Betadine

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language!
Betadine
100 mg/g, ointment
Povidone iodine
Please read the entire 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
physician, pharmacist, or nurse.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a physician, pharmacist, or nurse. See section 4.
• If there is no improvement or if the patient feels worse after 5 days, consult a physician.

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 pack and other information

1. What Betadine is and what it is used for

Betadine is intended for topical use only. The active substance in Betadine, povidone iodine, is a complex of iodine and the polymer polyvinylpyrrolidone, from which iodine is gradually released over time after application of Betadine. Free iodine has strong germicidal properties and acts 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 radioactive iodine scintigraphy (a test involving administration of radioactive iodine) or radioactive iodine therapy for thyroid disorders (see section "Warnings and precautions");
• if the patient has dermatitis herpetiformis (also known as Duhring's disease);
• with mercury-containing products, as concomitant use may damage the skin;
• do not use in children under 1 year of age.

Warnings and precautions
Before starting treatment with Betadine, consult your doctor or pharmacist.
Prolonged use may cause skin irritation, contact dermatitis (allergic or irritant skin reaction due to 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 its inherent colour.
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 eyes. If contact occurs, despite all precautions, immediately rinse eyes thoroughly with large amounts of water.
If Betadine is not intended for hand skin treatment, hands should be thoroughly washed after use.
Avoid contact with jewellery, especially silver-containing items.

Children and adolescents
Betadine should not be used 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 to be used.
Concomitant use of Betadine and enzymatic drugs administered for wound treatment leads to mutual reduction of their 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 should not be used simultaneously with reducing agents, alkali metal salts, or substances reacting with acids.
Use of Betadine before or after application of disinfectants containing octenidine may cause transient skin discoloration; therefore, simultaneous use should be avoided.
Prolonged use of Betadine should be avoided in patients receiving lithium therapy.
During treatment with Betadine, various diagnostic agents may cause false-positive results in laboratory tests (e.g. toluidine test and guaiac resin test for detection of hemoglobin or glucose in feces and urine). Inform your doctor about Betadine use before undergoing laboratory tests.
Use of povidone-iodine ointment may affect results of certain thyroid function tests (scintigraphy, determination of protein-bound iodine, radioactive iodine diagnostics) and may prevent planned radioactive iodine therapy of the thyroid gland. After discontinuation of Betadine treatment, an appropriate interval of 4 weeks should be maintained before performing subsequent scintigraphy (see section "When not to use Betadine").

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 recommended by the attending physician. If possible, use should be avoided due to iodine's ability to cross the placenta and enter human milk. Because of increased fetal and neonatal sensitivity to iodine, povidone-iodine may cause thyroid dysfunction in the fetus or newborn.
Limited human data are available regarding fertility effects of povidone-iodine. No data on fertility outcomes are available.

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

3. How to use Betadine

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 is intended for topical use only.
Apply a pea-sized amount of ointment (1 pea = 1 cm = 100 mg) to the affected skin 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 for more than 7 days without consulting a doctor.

Adults
Apply an amount of ointment equivalent to 8 or 9 peas once daily, or an amount equivalent to 4.5 peas twice daily, to the cleaned and dried skin area being treated.

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

• Children aged 2–5 years: apply no more than a single pea-sized amount per day.
• Children aged 6–8 years: apply no more than two pea-sized amounts per day (or one pea-sized amount twice daily).
• Children aged 9–13 years: apply no more than three pea-sized amounts per day (or 1.5 pea-sized amounts twice daily).
• Children aged 14–18 years: apply no more than five 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
When used as directed in the package leaflet, there is no risk of overdose.
In case of local overdose, thoroughly wash the affected skin area with warm water.
Betadine is for topical use only.
Prolonged local application of large amounts 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 emergency department:

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

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

Stopping Betadine treatment
To prevent recurrence and completely eliminate 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 product can cause adverse reactions, although not everyone will experience them.
Adverse reactions have been classified 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 affect up to 1 in 1,000 people):

• Allergic reactions.

Very rare (may affect up to 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 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, rapid heartbeat, or restlessness).
  Frequency not known (frequency cannot be estimated from available data):
• Hypothyroidism (may occur after prolonged or intensive use of Betadine, causing, for example, fatigue, weight gain, or slower heartbeat),
• Kidney disorders (acute kidney failure),
• Electrolyte disturbances (disturbances in water 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, for example in burn treatment),
• Skin discoloration at the site of application.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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
Phone: +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 this medicine.

5. How to store Betadine

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Shelf life after first opening of the tube: 2 years.
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 required. Such measures help protect the environment.

6. Contents of the pack 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: macrogol 400, macrogol 1000, macrogol 1500, macrogol 4000, sodium bicarbonate, purified water.

What Betadine looks like and contents of the pack
Reddish-brown ointment.
The pack consists of an aluminium tube with a cap containing 30 g of ointment, placed in a cardboard box.

For further detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Greece, 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.
Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation numbers in Greece, country of export: 44741/07/6-5-2008
28329/92/10-05-1995
Parallel Import Licence number: 231/20