CURADONA 100 mg/g GEL

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

Do not use Curadona:

• If you are allergic (hypersensitive) to iodinated products or medications or to any of the other components of this medication (listed in section 6).
• In newborns (from 0 to 1 month).

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Curadona.

Do not use this medication for a long time or on large areas of the skin without consulting a doctor, especially if:

• you have burns that affect more than 20% of the body surface
• you have large or open wounds
• you have kidney or liver disease
• you have a thyroid disorder
• you are being treated with lithium medications.

Do not heat the product before applying it.

This medication is for external use only, on the skin.

Avoid contact with the eyes, ears, and other mucous membranes.

Children

Curadona is contraindicated in children under 1 month. Do not use in children under 30 months without consulting a doctor.

Using Curadona with other medications

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

In particular, you should consult your doctor if you are using Curadona at the same time as:

• other products that contain mercury derivatives, as they react with iodine to form irritating compounds
• sodium thiosulfate (used to treat fungal infections)
• lithium.

Interference with diagnostic tests:

This medication may interfere with the results of thyroid function tests and tests for detecting hidden blood in stool and urine, so you should inform your doctor that you are using Curadona before undergoing these tests, due to contamination with iodinated povidone.

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.

Pregnant or breastfeeding women should avoid using this medication as it may cause transient hypothyroidism (a syndrome that occurs when thyroid gland activity decreases) in the fetus or breastfed infant.

Driving and Using Machines

No effects of this medication on the ability to drive and use machines have been reported.

3. How to use Curadona

Follow the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

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

For cutaneous use.

If you use more Curadona than you should

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

In cases of ingestion of large amounts of iodinated povidone, the following may occur: abdominal pain, diarrhea, fever, nausea, vomiting, metabolic acidosis, and hypernatremia, as well as alterations in kidney, liver, and thyroid function.

In these cases, if the patient is conscious, they should ingest milk every 15 minutes to alleviate stomach irritation. Additionally, to eliminate the iodinated povidone that may remain in the stomach, a starch solution should be administered, prepared by adding 15 mg of cornstarch or 15 mg of flour to 500 ml of water. If the patient suffers esophageal damage, stomach lavage or vomiting should not be induced.

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the product and the amount ingested.

4. Possible Side Effects

Like all medications, this medication can have side effects, although not everyone experiences them.

During the period of use of iodinated povidone, the following side effects have been observed, whose frequency could not be established with precision: rarely, skin disorders, such as local irritation, itching, or burning. In these cases, treatment should be suspended and the affected area washed with water.

However, side effects can be more severe if the product is used for a long time or applied to large wounds or extensive burns, mainly metabolic acidosis, hypernatremia (excess sodium in the blood), and disorders of kidney, liver, and thyroid function (especially in children).

Reporting Side Effects:

If you experience any type of side effect, consult your doctor or pharmacist, 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 Curadona

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

No special storage conditions are required.

Do not use this medication after the expiration date indicated on the packaging after CAD. 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 Curadona

• The active ingredient is iodinated povidone. Each gram of gel contains 100 mg of iodinated povidone.
• The other components (excipients) are: macrogol 400, macrogol 4000, macrogol 6000, and purified water.

Appearance of the Product and Package Contents

Curadona is a brown-colored gel for cutaneous use, presented in polyethylene tubes with a polypropylene cap in the following presentations: a box with 1 tube of 30 g, a box with 1 tube of 100 g, and a box with 5 tubes of 5 g.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

LAINCO, S.A.

Av. Bizet, 8-12

08191 RUBÍ (Barcelona)

Spain

Date of the Last Revision of this Package Leaflet:May 2018

Other Sources of Information

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