Betadine Unidosis 500 mg cutaneous solution in single-dose container

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Betadine single-dose 500 mg cutaneous solution in single-dose container

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 administering this medicine provided in this leaflet or as directed 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 effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve.

Contents of the leaflet

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

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

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

Betadine is indicated as a general-purpose antiseptic for the skin, for 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 single-dose

Do not use Betadine single-dose

• If you are allergic to povidone-iodine or to any of the other components of this medicine (listed in section 6).
• If you have hyperthyroidism or other acute thyroid diseases.
• Before, during, and after administration of radioactive iodine.
• With mercury-containing products 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 single-dose.

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 as preoperative preparation, avoid pooling underneath the patient. This may cause irritation and, rarely, severe skin reactions. Chemical burns of the skin may occur due to pooling. 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, Betadine should not be applied for prolonged periods or over large skin areas unless strictly indicated. Even after treatment ends, early signs of possible hyperthyroidism should be monitored, and, if necessary, thyroid function should be checked.

Do not use before or after radioactive iodine scintigraphy or radioactive iodine treatment for thyroid carcinoma.

Thyroid function tests should be performed if prolonged use is necessary.

Children

Newborn infants and young children are at higher risk of developing hypothyroidism. If used in children, thyroid function must be monitored.

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

Use of single-dose Betadine with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicinal products.

Do not use with mercurial compounds, silver compounds, hydrogen peroxide, or taurolidine (antiseptics).

Prolonged use should be avoided in patients receiving concomitant lithium therapy (used in psychiatry).

When used simultaneously or after antiseptics containing octenidine, transient dark discoloration of the affected areas may occur.

Interaction with diagnostic tests: 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 with radioactive iodine.

Inform your doctor if you are scheduled to undergo 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 have an allergy or skin irritation such as redness, small blisters, itching, or rash, which could appear immediately.

Pregnancy, breastfeeding, and fertility

If you are pregnant, 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 keep usage to the absolute minimum. Avoid prolonged use.

Its use could cause transient hypothyroidism in fetuses and newborns. Thyroid monitoring in children 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 single-dose

Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor, pharmacist, or nurse. In case of doubt, consult your doctor, pharmacist, or nurse.

For topical use only. 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

If an excessive amount of the product is applied and skin irritation occurs, wash the affected area thoroughly with plenty of 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 used.

If you have any further questions about the use of this medicine, ask 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, stop treatment and wash the affected area with water.

Rare adverse 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 fewer than 1 out of 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 Medicinal Products (https: www.notificaram.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Betadine single-dose

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Betadine single-dose container of 5 ml

The active substance is povidone-iodine 500 mg.

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

Appearance of the product and contents of the pack

Brown-colored solution.

Presented in high-density polyethylene containers, with 10 single-dose units of 5 ml.

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

Further information about this medicinal product can be obtained from 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 revision of this leaflet: June 2020

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