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 (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 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 speak to a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If you feel worse, you should contact your 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 pack 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, selectively virucidal and antiprotozoal).
The medicine is indicated for skin disinfection before injection, blood sampling, needle biopsy, transfusion, skin and mucous membrane disinfection before surgical procedures, for aseptic wound care, treatment of bacterial and fungal infections, and complete and partial disinfection of the patient before surgery.

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 you are allergic to iodine or povidone, or any of the other ingredients of this medicine (listed in section 6),
• if you have been diagnosed with hyperthyroidism or other overt thyroid disease,
• if you have herpes simplex skin infection (Duhring's disease),
• if you have kidney failure,
• before and after treatment of hyperthyroidism with radioactive iodine, or examination using radioactive iodine.

Warnings and precautions

Before starting to use the medicine, you should discuss it with your doctor or pharmacist.
In patients with latent thyroid function disorders (especially in the elderly), the use of this medicine for more than 14 days or on large areas of skin (more than 10% of the body surface) is only allowed if decided by a doctor, after careful consideration of the expected benefits and possible risks. In such cases, the doctor should monitor for early signs of hyperthyroidism and control thyroid function, even after stopping treatment (for up to 3 months).
During preparation for surgery, you should avoid the medicine accumulating under the patient. Prolonged exposure to the medicine may cause irritation or, less often, severe skin reactions. Chemical burns of the skin may occur due to the accumulation of fluid. In case of skin irritation, contact dermatitis, or hypersensitivity to the medicine, you should stop using it.
Do not heat the medicine before application. Store it in a place inaccessible to children.
Patients with thyroid nodules, goiter, or other non-toxic thyroid diseases are at risk of developing hyperthyroidism after administration of large amounts of iodine. In these patients, the medicine should not be used for a long time or on large areas of skin, unless decided by a doctor. The doctor should monitor for early signs of hyperthyroidism and control thyroid function.
You should exercise particular caution when using the medicine regularly in patients with pre-existing kidney failure.
You should avoid using the medicine in patients treated with lithium.
The use of the medicine may cause reduced absorption of iodine by the thyroid gland, which may disrupt the results of some tests and make it difficult to perform some tests (thyroid scintigraphy, determination of protein-bound iodine, diagnostic tests using radioactive iodine), and thus prevent planned treatment of thyroid diseases with radioactive iodine. After stopping the use of the medicine, you should not perform such tests for at least 1-4 weeks.
The oxidizing effect of the medicine may cause false-positive results in various diagnostic tests (e.g., toluidine and guaiac tests for hemoglobin and glucose in stool and urine).
The oxidizing properties of the medicine may cause corrosion of metals, while plastic and synthetic materials are generally resistant to iodinated povidone. There have been cases of reversible discoloration of some textile materials, e.g., clothing.
The medicine can be easily removed from textiles and other materials using warm water and soap. In case of stubborn stains, you can use an ammonia solution or a sodium thiosulfate solution.
The dark brown color of the medicine is an indicator of its effectiveness. If the color of the medicine becomes less intense, it indicates its weaker antimicrobial effect. Exposure to light and temperatures above 40°C accelerates the decomposition of the medicine. The medicine has antibacterial action at a pH range of 2-7.
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.

Children and adolescents

In newborns and infants up to 6 months of age, the medicine can only be used if decided by a doctor, in case of confirmed diagnosis and strict indications for the use of iodinated povidone. You should monitor thyroid function.
Newborns and infants up to 6 months of age are at risk of developing hypothyroidism after administration of large amounts of iodine. Therefore, in newborns and infants up to 6 months of age, the use of this medicine should be limited to the absolute minimum, due to significant penetration of the medicine through the skin into the body and increased sensitivity to iodine.
You should absolutely protect the child from swallowing the medicine.

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

You should tell your doctor or pharmacist about all medicines you are currently using or have recently used, as well as any medicines you plan to use.
Concomitant use of the medicine with hydrogen peroxide, enzymatic wound care products containing silver or taurolidine, and antiseptic agents may cause mutual weakening of the effects of these medicines.
The medicine should not be used concomitantly with mercury-containing medicines, due to the risk of forming a corrosive iodine-mercury compound.
If the medicine is applied to the same or adjacent skin area simultaneously or immediately after application of antiseptic agents containing octenidine, the medicine may cause transient skin discoloration.
Reactions with protein and unsaturated organic complexes may occur, which can be compensated by higher doses of this medicine (iodinated povidone).
You should avoid chronic use of the medicine, especially on large areas, in patients treated with lithium.
The medicine should not be used on the skin simultaneously with other medicines having reducing, acidic, or alkaloid properties.

