Label: information for the user

Betadinegel 100 mg/g gel

Povidone iodine

Read this entire 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.

-Consult your pharmacist if you need advice or more information.

-Consult your doctor, pharmacist, or nurse if you experience any adverse effects, 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.

1. What is Betadine gel and what is it used for.

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

3. How to use Betadine gel.

4. Possible adverse effects.

5. Storage of Betadine gel.

6. Contents of the package and additional information.

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

Betadine gel is indicated as a general-purpose skin antiseptic, for small wounds and superficial cuts, minor burns or scrapes.

Do not use Betadine gel

• 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 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.

Warnings and precautions

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

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 surgery, avoid accumulation under the patient. It may cause irritation and rarely severe skin reactions. Chemical burns to the skin may occur due to accumulation. In this case, discontinue use. Do not heat before applying.

Patients with goiter, thyroid nodules, or other non-acute thyroid diseases have a risk of developing hyperthyroidism with the administration of high doses 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, be aware of early symptoms of possible hyperthyroidism and, if necessary, control thyroid function.

Do not use before or after an iodine radioactive scan or treatment of thyroid cancer with radioactive iodine.

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

Children

Newborns and young children have a higher risk of developing hypothyroidism. If used in children, it is essential to monitor thyroid function.

Do not recommend use in children under one year.

Use of Betadine gel 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 mercurial derivatives, with silver, with hydrogen peroxide, or with taurolidina (antiseptics).

It is essential to avoid continuous use in patients undergoing simultaneous therapy with lithium (used in psychiatry).

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

Inform your doctor if:

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

Pregnancy, breastfeeding, and fertility

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

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

Its use may cause transient hypothyroidism in fetuses and newborns. It may be necessary to monitor thyroid function in children.

You should consult with your doctor about use in children between 1 and 2 years.

Driving and operating machinery

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

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

Skin use. After washing and drying, apply directly to the affected area 1 to 3 times a day. After application, it is recommended to cover the treated area with a gauze.

If you use more Betadine gel than you should

If 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.

Symptoms may include abdominal pain, anuria (suppression or decrease in urine), circulatory, respiratory, and metabolic problems. Excessive iodine may 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 skin 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, which manifests as 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, acute renal insufficiency, abnormal blood osmolarity, exfoliative dermatitis, dry skin, skin discoloration, 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 of Pharmacovigilance for Human Use Medications: 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.

No special storage conditions are required.Do not store at a temperature above 25C.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at 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.

Composition of Betadine gel

The active ingredient is povidone iodine. Each gram of gel contains 100 mg of povidone iodine.

The other components (excipients) are: macrogol 400, macrogol 4000, macrogol 6000 and purified water.

Appearance of the product and contents of the packaging

Brown-colored gel.

Available in 30 g and 100 g tubes.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

Netherlands

Responsible for manufacturing

MEDA Manufacturing, Bordeaux

Ave. 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 holder of the marketing authorization:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 Barcelona

Spain

Last review date of this leaflet:May 2022

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/