CURADONA scrub 7.5% skin solution

Povidone iodine

1. What isCURADONA scrub 7.5% skin solutionand for what it is used.

2. Before usingCURADONA scrub 7.5% skin solution

3. How to useCURADONA scrub 7.5% skin solution

4. Possible adverse effects.

5. Storage ofCURADONA scrub 7.5% skin solution

6. Additional information.

Povidone-iodine is an antiseptic (substance that prevents the growth of microorganisms) and disinfectant, which contains iodine.

It is indicated for the disinfectant washing of skin and hands with small wounds and superficial cuts, mild burns or abrasions.

Do not use CURADONA scrub 7.5% skin solution if:

-You are allergic to iodine, iodinated medications, or any of the components of this medication.

-Infants (0 to 1 month old).

Be especially careful with CURADONA scrub 7.5% skin solution

-Do not use this product 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, large or open wounds, renal failure, or thyroid disorders.

-If your doctor indicates that you need to use this medication for a long period of time or that it should be used on burns or large areas of the skin, you should consult with your doctor about the convenience of performing thyroid function tests.

-Do not heat the product before applying it.

-This product is for external use only, on the skin. Avoid contact with the eyes, ears, and other mucous membranes.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription.

Particularly, if you are usingCURADONA scrub 7.5%at the same time as other products containing mercury derivatives, as these react with iodine to form irritating compounds.

Patients undergoing lithium treatment should avoid continuous use ofCURADONA scrub 7.5%without first consulting a doctor.

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 usingCURADONA scrub 7.5%before they perform these tests.

Pregnancy

Consult your doctor or pharmacist before taking any medication.

Pregnant women should avoid continuous application ofCURADONA scrub 7.5%without first consulting a doctor.

Breastfeeding

Consult your doctor or pharmacist before taking any medication.

Administration is not recommended for women during the lactation period as the absorbed iodine may pass into breast milk, potentially causing hypothyroidism in the infant.

Driving and operating machinery

No effect on the ability to drive or operate machinery.

Use in children

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

CUTANEOUS USE.

Follow these instructions unless your doctor has given you different instructions.

Consult your doctor or pharmacist if you have any doubts. The normal dose is:

Use 2 to 3 times a day (or more often as needed), a small amount of product rubbing for 2-5 minutes until foam is obtained. Rinse with abundant water or with a sterile gauze soaked in water.

This product may stain the skin and clothing. In case this occurs, apply water to remove the stain from the skin and to remove stains from clothing, wash the garment with water and soap.

If symptoms worsen or persist after 5 days, consult your doctor.

If you use more CURADONA scrub 7.5% Cutaneous Solution than you should:

If you have used moreCURADONA scrub 7.5%than you should, consult your doctor or pharmacist. In case of overdose or accidental ingestion, contact the Toxicology Information Service, phone 91 562 04 20, indicating the product and the amount ingested.

In the event of applying an excessive amount of product and skin irritation occurs, wash the affected area with abundant water and, if irritation continues, see a doctor.

In cases of accidental ingestion of large amounts of povidone iodine, the following may occur: abdominal pain, diarrhea, fever, nausea, vomiting, metabolic acidosis, and hypernatremia, as well as renal, hepatic, and thyroid function alterations. 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 gastric irritation. Additionally, to absorb the remaining povidone iodine, 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 lavage or emesis cannot be performed.

Other measures to support vital functions, such as administering oxygen to maintain respiration and administering antihistamines, epinephrine, or corticosteroids for anaphylaxis treatment, may be considered.

Like all medications,Curadona scrub 7.5%may have adverse effects, although not everyone will experience them.

Although povidone iodine is less irritating than iodine, skin reactions may occur in rare cases, 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 reactions can be more severe if the product is used for a long time, or if it is applied to large wounds or extensive burns, potentially causing systemic adverse effects, such as metabolic acidosis, hypernatremia, and disorders of renal, hepatic, and thyroid function (especially in children).

In the event of observing the appearance of adverse reactions, they should be reported to the Pharmacovigilance systems, and treatment should be suspended if necessary.

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

No special storage conditions are required.

Keep out of the reach and sight of children.

EXPIRATION DATE

Do not useCURADONA scrub 7.5%after the expiration date indicated on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment..

Composition of CURADONA scrub 7.5% skin solution

Each 100 ml of solution contains as active ingredient:

7.5 g of iodinated povidone.

The other components (excipients) are: glycerol, cocoates of macrogolglycerol, sodium lauryl sulfate, potassium iodate, sodium hydroxide, and purified water, etc.

Appearance of the product and contents of the packaging

CURADONA scrub 7.5%is a skin solution for use that is presented in bottles with 100, 250, and 500 ml and in clinical containers with 10 bottles of 250 and 500 ml.

Holder of the marketing authorization and responsible for manufacturing:

LAINCO, S.A.

Av. Bizet, 8-12

08191 RUBÍ (Barcelona)

This prospectus has been approved in:

March 2007