Betadine 100 mg/ml cutaneous solution

Patient Information Leaflet

Introduction

Patient Information Leaflet

Betadine 100 mg/ml cutaneous solution

Povidone iodine

Read the entire leaflet carefully before you start using this medicine, because 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 adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

• You should consult a doctor if you worsen or do not get better.

Leaflet Contents

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

1. What Betadine cutaneous solution is and what it is used for

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

Betadine is indicated as a general-purpose antiseptic for the skin, in minor wounds and superficial cuts, mild burns, or abrasions.

In the hospital setting, it is indicated as an antiseptic for the surgical field, puncture sites, minor wounds, mild burns, and surgical instruments.

2. What you need to know before using Betadine cutaneous solution

Do not use Betadine cutaneous solution

• 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 disorders.
• 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

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

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 preparation for surgery, avoid pooling underneath the patient. This may cause irritation and, rarely, severe skin reactions. Chemical burns of the skin may occur due to accumulation. 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 if prolonged use is required.

Children

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

Its use is not recommended in children under one year of age.

Use of Betadine cutaneous solution with other medicines

Inform your doctor or pharmacist if you are currently 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 receiving concurrent lithium therapy (used in psychiatry).

Transient dark discoloration of treated areas may occur when used concomitantly or after antiseptics containing octenidine.

Diagnostic test interference: the use of povidone-iodine may lead to errors in toluidine or guaiacol tests for detecting 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 are scheduled for 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 or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Use only if strictly indicated, and limit duration and extent of use to the absolute minimum. Avoid prolonged use.

Its use may cause transient hypothyroidism in fetuses and newborns. Monitoring of thyroid function in infants may be necessary.

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

Driving and use of machines

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

3. How to use Betadine cutaneous solution

Follow exactly the instructions for use of the medicine contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

For cutaneous use. Wash and dry the affected area before applying the product. Repeat 2 to 3 times daily.

If you use more Betadine cutaneous solution than you should

If an excessive amount of the product is applied and skin irritation occurs, wash the affected area thoroughly with 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 telephone number: 91 562 04 20, indicating the product and the amount ingested.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience 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 less than 1 in 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 with 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.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

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 Medicines (https://www.notificaram.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Betadine cutaneous solution

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

No special storage conditions are required.

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

Medicines should not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to a SIGRE collection point at your pharmacy. If you are unsure how to dispose of unused medicines or their packaging, please consult your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Betadine cutaneous solution

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

The other components (excipients) are: glycerol (E 422), lauryl ether of macrogol 9, disodium phosphate, citric acid monohydrate, sodium hydroxide (E 524), potassium iodate and purified water.

Appearance of the product and contents of the container

Brown-coloured solution.

It is presented in packs containing 1 high-density polyethylene bottle with a black cap and reducer, containing 50 ml, 125 ml or 500 ml of solution, and in a pack of 30 bottles of 500 ml (clinical pack).

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

The Netherlands

Manufacturer

MEDA Manufacturing, Bordeaux

Av. Pdt. J. F. Kennedy. BP 100

Merignac – Cedex

F-33700

France

For further information about this medicinal product, please contact 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: August 2022

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