Label: information for the user

Betadine single-dose 1,000 mg topical solution in single-dose packaging

povidone-iodine

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

Follow exactly the administration instructions for the medication contained in this label or those indicated by your doctor, pharmacist, or nurse.

-Keep this label, as you may need to refer to it again.

-If you need advice or more information, consult your pharmacist.

-If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

-You should consult a doctor if your condition worsens or does not improve.

The povidone iodide, active principle of this medication, is an antiseptic (that destroys the germs that produce infections) that contains iodine.

Betadine is indicated as a skin antisepsis agentfor general use, in small wounds and superficial cuts, light burns or abrasions.

In the hospital setting, indicated as an antiseptic for the operating field, puncture sites, small wounds, light burns, and surgical materials.

No use Betadine unidosis

• 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 administration of radioactive iodine
• With products containing mercury due to the formation of a substance that can damage the skin.
• In children under one year.

Advertencias y precauciones

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

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

Patients with goiter, thyroid nodules, or other non-acute thyroid diseases have a risk of developing hyperthyroidism with the administration of high doses of iodine. In these patients, do not apply for prolonged periods of time and in extensive areas of skin unless strictly indicated. Even at the end of treatment, be aware of early symptoms of possible hyperthyroidism and, if necessary, control thyroid function.

Do not use before or after radioactive iodine scanning or treatment of thyroid cancer with radioactive iodine.

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

Children

Newborns and young children have a higher risk of developing hypothyroidism. If used in children, it is essential to monitor thyroid function.

Do not recommend use inchildren under one year

Use of Betadine unidosis with other medications

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

Do not use with mercury derivatives, with silver, with hydrogen peroxide, or with taurolidina (antiseptics).

It is essential to avoid continuous use in patients undergoing simultaneous therapy with lithium (used in psychiatry).

When used at the same time or after antiseptics with octenidine, dark transitory 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 type of diagnostic test.

Inform your doctor if:

• Symptoms do not improve or worsen
• You have received treatments with radioactive iodine 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, lactation, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Use only if strictly indicated, and maintain use to the absolute minimum. Avoid continuous use.

Use may cause transient hypothyroidism in fetuses and newborns. It may benecessary to monitor thyroid function in children.

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

Driving and operating machinery

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

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

Skin use.Clean 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 caseof applying an excessive amount of product and skin irritation occurs, wash the affected area with plenty of water, discontinue treatment, and if irritation continues, consult a doctor.

The symptoms may be abdominal pain, anuria (suppression or decrease in urine), circulatory, respiratory, and metabolic problems. Excessive iodine may cause goiter, hypothyroidism, and hyperthyroidism.

In case of accidental ingestion, visit a medical center or call the Toxicological 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.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Rare adverse effects (may affect between 1 and 10 of every 10,000 people) are hypersensitivity and contact dermatitis that manifest with red skin, small blisters, and itching.

Very rarely (may affect fewer than 1 of every 10,000 people), severe allergic reactions (anaphylaxis), hyperthyroidism with tachycardia and agitation, and angioedema (allergic swelling) have been observed.

Other adverse effects of unknown frequency have been hypothyroidism, electrolyte imbalance, metabolic acidosis, acute renal insufficiency, abnormal blood osmolarity, exfoliative dermatitis, dry skin, skin discoloration, and chemical burns on the skin.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse EffectsIf 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use (https: www.notificaram.es). By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date that appears 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 drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Betadine single-dose vial 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 contents of the packaging

Brown-colored solution.

Presented in high-density polyethylene containers, with 5 single-dose vials of 10 ml and 50 single-dose vials of 10 ml (clinical container).

Only some container sizes may be commercially available.

Holder of the marketing authorization andresponsible for manufacturing

Holder of the marketing authorization

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

Netherlands

Responsible for manufacturing

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 holder of the marketing authorization:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 Barcelona

Spain

Last review date of this leaflet:June 2020

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.es/