Betadine

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Betadine

100 mg/ml (10%), solution for the skin
Povidone-iodine

Table of contents:

• 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. Package contents 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.
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 total 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

• 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.

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

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 the doctor, after careful consideration of the expected benefits and possible risks. In such cases, the doctor should monitor whether the patient does not develop early symptoms of hyperthyroidism and control thyroid function, even after discontinuation of treatment (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 as a result of the accumulation of fluid.
In case of skin irritation, contact dermatitis, or hypersensitivity to the medicine, you should discontinue its use.
Do not heat the medicine before application. Store in a place inaccessible to children.
Patients with thyroid nodules, thyroid 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 the doctor decides to use the medicine.
The doctor should monitor whether the patient has developed early symptoms of hyperthyroidism and control thyroid function.
Particular caution should be exercised when regularly using the medicine in patients with pre-existing renal failure.
The medicine BETADINE, 100 mg/ml, solution for the skin, should be avoided 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, such tests should not be performed 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 difficult-to-remove stains, an ammonia solution or sodium thiosulfate solution should be used.
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 the doctor, in case of confirmed diagnosis and strict indications for the use of iodinated povidone. Thyroid function should be monitored.
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 the significant penetration of the medicine through the skin into the body and increased sensitivity to iodine.
Children must be absolutely protected 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 medicines containing mercury, due to the risk of forming a corrosive iodine-mercury compound.
In case of application of the medicine 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).
Chronic use of the medicine should be avoided, especially on large areas, in patients treated with lithium.
The medicine should not be applied to 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 uptake of iodine by the thyroid gland may decrease, which may make it difficult to perform some diagnostic tests (e.g., thyroid scintigraphy, determination of protein-bound iodine, diagnostic tests using radioactive iodine) or prevent treatment of thyroid diseases with radioactive iodine. To obtain unbiased results, an appropriate time interval (1-4 weeks) should be maintained 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 does not have a teratogenic effect.
The use of the medicine during pregnancy and breastfeeding is only allowed if decided by the doctor, in case of accurate diagnosis and strict indications for the use of the medicine.
Thyroid function should be monitored 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.
Infants must be absolutely protected from swallowing the medicine.

Driving and using machines

The medicine 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 the patient leaflet or as directed by your doctor or pharmacist.
In case of doubts, you should contact 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 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 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 lukewarm 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 as a result of 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 the doctor, in case of confirmed diagnosis and strict indications for the use of this medicine.
Thyroid function should be monitored.
Use of a higher dose of the medicine than recommended:
In case of use of higher doses than recommended, you should immediately contact your doctor. After use of 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 ingestion of the medicine, you should immediately contact your doctor or hospital.
In case of any further doubts related to the use of this medicine, you should contact 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 discontinue the use of the medicine and tell your doctor.
Very rare side effects (occurring in less than 1 in 10,000 people):
Anaphylactic reaction (a severe allergic reaction causing, among other things, difficulty breathing, dizziness, and decreased blood pressure). If such symptoms occur, you should immediately discontinue the use of the medicine and tell your doctor.
Angioedema (a severe allergic reaction causing swelling of the face or throat). If such symptoms occur, you should immediately discontinue the use of 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.
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 disturbances, metabolic acidosis, acute renal failure, and abnormal blood osmolality (may occur after use of 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 or nurse. 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you 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 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 packaging. The expiry date refers to the last day of the specified month.
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 that are no longer used. This will help protect the environment.

6. Package contents and other information

1 ml of the solution contains 100 mg of iodinated povidone and excipients: glycerol, nonoxynol 9, citric acid, potassium iodide, sodium phosphate, sodium hydroxide, purified water.
What Betadine, 100 mg/ml, solution for the skin looks like and what the package contains
The medicine is a solution with a iodine color.
A white plastic bottle with a dropper and a white cap, in a cardboard box.