NORMOVIDONA 100 mg/mL CUTANEOUS SOLUTION

Introduction

Package Leaflet: Information for the User

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

1. What Normovidona is and what it is used for

The iodinated povidone, the active ingredient of this medication, is an antiseptic (which destroys germs that cause infections) that contains iodine.

Normovidona is indicated as a general skin antiseptic, in cases of small wounds and superficial cuts, mild burns, or abrasions.

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 Normovidona

Do not use Normovidona

• If you are allergic to iodine, iodinated medications, or any of the other components of this medication (listed in section 6).
• In newborn patients (0 to 1 month).

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use Normovidona.

Do not use this product 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's 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

If your doctor indicates that it is necessary to use this medication for a long period or that it should be used on burns or extensive 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

Children

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

Interference with Diagnostic Tests:

This medication may interfere with the results of thyroid function tests and tests for detecting hidden blood in stool or urine, so you should inform your doctor before undergoing these tests.

Using Normovidona with Other Medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Do not apply iodinated povidone at the same time as other products that contain mercury derivatives, as they react with iodine to form irritating compounds.

Patients being treated with lithium should avoid continuous use of this product without consulting their doctor first.

Consult your doctor if you are using this medication at the same time as sodium thiosulfate (used to treat fungal infections).

Using Normovidona with Food and Beverages

No interaction has been described between the use of this medication and the consumption of food and beverages.

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

Normovidona does not affect the ability to drive or use machines.

3. How to Use Normovidona

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

Wash and dry the affected area before applying the product.

Apply a small amount directly to the affected area 2 to 3 times a day

This product may stain the skin and clothing. If 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 7 days, you should consult a doctor.

If you use more Normovidona than you should

In case you apply an excessive amount of product and skin irritation occurs, wash the affected area with plenty of water, suspend treatment, and if irritation continues, consult a doctor.

In cases of accidental ingestion of large amounts of iodinated povidone, the following may occur: stomach pain, diarrhea, fever, nausea, vomiting, metabolic acidosis (excessive blood acidity), and hypernatremia (elevated blood sodium levels), as well as alterations in kidney, liver, and thyroid function.

In case of accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

In cases of accidental ingestion, if the patient is conscious, they should ingest milk every 15 minutes to alleviate stomach irritation. Additionally, to eliminate the remaining iodinated povidone, 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, lavage or emesis (vomiting) should not be performed.

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

4. Possible Side Effects

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

During the period of use of iodinated povidone, the following side effects have been observed, whose frequency cannot 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, potentially causing general adverse effects, such as metabolic acidosis (excessive blood acidity), hypernatremia (elevated blood sodium levels), and disorders of kidney, liver, and thyroid function (especially in children).

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting Side Effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Normovidona

Keep this medication out of sight and reach of children.

This medication does not require any special storage temperature. Keep the bottle perfectly closed. Store the package in the outer packaging to protect it from light.

Do not use this medication after the expiration date shown on the bottle 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 packages and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Normovidona

The active ingredient is iodinated povidone. Each milliliter of solution contains 100 mg of iodinated povidone.

The other components (excipients) are: disodium phosphate and purified water.

Appearance of the Product and Package Contents

Normovidona is presented in 50 ml bottles containing a reddish-brown solution.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Date of the Last Revision of this Package Leaflet:April 2009

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.es/