Betadine

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Betadine
100 mg/g, ointment
Povidone iodine
Please read this 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 patient leaflet or as directed by
a doctor, pharmacist, or nurse.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Table of contents of the leaflet:

1. What Betadine is and what it is 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 Betadine is and what it is used for

Betadine 100 mg/g ointment is intended for topical use only. The active substance, povidone iodine, is a complex of iodine with the polymer polyvinylpyrrolidone, from which iodine is gradually released over time after application of Betadine. Free iodine has strong bactericidal properties and is also effective against viruses, fungi, and certain protozoa. Betadine is an antiseptic agent.
Betadine is used in the local treatment of burns, wounds, abrasions, trophic ulcers, and 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 is not functioning properly (e.g. hyperthyroidism or other thyroid disorders);
• before, during, or after radioiodine scintigraphy (a test in which radioactive iodine is administered) or radioiodine treatment for thyroid disorders; (see section "Warnings and precautions");
• if the patient has dermatitis herpetiformis (also known as Duhring's disease);
• with products containing mercury, as concomitant 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 of the medicine.
This medicine may temporarily stain the skin at the site of application due to the inherent colour of the product.
Do not heat the skin before applying the medicine.
Patients with impaired kidney function (renal insufficiency) should exercise particular caution.
Avoid contact of Betadine with the eyes. If contact occurs despite taking all necessary precautions, immediately rinse the eyes thoroughly with large amounts of water.
If the medicine is not intended for hand skin treatment, hands should be washed thoroughly after use.
Avoid contact with jewellery, especially silver-containing items.

Children and adolescents
Do not use Betadine in children under 1 year of age.
Betadine is not recommended for use in children under 2 years of age.

Betadine with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Concomitant use of Betadine and enzymatic agents used for wound treatment may result in mutual reduction of efficacy.
Products containing silver, mercury (see section "When not to use Betadine"), hydrogen peroxide, benzoic acid, or taurolidine may interact with povidone-iodine and mutually reduce their effectiveness. Therefore, simultaneous use should be avoided.
Povidone-iodine contained in Betadine ointment should not be used simultaneously with reducing agents, alkali metal salts, or substances reacting with acids.
Using Betadine before or after application of disinfectants containing octenidine may cause transient skin discolouration; therefore, simultaneous use should be avoided.
Avoid prolonged use of Betadine in patients receiving lithium therapy.
During use of Betadine, various diagnostic tests may yield false-positive laboratory results (e.g. toluidine test and guaiac resin test for detection of haemoglobin or glucose in faeces and urine). Inform your doctor about the use of Betadine ointment before undergoing laboratory tests.
The use of povidone-iodine ointment may affect the results of certain thyroid function tests (scintigraphy, determination of protein-bound iodine, radioiodine diagnostics) and may prevent planned radioiodine therapy of the thyroid gland. After completion of treatment with Betadine ointment, an appropriate interval of 4 weeks should be maintained before performing subsequent scintigraphy (see section "When not to use Betadine ointment").

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her 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, its use should be avoided due to the ability of iodine to cross the placenta and be excreted in human milk. Due to the increased sensitivity of the foetus and newborn to iodine, povidone-iodine may cause thyroid dysfunction in the foetus or newborn.
There are limited data on fertility in humans for povidone-iodine. No data are available regarding fertility outcomes.

Driving and operating machinery
Betadine does not affect the ability to drive or operate machinery.

3. How to use Betadine ointment

This medicine should always be used exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Betadine ointment is intended for external use on the skin only.
Apply a pea-sized amount of ointment (1 pea-sized amount = 1 cm = 100 mg) to the affected area as needed, once or twice daily, for no longer than 7 days.
If the skin condition does not improve within 7 days, or if infection recurs after treatment (redness, pain, swelling, pus), consult your doctor.
Do not use Betadine ointment for more than 7 days without consulting a doctor.

Adults
Apply a quantity of ointment equivalent to 8 or 9 pea-sized amounts once daily, or a 4.5-pea amount twice daily, to the cleaned and dried skin area being treated.

Use in children and adolescents (aged 2–18 years):
Betadine ointment is not recommended for children under 2 years of age and must not be used in newborns and infants under 1 year of age (see section "When not to use Betadine ointment").

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

The wound may be covered with a dressing or bandage, depending on the extent and severity of the injury.
Do not use near the eyes.

Use of more than the recommended dose of Betadine ointment
When used according to the instructions in 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 external use on the skin only.
Prolonged topical use of large quantities of ointment over large skin areas increases the risk of overdose.

In case of accidental ingestion and observation of the following symptoms of acute poisoning, seek immediate medical attention at a doctor's office or hospital emergency department:

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

Missed dose of Betadine ointment
If a dose is missed, continue treatment as previously directed as soon as you remember, but do not apply a double dose to make up for the missed dose.

Stopping Betadine ointment treatment
To prevent recurrence and completely eliminate the infection, continue using the medicine for as long as recommended.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions have been categorized according to their frequency of occurrence.
You should stop using this medicine and contact your doctor or the
nearest hospital immediately if any of the following adverse reactions occur:
Rare (may occur in no more than 1 in 1,000 people):

• Allergic reactions.

Very rare (may occur in no more than 1 in 10,000 people):

• Anaphylactic reaction (a severe allergic reaction causing, among others, breathing difficulties, dizziness, and low blood pressure),
• Angioedema (a severe allergic reaction causing swelling of the face or throat).

The following adverse reactions have also been reported:
Rare (may occur in no more than 1 in 1,000 people):

• Skin inflammation (so-called contact dermatitis) with symptoms such as redness, small blisters, and itching.

Very rare (may occur in no more than 1 in 10,000 people):

• Hyperthyroidism (may cause increased appetite, weight loss, excessive sweating, rapid heartbeat, or restlessness).

Frequency unknown (cannot be estimated from available data):

• Hypothyroidism (may occur after prolonged or intensive use of Betadine, causing, for example, fatigue, weight gain, or slow heartbeat).
• Kidney disorders (acute kidney failure),
• Electrolyte imbalances (disturbances in fluid and electrolyte balance), metabolic acidosis (decreased blood pH due to accumulation of acids in the body),
• Abnormal blood osmolality (amount of osmotically active substances in the blood) (may occur after application of very large amounts of the medicine, e.g. in burn treatment),
• Skin discoloration at the site of application.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Betadine

Keep the medicine out of the sight and reach of children.
Store below 25°C in the original packaging to protect from light.
Do not store in the refrigerator and do not freeze.
Shelf life after first opening of the tube: 24 months.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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 bicarbonate, macrogol 400, macrogol 4000, macrogol 1000, macrogol 1500, purified water.

What Betadine looks like and contents of the pack
Brown ointment with a characteristic odour.
The pack contains 20 g of ointment in an aluminium tube with a cap, in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.

Responsible party in the Czech Republic, 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing authorisation number in the Czech Republic, country of export: 32/387/92-S/C
Marketing authorisation number for parallel import: 89/21