Betadine

Package Leaflet: Information for the User

Betadine, 100 mg/g, Ointment

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 this package leaflet for the patient, or according to the doctor's, pharmacist's, or nurse's instructions.

• Keep this package leaflet, you may need to read it again.
• If you need advice or additional information, ask your pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If after 7 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Package Leaflet:

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

1. What is Betadine and what is it used for

Betadine, 100 mg/g, ointment is for use on the skin only. The active substance of the medicine, povidone iodine, is a combination of iodine and polyvinylpyrrolidone polymer, from which iodine is released over a period of time after applying Betadine. Free iodine has strong bactericidal properties, also acting on viruses, fungi, and some protozoa. Betadine is a disinfectant.

Betadine is used for local treatment of burns, wounds, abrasions, trophic ulcers, skin infections.

2. Important information before using Betadine

When not to use Betadine

• if you are allergic to povidone iodine or any of the other ingredients of this medicine (listed in section 6);
• if your thyroid gland does not work properly (e.g., hyperthyroidism or other thyroid disorders);
• before, during, or after scintigraphy with radioiodine (a test in which radioactive iodine is administered) or treatment of thyroid diseases with radioiodine; (see "Warnings and precautions");
• if you have herpetic skin lesions (herpetic dermatitis, also known as Duhring's disease);
• with products containing mercury, as concurrent use may damage the skin;
• do not use in children under 1 year of age.

Warnings and precautions

Before starting to use Betadine, discuss it with your doctor or pharmacist.

Prolonged use may cause skin irritation, contact dermatitis (allergic rash or skin irritation caused by contact with an allergen), and in rare cases, severe skin reactions. If irritation or allergic reactions occur, discontinue use.

This medicine may temporarily discolor the skin at the application site, due to the color of the medicine itself.

Do not heat the skin before applying the medicine.

Patients with kidney function disorders (renal insufficiency) should exercise special caution.

Avoid contact of Betadine with the eyes. If this happens despite all precautions, rinse your eyes immediately with plenty of water.

If the medicine is not intended for treating skin on the hands, wash your hands thoroughly after use.

Avoid contact with jewelry, especially those containing silver.

Children and adolescents

Betadine should not be used in children under 1 year of age.

Betadine is not recommended for children under 2 years of age.

Betadine and other medicines

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

Concurrent use of Betadine and enzymatic medicines administered to treat wounds may mutually weaken their effects.

Products containing silver, mercury (see "When not to use Betadine"), hydrogen peroxide, benzoyl peroxide, or taurolidine may interact with povidone iodine and mutually weaken their effects. Therefore, avoid concurrent use.

Povidone iodine in Betadine ointment should not be used concurrently with reducing agents, alkali metal salts, or substances that react with acids.

Using Betadine before or after applying disinfectant medicines containing octenidine may cause transient skin discoloration, so they should not be used concurrently.

Avoid prolonged use of Betadine in patients receiving lithium therapy.

During the use of Betadine, various diagnostic agents may give false-positive laboratory test results (e.g., toluidine test and guaiac resin test for hemoglobin or glucose in stool and urine). Before laboratory tests, inform your doctor about the use of Betadine ointment.

The use of povidone iodine ointment may affect the results of some thyroid function tests (scintigraphy, iodine-bound protein determination, radioiodine diagnostics) and prevent planned radioiodine therapy of the thyroid. After completing treatment with Betadine ointment, wait for an appropriate time interval of 4 weeks before performing another scintigraphy (see "When not to use Betadine").

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.

In pregnancy and breastfeeding, povidone iodine should only be used if strictly indicated and recommended by your doctor.

Avoid using the medicine whenever possible due to the ability of iodine to pass through the placenta and into breast milk. Due to the increased sensitivity of the fetus and newborn to iodine, povidone iodine may cause thyroid function disorders in the fetus or newborn.

There are limited data on human fertility for povidone iodine. No data on fertility outcomes are available.

Driving and using machines

Betadine does not affect the ability to drive or use machines.

3. How to use Betadine

This medicine should always be used exactly as described in this package leaflet for the patient or according to the doctor's or pharmacist's instructions.

In case of doubt, consult your doctor or pharmacist.

Betadine ointment is for use on the skin only.

