Leaflet: information for the user

Betatul 250 mg impregnated dressing

Iodine povidone

Read this leaflet carefully before starting to use this medicine, as it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.

• For advice on any matter relating to this medicine or for information about any aspect of its use, consult your pharmacist.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.
• You must consult a doctor if it worsens or does not improve.

1.What is Betatul and for what it is used

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

3. How to use Betatul

4. Possible side effects

5. Storage of Betatul

6. Contents of the package and additional information

The povidone-iodine, active ingredient of this medication, is an antiseptic (that destroys the germs that produce infections) that contains iodine.

Betatul is indicated as a general skin antiseptic, for small wounds and superficial cuts, minor burns, scrapes.

No use Betadine

• 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 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.

Warnings and precautions

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

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 have a risk of developing hyperthyroidism with the administration of high doses of iodine. In these patients, do not apply for prolonged periods of time and in extensive areas of skin unless strictly indicated. Even at the end of treatment, be aware of early symptoms of possible hyperthyroidism and, if necessary, control thyroid function.

Do not use before or after an iodine radioactive scan or treatment of thyroid cancer with radioactive iodine.

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

Children

Newborns and young children have a higher risk of developing hypothyroidism. If used in children, it is essential to monitor thyroid function.

Do not recommend use in children under 1 year.

Use of Betadine with other medications

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

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

It is essential to avoid continuous use in patients undergoing simultaneous therapy with lithium (used in psychiatry).

When used at the same time or after antiseptics with octenidine, dark transitory discoloration of the involved 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:

• Symptoms do not improve or worsen
• You have received treatments with radioactive iodine 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, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Use only if strictly indicated, and your use should be maintained at the absolute minimum. Avoid continuous use.

Your use may produce transient hypothyroidism in fetuses and newborns. It may be necessary to monitor thyroid function in children.

You should consult with your doctor about use in children between 1 and 2 years.

Driving and operating machinery

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

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

Cutaneous use. After washing and drying, apply directly to the affected area. Cover with a gauze or cotton. Secure with a bandage.

Change daily or every 2 days.

If you use more Betatul than you should

In case an excessive amount of the product is applied and skin irritation occurs, wash the affected area with plenty of water, discontinue treatment, and if irritation continues, consult a doctor.

Symptoms may include abdominal pain, anuria (suppression or decrease in urine), circulatory, respiratory, and metabolic problems. Excessive iodine may cause goiter, hypothyroidism, and hyperthyroidism.

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

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

In rare cases where skin irritation or an allergic reaction occurs, discontinue treatment and wash the affected area with water.

Rare adverse effects (may affect between 1 and 10 of every 10,000 people) are hypersensitivity and contact dermatitis that manifest with red skin, small blisters, and itching.

Very rarely (may affect fewer than 1 of every 10,000 people), severe allergic reactions (anaphylaxis), hyperthyroidism with tachycardia and agitation, and angioedema (allergic swelling) have been observed.

Other adverse effects of unknown frequency have been hypothyroidism, electrolyte imbalance, metabolic acidosis, acute renal insufficiency, abnormal blood osmolarity, exfoliative dermatitis, dry skin, skin discoloration, and chemical burn on the skin.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

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

Keep this medication out of the 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 that appears on the packaging afterCAD or EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Betatul

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

Appearance of the product and contents of the packaging

Packaging containing 10 polypropylene bags with 1 impregnated dressing each.

Holder of the marketing authorization andresponsible for manufacturing

Holder of the marketing authorization

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

Netherlands

Responsible for manufacturing

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

Last review date of this leaflet:August 2022

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/