CURADONA UNIDOSIS 100 mg/mL CUTANEOUS SOLUTION

Introduction

Package Leaflet: Information for the User

Curadona Unidosis 100 mg/ml Cutaneous Solution

Povidone Iodine

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

Follow the administration instructions for 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 your condition worsens or does not improve after 7 days.

Contents of the Package Leaflet

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

1. What Curadona Unidosis is and what it is used for

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

Curadona Unidosis is indicated as a general antiseptic for:

• Skin (for small wounds and superficial cuts, minor 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 your condition worsens or does not improve after 7 days.

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

Do not use Curadona Unidosis

• If you are allergic to povidone iodine, 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 Unidosis.

Do not use this medication for a long time or on large areas of skin without consulting your 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.

Other Medications and Curadona Unidosis

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 Unidosis 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. Therefore, you should inform your doctor that you are using Curadona Unidosis before undergoing these 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 Unidosis

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

For cutaneous use.

Wash and dry the affected area before applying the product.

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

If you use more Curadona Unidosis than you should

If you have used more Curadona Unidosis 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 irritation continues, consult a doctor.

In cases of ingestion of large amounts of povidone iodine, 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 povidone iodine 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 povidone iodine, the following side effects have been observed, whose frequency cannot be established with precision: occasionally, 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, 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 Unidosis

No special storage conditions are required.

Keep this medication out of 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 unused medications at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Curadona Unidosis

• The active ingredient is povidone iodine. Each milliliter of solution contains 100 mg of povidone iodine.
• The other components (excipients) are: glycerol (E-422), polyoxyethylene alkyl ether, disodium hydrogen phosphate dihydrate, citric acid monohydrate, sodium hydroxide (E-524), and purified water.

Appearance of the Product and Package Contents

Brown solution for cutaneous use available in plastic bottles with a dropper and cap.

Available in single-unit packages of 5 tubes of 10 ml and 5 tubes of 5 ml, and in clinical packages of 200 tubes of 10 ml and 200 tubes of 5 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/