BETADINE BUCAL 100 mg/mL ORAL SOLUTION

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

Do not use Betadine oral

• If you are allergic to povidone iodine or to any of the other components of this medicine (listed in section 6).
• If you have hyperthyroidism or other acute thyroid diseases.
• Before, during, and after the administration of radioactive iodine
• With products that contain mercury due to the formation of a substance that can damage the skin.
• In children under one year of age.

Warnings and precautions

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

Do not ingest. Avoid contact with eyes, ears. Consult your doctor if symptoms persist, worsen, or fever appears.

Patient with goiter, thyroid nodules, or other non-acute thyroid diseases are at risk of developing hyperthyroidism with the administration of high amounts of iodine. In these patients, it should not be applied for prolonged periods of time and in extensive areas of skin unless strictly indicated. Even at the end of treatment, you should be alert to early symptoms of possible hyperthyroidism and, if necessary, control thyroid function.

It should not be used before or after a radioactive iodine scan or treatment of thyroid carcinoma with radioactive iodine.

When used oropharyngeally, caution should be taken to avoid aspiration of Betadine oral into the respiratory tract as it may cause complications such as pneumonitis. It is important in intubated patients.

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

Children

Newborns and small children are at greater risk of developing hypothyroidism. If used in children, it is essential to monitor the thyroid.

Do not use in children under 1 year of age.

Using Betadine oral with other medicines

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

Do not use with mercurial derivatives, silver, hydrogen peroxide, or taurolidine (antiseptics).

Continuous use should be avoided in patients undergoing simultaneous therapy 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 tests with toluidine or guaiacol to determine hemoglobin or glucose in feces or urine. It may also interfere with thyroid tests and treatments with radioactive iodine. Inform your doctor when you need to undergo any diagnostic test.

Tell your doctor if:

• Symptoms do not improve or worsen
• You have received radioactive iodine treatments in the last 4 weeks
• You have an allergy or skin irritation such as redness, small blisters, itching, or rash that may appear immediately.

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.

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

Its use could produce transient hypothyroidism in fetuses and newborns. Thyroid control may be necessary in children.

You should consult your doctor about using it in children between 1 and 2 years old.

Driving and using machines

Betadine does not affect the ability to drive or use machinery.

3. How to use Betadine oral

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor, pharmacist, or nurse.

Use as mouthwashes or gargles. After brushing your teeth, dilute one level capful of product in half a glass of water. Repeat 2 or 3 times a day.

If you use more Betadine oral 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.

Symptoms could be abdominal pain, anuria (suppression or decrease of urine), circulatory, respiratory, and metabolic problems. 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 gets 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 every 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 every 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, skin discoloration, and chemical burns to 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 Medicines and Healthcare Products Agency (AEMPS) website: 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 oral

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

No special storage conditions are required.

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.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medicines at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the package and additional information

Composition of Betadine oral

The active ingredient is povidone iodine. Each ml of solution contains 100 mg of povidone iodine.

The other components (excipients) are: glycerol (E 422), peppermint flavor, sodium saccharin, sodium hydroxide (E 524), and purified water.

Appearance of the product and contents of the package

Brown-colored solution.

It is presented in a 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,

Netherlands

Manufacturer

MEDA Manufacturing, Bordeaux

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:August 2022

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