Betadine Vaginal 100 mg/ml vaginal solution
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Betadine vaginal 100 mg/ml vaginal solution
Povidone iodine
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for administration of the medicine contained in this leaflet or as advised by your doctor, pharmacist, or nurse.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or does not improve.
Contents of the leaflet
- What Betadine vaginal is and what it is used for.
- What you need to know before using Betadine vaginal.
- How to use Betadine vaginal.
- Possible side effects.
- How to store Betadine vaginal.
- Contents of the pack and other information.
1. What Betadine vaginal is and what it is used for
Povidone iodine, the active ingredient in this medicine, is an antiseptic (which destroys germs that cause infections) containing iodine.
Betadine is indicated as a topical vaginal antiseptic used for antiseptic washing of the external vaginal area and for relief of symptoms associated with vaginal infections.
2. What you need to know before using Betadine vaginal
Do not use Betadine vaginal
- If you are allergic to povidone-iodine or to any of the other ingredients of this medicine (listed in section 6).
- If you have hyperthyroidism or other acute thyroid disorders.
- Before, during, and after administration of radioactive iodine.
- With mercury-containing products due to the formation of a substance that may damage the skin.
- In children under one year of age.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to use Betadine vaginal.
For vaginal use only. Do not ingest. Avoid contact with eyes, ears, and other mucous membranes. Consult your doctor if symptoms persist or worsen.
If used as preparation prior to surgery, avoid pooling underneath the patient. This may cause irritation and, rarely, severe skin reactions. Chemical burns of the skin may occur due to pooling. In such cases, discontinue use. Do not heat before application.
Patients with goiter, thyroid nodules, or other non-acute thyroid disorders are at risk of developing hyperthyroidism when exposed to high iodine levels. In these patients, prolonged use and application over large skin areas should be avoided unless strictly indicated. Even after treatment has ended, early symptoms of possible hyperthyroidism should be monitored, and thyroid function should be checked if necessary.
Do not use before or after radioactive iodine scintigraphy or treatment of thyroid carcinoma with radioactive iodine.
Thyroid function tests should be performed in case of prolonged use.
Children
Newborn infants and young children are at higher risk of developing hypothyroidism. If used in children, thyroid function must be monitored.
Use in children under one year of age is not recommended.
Use of Betadine vaginal with other medicines
Inform your doctor or pharmacist if you are currently using, have recently used, or may need to use any other medicinal products.
Do not use with mercury-containing compounds, silver-containing products, hydrogen peroxide, or taurolidine (antiseptics).
Prolonged use should be avoided in patients receiving concomitant lithium therapy (used in psychiatry).
When used simultaneously or after antiseptics containing octenidine, transient dark discoloration of the affected areas may occur.
Interaction with diagnostic tests: the use of povidone-iodine may lead to errors in toluidine or guaiacol tests for detecting hemoglobin or glucose in feces or urine. It may also interfere with thyroid function tests and treatments with radioactive iodine.
Inform your doctor if you are scheduled to undergo any diagnostic testing.
Inform your doctor if:
- Symptoms do not improve or worsen
- You have received treatment with radioactive iodine within the last 4 weeks
- You have an allergy or skin irritation such as redness, small blisters, itching, or rash, which may appear immediately.
Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Use only if strictly indicated, and limit use to the minimum necessary. Avoid prolonged use.
Its use may cause transient hypothyroidism in fetuses and newborns. Thyroid monitoring in infants may be required.
Consult your doctor regarding use in children between 1 and 2 years of age.
Driving and use of machines
Betadine does not affect the ability to drive or operate machinery.
3. How to use Betadine vaginal
Follow exactly the dosage instructions for the medicine contained in this leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
Vaginal use. Wash with a dilution of 2 level applicators of product per liter of boiled and lukewarm water.
Apply 1 to 2 times daily (or more frequently, as needed).
If you use more Betadine vaginal than you should
If an excessive amount of product is applied and skin irritation occurs, wash the affected area thoroughly with abundant water, discontinue treatment, and if irritation persists, consult a doctor.
Symptoms may include abdominal pain, anuria (suppression or reduction of urine), circulatory, respiratory, and metabolic problems. Excess iodine may cause goiter, hypothyroidism, and hyperthyroidism.
In case of accidental ingestion, go to a medical center or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the product and the amount ingested.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
In rare cases where skin irritation or allergy occurs, discontinue treatment and wash the affected area with water.
Rare adverse effects (may affect between 1 and 10 out of every 10,000 people) are hypersensitivity and contact dermatitis, which manifests as red skin, small blisters, and itching.
Very rarely (may affect fewer than 1 in 10,000 people), anaphylactic reactions (severe allergic reaction), hyperthyroidism with tachycardia and agitation, and angioedema (swelling caused by allergy) have been observed.
Other adverse effects with unknown frequency include hypothyroidism, electrolyte imbalance, metabolic acidosis, acute renal failure, abnormal blood osmolarity, exfoliative dermatitis, dry skin, skin discoloration, and chemical burn on the skin.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines (https://www.notificaram.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Betadine Vaginal
Keep this medicine out of sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the packaging after CAD or EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Betadine Vaginal
The active substance is povidone iodine. Each ml of solution contains 100 mg of povidone iodine.
The other components (excipients) are: lauric ether of macrogol 9, sodium hydroxide (E 524) and purified water.
Appearance of the product and contents of the pack
Brown-coloured solution.
Presented in packs containing 1 high-density polyethylene bottle with a black cap and reducer, containing 125 ml.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Cooper Consumer Health B.V.
Verrijn Stuartweg 60,
1112 AX Diemen,
The Netherlands
Manufacturer
MEDA Manufacturing, Bordeaux
Av. Président J. F. Kennedy. BP 100
Medignac – Cedex
F-33700
France
For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Vemedia Pharma Hispania, S.A.
C/ Aragón, 182, 5th floor
08011 Barcelona
Spain
Date of the most recent revision of this leaflet: November 2023
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) https://www.aemps.gob.es/