BETATUL 250 MG IMPREGNATED DRESSING

2. What you need to know before starting to use Betatul

Do not use Betatul

• If you are allergic to povidone iodine or any of the other components of this medication (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 1 year of age.

Warnings and Precautions

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

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

Patients 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 to extensive skin areas unless strictly indicated. Even after treatment, be alert for early symptoms of possible hyperthyroidism and, if necessary, monitor 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 young children are at greater risk of developing hypothyroidism. If used in children, it is essential to monitor the thyroid.

Use in children under 1 year of age is not recommended.

Using Betatul with Other Medications

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

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 simultaneously or after antiseptics with octenidine, transient dark discoloration of the involved areas may occur.

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:

• 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 medication.

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 use in children between 1 and 2 years of age.

Driving and Using Machines

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

3. How to Use Betatul

Follow the administration instructions for the medication contained in this package 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. Cover with a gauze or cotton swab. Secure with a bandage.

Change every day or every 2 days.

If you use more Betatul than you should

In case of excessive application of the product 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 decreased urine output), circulatory, respiratory, and metabolic problems. Excess iodine can cause 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 medication, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medications, this medication 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 renal failure, abnormal blood osmolarity, exfoliative dermatitis, dry skin, skin discoloration, and chemical burns to the skin.

If you consider any of the side effects you are experiencing to be serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting Side Effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use (https://www.notificaram.es). By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Betatul

Keep this medication out of sight and reach of children.

Store below 30°C in its original packaging to protect it from light and moisture.

Do not use this medication after the expiration date shown on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Betatul

The active ingredient is povidone iodine. Each 10 x 10 cm impregnated gel dressing contains 250 mg of povidone iodine. The other components (excipients) are: polyethylene glycol 400, polyethylene glycol 4000, polyethylene glycol 6000, purified water, and hydrophilic gauze.

Appearance of the Product and Package Contents

Package containing 10 polypropylene sachets with 1 impregnated dressing each.

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 medication by contacting the local representative of the Marketing Authorization Holder:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 Barcelona

Spain

Date of the Last Revision of this Package Leaflet:August 2022

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