Warning

Due to the oxidizing properties of this medicine, in the case of certain tests for detecting hidden blood in stool or detecting blood or glucose in urine, contamination with the medicine may give false-positive results.
During the use of the medicine, the absorption of iodine by the thyroid gland may decrease, which may disrupt the results of some diagnostic tests (e.g., thyroid scintigraphy, determination of protein-bound iodine, diagnostic tests using radioactive iodine) or prevent the treatment of thyroid diseases with radioactive iodine. To obtain unbiased results, you should maintain a sufficiently long time interval (1-4 weeks) between the end of the use of this medicine and thyroid scintigraphy.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before using this medicine.
Iodinated povidone has no teratogenic effect.
The use of the medicine during pregnancy and breastfeeding is only allowed if decided by a doctor, in case of accurate diagnosis and strict indications for the use of the medicine. You should monitor thyroid function in the mother and child.
The use of the medicine should be limited to a short period.
Iodine penetrates the placenta and into breast milk and reaches higher concentrations in breast milk than in blood.
You should absolutely protect the infant from swallowing the medicine.

Driving and using machines

The medicine has no effect on the ability to drive vehicles and operate machines.

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

This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist.
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 care, skin and 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 entire body of the patient and left on for at least 2 minutes, then rinsed with warm water.
During preparation for surgery, you should avoid the medicine accumulating under the patient. Prolonged exposure to the medicine may cause irritation or, less often, severe skin reactions. Chemical burns of the skin may occur due to the accumulation of fluid.

Use in children

In newborns and infants up to 6 months of age, the medicine can only be used if decided by a doctor, in case of confirmed diagnosis and strict indications for the use of this medicine.
You should monitor thyroid function.

Use of a higher dose of the medicine than recommended

In case of using higher doses than recommended, you should immediately contact your doctor.
After using very large amounts of the medicine, symptoms of poisoning may occur, such as anuria, circulatory collapse, laryngeal edema, absence of pulse or weak pulse, pulmonary edema, and metabolic disorders.
In case of swallowing the medicine, you should immediately contact your doctor or hospital.
If you have any further doubts about the use of this medicine, you should speak to your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare side effects (occurring in 1 to 10 in 10,000 people):
Hypersensitivity reactions, contact dermatitis (with symptoms such as redness, small blisters, and itching). If such symptoms occur, you should stop using the medicine and tell your doctor.
Very rare side effects (occurring in less than 1 in 10,000 people):
Anaphylactic reaction (a life-threatening allergic reaction causing, among other things, difficulty breathing, dizziness, and decreased blood pressure). If such symptoms occur, you should immediately stop using the medicine and tell your doctor.
Angioedema (a life-threatening allergic reaction causing swelling of the face or throat). If such symptoms occur, you should immediately stop using the medicine and tell your doctor.
Hyperthyroidism (excessive thyroid activity causing, among other things, increased appetite, weight loss, sweating, faster heart rate, or restlessness.
Side effects with unknown frequency (cannot be estimated from the available data):
Hypothyroidism after prolonged or more intense use of the medicine.
Kidney function disorders.
Chemical burns of the skin (may occur due to the accumulation of the medicine under the patient during preparation for surgery); electrolyte disturbances, metabolic acidosis, acute kidney failure, and abnormal blood osmolality (may occur after using large amounts of the medicine).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 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.
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.
Store in a place out of 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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

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

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

The medicine is a solution with a iodine color.
A plastic bottle containing 30 ml of the medicine, in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Greece, the country of export:

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

Manufacturer:

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

Parallel importer:

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

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56 Street
02-234 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
Tymiankowa 24/28 Street
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
Beskidzka 190 Street
91-610 Łódź
Marketing authorization number in Greece, the country of export: 44734/07/6-5-2008
28328/92/10-05-1995
Parallel import authorization number: 80/23
Date of leaflet approval: 10.05.2023
[Information about the trademark]