Betadine

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Betadine, 100 mg/g (10%), 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.
• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4. If there is no improvement or the patient feels worse after 5 days, a doctor should be contacted.

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

• before and after treatment with radioactive iodine and scintigraphy.

Warnings and precautions

Before starting to use Betadine, the doctor or pharmacist should be consulted.

• Patient with renal failure should not use the medicine for a long time unless advised by a doctor.
• 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.
• Patient 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.
• The use of Betadine should be avoided in patients receiving lithium therapy.

Children and adolescents

In children, the treatment time 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

The pharmacist should be informed about all medicines currently being taken or recently taken, as well as any medicines the patient plans to take.

• Medicines containing mercury, silver, hydrogen peroxide, benzoic acid, or taurolidine may interact with povidone-iodine and should therefore be avoided during treatment with Betadine.
• Different diagnostic agents may give false-positive laboratory test results (e.g., toluidine and guaiac tests for hemoglobin or glucose in stool and urine) during the use of Betadine.
• 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, a doctor or pharmacist should be consulted.
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 medicine. If the doctor decides to use the medicine, the dose and duration of therapy should be limited, as the absorbed iodine 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 for 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 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. In case of doubt, a doctor or pharmacist should be consulted.
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, a doctor should be contacted 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 medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are defined by 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, low 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 heartbeat), kidney function disorders, chemical skin burns (may occur as a result of the "accumulation" of the medicine 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 medicine, for example, in the treatment of burns).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. 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
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Betadine

Do not store above 25°C.
Shelf life after first opening - 2 years.
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. The pharmacist should be asked 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 30 g of ointment in an aluminum tube with a screw cap, in a cardboard box.
For further information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Greece, the country of export:

Lavipharm A.E.
Agias Marinas
190 02 Peania, Attica
Greece

Manufacturer:

Lavipharm A.E.
Agias Marinas
190 02 Peania, Attica
Greece

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
License number in Greece, the country of export: 28329/92/10-05-1995
44741/07/06-05-2008

Parallel import license number: 418/12

Date of leaflet approval:08.07.2022
[Information about the trademark]