Label: information for the user

Betadine 10 mg/ml oral rinse solution

povidone-iodine

Read this label carefully before starting to use this medication, as it contains important information for you.

Follow exactly the medication administration instructions contained in this label or those indicated by your doctor, pharmacist, or nurse.

-Keep this label, as you may need to refer to 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 not listed in this label. See section 4.

-You should consult a doctor if your condition worsens or does not improve after 14 days of treatment.

The active ingredient, povidone iodine, is an antiseptic (that destroys the germs that cause infections) containing iodine.

Betadine is indicated in children aged 6 years and older and adults as a buccal and pharyngeal antiseptic for the symptomatic relief of mild oral infections, such as mouth ulcers and small ulcers. Bad breath. Hoarseness and cough.

Do not use Betadine

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

Patients with goiter, thyroid nodules, or other non-acute thyroid diseases, except for explicit doctor's indication, should not use for prolonged periods of time or apply the medication to extensive skin areas, due to increased risk of hyperthyroidism. After treatment, monitor early symptoms of possible hyperthyroidism and, if necessary, control thyroid function.

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Wait 1 to 2 weeks between exposure to povidone and performing a thyroid function test (iodine radioactive scan) or treatment of thyroid cancer with radioactive iodine.

Caution in intubated patients due to risk of complications such as pneumonitis.

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

Children

Newborns and young children have a higher risk of developing hypothyroidism as a result of cutaneous absorption (due to greater skin permeability) and increased sensitivity to iodine. If used in children, it is essential to monitor thyroid function.

Do not use in children under 6 years old without doctor's indication.

Use of Betadine with other medications

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

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

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

• When used at the same time or after antiseptics with octenidina, dark transitory 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 type of diagnostic test.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Iodine can cross the placental barrier and be excreted in breast milk. Its use may cause transient hypothyroidism in fetuses and newborns. Thyroid function monitoring may be necessary in children.

Use only if strictly indicated, and maintain its use to the absolute minimum. Avoid continuous use.

Betadine contains alcohol

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

Follow exactly the medication administration instructions contained in this leaflet or those 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 old is: After brushing your teeth, rinsing your mouth, and gargling with 15 ml of the product (a full cap). Repeat 2 to 3 times a day. Do not exceed the recommended dose.

If you use more Betadine than you should

In case an excessive amount of product is applied and skin irritation occurs, wash the affected area with plenty of water, discontinue treatment, and if irritation continues, see a doctor. Excessive iodine can cause goiter, hypothyroidism, and hyperthyroidism.

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

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

In rare cases where irritation or an allergic reaction occurs, discontinue treatment and wash the affected area with water.

Rare adverse effects (may affect between 1 and 10 of every 10,000 people) are hypersensitivity and contact dermatitis that manifests with red skin, small blisters, and itching.

Very rarely (may affect fewer than 1 of every 10,000 people), severe allergic reactions (anaphylaxis), hyperthyroidism with tachycardia and agitation, and angioedema (allergic swelling) have been observed.

Other adverse effects of unknown frequency have been hypothyroidism, electrolyte imbalance, metabolic acidosis, pneumonitis (complications of aspiration – see section “Warnings and Precautions”), acute renal failure, abnormal blood osmolarity, dry skin, and chemical burns on the skin.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

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

Do not store above30?C

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Betadine Composition

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

The other components (excipients) are: 96% ethanol, 85% glycerol, 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 dosing cup and a child-resistant safety cap.

To open the bottle, unscrew the cap by pressing down and turning in a clockwise direction until you hear a sound. After use, screw the cap in the opposite direction to the clock hands.

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

For more information about this medication, please contact the local representative of the marketing authorization holder:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 Barcelona

Spain

Last review date of this leaflet:April 2023

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/