BETADINE 10 PERCENT VAGINAL SOLUTION: This medication is an iodized antiseptic. It is indicated in the local top-up treatment of certain vaginal infections.
For warnings, precautions for use and contraindications, please consult the instructions for use .
DO NOT LEAVE THIS MEDICINE IN THE REACH OF CHILDREN
This medication is an iodized antiseptic . It is indicated in the local adjunctive treatment of certain vaginal infections .
Gynecological infections: what symptoms ?
Among the most frequent warning signs are:
Dosage :
Frequency of administration : the frequency of administration is determined by the doctor according to the needs of the patient.
Duration of treatment : the use of this medication requires prior consultation with your doctor. Do not exceed the recommended duration of treatment and follow the advice for use. In all cases, strictly comply with your doctor's prescription.
If you use more Betadine 10% vaginal solution than you should: in case of massive oral ingestion, contact a doctor quickly.
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.
Do not use this medication for a prolonged period without medical advice: risk of iodine passing through the blood, which could lead to disruption of the functioning of the thyroid.
In the event of a genital infection, your partner may be infected when he has no symptoms. If not treated together, recontamination is possible.
IN CASE OF DOUBT DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR PHARMACIST
The drug betadine 10 percent vaginal solution present in the form of a gel tube of 30 g.
Attention, the drug betadine vaginal solution 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.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated on: 20/07/2017
BETADINE 10 PER CENT, vaginal solution
Povidone iodine
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.
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?
This medication is an iodized antiseptic.
2. BEFORE YOU USE BETADINE 10 PERCENT, Vaginal Solution?
List of information needed before taking the medication
Not applicable.
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.
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?
Not applicable.
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.
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.
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.
Before opening: no special precautions for storage.
If necessary, warnings against visible signs of deterioration
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.
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
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 Afssaps 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: ovule; box of 8.
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BEADIN: vaginal solution (brown); 125 ml bottle.
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Laboratory Meda Pharma
| p ovule | p 100 ml | |
| Polyvidone iodine | 250 mg | 10 g |
| Iodine | 25 mg | 1 g |
Usual dosage:
