Leaflet: information for the user

Normovidona 100 mg/ml topical solution

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 it worsens or does not improve after 7 days.

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

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

Normovidona is indicated as a general-purpose skin antiseptic, in the case of small wounds and superficial cuts, mild burns or scrapes.

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

No use Normovidona

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

Children

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

Interference with diagnostic tests:

This medication may interfere with thyroid function tests and tests for occult blood in stool or urine, so inform your doctor before these tests are performed.

Use of Normovidona with other medications

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

Do not apply povidone iodine at the same time as other products containing mercury derivatives, as these react with iodine to form irritating compounds.

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

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

Use of Normovidona with food and beverages

No effects have been described between the use of this medication and the consumption of food and beverages.

Pregnancy and breastfeeding

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

Normovidona does not affect the ability to drive or operate machinery.

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

Clean 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. 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 7 days, you must consult your doctor.

If you use more Normovidona than you should

In case an excessive amount of product is applied and skin irritation occurs, wash the affected area with plenty of water, discontinue treatment and, if irritation continues, see your doctor.

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

In case of accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological 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 drink milk every 15 minutes to alleviate stomach irritation. Additionally, to eliminate any 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 (vomiting) cannot be performed.

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

Like all medications, this medication may produce adverse effects, although not everyone will 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 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, potentially producing general adverse effects, such as metabolic acidosis (excessive acidity in the blood), hypernatremia (elevated sodium levels in the blood), and disorders of kidney, liver, and thyroid function (especially in children).

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.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: 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.

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

Do not use this medication after the expiration date that appears on the bottle after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. In this way, you will help protect the environment.

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 contents of the packaging

Normovidona is presented in 50 ml bottles containing a brownish-red solution.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Date of the last review of this leaflet:April 2009

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