Betadine

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Betadine

100 mg/ml, solution for skin

Povidone-iodine

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. See section 4.
• If you do not feel better or if you feel worse, you should contact your doctor.

Table of contents of the leaflet:

• 1. What is Betadine, 100 mg/ml, solution for skin, and what is it used for
• 2. Important information before using Betadine, 100 mg/ml, solution for skin
• 3. How to use Betadine, 100 mg/ml, solution for skin
• 4. Possible side effects
• 5. How to store Betadine, 100 mg/ml, solution for skin
• 6. Contents of the pack and other information.

1. What is Betadine, 100 mg/ml, solution for skin, and what is it used for

Betadine, 100 mg/ml, solution for skin - is intended exclusively for use on the skin. It acts on many microorganisms (bactericidal, fungicidal, and selectively virucidal). The medicine is indicated for skin disinfection before injection, blood sampling, needle biopsy, transfusion, for disinfection of skin and mucous membranes before surgical procedures, for aseptic wound dressing, treatment of bacterial and fungal infections, and complete and partial disinfection of the patient before surgery. If you do not feel better or if you feel worse, you should contact your doctor.

2. Important information before using Betadine, 100 mg/ml, solution for skin

When not to use Betadine, 100 mg/ml, solution for skin

• if you are allergic to iodine or povidone, or any of the other ingredients of this medicine (listed in section 6),
• if you have thyroid dysfunction (e.g., if your thyroid does not work properly),
• if you have herpetic skin lesions (Duhring's disease),
• if you have kidney failure,
• before, during, or after scintigraphy with radioiodine (a test in which radioactive iodine is administered) and before, during, or after treatment with radioiodine for thyroid diseases (see section "Warnings and precautions"),
• with mercury-containing medications, as concomitant use may damage the skin.

Betadine should not be used in newborns and infants before the age of 1 year, and its use is not recommended in children under 2 years of age.

Warnings and precautions

Before starting to use Betadine, 100 mg/ml, solution for skin, you should discuss it with your doctor or pharmacist. During preparation for surgery, you should avoid the accumulation of the medicine under the patient. Prolonged exposure to the medicine may cause irritation or, less frequently, severe skin reactions. Chemical burns of the skin may occur due to the accumulation of the solution. In case of skin irritation, contact dermatitis, or hypersensitivity to the medicine, you should stop using it. This medicine may temporarily discolor the skin at the application site, which is due to the inherent color of the medicine. Do not heat the medicine before application. The oxidizing properties of the medicine may cause corrosion of metals, while plastics and synthetic materials are generally resistant to povidone-iodine. There have been cases of reversible discoloration of certain textiles, e.g., clothing. The medicine can be easily removed from textiles and other materials using warm water and soap. In case of difficult-to-remove stains, you should use an ammonia solution or a sodium thiosulfate solution. Exposure to light and temperatures above 40°C accelerates the decomposition of the medicine. The medicine works at a pH range of 2.0-7.0. Avoid contact of the medicine with the eyes. If the medicine gets into the eyes, you should open the eyelids and rinse the eyes with a large amount of running water for 10-15 minutes. The patient should be examined by an ophthalmologist. Avoid contact with jewelry, especially those containing silver.

Children and adolescents

Betadine, 100 mg/ml, solution for skin, should not be used in newborns and infants before the age of 1 year, and its use is not recommended in children under 2 years of age.

Betadine, 100 mg/ml, solution for skin, and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

• Concomitant use of povidone-iodine with enzymatic medications for wound treatment may reduce the effectiveness of both medicines. Wound treatments containing hydrogen peroxide, silver, or taurolidine, as well as antiseptic agents, may interact with povidone-iodine and cause mutual weakening of the action of these medicines. You should not use this medicine with reducing substances, alkalines, tannic acid, salicylic acid, and silver or mercury salts, as well as taurolidine, hydrogen peroxide.
• The medicine should not be used concomitantly with mercury-containing medications due to the risk of forming a corrosive iodine-mercury compound (see section "When not to use Betadine, 100 mg/ml, solution for skin").
• Using the medicine before or after applying antiseptic medications containing octenidine may cause transient skin discoloration, so it should not be used concomitantly with these medicines.
• The povidone-iodine complex may react with protein and other unsaturated organic compounds, which will reduce its effectiveness.
• You should avoid prolonged use of this medicine, especially on large surfaces, in patients treated with lithium.

During the use of Betadine, various diagnostic measures may give false-positive laboratory test results (e.g., toluidine and guaiac tests for hemoglobin or glucose in stool and urine). Before laboratory tests, you should inform your doctor about the use of Betadine. The use of a medicine containing povidone-iodine may affect the results of some thyroid function tests (e.g., thyroid scintigraphy, determination of protein-bound iodine, or tests using radioactive iodine) or prevent the treatment of thyroid diseases with iodine (treatment with radioactive iodine). To obtain unbiased results, you should maintain a 4-week interval from treatment with Betadine before performing a new thyroid scintigram (see section "When not to use Betadine, 100 mg/ml, solution for skin").

