BETADINE 100 mg/ml CUTANEOUS SOLUTION

Introduction

Package Leaflet: Information for the User

Betadine 100 mg/ml Cutaneous Solution

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 side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve.

Contents of the Package Leaflet

1. What Betadine cutaneous solution is and what it is used for.
2. What you need to know before starting to use Betadine cutaneous solution.
3. How to use Betadine cutaneous solution.
4. Possible side effects.
5. Storage of Betadine cutaneous solution.
6. Contents of the packaging and additional information.

1. What Betadine Cutaneous Solution is and What it is Used For

The active ingredient of this medication, povidone iodine, is an antiseptic (which destroys germs that cause infections) that contains iodine.

Betadine is indicated as a general skin antiseptic, for small wounds and superficial cuts, minor burns, or abrasions.

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

2. What You Need to Know Before Starting to Use Betadine Cutaneous Solution

Do Not Use Betadine Cutaneous Solution

• 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 that contain 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 cutaneous solution.

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 to the skin can occur due to accumulation. In that 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 prolonged periods or to extensive skin areas unless strictly indicated. Even at the end of treatment, be alert to early symptoms of possible hyperthyroidism, and if necessary, monitor thyroid function.

It should not be used before or after radioactive iodine scintigraphy 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 greater 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.

Using Betadine Cutaneous Solution 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 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 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 produce transient hypothyroidism in fetuses and newborns. Thyroid monitoring may be necessary in children.

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

Driving and Using Machines

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

3. How to Use Betadine Cutaneous Solution

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. Wash and dry the affected area before applying the product. Repeat 2 to 3 times a day.

If You Use More Betadine Cutaneous Solution Than You Should

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

Symptoms could be abdominal pain, anuria (suppression or reduction of 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 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 skin irritation or allergy occurs, discontinue treatment and wash the affected area with water.

Rare side effects (may affect between 1 and 10 out of 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 side effects of unknown frequency have been hypothyroidism, electrolyte imbalance, metabolic acidosis, acute renal failure, abnormal blood osmolarity, exfoliative dermatitis, dry skin, skin discoloration, and chemical burns to the skin.

If you consider any of the side effects you are experiencing to be serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting Side Effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect 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 Cutaneous Solution

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown 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 the 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. Contents of the Packaging and Additional Information

Composition of Betadine Cutaneous Solution

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

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

Appearance of the Product and Contents of the Packaging

Brown-colored solution.

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

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:August 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/