Betadine 100 mg/g gel

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Betadine Gel 100 mg/g gel

Povidone iodine

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those given 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 any 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 condition worsens or does not improve.

Contents of the leaflet

1. What Betadine Gel is and what it is used for.
2. What you need to know before using Betadine Gel.
3. How to use Betadine Gel.
4. Possible side effects.
5. How to store Betadine Gel.
6. Contents of the pack and other information.

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

Povidone iodine, the active substance in this medicine, is an antiseptic (which destroys germs that cause infections) containing iodine.

Betadine gel is indicated as a general antiseptic for skin use, in cases of minor wounds and superficial cuts, mild burns, or abrasions.

2. What you need to know before using Betadine gel

Do not use Betadine gel

• If you are allergic to povidone iodine or to any of the other ingredients of this medicine (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 may damage the skin.
• In children under one year of age.

Warnings and precautions

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

For 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 preoperative preparation, avoid pooling underneath the patient. This may cause irritation and, rarely, severe skin reactions. Chemical skin burns may occur due to pooling. In such cases, discontinue use. Do not heat before application.

Patients with goiter, thyroid nodules, or other non-acute thyroid diseases are at risk of developing hyperthyroidism when exposed to high amounts of iodine. In these patients, prolonged application over large skin areas should be avoided unless strictly indicated. Even after treatment ends, early signs of possible hyperthyroidism should be monitored, and thyroid function should be checked if necessary.

Do not use before or after radioactive iodine scintigraphy or treatment of thyroid carcinoma with radioactive iodine.

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

Children

Newborns and young children are at higher risk of developing hypothyroidism. Thyroid monitoring is important if used in children.

Use in children under one year of age is not recommended.

Use of Betadine gel with other medicines

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

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

Prolonged use should be avoided in patients undergoing simultaneous lithium therapy (used in psychiatry).

When used concurrently or after antiseptics containing octenidine, transient dark discoloration of the affected areas may occur.

Interaction with diagnostic tests: the use of povidone iodine may lead to errors in tests using toluidine or guaiacol to detect hemoglobin or glucose in feces or urine. It may also interfere with thyroid function tests and treatments involving radioactive iodine.

Inform your doctor if you need to undergo any diagnostic testing.

Inform your doctor if:

• Symptoms do not improve or worsen
• You have received treatment with radioactive iodine within the last 4 weeks
• You experience allergy or skin irritation such as redness, small blisters, itching, or rash, which may appear immediately.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Use only if strictly indicated, and limit use to the absolute minimum. Avoid prolonged or repeated use.

Its use could cause transient hypothyroidism in fetuses and newborns. Thyroid monitoring in infants may be necessary.

Consult your doctor regarding use in children between 1 and 2 years of age.

Driving and using machines

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

3. How to use Betadine gel

Follow exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse. In case of doubt, consult your doctor, pharmacist, or nurse.

For external use only. After washing and drying, apply directly to the affected area 1 to 3 times daily. After application, it is advisable to cover the treated area with 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 thoroughly with abundant water, discontinue treatment, and if irritation persists, consult a doctor.

Symptoms may include abdominal pain, anuria (suppression or reduction of urine), circulatory, respiratory, and metabolic problems. Excess iodine may cause goiter, hypothyroidism, and hyperthyroidism.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

Rare adverse 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 rarely (may affect fewer than 1 in every 10,000 people), anaphylactic reactions (severe allergic reaction), hyperthyroidism with tachycardia and agitation, and angioedema (swelling caused by allergy) have been observed.

Other adverse effects of unknown frequency include hypothyroidism, electrolyte imbalance, metabolic acidosis, acute renal failure, abnormal blood osmolarity, exfoliative dermatitis, dry skin, skin discoloration, and chemical burn on the skin.

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Betadine gel

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

Do not store above 25°C.

Do not use this medicine after the expiry date indicated on the packaging after EXP. The expiry date refers to the last day of the month shown.

Dispose of the tube with any remaining gel 6 months after first opening.

Medicines should not be disposed of via wastewater drains or household waste. Return unused medicines and their containers to your pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and additional information

Composition of Betadine gel

The active substance 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 package

Brown-colored gel.

It is available in 30 g and 100 g tubes.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Meda Pharma, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

Manufacturer

MEDA Manufacturing, Bordeaux

Ave. Pres. J. F. Kennedy. BP 100

Merignac – Cedex

F-33700

France

You can request further information about this medicinal product 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 most recent review of this leaflet: January 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/