BETADINE 350 MG IMPREGNATED DRESSING

Introduction

Package Leaflet: Information for the User

Betadine 350 mg Impregnated Dressing

Povidone-Iodine

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

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

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve.

Package Leaflet Contents

1. What Betadine is and what it is used for.
2. What you need to know before starting to use Betadine.
3. How to use Betadine.
4. Possible side effects.
5. Storage of Betadine.
6. Package Contents and Additional Information.

1. What Betadine is and what it is used for

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

Betadine impregnated dressing is indicated for general skin disinfection, small wounds and superficial cuts, minor burns, and abrasions.

In the hospital setting, it is indicated as an antiseptic in puncture areas.

2. What you need to know before starting to use Betadine impregnated dressing

Do not use Betadine impregnated dressing

• 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 30 months.

Warnings and Precautions

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

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

Patients 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 extended periods or to large areas of skin unless strictly indicated. Even after treatment, it is essential to monitor for 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.

Children

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

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

The use in children under 30 months should be evaluated by a doctor.

Using Betadine impregnated dressing 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 simultaneously or after antiseptics with octenidine, transient dark discoloration of the affected 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 radioactive iodine treatments. 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; use should be kept to a minimum. Avoid continuous use.

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

Driving and Using Machines

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

3. How to use Betadine impregnated dressing

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.

Dosage

Wash your hands thoroughly. Wash and dry the affected area before applying the product. Open the bag and remove the dressing. Clean the affected area carefully with the dressing. Discard the dressing and let the affected area dry completely.

Do not use for more than 5 days or on large areas of skin without consulting your doctor first.

Method of Administration

For cutaneous use

If you use more Betadine impregnated dressing than you should

In case of excessive application of the product and skin irritation, wash the affected area with plenty of water, discontinue treatment, and if irritation persists, consult a doctor.

Symptoms may include abdominal pain, anuria (suppression or decreased urine output), 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 further questions on the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

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

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

Rare side effects (may affect between 1 and 10 in 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 10,000 people) include anaphylactic reactions (severe allergic reaction), hyperthyroidism with tachycardia and agitation, and angioedema (allergic swelling).

Other side effects of unknown frequency include hypothyroidism, exfoliative dermatitis, dry skin, skin discoloration (reversible, removed with water), and chemical burns on the skin.

In case of use on large areas of skin and in severely burned patients, problems related to renal function may be observed: electrolyte imbalance, metabolic acidosis, pneumonitis (aspiration complications - see "Warnings and Precautions" section), acute renal failure, abnormal blood osmolarity,

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: 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 impregnated dressing

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

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

No special storage conditions are required. Do not store the opened package.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Betadine impregnated dressing

The active ingredient is povidone-iodine 350 mg per impregnated dressing.

The other ingredients (excipients) are: lauryl ether macrogol, disodium phosphate dihydrate, citric acid monohydrate, sodium hydroxide, potassium iodate, purified water.

The composition of the dressing: non-woven viscose/polyester (0.8 g).

Appearance of the Product and Package Contents

This medication is in the form of an impregnated dressing, folded several times onto itself, impregnated with a brown-colored solution.

This medication is available in boxes of 1, 6, and 50 dressings, one dressing per package (paper polyinerte-aluminum-polyamide).

Not all presentations may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

Netherlands

Manufacturer

MEDA Manufacturing, Bordeaux (France)

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, 5ª planta

08011 Barcelona

Spain

Date of the Last Revision of this Package Leaflet:August 2023

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