Apply a pea-sized amount (1 pea = 1 cm = 100 mg) to the affected skin as needed, once or twice a day, for no longer than 7 days.

If the skin condition does not improve within 7 days or if the infection recurs (redness, pain, swelling, purulent discharge) after treatment, consult your doctor.

Do not use Betadine ointment for more than 7 days without consulting your doctor.

Adults

Apply an amount the size of 8 or 9 peas once a day, or an amount the size of 4.5 peas twice a day to the cleaned and dried skin surface in the treated area.

Use in children and adolescents (2-18 years):

Betadine ointment is not recommended for children under 2 years of age and should not be used in newborns and infants before the age of 1 (see "When not to use Betadine").

• For children aged 2-5 years, apply no more than a pea-sized amount per day.
• For children aged 6-8 years, apply no more than 2 pea-sized amounts per day (or 1 pea-sized amount twice a day).
• For children aged 9-13 years, apply no more than 3 pea-sized amounts per day (or 1.5 pea-sized amounts twice a day).
• For children aged 14-18 years, apply no more than 5 pea-sized amounts per day (or 2.5 pea-sized amounts twice a day).

The wound can be covered with a dressing or bandage, depending on the extent and severity of the damage.

Do not use near the eyes.

Using more than the recommended dose of Betadine

When used according to the package leaflet, there is no risk of overdose.

In case of local overdose, it is recommended to thoroughly wash the affected skin area with warm water.

Betadine ointment is for use on the skin only.

Prolonged use of large amounts of ointment on a large skin area increases the risk of overdose.

In case of accidental ingestion and observation of the following symptoms of acute poisoning, consult a doctor or go to the hospital emergency department:

• abdominal symptoms,
• lack of urine (anuria),
• circulatory failure,
• breathing difficulties,
• metabolic disorders,
• rapid heartbeat,
• drop in blood pressure,
• seizures,
• fever.

Missing a dose of Betadine

If you miss a dose, continue using the medicine as before, as soon as you remember, but do not use a double dose to make up for the missed dose.

Stopping the use of Betadine

To avoid recurrence and completely eliminate the infection, use the medicine for as long as recommended.

If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Betadine can cause side effects, although not everybody gets them.

Side effects are listed by frequency of occurrence.

Stop using this medicine and contact your doctor or the nearest hospital immediately if you experience any of the following side effects:

if you experience any of the following side effects:

• allergic reactions.

Rare (may affect up to 1 in 1,000 people):

• anaphylactic reaction (severe allergic reaction causing, among other things, difficulty breathing, dizziness, low blood pressure),
• angioedema (severe allergic reaction causing 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, excessive sweating, faster heartbeat, or restlessness).

Frequency not known (cannot be estimated from the available data):

• hypothyroidism (may occur after prolonged or intensive use of Betadine, causing, for example, fatigue, weight gain, slower heartbeat),
• kidney disorders (acute renal failure),
• electrolyte disorders (water-electrolyte imbalance), metabolic acidosis (decrease in blood pH due to accumulation of acids in the body),
• abnormal blood osmolality (amount of osmotically active substances in the blood, may occur after using very large amounts of the medicine, e.g., in the treatment of burns),
• skin discoloration at the application site.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor 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.

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Betadine

Store below 25°C. Store in the original packaging to protect from light.

Shelf life after first opening the tube: 24 months.

Keep the medicine out of the sight and reach of children.

Do not use this medicine after the expiry date (EXP) stated on the carton and tube.

The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required.

This will help protect the environment.

6. Package contents and other information

What Betadine contains

The active substance is povidone iodine. Each gram of ointment contains 100 mg of povidone iodine.

The other ingredients are: sodium hydrocarbonate, macrogol 400, macrogol 4000, macrogol 1000, macrogol 1500, purified water.

What Betadine looks like and contents of the pack

Brown ointment with a specific smell.

The package contains 20 g of ointment in an aluminum tube with a PE cap, in a cardboard box.

Marketing authorization holder:

Egis Pharmaceuticals PLC

Keresztúri út 30-38

1106 Budapest

Hungary

Manufacturer:

Egis Pharmaceuticals PLC

Mátyás király u. 65

9900 Körmend

Hungary

To obtain more detailed information, contact the representative of the marketing authorization holder:

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: