BETADINE 250 mg Ova 8 is a drug indicated for the adjunctive treatment of vaginal infections with sensitive organisms.
For warnings, precautions for use and contraindications, please consult the instructions for use .
DO NOT LEAVE THIS MEDICINE IN THE REACH OF CHILDREN
BETADINE 250 mg 8 Ovules is a medication indicated in the adjunctive treatment of vaginal infections with sensitive germs .
The mucous membranes differ from the skin in their structure and their disinfection requires other methods to be effective. Bacterial colonization of the mucous membranes is influenced by various factors, including age, hormones, gender and certain pathological factors.
Under normal conditions, the resident flora of the mucous membranes constitutes a stable microbial ecosystem including aerobic microorganisms and anaerobic microorganisms. When this system is disturbed by endogenous or exogenous factors, the mucous membrane is colonized by unwanted microorganisms in greater numbers. This unwanted colonization can be caused by germs from the outside, but germs from the body itself, originating from the mucous sphere or adjacent skin, can play a role in the onset of an infection.
POVIDONE IODEE; MACROGOL 1000; QSP 1 TITLE OVULE AT 10% IODINE
IN CASE OF DOUBT DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR PHARMACIST
8-egg pods
Attention, the drug 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.
All products of the MEDA PHARMA laboratory
All disinfectant antispetic products
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated on: 20/07/2017
BETADINE 250 mg, ovule
Polyvidone 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 250 mg, ovule AND WHAT IT IS USED FOR?
2. BEFORE YOU USE BETADINE 250 mg, ovule?
3. HOW TO USE BETADINE 250 mg, ovule?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE BETADINE 250 mg, ovule?
6. ADDITIONAL INFORMATION
1. WHAT IS BETADINE 250 mg, ovule AND WHAT IT IS USED FOR?
This medication is an iodized antiseptic.
This medication is indicated in the local adjunctive treatment of certain vaginal infections.
2. BEFORE YOU USE BETADINE 250 mg, ovule?
List of information needed before taking the medication
Not applicable.
Never use BETADINE 250 mg, egg:
· 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 250 mg, an egg.
· in case of repeated use during pregnancy, from the 2nd trimester of pregnancy.
· in case of breastfeeding.
BETADINE 250 mg, ovule is GENERALLY DISCONTINUED unless your doctor has advised otherwise:
· in combination with spermicidal products and mercury-derived antiseptics.
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 250 mg, ovule:
Special warnings
DO NOT BROADLY INTERRUPT THE TREATMENT WITHOUT THE NOTICE OF YOUR DOCTOR.
DO NOT INJECT, DO NOT SWALLOW.
Precautions for use
The iodine of this medication can pass through the mucosa and pass into the general circulation ( see Possible side effects ), especially in case of repeated use or application to a fragile 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).
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
NEVER LEAVE TO CHILDREN.
Interaction with other medicines
Use of 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 250 mg, ovule?
Not applicable.
Dosage and Mode and Route of Administration
Vaginal pathway
RESERVED FOR ADULTS
Set up an egg every evening for 8 to 16 days.
The egg must be inserted deep into the vagina.
Frequency and Timing of Medication
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.
Symptoms and Instructions for Overdose
If you used more BETADINE 250 mg, ovule than you should:
In case of overdose, there may be an iodine overload that may affect the functioning of the thyroid gland. Quickly see a doctor.
Instructions for omission of one or more doses
Not applicable.
Do not interrupt treatment without your doctor's advice.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, BETADINE 250 mg, egg is likely to have side effects, although not everyone is subject to it.
· Possibility of iodine overload, in case of repeated and prolonged administration which may modify the functioning of the thyroid gland;
· possibility of irritation of the mucous membranes;
· unusually, hypersensitivity reactions: urticaria, angioedema, anaphylactic shock, anaphylactoid reaction may occur.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE BETADINE 250 mg, ovule?
Keep out of the reach and sight of children.
Do not use BETADINE 250 mg, egg after the expiry date which is stated on the outer packaging
Store at a temperature of 25 ° C or lower.
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 250 mg, ovule contain?
The active substance is:
Polyvidone iodine (Titrated with 10% iodine) ....................................... .................................................. ....... 250 mg
For an egg of 2.9 g.
The other component is:
Excipients : macrogol 1000.
Pharmaceutical form and content
What is BETADINE 250 mg, ovule and contents of the pack?
This medication is in the form of an ovule. Box of 8 eggs.
40-44 WASHINGTON STREET
75008 PARIS
40-44 Washington Street
75008 PARIS
AVENUE JF KENNEDY
33700 MERIGNAC
or
RECIPHARM PARETS SLU
RAMON Y CAJAL, 2
080150 PARETS DEL VALLES
BARCELONA
SPAIN
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: