Betadine Unidosis 1,000 mg cutaneous solution in single-dose container

Patient Information Leaflet

Introduction

Patient Information Leaflet

Betadine single-dose 1,000 mg cutaneous solution in single-dose container

povidone iodine

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

Follow exactly the instructions for taking this medicine provided in this leaflet or those given 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 you worsen or do 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. Storage of Betadine single-dose.
6. Contents of the pack and additional information.

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

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

Betadine is indicated as a general-purpose skin antiseptic 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 products containing mercury 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 using 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 to 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 thyroid function should be checked if necessary.

This product should not be used before or after radioactive iodine scans or treatment of thyroid carcinoma with radioactive iodine.

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

Children

Newborns and young children are at higher risk of developing hypothyroidism. If used in children, it is important to monitor thyroid function.

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

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Use of Betadine single-dose with other medicines

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

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

Prolonged use should be avoided in patients undergoing 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 blue or guaiac tests for detecting hemoglobin or glucose in feces or urine. It may also interfere with thyroid function tests and treatments involving radioactive iodine.

Inform your doctor if you are scheduled to undergo any diagnostic testing.

Also inform your doctor if:

• Symptoms do not improve or worsen
• You have received treatment with radioactive iodine within the last 4 weeks
• You experience allergy or skin irritation such as redness, small blisters, itching, or rash, which may appear immediately.

Pregnancy, lactation and fertility

If you are pregnant or 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; its use should be kept to the absolute minimum. Avoid prolonged use.

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

You should 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 use provided in this leaflet or those indicated by your doctor, pharmacist, or nurse. If in 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 daily.

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 abundant 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, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse 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 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 effect 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 can 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 CAD or EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or in household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Betadine single-dose container, 10 ml

The active substance is povidone iodine 1,000 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-coloured solution.

It is presented in high-density polyethylene single-dose containers, available in packs of 5 units of 10 ml and 50 units of 10 ml (clinical pack).

Only certain pack sizes may be marketed.

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

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 Barcelona

Spain

Date of most recent review of this leaflet: June 2020

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