BETADINE SOAPY 75 mg/ml CUTANEOUS SOLUTION

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

Do not use Betadine Soap

• 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.
• Before, during, and after the administration of radioactive iodine
• With products containing 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 Soap.

External use only. Do not ingest. Avoid contact with eyes, ears, and other mucous membranes. Consult your doctor if symptoms persist or worsen.

If used in preparation before an operation, avoid accumulation under the patient. It can cause irritation and rarely severe skin reactions. Chemical burns on the skin can occur due to accumulation. In that case, suspend its use. Do not heat before applying.

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 or on extensive skin areas unless strictly indicated. Even at the end of treatment, 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.

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

This medication contains 110 mg of benzoic acid in each 100 ml. Benzoic acid can cause local irritation.

Children

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

The use of Betadine Soap is not recommended in children under one year of age.

Using Betadine Soap with Other Medications

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

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 can lead to errors in tests with toluidine or guaiacol to determine hemoglobin or glucose in feces or urine. It can also interfere with thyroid tests and treatments with radioactive iodine.

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

Inform 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 medication.

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

Its use could cause 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 operate machinery.

3. How to Use Betadine Soap

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

Cutaneous use. Use a small amount of the product, rubbing for about 2-5 minutes until foam is obtained. Rinse with plenty of water or with a sterile gauze soaked in water. Apply 2-3 times a day (or more often as needed).

If you use more Betadine Soap than you should

In case you apply an excessive amount of product and skin irritation occurs, wash the affected area with plenty of water, suspend treatment, and if irritation continues, consult your doctor.

Symptoms could be abdominal pain, anuria (suppression or decrease in urine), circulatory, respiratory, and metabolic problems. Excess iodine can cause 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 using this medication, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

In rare cases where skin 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 as 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 an allergy).

Other side effects of unknown frequency have been hypothyroidism, electrolyte imbalance, metabolic acidosis, acute kidney failure, abnormal blood osmolarity, exfoliative dermatitis, dry skin, skin discoloration, and chemical burns on the skin.

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Betadine Soap

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

Store below 25°C.

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

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

6. Package Contents and Additional Information

Composition of Betadine Soap

The active ingredient is povidone iodine. Each ml of solution contains 75 mg of povidone iodine.

The other components (excipients) are: a solution of ethoxylated ammonium lauryl sulfate (contains benzoic acid), polyethylene glycol 400, sodium hydroxide, potassium iodate, and purified water.

Appearance of the Product and Package Contents

Brown soap solution.

It is presented in high-density polyethylene bottles with a black cap and reducer, containing 500 ml of solution.

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 medication 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 Package Leaflet:2022

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