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/g (10%), ointment

Povidone iodine

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. Package contents and other information

1. What is Betadine and what is it used for

Betadine, 100 mg/g, ointment is intended exclusively for use on the skin. The active substance of the drug, povidone iodine, is a combination of iodine and polyvinylpyrrolidone polymer, from which iodine is released over a period of time after applying the Betadine drug. Free iodine has strong bactericidal properties - it acts on viruses, fungi, and some protozoa. Betadine is a disinfectant.
Betadine is used in the local treatment of burns, wounds, abrasions, trophic ulcers, skin infections.

2. Important information before using Betadine

When not to use Betadine

• in hyperthyroidism;
• in patients with thyroid diseases (especially in people with nodular colloid goiter, endemic goiter, and Hashimoto's thyroiditis);
• in Duhring's dermatitis herpetiformis;
• before and after treatment with radioactive iodine and scintigraphy.

Warnings and precautions

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

You should carefully read the contents of the leaflet, as it contains important information for

the patient.

• This drug should always be used exactly as described in the patient leaflet or as directed by your doctor, pharmacist, or nurse.
• You should keep this leaflet, so that you can read it again if you need to.
• If you need advice or additional information, you should ask your pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. See point 4. If there is no improvement or you feel worse after 5 days, you should contact your doctor.
• Patient with renal impairment should not use the drug for a long time unless advised by a doctor.
• After prolonged use of the drug, thyroid function tests should be performed.
• Prolonged use may cause skin irritation, contact dermatitis, allergic reactions, and in rare cases, severe skin reactions. If irritation or allergic reactions occur, you should stop using the drug.
• The drug should not be heated before applying it to the skin.
• Patient with thyroid disease should not use the drug for a long time or on a large skin surface, as the iodine absorbed from Betadine may cause hyperthyroidism. In these patients, the doctor should monitor thyroid function and choose treatment individually for each patient.
• If symptoms of hyperthyroidism occur after treatment, thyroid function tests should be performed.
• You should avoid using Betadine in patients receiving lithium therapy. Children and adolescents The treatment duration in children should be as short as possible and the dose as small as possible. If necessary, thyroid function tests should be performed. You should not allow children to take the drug orally or swallow it.

Other drugs and Betadine

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

• Drugs containing mercury, silver, hydrogen peroxide, benzoic acid, or taurolidine may interact with povidone iodine and should therefore be avoided during concurrent use with Betadine.
• During the use of Betadine, various diagnostic agents may give false-positive laboratory test results (e.g., toluidine and guaiac tests for detecting hemoglobin or glucose in stool and urine).
• Absorption of iodine from Betadine may interfere with thyroid function tests.
• Concomitant use of Betadine with enzymatic ointment for wound treatment may reduce the effectiveness of both drugs.
• Using Betadine on the same or adjacent skin area simultaneously or immediately after applying antiseptic drugs containing octenidine may cause transient skin discoloration.

Pregnancy and breastfeeding

In pregnancy and during breastfeeding, or if you suspect that you are pregnant, or if you plan to become pregnant, you should consult your doctor or pharmacist before using any drug.
In pregnancy and during breastfeeding, the use of Betadine is allowed only in case of accurate diagnosis and absolute indications for the use of the drug. If the doctor decides to use the drug, he should limit the dose of the drug and the duration of therapy, as the absorbed iodine may pass through the placenta and into breast milk. The use of the drug may cause transient hyperthyroidism in the fetus or newborn. Thyroid function tests may be necessary for the child. You should protect children from situations where they could take the drug orally or swallow it.

Driving and using machines

Using Betadine does not affect the ability to drive and use machines.

3. How to use Betadine

This drug should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
For use on the skin.
In the treatment of infections: the ointment is applied once or twice a day for a maximum of 14 days.
The affected skin should be cleaned and dried. The ointment is applied to the affected skin. A dressing or bandage can be applied.

Using a higher dose of Betadine than recommended

In case of suspected overdose, you should contact your doctor immediately.
Excess iodine may cause the development of goiter, hypothyroidism, or hyperthyroidism.
Absorption of iodine by the body in case of repeated use of Betadine on extensive wounds or burns may cause symptoms of iodine poisoning, such as metallic taste in the mouth, salivation, burning or pain in the throat and mouth, eye irritation and swelling, skin reactions, gastrointestinal disorders, and kidney failure.

4. Possible side effects

Like all drugs, this drug can cause side effects, although not everybody gets them.
Side effects are defined based on their frequency of occurrence.
Rare (affects up to 10 in 10,000 people)
Allergic reactions, contact dermatitis (with symptoms such as skin redness, small blisters, and skin itching).
Very rare (affects less than 1 in 10,000 people)
Anaphylactic reaction (severe allergic reaction causing, among other things, difficulty breathing, dizziness, decreased blood pressure), hyperthyroidism (may cause increased appetite, weight loss, sweating, rapid heartbeat, or restlessness) in patients with thyroid disease, angioedema (severe allergic reaction causing swelling of the face or throat).
Frequency not known (cannot be estimated from the available data)
Hypothyroidism (may occur after prolonged or intensive use of the drug, causing, for example, fatigue, weight gain, slower heartbeat), kidney function disorders, chemical skin burns (may occur as a result of the "accumulation" of the drug under the patient during preparation for surgery), electrolyte disturbances, metabolic acidosis, acute kidney failure, abnormal blood osmolality (may occur after using very large amounts of the drug, for example, in the treatment of burns).

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your 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, 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 drug.

5. How to store Betadine

Do not store above 25°C.
Shelf life after first opening - 2 years.
The drug should be stored out of sight and reach of children.
Do not use this drug after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
Drugs should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of drugs that are no longer needed. 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 what the package contains

Brown ointment with a specific smell.
The package contains 30 g of ointment in an aluminum tube with a screw cap, 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Authorization number in Greece, the country of export:28329/92/95
Parallel import authorization number:423/12
Date of leaflet approval: 30.05.2022
[Information about the trademark]