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Betadine Antiseptic Vaginal Solution 125 ml
Over-the-counter medication

Betadine Antiseptic Vaginal Solution 125 ml

Brand : Bétadine Bétadine
used for :

Betadine Antiseptic Vaginal Solution 125 ml is an iodine-based antiseptic medication. It is indicated for the adjunctive local treatment of certain vaginal infections in gynecology.

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Reference : 3400930108550
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For warnings, precautions,and contraindications, please refer to the package insert.

KEEP THIS MEDICATION OUT OF THE REACH OF CHILDREN

Description of Betadine Vaginal Solution

This medication is an iodine-based antiseptic. It is indicated for the local adjunctive treatment of certain vaginal infections.

Gynecological infections: What are the symptoms?
Among the most common warning signs are:

  • Abnormal vaginal discharge. Its color, amount, texture, or odor catches your attention.
  • Swelling and redness of the vulva.
  • Burning and/or itching in the vulva and vagina.
  • Small warts or blisters on the vulva, vagina, or perineum (the area between the anus and the vagina). These may be a sign of sexually transmitted infections.
  • Pain in the lower abdomen.

Directions forUse 

Dosage:

  • Diluted use with a vaginal injection kit: one or two vaginal injections daily; dilute two tablespoons per liter of lukewarm water.
  • Use: undiluted: apply the undiluted solution internally or externally.

Frequency of administration: The frequency of administration is determined by the doctor based on the patient’s needs.

Duration of treatment: Use of this medication requires prior consultation with your doctor. Do not exceed the recommended duration of treatment and follow the directions for use. In all cases, strictly follow your doctor’s prescription.

If you have used more Betadine 10% vaginal solution than you should have: In the event of massive oral ingestion, contact a doctor immediately.

Composition 

The active ingredient is: povidone-iodine 10.00 g per 100 mL.

The other ingredients are:macrogol lauricether(9), sodium hydroxide (q.s. pH=2), purified water.

Precautions for Use of Betadine Vaginal Solution

Do not use this medication for an extended period without medical advice: there is a risk of iodine entering the bloodstream, which could disrupt thyroid function.
In the event of a genital infection, your partner may be infected even if he shows no symptoms. If he is not treated at the same time, reinfection is possible.

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

Overview of Betadine Vaginal Solution

Betadine 10 percent vaginal solution is available in a 125-ml bottle

Medication Warnings

Please note: Betadine vaginal solution is not like other products. Read the medication guide carefully before ordering. Keep medications out of the reach of children. If symptoms persist, consult your doctor or pharmacist. Be aware of potential interactions with your current medications.

  • Please inform your online pharmacist of any current treatments to identify potential interactions. The order confirmation form includes a custom message field for this purpose.
  • Click here to view the package insert for this medication on the website of the French National Agency for Medicines and Health Products Safety.
  • Pharmacovigilance: Report any adverse effects related to the use of a medication.

Betadine Antiseptic Vaginal Solution 125 ml: Your Partner in Gynecology

Betadine Antiseptic Vaginal Solution 125 ml is your iodine-based antiseptic solution for the adjunctive local treatment of certain vaginal infections in gynecology. Discover how Betadine can help you maintain the health and well-being of your intimate area.

  • Trusted Iodine-Based Antiseptic: Betadine is a trusted name in iodine-based antiseptics. Our solution is specially formulated to be gentle and effective for vaginal use.

  • Topical Treatment: Vaginal infections can be uncomfortable and bothersome. Betadine 125ml Vaginal Antiseptic Solution is designed for topical adjunctive treatment, helping you feel better.

  • Gynecological Support: As an antiseptic solution, Betadine is recommended by healthcare professionals to support gynecological health.

Trusted by Users

  • Proven Effectiveness: Betadine has a proven track record in treating vaginal infections. Satisfied users attest to its effectiveness.

  • Intimate Well-Being: Taking care of your intimate health is essential. Betadine helps you maintain optimal vaginal well-being.

  • Everyday Confidence: With Betadine Antiseptic Vaginal Solution 125ml, you can feel confident in your gynecological care routine.

Take Care of Your Gynecological Health with Betadine

Don’t ignore vaginal infections or let them bother you. Betadine Antiseptic Vaginal Solution 125 ml is here to help you maintain the health of your intimate area and feel comfortable every day.

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

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.

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.

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