Leaflet: information for the user

Curadona 100 mg/g gel

Povidone iodine

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

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

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

1. What is Curadona 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. Contents of the pack and additional information

It is a general-purpose skin antiseptic for use on small wounds and superficial cuts, minor burns or scrapes.

Consult a doctor if it worsens or does not improve after 7 days.

No use Curadona:

• If you are allergic (hypersensitive) to iodine-containing products or medications or to any of the other components of this medication (listed in section 6).
• In newborns (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 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.

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.

Use of Curadona with other medications

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

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

• Other products containing mercury derivatives, as these react with iodine to form irritating compounds.
• Sodium thiosulfate (used for the treatment of fungal infections).
• Lithium.

Interference with diagnostic tests:

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

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and operating machinery

No effects of this medication on the ability to drive and operate machinery have been described.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of 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 recommended to cover the treated area with a gauze.

Skin 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, discontinue treatment, and if irritation continues, seek medical attention.

In cases of ingestion of large amounts of povidone iodine, 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 drink milk every 15 minutes to alleviate stomach irritation. Additionally, in order to eliminate 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, the stomach lavage or inducing vomiting cannot be performed.

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.

Like all medications, this medicationmay have adverse effects, although not all people may experience them.

During the period of use of povidone iodine, the following adverse effects have been observed, whose frequency has not been established with precision: rarely, 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, adverse effects can be more severe if the product is used for a long time, or if it is 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 Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through theSpanish 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.

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.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Curadona

• The active principle 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 contents of the packaging

Curadonais a brown gel for cutaneous use that is presented in polyethylene tubes with polypropylene stoppers in the following presentations: a case with 1 tube of 30 g, a case with 1 tube of 100 g and a case with 5 tubes of 5 g.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing:

LAINCO, S.A.

Av. Bizet, 8-12

08191 RUBÍ (Barcelona)

Spain

Last review date of this leaflet:May2018

Other sources of information

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