Betadine 10 CENT GEL TUBE 30G

3400931988014

Gifrer Gifrer

The drug Betadine Gel 10 Percent in 30g tube is indicated e n case of wounds or burns superficial and extended in the adjunctive treatment of certain diseases of the skin (and mucous membranes), primitive bacterial or may become secondarily infected.


 


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The advice of your pharmacist

Used for : Local adjunctive treatment of i, and post-operative care in sto

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Betadine 10 CENT GEL TUBE 30G

 

 

 
 
 

For warnings, precautions for use

and cons-indications, please refer to the notice no use data.

 

DO NOT LET THIS MEDICINE OUT OF REACH OF CHILDREN

 

 

Description Betadine gel 30g tube 10 percent

The drug Betadine gel 30g tube is 10 percent antiseptic.

It is recommended:
· In case of wounds or burns superficial and extended
· Originally in bacterial or secondary infection may adjunctive treatment of certain diseases of the skin (and mucous membranes).

 

Tips util ization

Mode of administration
Dermal.

Dosage
Single local application or dressing.
This medicine is for external use only.

 

Composition

100 g tube Betadine gel: 10 g Povidone Iodine. List of ingredients: macrogol 400, macrogol 4000, macrogol 6000, purified water.

 

Precautions betadine gel 30g tube 10 percent  

Special warnings
Iodine this drug can penetrate the skin (especially in the case of repeated or some fragile skin use).
Avoid prolonged or repeated use.
Special attention is needed when regular applications built on injured patients with renal insufficiency skin, especially in the burn (see What are the possible side effects?).

Precautions
The use in children 1 to 30 months is not recommended. If it is necessary, apply a brief and very extensive. Washing with sterile water after application.
Particular caution should be exercised when skin "fragile" in children, pregnant women.


IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST

 

Presentation betadine gel 30g tube 10 percent

The drug gel Betadine 10 percent is in the form of tube 30 g of gel.

 

Warnings on drugs

Un Conseil ? Une Question ?

Please note, 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. Beware of incompatibilities on your products in.


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

Click here to find record of this drug on the website of the National Security Agency of Medicines and Health Products.

Pharmacovigilance : Report or a related side effect (s) (s) (s) the use of a drug

 

 

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Local antiseptic

polyvidone iodine

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

PRESENTATIONS (summary)

BÉTADINE 10%: gel for skin application; 30 g tube.
-

BÉTADINE TULLE 10%: medicated dressing (gel impregnated hydrophilic gauze pad ); box of 5.
-

BÉTADINE TULLE 10%: medicated dressing (gel impregnated hydrophilic gauze pad ); box of 10.
-

Laboratory Meda Pharma

COMPOSITION (summary)
p 100 g p dressing
Polyvidone iodine 10 g 300 mg

INDICATIONS (summary)
This medication is a local antiseptic that contains iodine.
It is used for the antisepsis of wounds and small superficial burns the adjunctive treatment of lesions of the skin and mucous membranes , infected or at risk of infection.
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
  • a history of allergy to polyvidone iodine,
  • newborn (less than 1 month),
  • pregnancy (from the 4th month onwards, in case of prolonged use),
  • breastfeeding , in case of prolonged treatment.
WARNING (Contents)
Avoid prolonged use of this medication, especially in children, mucous membranes and on extensive or deeply injured surfaces, without the advice of your doctor: risk of passing of iodine in the blood, which could lead to disruption of thyroid function .
As a precautionary measure, in infants , short and short applications followed by washing with boiled water. In addition, this drug is contraindicated in newborns .
DRUG INTERACTIONS (summary)
The combination with other antiseptics is not recommended: risk of cancellation of their effects or formation of caustic substances (especially with mercurial antiseptics).
PREGNANCY AND BREAST-FEEDING (summary)
This medication contains iodine, which can pass into the blood of the pregnant woman or into the milk of the breastfeeding woman and disrupt the functioning of her child's thyroid gland. This risk, theoretical, is only to be taken into account in case of prolonged use.
When in doubt, do not use this medication for more than a few days without medical advice and do not apply it to the nipple if you are breast-feeding.
DIRECTIONS FOR USE AND DOSAGE (summary)
In case of soiled wound, a preliminary cleaning followed by a careful rinsing is essential.
The gel is applied directly to the wound; it may optionally be covered with a dressing.
The medicated dressing is applied to the wound and then covered with a compress of gauze and maintained by a bandage. It is changed every day or every 2 days.
TIPS (summary)
Simple washing with soap and water makes it possible to eliminate the majority of germs ; it should be followed by a careful rinse because the soap can inactivate some antiseptics .
All antiseptics may be contaminated with germs: do not store them unnecessarily.
The brown color of the skin due to the drug is eliminated with water; similarly, stains on clothing disappear after washing.
POSSIBLE ADVERSE EFFECTS (summary)
Skin irritation, contact dermatitis .
In case of prolonged use: disruption of the functioning of the thyroid gland.


GLOSSARY (summary)


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


antecedent
Affection healed or always in evolution. The antecedent may be personal or family. The background is the history of a person's health.


antisepsis
Action to destroy bacteria, microscopic fungi or viruses present especially on the skin, mucous membranes and wounds.
The action of an antiseptic is not always immediate: a delay of a few minutes is sometimes necessary before the germs are inactivated.


antiseptic
A substance that locally destroys bacteria, reducing their numbers and preventing their proliferation. Some antiseptics are also active on microscopic fungi and viruses.


eczema
Skin disease manifested by pimples and itching. Eczema may be due to contact with an allergic substance (contact eczema) or be linked to a genetic predisposition (atopic eczema).


seeds
A general term that refers to all microscopic organisms likely to cause infection: bacteria, viruses, parasites, fungi.


mucous
Tissue (membrane) that lines the cavities and ducts of the body communicating with the outside (digestive tract, respiratory tract, urinary tract, etc.).


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


new born
Child less than one month old.


thyroid
Gland located at the base of the neck, which secretes hormones rich in iodine.


treatment
Treatment that complements the action of a specific treatment, but generally does not achieve healing on its own.

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

NOTICE

ANSM - Updated on: 26/08/2016

Name of the medicinal product

BETADINE 10 PER CENT, gel

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 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?

Pharmacotherapeutic group

ANTISEPTICS AND DISINFECTANTS

Therapeutic indications

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.

Cons-indications

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.

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 BETADINE 10 PERCENT, GEL?

Instructions for proper use

Not applicable.

Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment

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.

Risk of withdrawal syndrome

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.

Expiration date

Do not use BETADINE 10 PERCENT, gel after the expiry date stated on the carton.

Storage conditions

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.

6. ADDITIONAL INFORMATION

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.

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

MEDA PHARMA

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 ANSM website (France).

Information for health professionals only

Not applicable.

Other

Not applicable.

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Betadine antiseptic is a drug for external use, for the disinfection and the antisepsis of skin or mucous membranes.

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