BETADINE GEL 100 mg/g GEL

2. What you need to know before starting to use Betadine gel

Do not use Betadine gel

• If you are allergic to povidone iodine or any of the other components of this medicine (listed in section 6).
• If you have hyperthyroidism or other acute thyroid diseases.
• Before, during, and after the administration of radioactive iodine
• With products that contain mercury due to the formation of a substance that can damage the skin.
• In children under one year of age.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Betadine gel.

External use only. Do not ingest. Avoid contact with eyes, ears, and other mucous membranes. Consult your doctor if symptoms persist or worsen.

If used in preparation before an operation, avoid accumulation under the patient. It can cause irritation and rarely severe skin reactions. Chemical burns can occur on the skin due to accumulation. In that case, suspend its use. Do not heat before applying.

Patient with goiter, thyroid nodules, or other non-acute thyroid diseases are at risk of developing hyperthyroidism with the administration of high amounts of iodine. In these patients, it should not be applied for prolonged periods or on extensive skin areas unless strictly indicated. Even at the end of treatment, it is necessary to be alert to early symptoms of possible hyperthyroidism and, if necessary, to control thyroid function.

It should not be used before or after a radioactive iodine scan or treatment of thyroid carcinoma with radioactive iodine.

Thyroid function tests should be performed in case of prolonged use.

Children

Newborns and small children are at greater risk of developing hypothyroidism. If used in children, it is essential to monitor the thyroid.

It is not recommended for use in children under one year of age.

Using Betadine gel with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

Do not use with mercurial derivatives, silver, hydrogen peroxide, or taurolidine (antiseptics).

Continuous use should be avoided in patients undergoing simultaneous therapy with lithium (used in psychiatry).

When used at the same time or after antiseptics with octenidine, transient dark discoloration of the affected areas may appear.

Interaction with diagnostic tests: the use of povidone iodine may lead to errors in tests with toluidine or guaiacol to determine hemoglobin or glucose in feces or urine. It may also interfere with thyroid tests and treatments with radioactive iodine.

Inform your doctor when you need to undergo any diagnostic test.

Inform your doctor if:

• The symptoms do not improve or worsen
• You have received radioactive iodine treatments in the last 4 weeks
• You have an allergy or skin irritation such as redness, small blisters, itching, or rash that may appear immediately.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Use only if strictly indicated; its use should be kept to a minimum. Avoid continuous use.

Its use could produce transient hypothyroidism in fetuses and newborns. Thyroid monitoring may be necessary in children.

You should consult your doctor about using it in children between 1 and 2 years old.

Driving and using machines

Betadine does not affect the ability to drive or use machinery.

3. How to use Betadine gel

Follow the administration instructions of the medicine contained in this leaflet or as indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor, pharmacist, or nurse.

Topical use. After washing and drying, apply directly to the affected area 1 to 3 times a day. After application, it is advisable to cover the treated area with a gauze.

If you use more Betadine gel than you should

In case of excessive product application and skin irritation, wash the affected area with plenty of water, suspend treatment, and if irritation continues, consult a doctor.

Symptoms could be abdominal pain, anuria (suppression or decrease of urine), circulatory, respiratory, and metabolic problems. Excess iodine can produce goiter, hypothyroidism, and hyperthyroidism.

In case of accidental ingestion, go to a medical center or call the Toxicology Information Service, phone: 91 562 04 20, indicating the product and the amount ingested.

If you have any other doubts about using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

In rare cases where skin irritation or allergy occurs, suspend treatment and wash the affected area with water.

Rare side effects (may affect between 1 and 10 out of 10,000 people) are hypersensitivity and contact dermatitis, which manifests with red skin, small blisters, and itching.

Very rare side effects (may affect less than 1 in 10,000 people) include anaphylactic reactions (severe allergic reaction), hyperthyroidism with tachycardia and agitation, and angioedema (swelling caused by allergy).

Other side effects of unknown frequency include hypothyroidism, electrolyte imbalance, metabolic acidosis, acute kidney failure, abnormal blood osmolarity, exfoliative dermatitis, dry skin, skin discoloration, and chemical burns on the skin.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Betadine gel

Keep this medicine out of the sight and reach of children.

No special storage conditions are required. Do not store above 25°C.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Betadine gel composition

The active ingredient is povidone iodine. Each gram of gel contains 100 mg of povidone iodine.

The other components (excipients) are: macrogol 400, macrogol 4000, macrogol 6000, and purified water.

Appearance of the product and package contents

Brown-colored gel.

It is presented in 30g and 100g tubes.

Marketing authorization holder and manufacturer

Marketing authorization holder

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

Netherlands

Manufacturer

MEDA Manufacturing, Bordeaux

Av. Pdt. J. F. Kennedy. BP 100

Merignac – Cedex

F-33700

France

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5ª planta

08011 Barcelona

Spain

Date of the last revision of this leaflet:May 2022

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) https://www.aemps.gob.es/