povidone iodine ................................................ .................................................. .................................. 10 g
For an ointment distributed at a rate of 3 g / dm 2 on a cotton hydrophilic gauze of 47 g / m 2 .
The other components are :
Macrogol 400, macrogol 4000, macrogol 6000, purified water.
Pharmaceutical form and content
What is BETADINE TULLE 10 PER CENT, medicated dressing and contents of the pack?
This medication is in the form of medicinal dressings. Sachets of 5 or 10.
40-44 WASHINGTON STREET
75008 PARIS
40-44 Washington Street
75008 PARIS
MEDA MANUFACTURING
Avenue JF Kennedy
33700 MERIGNAC
Names of the medicinal product in the Member States of the European Economic Area
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Detailed information on this medicine is available on the ANSM website (France).
Information for health professionals only
Not applicable.
Local antiseptic
polyvidone iodine
. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
BÉTADINE 10%: gel for skin application; 30 g tube.
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BÉTADINE TULLE 10%: medicated dressing (gel impregnated hydrophilic gauze pad ); box of 5.
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BÉTADINE TULLE 10%: medicated dressing (gel impregnated hydrophilic gauze pad ); box of 10.
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Laboratory Meda Pharma
| p 100 g | p dressing | |
| Polyvidone iodine | 10 g | 300 mg |
