Betadine

Package Leaflet: Information for the User

Betadine, 100 mg/ml, Skin Solution

Povidone Iodine

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

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

• The package leaflet should be kept in case it needs to be read again.
• -If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any not listed in the package leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse, a doctor should be consulted.

Package Leaflet Contents:

• 1. What is Betadine, 100 mg/ml, Skin Solution and what is it used for
• 2. Important information before using Betadine, 100 mg/ml, Skin Solution
• 3. How to use Betadine, 100 mg/ml, Skin Solution
• 4. Possible side effects
• 5. How to store Betadine, 100 mg/ml, Skin Solution
• 6. Package contents and other information.

1. What is Betadine, 100 mg/ml, Skin Solution and what is it used for

Betadine, 100 mg/ml, Skin Solution is for use on the skin only. It acts on many microorganisms (bactericidal, fungicidal, and selectively virucidal). The medicine is indicated for skin disinfection before injection, blood sampling, needle biopsy, transfusion, skin and mucous membrane disinfection before surgical procedures, aseptic wound dressing, treatment of bacterial and fungal infections, and total and partial disinfection of the patient before surgery. If there is no improvement or the patient feels worse, a doctor should be consulted.

2. Important information before using Betadine, 100 mg/ml, Skin Solution

When not to use Betadine, 100 mg/ml, Skin Solution

• if the patient is allergic to iodine or povidone, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has thyroid disorders (e.g., if the patient's thyroid does not work properly),
• if the patient has herpetic skin lesions (Duhring's disease),
• if the patient has 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 medicines, 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, Skin Solution, the doctor or pharmacist should be consulted. During preparation for surgery, accumulation of the medicine under the patient should be avoided. Prolonged exposure to the medicine may cause irritation or, less frequently, severe skin reactions. Chemical burns of the skin may occur due to accumulation of the solution. In case of skin irritation, contact dermatitis, or hypersensitivity to the medicine, its use should be discontinued. This medicine may temporarily discolor the skin at the application site, due to the color of the medicine itself. The medicine should not be heated before application. The oxidizing properties of the medicine may cause corrosion of metals, while plastic 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, an ammonia solution or a sodium thiosulfate solution should be used. 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. Contact with the eyes should be avoided. If the medicine gets into the eyes, the eyelids should be opened and the eyes flushed with a large amount of running water for 10-15 minutes. The patient should be examined by an ophthalmologist. Contact with jewelry, especially silver, should be avoided.

Children and adolescents

Betadine, 100 mg/ml, Skin Solution 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, Skin Solution and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

• Concomitant use of povidone iodine with enzymatic wound care medicines may reduce the effectiveness of both medicines. Wound care medicines containing hydrogen peroxide, silver, or taurolidine, as well as antiseptic agents, may interact with povidone iodine and cause mutual weakening of the effects of these medicines. This medicine should not be used with reducing substances, alkalines, tannic acid, salicylic acid, or silver and mercury salts, taurolidine, hydrogen peroxide.
• The medicine should not be used concomitantly with mercury-containing medicines, due to the risk of forming a corrosive iodine-mercury compound (see section "When not to use Betadine, 100 mg/ml, Skin Solution").
• Using the medicine before or after application of antiseptic medicines 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, leading to a reduction in its effectiveness.
• Chronic use of this medicine, especially on large surfaces, should be avoided in patients treated with lithium.

During use of Betadine, various diagnostic tests may yield false-positive laboratory test results (e.g., toluidine and guaiac tests for hemoglobin or glucose in stool and urine). Before laboratory tests, the doctor should be informed about the use of Betadine. 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 treatment of thyroid diseases with iodine (treatment with radioactive iodine). To obtain unbiased results, a 4-week break from Betadine treatment should be maintained before performing a new thyroid scintigram (see section "When not to use Betadine, 100 mg/ml, Skin Solution").

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor before using this medicine. During pregnancy and breastfeeding, the medicine should be used only if strictly necessary and under the direction of a doctor. If possible, use of the medicine should be avoided due to the passage of iodine 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 disorders 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, Skin Solution does not affect the ability to drive or use machines.

3. How to use Betadine, 100 mg/ml, Skin Solution

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted. Betadine, 100 mg/ml, Skin Solution is for use on the skin only. It can be used undiluted or as a 10% aqueous solution (1:10 dilution) or 1% aqueous solution (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, mucous membrane disinfection, and treatment of bacterial and fungal infections, a 10% (1:10) solution of the medicine should be used. For patient bathing before surgery, a 1% (1:100) solution of the medicine should be used, with the diluted solution evenly distributed over the patient's entire body and left on for at least 2 minutes, then rinsed with lukewarm water. During preparation for surgery, accumulation of the medicine under the patient should be avoided. Prolonged exposure to the medicine may cause irritation or, less frequently, severe skin reactions. Chemical burns of the skin may occur due to accumulation of the solution.

Use in children

Betadine, 100 mg/ml, Skin Solution 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, Skin Solution"). Use of a higher than recommended dose of the medicine: Betadine, 100 mg/ml, Skin Solution is for use on the skin only. When used as directed in the package leaflet, there is no risk of overdose. In case of accidental ingestion and observation of the following symptoms of acute poisoning, a doctor or hospital emergency department should be consulted:

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

In case of any further doubts about the use of this medicine, a doctor, pharmacist, or nurse should be consulted.

4. Possible side effects

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

• Hypersensitivity reactions

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

• Anaphylactic reaction (a severe allergic reaction that can cause difficulty breathing, dizziness, and decreased blood pressure).
• Angioedema (a severe allergic reaction that can cause swelling of the face or throat).

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

• Contact dermatitis (with symptoms such as redness, small blisters, and itching).

Very rare (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 fatigue, weight gain, slower heartbeat),
• Renal function disorders,
• Chemical burns of the skin (may occur due to accumulation of the medicine under the patient during preparation for surgery),
• Electrolyte disorders (water-electrolyte imbalance),
• Metabolic acidosis (decrease in blood pH due to 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 side effects occur, including any not listed in the package leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

• 5. How to store Betadine, 100 mg/ml, Skin Solution, Store in a temperature below 25°C. Store in the original package to protect from light. Shelf life after first opening of 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 package. The expiry date refers to the last day of the month stated. Store in a place out of sight and reach of children. Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Package contents and other information

The active substance of the medicine is povidone iodine. Each ml of the solution contains 100 mg of povidone iodine. The other excipients are: glycerol 85%, nonoxynol 9, citric acid anhydrous, disodium phosphate anhydrous, sodium hydroxide, purified water.

What Betadine, 100 mg/ml, Skin Solution looks like and what the package contains

The medicine is a iodine-colored solution. A green polyethylene bottle with a dropper and a white polypropylene cap, containing 30 ml or 120 ml of the medicine, in a cardboard box. A green polyethylene bottle with a dropper and a white polypropylene cap, containing 1000 ml of the medicine.

Marketing authorization holder

Egis Pharmaceuticals PLC, Keresztúri út 30-38, 1106 Budapest, Hungary

Manufacturer

Egis Pharmaceuticals PLC, Lacta Factory, Mátyás király u. 65, 9900 Körmend, Hungary For more detailed information on this medicine, the representative of the marketing authorization holder should be contacted: EGIS Polska Sp. z o.o., ul. Komitetu Obrony Robotników 45D, 02-146 Warsaw, Phone: +48 22 417 92 00

Date of last revision of the package leaflet: