Betadine 10 mg/ml oral rinse solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Betadine 10 mg/ml mouthwash 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 use provided in this leaflet or those given 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 adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 14 days of treatment.

Contents of the leaflet

1. What Betadine is and what it is used for.
2. What you need to know before using Betadine.
3. How to use Betadine.
4. Possible side effects.
5. How to store Betadine.
6. Contents of the pack and other information.

1. What Betadine 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 in children from 6 years of age and adults as an oropharyngeal antiseptic for the symptomatic relief of mild oral infections, such as aphthae and small ulcers. Bad breath. Hoarseness and voice loss.

2. What you need to know before using Betadine

Do not use Betadine

• 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.
• In children under 6 years of age.
• Before, during, or after radioactive iodine thyroid function tests (radioiodine scintigraphy) or treatment of thyroid carcinoma with radioactive iodine.

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Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Betadine.

Do not ingest. Avoid contact with eyes and ears.

Patients with goiter, thyroid nodules, or other non-acute thyroid disorders should not use this product for prolonged periods or apply it over large areas of skin, unless specifically instructed by a physician, due to an increased risk of hyperthyroidism. After treatment, early symptoms of possible hyperthyroidism should be monitored, and, if necessary, thyroid function should be checked.

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Allow an interval of 1 to 2 weeks between exposure to povidone-iodine and performing a radioactive iodine uptake test (thyroid function test) or treatment of thyroid carcinoma with radioactive iodine.

Use with caution in intubated patients due to the risk of complications such as pneumonitis.

Thyroid function tests should be performed in case of prolonged use.

Children

Newborns and young children are at higher risk of developing hypothyroidism due to cutaneous absorption (as a result of increased skin permeability) and greater sensitivity to iodine. When used in children, monitoring of thyroid function is important.

Do not use in children under 6 years of age without medical advice.

Using Betadine with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

• Do not use with other oral antiseptics such as mercurial derivatives, silver-containing products, hydrogen peroxide, or taurolidine.

• Avoid concomitant use with lithium (used in psychiatry).

• When used together with 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 the determination of hemoglobin or glucose in feces or urine.

It may also interfere with thyroid function tests and treatments with radioactive iodine. See “Warnings and precautions”.

Inform your doctor if you are scheduled for any diagnostic test.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Iodine can cross the placental barrier and is excreted in breast milk. Its use may cause transient hypothyroidism in fetuses and newborns. Monitoring of thyroid function in infants may be necessary.

Use only if strictly indicated, and limit use to the absolute minimum. Avoid prolonged or continuous use.

Betadine contains alcohol

This medicine contains 511 mg of alcohol (ethanol), equivalent to 34 mg per ml. It may cause a burning sensation on damaged skin.

3. How to use Betadine

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

The recommended dose for adults and children over 6 years of age is: After brushing your teeth, rinse and gargle with 15 ml of the product (one flat cap). Repeat 2 to 3 times daily. Do not exceed the recommended dose.

If you use more Betadine than you should

If an excessive amount of the product is applied and skin irritation occurs, wash the affected area thoroughly with abundant water, discontinue treatment, and if irritation persists, consult a doctor. 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 phone number: 91 562 04 20, indicating the product and the amount ingested.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

In rare cases of irritation or allergy, discontinue treatment and wash the affected area with water.

Rare adverse effects (may affect between 1 and 10 out of 10,000 people) are hypersensitivity and contact dermatitis, manifesting as red skin, small blisters, and itching.

Very rarely (may affect less 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 of unknown frequency include hypothyroidism, electrolyte imbalance, metabolic acidosis, pneumonitis (aspiration complications – see section “Warnings and precautions”), acute renal failure, abnormal blood osmolality, dry skin, and chemical burn on the skin.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Betadine

Keep this medicine out of sight and reach of children.

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.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Betadine

The active substance is povidone-iodine. Each ml of solution contains 10 mg of povidone-iodine.

The other components (excipients) are: Ethanol 96%, glycerol 85%, cineole, levomenthol, sodium saccharin, citric acid monohydrate, disodium phosphate dihydrate, sodium hydroxide, potassium iodate, purified water.

Appearance of the product and contents of the container

Brown-coloured solution. Transparent (PE) bottle of 200 ml.

The bottle comes with a graduated dosing cup and a child-resistant safety cap.

To open the bottle, unscrew the cap by pressing downwards and turning clockwise until you hear a click. After use, screw the cap back on in the counterclockwise direction.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

The Netherlands

Manufacturer

MEDA Manufacturing

Av. Pdt. J. F. Kennedy. BP 100

Merignac – Cedex

F-33700

France

For further information about 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 review of this leaflet: April 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/