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should ask your doctor for advice before using this medicine. During pregnancy and breastfeeding, the medicine should be used only if strictly necessary and under the direction of your doctor. If possible, the use of the medicine should be avoided due to the penetration of iodine contained in the medicine through the placenta and into breast milk. Due to the high sensitivity of the fetal and newborn thyroid to iodine, povidone-iodine may cause thyroid dysfunction in the fetus or newborn. There are limited data on fertility in humans for povidone-iodine. No data on fertility outcomes are available.

Driving and using machines

Betadine, 100 mg/ml, solution for skin, does not affect the ability to drive and use machines.

3. How to use Betadine, 100 mg/ml, solution for skin

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. In case of doubt, you should ask your doctor or pharmacist. Betadine, 100 mg/ml, solution for skin, is used either undiluted or as a 10% aqueous solution of the medicine (1:10 dilution) or 1% aqueous solution of the medicine (1:100 dilution), depending on the application site. The diluted solution should be prepared immediately before use. For skin disinfection before injection, blood sampling, needle biopsy, transfusion, or infusion, the medicine is applied to healthy, intact skin for 1-2 minutes. For aseptic wound dressing, disinfection of mucous membranes, and treatment of bacterial and fungal infections, you should use a 10% (1:10) solution of the medicine. For patient bathing before surgery, you should use a 1% (1:100) solution of the medicine, spreading it evenly over the entire body and leaving it on for at least 2 minutes, then rinsing with lukewarm water. During preparation for surgery, you should avoid the accumulation of the medicine under the patient. Prolonged exposure to the medicine may cause irritation or, less frequently, severe skin reactions. Chemical burns of the skin may occur due to the accumulation of the solution.

Use in children

Betadine, 100 mg/ml, solution for skin, should not be used in children before the age of 1 year, and its use is not recommended in children under 2 years of age (see section "When not to use Betadine, 100 mg/ml, solution for skin").

Use of a higher dose of the medicine than recommended:

Betadine, 100 mg/ml, solution for skin, is intended exclusively for use on the skin. When used in accordance with the information contained in the leaflet, there is no risk of overdose. In case of accidental ingestion and observation of the following symptoms of acute poisoning, you should contact a doctor or the hospital emergency department:

• abdominal symptoms,
• circulatory failure,
• metabolic disorders (including metabolic acidosis),
• renal dysfunction (including anuria),
• rapid heartbeat (tachycardia),
• low blood pressure (hypotension),
• breathing difficulties (laryngeal edema leading to asphyxia or pulmonary edema),
• seizures,
• fever,
• it may also cause hyperthyroidism or hypothyroidism.

In case of any further doubts regarding the use of this medicine, you should ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Rarely (may affect up to 1 in 1,000 people):

• Hypersensitivity reactions.

Very rarely (may affect up to 1 in 10,000 people):

• Anaphylactic reaction (a severe allergic reaction causing, among other things, difficulty breathing, dizziness, and decreased blood pressure).
• Angioedema (a severe allergic reaction causing swelling of the face or throat).

The following side effects have also been reported: Rarely (may affect up to 1 in 1,000 people):

• Skin inflammation (contact dermatitis) with symptoms such as redness, small blisters, and itching.

Very rarely (may affect up to 1 in 10,000 people):

• Hyperthyroidism (may cause increased appetite, weight loss, sweating, faster heartbeat, or restlessness in patients with thyroid disease).

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• Hypothyroidism (may cause, for example, fatigue, weight gain, slower heartbeat),
• Renal dysfunction,
• Chemical burns of the skin (may occur due to the accumulation of the medicine under the patient during preparation for surgery),

electrolyte disturbances (water-electrolyte imbalance),

• metabolic acidosis (decrease in blood pH due to the accumulation of acids in the body),
• acute renal failure,
• abnormal blood osmolality (amount of osmotically active substances in the blood),
• discoloration of the skin at the application site.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C, 02-222 Warsaw Tel.: +48 22 49 21 301 Fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl By reporting side effects, you can help provide more information on the safety of this medicine.

• 5. How to store Betadine, 100 mg/ml, solution for skin,

Do not store above 25°C. Shelf life after first opening the bottle: 3 months, stored at a temperature of 5°C - 15°C. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month. Keep out of the sight and reach of children. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

1 ml of the solution contains 100 mg of povidone-iodine and the following excipients: glycerol, nonoxynol-9, sodium phosphate, citric acid, sodium hydroxide, potassium iodide, water.

What Betadine 100 mg/ml, solution for skin, looks like and what the pack contains

The medicine is a solution with the color of iodine. Plastic bottle in a cardboard box. For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the country of export:

Lavipharm S.A. Agias Marinas 190 02 Peania, Attica Greece

Manufacturer:

Lavipharm S.A. Agias Marinas 190 02 Peania, Attica Greece

Parallel importer:

Medezin Sp. z o.o. ul. Zbąszyńska 3 91-342 Łódź

Repackaged by:

Medezin Sp. z o.o. ul. Zbąszyńska 3 91-342 Łódź Authorization number in Greece, the country of export: 44734/07/6-5-2008 Parallel import authorization number: 292/20

Date of leaflet approval: 02.07.2025

[Information about the trademark]