Betadine

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

BETADINE

100 mg/ml (10%), solution for the 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 a doctor or pharmacist.

• The 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 side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

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

BETADINE, 100 mg/ml, solution for the skin - is intended 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, for skin and mucous membrane disinfection before surgical procedures, for aseptic wound dressing, treatment of bacterial and fungal infections, and complete and partial disinfection of the patient before surgery.
If there is no improvement or the patient feels worse, they should contact their doctor.

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

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

• 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 dysfunction (e.g., if the patient's thyroid does not work properly),
• if the patient has herpetic skin inflammation (Duhring's disease),
• if the patient has kidney failure,
• before or during scintigraphy with radioiodine or treatment of thyroid cancer with radioiodine. Before and during treatment of thyroid cancer with radioiodine or scintigraphy with radioactive iodine, an appropriate time interval of at least 1-2 weeks should be maintained between the last exposure to povidone-iodine and such procedures,
• with mercury-containing medicines, as concomitant use may damage the skin.

Page 1 6
BETADINE medicine 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 the skin, the patient should discuss it with their doctor or pharmacist.
During preparation for surgery, the 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 as a result of the accumulation of the solution. In case of skin irritation, contact dermatitis, or hypersensitivity to the medicine, its use should be discontinued.
The medicine should not be heated 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, such as 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.
Eye contact with the medicine should be avoided. If the medicine gets into the eyes, the eyelids should be opened and the eyes should be rinsed 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, solution for the 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 the skin, and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• Concomitant use of povidone-iodine with enzymatic medicines for wound treatment may reduce the effectiveness of both medicines. Wound treatment medicines 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. This medicine should not be used with reducing substances, alkalies, tannic acid, salicylic acid, and silver or 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, solution for the skin").
• Using the medicine before or after applying 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, which will reduce its effectiveness.

Page 2 6

• Chronic use of this medicine should be avoided, especially on large surfaces, in patients treated with lithium.

During the use of BETADINE medicine, 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, the doctor should be informed about the use of BETADINE medicine.
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, tests using radioactive iodine) or make it impossible to treat thyroid diseases with iodine (treatment with radioactive iodine).
To obtain unbiased results, an appropriate time interval (at least 1-2 weeks) should be maintained between the end of the use of this medicine and thyroid scintigraphy (see section "When not to use BETADINE, 100 mg/ml, solution for the skin").

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
In pregnancy and breastfeeding, the medicine should be used only when strictly indicated and prescribed by the attending physician. 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.

Driving and using machines

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

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

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted.
BETADINE, 100 mg/ml, solution for the 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.
In skin disinfection before injection, blood sampling, needle biopsy, transfusion, or infusion, the medicine is applied to healthy, intact skin for 1-2 minutes.
In the case of aseptic wound dressing, mucous membrane disinfection, and treatment of bacterial and fungal infections, a 10% (1:10) solution of the medicine should be used.
In the case of 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, the 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 as a result of the accumulation of the solution.

Use in children

Page 3 6
BETADINE, 100 mg/ml, solution for the 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 the skin").

Use of a higher than recommended dose of the medicine:

BETADINE, 100 mg/ml, solution for the skin, is intended for use on the skin only.
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, the patient should consult a doctor or go to the hospital emergency department:

• 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 related to the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

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, among other things, 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):

• Skin inflammation (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 of unknown frequency (frequency cannot be estimated from the available data):

• Hypothyroidism (may cause, for example, fatigue, weight gain, slower heartbeat),
• Renal function disorders,
• Chemical burns of the skin (may occur as a result of the accumulation of the medicine under the patient during preparation for surgery),
• Electrolyte disorders (water-electrolyte imbalance),
• Metabolic acidosis (decrease in blood pH due to the accumulation of acids in the body),

Page 4 6

• Acute renal failure,
• Abnormal blood osmolality (amount of osmotically active substances in the blood).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects can help gather more information on the safety of the medicine

5. How to store BETADINE, 100 mg/ml, solution for the 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.
Store in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging 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, nonoxynol 9, citric acid, sodium phosphate, sodium hydroxide, water, potassium iodide.

What BETADINE, 100 mg/ml, solution for the skin looks like and what the packaging contains

The medicine is a solution with the color of iodine.
A white plastic bottle with a dropper and a white cap in a cardboard box.
The packaging contains 30 ml of the solution.
For more detailed information, the marketing authorization holder or parallel importer should be consulted.

Marketing authorization holder in Greece, the country of export:

Lavipharm S.A.
Agias Marinas
19002 Peania Attica
Greece

Manufacturer:

Lavipharm S.A.
Agias Marinas
19002 Peania Attica
Page 5 6
Greece

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in Greece, the country of export: 44734/07/6-5-2008
28328/92/10-05-1995

Parallel import authorization number: 244/10

Date of leaflet approval: 26.06.2024

[Information about the trademark]
Page 6 6