Betadine Gel 10 Percent in 30g tubes is indicated for superficial, small wounds or burns, in the adjunctive treatment of certain diseases of the skin (and mucous membranes), primarily bacterial or liable to superinfection.
For warnings, precautions and contraindications, please refer to thepackageinsert.
KEEP OUT OF REACH OF CHILDREN
Antiseptics
Although the term "disinfection" is used indiscriminately in everyday language, it implies the use of antiseptics and disinfectants. The latter are applied to inert media such as surfaces or instruments, while antiseptics are substances applied to living tissue to inhibit or destroy pathogenic micro-organisms.
Betadine gel 10 percent tube 30g is an antiseptic.
It is recommended :
Directions for use
Apply to the skin.
Dosage
As a simple local application or dressing.
For external use only.
For 100 g tube of betadine gel: Polyvidone iodine 10 g. List of excipients : Macrogol 400, macrogol 4000, macrogol 6000, purified water.
Special warnings
The iodine in this product may penetrate the skin (particularly if used repeatedly or on certain fragile skins).
Avoid prolonged or repeated use.
Special care should be taken with regular applications to damaged skin in patients with renal insufficiency, particularly burn victims (see What are the possible side effects?).
Precautions for use
Do not use on children aged between 1 and 30 months. If necessary, apply briefly and sparingly. Rinse with sterile water after application.
Particular care should be taken with "fragile" skin, children and pregnant women.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Betadine gel 10 percent comes in a 30g tube.
Betadine is not a product like any other. Read the package insert carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, ask your doctor or pharmacist for advice. Beware of incompatibilities with your current products.
Betadine Gel 10 Percent, available in 30g tubes, is your ally in the treatment of superficial, small wounds and burns. It is also used as an adjunctive treatment for certain bacterial skin (and mucous membrane) diseases or those liable to superinfection. Find out how Betadine Gel 10 Percent can care for your skin.
Wound and burn care: Superficial wounds and burns need special attention. Betadine Gel 10 Percent is designed to protect and promote healing of these skin conditions.
Adjunctive treatment: In addition to its use for wounds and burns, this gel is also recommended as an adjunctive treatment for certain skin and mucous membrane diseases of bacterial origin or susceptible to superinfection.
Active Protection: Betadine Gel 10 Percent forms a protective barrier on the skin, helping to prevent infection and promote healing.
Proven effectiveness: Betadine is a trusted name in skin care. Our gel has a proven track record in treating wounds, burns and skin conditions.
Soothing and Protective: By using Betadine Gel 10 Percent, you give your skin the soothing and protection it needs to heal quickly and safely.
Take care of your skin: Your skin is a vital organ. By caring for it with Betadine, you're investing in your long-term well-being.
Don't let wounds, burns or skin conditions bother you. Betadine Gel 10 Percent is there to protect, care for and promote the healing of your skin.
All MEDA PHARMA laboratory products
All antiseptic disinfectant products
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated on: 26/08/2016
BETADINE 10 PER CENT, gel
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.
In this notice :
1. WHAT IS BETADINE 10 PERCENT, GEL AND IN WHAT CASES IS IT USED?
2. BEFORE YOU USE BETADINE 10 PERCENT, GEL?
3. HOW TO USE BETADINE 10 PERCENT, GEL?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE BETADINE 10 PERCENT, GEL?
6. ADDITIONAL INFORMATION
1. WHAT IS BETADINE 10 PERCENT, GEL AND IN WHAT CASES IS IT USED?
ANTISEPTICS AND DISINFECTANTS
This medication is an antiseptic.
It is recommended:
· in the case of superficial wounds or burns,
· in the adjunctive treatment of certain diseases of the skin (and mucous membranes), originally bacterial or susceptible to superinfection.
2. BEFORE YOU USE BETADINE 10 PERCENT, GEL?
List of information needed before taking the medication
Not applicable.
Never use BETADINE 10 PERCENT, gel 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,
· 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 seafood anaphylaxis do not constitute a contraindication to the use of BETADINE 10%.
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 10 PERCENT, gel:
Special warnings
Iodine can pass through the skin (especially if used repeatedly or on some fragile skin).
Avoid prolonged or repeated use.
Special attention is required for regular applications on injured skin in patients with renal insufficiency, especially in severe burns ( see Possible side effects ).
Precautions for use
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.
Special caution is required in case of "fragile" skin, in the child, the pregnant woman.
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
Do not combine products containing mercury: formation of highly irritating derivatives.
· Possible modification of the results of thyroid examinations.
Avoid the simultaneous or successive use of different antiseptics including mercury-derived antiseptics.
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.
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 10 PERCENT, GEL?
Not applicable.
Dosage / Mode and route of administration
In single application or dressing.
This medicinal product is for external use only.
Dermal.
Symptoms and Instructions for Overdose
If you used more BETADINE 10 PER CENT, gel than you should:
Massive accidental ingestion is to be treated in a specialized environment.
Instructions for omission of one or more doses
Not applicable.
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 fragile skin 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 10 PER CENT, gel.
· When used on large surfaces and in severe burns, general effects of 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 10 PERCENT, GEL?
Keep out of the reach and sight of children.
Do not use BETADINE 10 PERCENT, gel after the expiry date stated on the carton.
After first opening, the product can be stored for 6 months.
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.
Full list of active substances and excipients
What does BETADINE contain 10 percent, gel?
The active substance is:
Polyvidone iodine ................................................ .................................................. ................................. 10 g
For 100 g of gel.
The other components are:
Macrogol 400, macrogol 4000, macrogol 6000, purified water.
Pharmaceutical form and content
What is BETADINE 10 PERCENT, gel and contents of the pack?
This medication is in the form of a gel. Tube of 4, 30, 50 or 100 g.
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MEDA MANUFACTURING
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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.
Detailed information on this medicine is available on the ANSM website (France).
Information for health professionals only
Not applicable.
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 |
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