Betadine

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

Betadine

100 mg/g, ointment

Povidone-iodine

You should carefully read the contents of the leaflet, 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 consult 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 there is no improvement or the patient feels worse after 5 days, they should contact their 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 applying the Betadine medicine. 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 patients with nodular colloid goiter, endemic goiter, and Hashimoto's thyroiditis),
• in herpetic dermatitis of Duhring,
• 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.

• Patients with renal failure should not use the medicine for a long time unless a doctor has prescribed it.
• After prolonged use of the medicine, 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, the use of the medicine should be stopped.
• The medicine should not be heated before applying it to the skin.
• Patients with thyroid diseases should not use the medicine 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 the treatment individually for each patient.
• If symptoms of hyperthyroidism occur after treatment, thyroid function tests should be performed.
• Using Betadine in patients receiving lithium therapy should be avoided. Children and adolescents The treatment duration in children should be as short as possible, and the dose used should be as small as possible. If necessary, thyroid function tests should be performed. Children should not be allowed to ingest the medicine.

Other medicines and Betadine

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

• Medicines containing mercury, silver, hydrogen peroxide, benzoic acid, or taurolidine may interact with povidone-iodine, so their concurrent use with Betadine should be avoided.
• 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 medicines.
• Using Betadine on the same or adjacent skin area simultaneously or immediately after applying antiseptic medicines containing octenidine may cause transient skin discoloration.

Pregnancy and breastfeeding

In pregnancy and during breastfeeding, or if pregnancy is suspected, or if a woman is planning to become pregnant, before using any medicine, she should consult a doctor or pharmacist.
In pregnancy and during breastfeeding, the use of Betadine is allowed only in cases of accurate diagnosis and absolute indications for the use of the medicine. If the doctor decides to use the medicine, they should limit the dose and duration of treatment, as the iodine absorbed from Betadine may pass through the placenta and into breast milk. The use of the medicine may cause transient hyperthyroidism in the fetus or newborn. Thyroid function tests may be necessary in the child. Children should be protected from situations where they could take the medicine orally or ingest it.

Driving and using machines

Using Betadine does not affect the ability to drive vehicles or operate 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. If you have any doubts, you should consult a 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 immediately contact a doctor.
Excessive 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 renal failure.

4. Possible side effects

Like all medicines, Betadine can cause side effects, although not everybody gets them.
Side effects are defined by their frequency of occurrence.
Rare (affect up to 10 in 10,000 people)
Allergic reactions, contact dermatitis (with symptoms such as skin redness, small blisters, and skin itching).
Very rare (affect 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 medicine, causing, for example, fatigue, weight gain, slower heart rate), kidney function disorders, chemical skin burns (may occur as a result of the medicine accumulating under the patient during preparation for surgery), electrolyte disturbances, metabolic acidosis, acute renal failure, abnormal blood osmolality (may occur after using very large amounts of the medicine, 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 medicine.

5. How to store Betadine

Store in a temperature below 25°C. Store in the original packaging to protect from light. Do not store in the refrigerator or freeze.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Shelf life after first opening: 24 months.
Medicines should be kept out of the 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 needed. This will help protect the environment.

6. Contents of the packaging 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 packaging contains

Brown ointment with a specific smell. The packaging contains 20 g of ointment in an aluminum tube in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

Egis Pharmaceuticals PLC
Keresztúri út 30-38.
1106 Budapest
Hungary

Manufacturer:

Egis Pharmaceuticals PLC
Mátyás Király u. 65.
9900 Körmend
Hungary

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
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in the Czech Republic, the country of export: 32/387/92-S/C
Parallel import authorization number: 303/22
Date of leaflet approval: 03.08.2022
[Information about the trademark]