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/g, ointment

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, pharmacist, or nurse.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should ask a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
• If after 5 days there is no improvement or the patient feels worse, they should contact a doctor.

Table of contents of the 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. Contents of the packaging and other information

1. What is Betadine and what is it used for

Betadine, 100 mg/g, ointment is intended 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 application of the Betadine medicine. Free iodine has strong bactericidal properties, acts 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 the patient is allergic to povidone iodine or any of the other ingredients of this medicine (listed in section 6);
• if the 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 the patient has herpetic skin inflammation (called herpetic dermatitis of Duhring);
• 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, you should discuss it with your doctor or pharmacist.

Long-term 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, you should stop using the medicine.

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

Do not heat the skin before applying the medicine.

Patients with kidney function disorders (renal failure) should be particularly careful.

You should avoid contact of Betadine with the eyes. If this happens, despite all precautions, you should immediately rinse your eyes with a large amount of water.

If the medicine is not intended for skin treatment of the hands, after using this medicine, you should wash your hands thoroughly.

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

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

Concurrent use of Betadine and enzymatic medicines administered for wound treatment causes mutual weakening of their effects.

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

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

Using Betadine before or after applying disinfectant medicines containing octenidine may cause transient skin discoloration, so you should not use them concurrently.

You should avoid long-term 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, you should inform your doctor about the use of Betadine.

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

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 or pharmacist before using this medicine.

During pregnancy and breastfeeding, povidone iodine 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 ability of iodine to penetrate the placenta and human 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 and use machines.

3. How to use Betadine

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, you should consult a doctor or pharmacist.

Betadine is intended for use on the skin only.

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

If the skin condition does not improve within 7 days or if the infection recurs after treatment (redness, pain, swelling, purulent discharge), you should consult a doctor. Do not use Betadine for more than 7 days without consulting a doctor.

Adults

Apply an amount of ointment 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 (aged 2-18):

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

• For children aged 2-5 years, apply an amount no larger than a pea per day.
• For children aged 6-8 years, apply an amount no larger than 2 peas per day (or 1 pea twice a day).
• For children aged 9-13 years, apply an amount no larger than 3 peas per day (or 1.5 peas twice a day).
• For children aged 14-18 years, apply an amount no larger than 5 peas per day (or 2.5 peas 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 in the eye area.

Using a larger dose of Betadine than recommended

When used as directed in the 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 is intended for use on the skin only.

Long-term 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, you should consult a doctor or go to the hospital emergency department:

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

Missing a dose of Betadine

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

Stopping the use of Betadine

To avoid relapses and completely eliminate the infection, you should use the medicine for as long as recommended.

If you have any further doubts about the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

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

Side effects are defined by their frequency of occurrence.

You should stop using this medicine and immediately contact a doctor or

the nearest hospitalif you experience any of the following side effects:

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

• allergic reactions.

Very rare (may affect up to 1 in 10,000 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 (so-called 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 long-term 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),
• discoloration of the skin at the application site.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should 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

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 gather more information on the safety of the medicine.

5. How to store Betadine

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

The medicine should be stored 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 specified month.

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 needed. This will help protect the environment.

6. Contents of the packaging and other information

What Betadine contains

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

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

What Betadine looks like and what the packaging contains

Brown ointment with a specific smell.

The packaging of the medicine is an aluminum tube with a screw cap containing 30 g of ointment, placed in a cardboard box.

To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the country of export:

Lavipharm S.A.

Agias Marinas

190 02 Peania, Attica

Greece

Manufacturer:

Lavipharm S.A.

Agias Marinas

190 02 Peania, Attica

Greece

Parallel importer:

Medezin Sp. z o.o.

ul. Zbąszyńska 3

91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.

ul. Zbąszyńska 3

91-342 Łódź

CEFEA Sp. z o.o. Sp. komandytowa

ul. Działkowa 56

02-234 Warsaw

Pharma Innovations Sp. z o.o.

ul. Jagiellońska 76

03-301 Warsaw

Laboratorium Galenowe Olsztyn Sp. z o.o.

ul. Spółdzielcza 25A

11-001 Dywity

Synoptis Industrial Sp. z o.o.

ul. Szosa Bydgoska 58

87-100 Toruń

IVA Pharm Sp. z o.o.

ul. Drawska 14/1

02-202 Warsaw

Marketing authorization number in Greece, the country of export: 44741/07/6-5-2008

28329/92/10-05-1995

Parallel import authorization number: 231/20

Date of leaflet approval: 10.12.2024

[Information about the trademark]