BETADINE 10 mg/ml MOUTH RINSE SOLUTION

Introduction

Leaflet: information for the user

Betadine 10 mg/ml mouthwash solution

povidone-iodine

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.

Follow the administration instructions for the medicine exactly as stated in this leaflet or as indicated 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 side effects, consult 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 symptoms worsen or 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 starting to use Betadine.
3. How to use Betadine.
4. Possible side effects.
5. Storage of Betadine.
6. Package contents and additional information.

1. What Betadine is and what it is used for

The active ingredient of this medicine, povidone-iodine, is an antiseptic (which destroys germs that cause infections) that contains iodine.

Betadine is indicated for children from 6 years of age and adults as a buccopharyngeal antiseptic for the symptomatic relief of mild oral infections, such as canker sores and small ulcers. Bad breath. Hoarseness and loss of voice.

2. What you need to know before starting to use Betadine

Do not use Betadine

• If you are allergic to povidone-iodine or any of the other components of this medicine (listed in section 6).
• If you have hyperthyroidism or other acute thyroid diseases.
• In children under 6 years of age.
• Before, during, or after thyroid function tests (radioactive iodine 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, ears.

Patient with goiter, thyroid nodules, or other non-acute thyroid diseases should not use for prolonged periods or apply the medicine to extensive skin areas, due to a higher risk of hyperthyroidism. After treatment, there should be monitoring of early symptoms of possible hyperthyroidism and, if necessary, control of thyroid function.

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Wait for an interval of 1 to 2 weeks between exposure to povidone and the performance of a radioactive iodine scintigraphy (thyroid function test) or treatment of thyroid carcinoma with radioactive iodine.

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 small children have a higher risk of hypothyroidism as a consequence of skin absorption (due to greater skin permeability) and greater sensitivity to iodine. If used in children, it is essential to monitor thyroid function.

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

Using Betadine with other medicines

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

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

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

• When used at the same time or after antiseptics with octenidine, transient dark discoloration of the involved areas may appear.

• Interaction with diagnostic tests:

The use of povidone-iodine may lead to errors in determining hemoglobin or glucose in feces or urine.

It may also interfere with thyroid tests and treatments with radioactive iodine. See "Warnings and precautions".

Inform your doctor when you need to undergo any diagnostic test.

Pregnancy, breastfeeding, and fertility

If you are pregnant or 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 be excreted in breast milk. Its use could produce transient hypothyroidism in fetuses and newborns. Thyroid control may be necessary in children.

Use only if strictly indicated; its use should be kept to an absolute minimum. Avoid continuous use.

Betadine contains alcohol

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

3. How to use Betadine

Follow the administration instructions for the medicine exactly as stated in this leaflet or as indicated by your doctor, pharmacist, or nurse. In case of 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 your mouth and gargle with 15 ml of product (one level cap). Repeat 2 to 3 times a day. Do not exceed the recommended dose.

If you use more Betadine than you should

In case of excessive application of the product and skin irritation, wash the affected area with plenty of water, suspend treatment, and if irritation continues, consult a doctor. Excess iodine can produce goiter, hypothyroidism, and hyperthyroidism.

In case of accidental ingestion, go to a medical center or call the Toxicology Information Service, phone: 91 562 04 20, indicating the product and the amount ingested.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

In rare cases where irritation or allergy occurs, suspend treatment and wash the affected area with water.

Rare side effects (may affect between 1 and 10 in 10,000 people) are hypersensitivity and contact dermatitis, which manifests with red skin, small blisters, and itching.

Very rare side effects (may affect less than 1 in 10,000 people) include anaphylactic reactions (severe allergic reaction), hyperthyroidism with tachycardia and agitation, and angioedema (swelling caused by allergy).

Other side effects of unknown frequency include hypothyroidism, electrolyte imbalance, metabolic acidosis, pneumonitis (aspiration complications - see "Warnings and precautions"), acute renal failure, abnormal blood osmolarity, dry skin, and chemical burns on the skin.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Betadine

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

Do not store above 30°C

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medicines at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package contents and additional information

Betadine composition

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

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

Product appearance and packaging contents

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

The bottle has a graduated measuring cup and a child-resistant cap.

To open the bottle, unscrew the cap by pressing down and turning it clockwise until you hear a sound. After use, screw the cap counterclockwise.

Marketing authorization holder and manufacturer

Marketing authorization holder

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

Netherlands

Manufacturer

MEDA Manufacturing

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

Merignac – Cedex

F-33700

France

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 Barcelona

Spain

Date of the last revision of this leaflet:April 2023

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/