CURADONA 100 mg/mL CUTANEOUS SOLUTION

Introduction

Package Leaflet: Information for the User

Curadona 100 mg/ml Cutaneous Solution

Iodinated Povidone

Read the entire package leaflet carefully before starting to use this medication,as it contains important information for you.

Follow the administration instructions of the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the Package Leaflet

1. What Curadona is and what it is used for
2. What you need to know before starting to use Curadona
3. How to use Curadona
4. Possible side effects
5. Storage of Curadona
6. Package Contents and Additional Information

1. What Curadona is and what it is used for

The iodinated povidone, the active principle of this medication, is an antiseptic and disinfectant (substance that prevents the growth of microorganisms) that contains iodine.

Curadona is indicated as a general antiseptic for:

• Skin (for small wounds and superficial cuts, mild burns, or abrasions).
• Surgical field, puncture sites, wounds, burns, and surgical equipment.
• Microbial and mycotic dermatitis.
• Irrigation of septic body areas (peritoneum, pleura, bones).

You should consult a doctor if it worsens or does not improve after 7 days.

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

Do not use Curadona:

• If you are allergic to iodinated povidone, other iodine-based products or medications, or 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-based 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.

Other Medications and Curadona

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 (a medication used to treat some depressions).

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 such tests.

Use in Children

Do not administer this medication to children under 30 months without consulting a doctor first.

Pregnancy and Breastfeeding

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 infant.

Driving and Using Machines

The use of this medication does not affect the ability to drive and/or use machines.

3. How to Use Curadona

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

Recommended dose: Apply a small amount directly to the affected area, 2 to 3 times a day.

Method of administration

Topical use.

Wash and dry the affected area before applying the product.

If the symptoms worsen or persist after 7 days, you should consult a doctor.

If you use more Curadona than you should

If you have used more Curadona than you should, consult your doctor or pharmacist. In case of overdose or accidental ingestion, consult the Toxicology Information Service immediately, phone 91 562 04 20, indicating the medication and the amount ingested.

In the event that an excessive amount of product is applied and skin irritation occurs, wash the affected area with plenty of water, suspend treatment, and if the 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 (excess sodium in the blood), as well as alterations in kidney, liver, and thyroid function. Excess iodine can also cause goiter, hypothyroidism, or hyperthyroidism.

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.

Other supportive measures may be used to maintain vital functions, such as oxygen administration to maintain respiration and the administration of antihistamines, epinephrine, or corticosteroids to treat anaphylaxis.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

During the period of use of iodinated povidone, the following side effects have been observed, whose frequency cannot be established with precision: occasionally, skin disorders, such as local irritation, itching, or stinging. In these cases, treatment should be suspended, and the affected area should be 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, and systemic side effects may occur, such as primarily 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

No special storage conditions are required.

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

Do not use this medication after the expiration date shown 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. In case of 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 principle is iodinated povidone. Each milliliter of solution contains 100 mg of iodinated povidone.
• The other components (excipients) are: glycerol (E-422), polyoxyethylene alkyl ether, sodium phosphate, citric acid, sodium hydroxide (E-524), and purified water.

Appearance of the Product and Package Contents

Brown-colored solution for topical use, available in plastic bottles with a dropper and cap. Available in single-unit packages of 30, 60, and 250 ml, and in clinical packages of 10 bottles of 250 ml, 10 bottles of 500 ml, and 25 bottles of 125 ml.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

LAINCO, S.A. – Avda. Bizet, 8-12 - 08191 Rubí (Barcelona) Spain

Date of the Last Revision of this Package Leaflet:September 2024

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/