BETADINE UNIDOSIS 1.000 mg CUTANEOUS SOLUTION IN SINGLE-DOSE PACKAGING

1. What Betadine single-dose is and what it is used for

Povidone-iodine, the active ingredient of this medication, 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 single-dose

Do not use Betadine single-dose

• 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 single-dose.

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, it is necessary to be alert to early symptoms of possible hyperthyroidism and, if necessary, to monitor 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 greater risk of developing hypothyroidism. If used in children, it is essential to monitor the thyroid.

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

Using Betadine single-dose 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 at the same time 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 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 cause 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 of age.

Driving and using machines

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

3. How to use Betadine single-dose

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor, pharmacist, or nurse.

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

After use, discard any remaining liquid.

If you use more Betadine single-dose than you should

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

Symptoms could 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 used.

If you have any other questions 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 (affecting 1 to 10 in every 10,000 people) are hypersensitivity and contact dermatitis, which manifests as red skin, small blisters, and itching.

Very rare side effects (affecting less than 1 in every 10,000 people) include anaphylactic reactions (severe allergic reaction), hyperthyroidism with tachycardia and agitation, and angioedema (swelling caused by allergy).

Other side effects of unknown frequency have been hypothyroidism, electrolyte imbalance, metabolic acidosis, acute kidney 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 leaflet, inform your doctor or pharmacist.

Reporting side effectsIf 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 leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use (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 single-dose

Keep this medication out of sight and reach of children.

Do not store at a temperature above 30°C.

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 thrown down the drain or into the trash. Deposit the packaging and any unused medications at the SIGRE 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 single-dose per single-dose package of 10 ml

The active ingredient is povidone-iodine 1,000 mg.

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 package contents

Brown-colored solution.

It is presented in high-density polyethylene packages, with 5 single-dose packages of 10 ml and 50 single-dose packages of 10 ml (clinical packaging).

Only some package sizes 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

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 leaflet:June 2020

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/