BETADINE 10 PERCENT VAGINAL SOLUTION

BETADINE 10 PERCENT VAGINAL SOLUTION View larger

3400930108550

Gifrer Gifrer

BETADINE 10 PERCENT VAGINAL SOLUTION: This medication is an iodized antiseptic. It is indicated in the local top-up treatment of certain vaginal infections.

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The advice of your pharmacist

Used for : treatment of vaginal infections, treatment of vaginal infections

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BETADINE 10 PERCENT VAGINAL SOLUTION

For warnings, precautions for use

and contraindications, please consult the instructions for use .

DO NOT LEAVE THIS MEDICINE WITHIN THE REACH OF CHILDREN

Description of betadine 10 percent vaginal solution

This medicine is an iodized antiseptic. It is indicated in the local top-up treatment of certain vaginal infections.

Tips for use

Dosage: diluted use with a vaginal injection kit: one or two vaginal injections daily: dilute two tablespoons per liter of warm water. Use: pure: internal or external painting with the pure solution . Frequency of administration: The frequency of administration is determined by the physician according to the needs of the patient. Duration of treatment: the use of this medicine, first requires consultation with your doctor. Do not exceed the recommended treatment time and follow the instructions for use. In all cases strictly abide by your doctor's prescription. If you have used more Betadine 10% vaginal solution than you should have: if you have massive oral ingestion, contact a doctor promptly.

Composition

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.

Precautions for betadine 10 percent vaginal solution

Do not use this medicine for prolonged periods without medical advice: risk of iodine entering the bloodstream, which could result in disruption of thyroid function.
In case of genital infection, your partner may be contaminated while he has no symptom. If not treated together, recontamination is possible.

IF IN DOUBT DO NOT HESITATE TO ASK THE ADVICE OF YOUR DOCTOR OR PHARMACIST

Presentation of betadine 10 percent vaginal solution

The drug b etadine 10 percent vaginal solution present as a 30 g gel tube.

Warnings on drugs

Un Conseil ? Une Question ?

Be careful, the drug is not a product like any other. Read the package leaflet carefully before ordering. Do not let the medicine reach children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.

 

Please inform your online pharmacist of ongoing treatments to identify any incompatibilities. The order validation form contains a custom message field provided for this purpose.

Click here to find the package leaflet for this medicine on the website of the National Agency for the Safety of Medicines and Health Products.

Pharmacovigilance : Report an adverse effect (s) related to the use of a drug

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VIDAL OF THE FAMILY

GYNECOLOGICAL BÉTADINE

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: ovule; box of 8.
-

BEADIN: vaginal solution (brown); 125 ml bottle.
-

Laboratory Meda Pharma

COMPOSITION (summary)
p ovule p 100 ml
Polyvidone iodine 250 mg 10 g
Iodine 25 mg 1 g

INDICATIONS (summary)
This medication is a local antiseptic that contains iodine.
It is used in the adjuvant treatment of vaginal infections.
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
  • a history of allergy to polyvidone iodine,
  • pregnancy (from the 4th month onwards, in case of prolonged use),
  • breastfeeding in case of prolonged treatment.
WARNING (Contents)
Do not use this medication for long periods without medical advice: risk of iodine passing through the blood, which could cause disruption of thyroid function .
In the case of genital infection, your partner may be infected with no symptoms . If not treated together, recontamination is possible.
DRUG INTERACTIONS (summary)
This medication may interact with:
  • spermicides: cancellation of the local contraceptive effect;
  • antiseptics : cancellation of their effects or formation of caustic substances with mercurial antiseptics.
PREGNANCY AND BREAST-FEEDING (summary)
This medication contains iodine, which may pass into the blood of the pregnant woman or into the milk of the breastfeeding woman and interfere with the functioning of the child's thyroid gland. This risk, theoretical, is only to be taken into account in case of prolonged use.
If in doubt, do not use this medicine more than a few days without medical advice.
DIRECTIONS FOR USE AND DOSAGE (summary)
Ovum: it is placed at the bottom of the vagina, preferably in the evening at bedtime. It can be used after irrigation with the vaginal solution.
Vaginal solution: in external or internal brushing, it is used pure and applied with the aid of a compress; in vaginal irrigation , it should be diluted (2 tablespoons per liter of lukewarm water). Do not store excess diluted solution.

Usual dosage:

  • Adult :
  • Ovule: 1 per day, for 8 to 16 days.
  • Vaginal solution: 1 or 2 vaginal irrigations or brushing per day.
TIPS (summary)
Introduce the egg in a lying position, then lie down for 5 to 10 minutes. By melting in the vagina, the ovum can be the cause of an inconvenient discharge: it is advisable to put a protection.
The spots due to the drug disappear after washing.
During menstruation, do not stop treatment and avoid wearing tampons.
POSSIBLE ADVERSE EFFECTS (summary)
Allergic reaction , local irritation.
In case of prolonged use: disruption of thyroid function .


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.


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


contraceptive
Who opposes conception: oral contraceptive (pill), local (IUD, spermicide, diaphragm and condom).


vaginal irrigation
A method of administering a drug to the vagina. The solution, pure or diluted, is introduced by means of a cannula connected to a bulb or to the tubing of a container placed in height.


Allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.


symptom
Trouble felt by a person with an illness. The same symptom can translate different diseases and the same disease does not necessarily give the same symptoms in all the patients.


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.

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: 20/07/2017

Name of the medicinal product

BETADINE 10 PER CENT, vaginal solution

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 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.

Review summary

In this notice :

1. WHAT IS BETADINE 10 PERCENT, Vaginal Solution AND WHAT IT IS USED FOR?

2. BEFORE YOU USE BETADINE 10 PERCENT, Vaginal Solution?

3. HOW TO USE BETADINE 10 PER CENT, Vaginal Solution?

4. WHAT ARE POSSIBLE SIDE EFFECTS?

5. HOW TO STORE BETADINE 10 PER CENT, Vaginal Solution?

6. ADDITIONAL INFORMATION

1. WHAT IS BETADINE 10 PERCENT, Vaginal Solution AND WHAT IT IS USED FOR?

Pharmacotherapeutic group

This medication is an iodized antiseptic.

Therapeutic indications

This medication is indicated in the local adjunctive treatment of certain vaginal infections and in the vulvo-vaginal preparation before invasive medical procedure or act of surgery of the urogenital sphere.

2. BEFORE YOU USE BETADINE 10 PERCENT, Vaginal Solution?

List of information needed before taking the medication

Not applicable.

Cons-indications

Never use BETADINE 10 PERCENT, Vaginal Solution:

· in the case of a history of intolerance or allergy to any of the constituents, in particular povidone iodine or products containing povidone.
There is no cross-reaction with iodinated contrast media. A history of allergic-type accidents to iodinated contrast media or seafood anaphylaxis is not a contraindication to the use of BETADINE 10% vaginal solution.

· in case of repeated use during pregnancy, from the 2nd trimester of pregnancy.

· in case of breastfeeding.

BETADINE 10%, vaginal solution is GENERALLY DISCONTINUED unless your doctor advises otherwise:

· in combination with spermicidal products and mercury-derived antiseptics.

Precautions for use; special warnings

Take special care with BETADINE 10 PER CENT, Vaginal Solution:

Special warning

Iodine may pass through the mucosa and pass into the general circulation (see section What are the possible side effects), particularly in case of repeated use or application to a weakened mucosa. Prolonged or repeated use of this medication is therefore discouraged. The passage of iodine in the general circulation is favored in cases of renal insufficiency.

Do not use with spermicidal products (risk of inactivation).

Precautions for use

Avoid dripping. Prolonged contact with undried solution may cause irritation and rarely severe burn-type skin reactions.

Interaction with other medicines

Taking or using other medicines:

If you are taking or have recently taken any other medicines, including medicines obtained without a prescription including mercury-containing antiseptics and spermicidal products (risk of inactivation), 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

Due to the presence of iodine, the use of this drug, in the case of repeated use , is contraindicated from the 2nd trimester.

It will only be used occasionally on the advice of your doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

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 PER CENT, Vaginal Solution?

Instructions for proper use

Not applicable.

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

Dosage

Diluted use with vaginal injections kit:

One or two daily vaginal injections: dilute with two tablespoons per liter of lukewarm water.

Pure use:

Internal or external brushing with pure solution.

Method and route of administration:

Vaginal pathway.

Frequency of administration:

The frequency of administration is determined by the physician according to the needs of the patient.

Duration of treatment:

The use of this medication requires a consultation with your doctor.

Do not exceed the recommended treatment time and follow the instructions for use.

IN ALL CASES COMPLY WITH THE ORDER OF YOUR DOCTOR STRICTLY

Symptoms and Instructions for Overdose

If you used more BETADINE 10 PER CENT, vaginal solution than you should:

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 10 PER CENT, vaginal solution is likely to have unwanted effects, although not everyone is subject to it.

· in the case of repeated and prolonged use on certain fragile or fragile skin, particularly in premature and severe burns, there may be an iodine overload which may modify the functioning of the thyroid gland.

· local skin reactions may occur: burn-type caustic dermatitis in case of maceration and contact dermatitis.

· possibility of irritation of the mucous membranes;

· unusually, hypersensitivity reactions: urticaria, angioedema, anaphylactic shock, anaphylactoid reaction may occur.

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 through 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 PER CENT, Vaginal Solution?

Keep out of the reach and sight of children.

Expiration date

Do not use BETADINE 10 PERCENT, vaginal solution 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: no special precautions for storage.

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 does BETADINE contain 10%, vaginal solution?

The active substance is:

Povidone iodine (titrated to 10% iodine) ....................................... .................................................. ......... 10.00 g

For 100 ml.

The other components are :

Macrogol lauric acid (9), sodium hydroxide (qs pH = 2), purified water.

Pharmaceutical form and content

What is BETADINE 10 PERCENT, vaginal solution and contents of the pack?

This medication is in the form of a vaginal solution.

Box of 1 bottle of 30, 125, 250, 500 or 5 l or box of 50 vials of 5 or 10 ml.

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.

Find all the products on Gifrer Care and kind your bio pharmacy online: help repel oleo-limestone water flavored with orange blossom.

Betadine Pharmacy Online: Sales and authorized secure Betadine in your bio licensed pharmacy ARS Care and Nature


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

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