Normovidona 100 mg/ml cutaneous solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Normovidone 100 mg/ml cutaneous solution
Povidone iodine
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or does not improve after 7 days.
Contents of the leaflet
- What Normovidone is and what it is used for
- What you need to know before using Normovidone
- How to use Normovidone
- Possible side effects
- How to store Normovidone
- Contents of the pack and other information
1. What Normovidona is and what it is used for
Povidone iodine, the active substance in this medicine, is an antiseptic (which destroys germs that cause infections) containing iodine.
Normovidona is indicated as a general antiseptic for use on the skin, in cases of minor 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 using Normovidona
Do not use Normovidona
- If you are allergic to iodine, iodine-containing medicines, or any of the other ingredients of this medicine (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 long periods or on large areas of skin without consulting your doctor, especially if:
- you have burns affecting more than 20% of the body surface,
- you have large or open wounds,
- you suffer from kidney or liver disease,
- you have a thyroid disorder,
- you are being treated with lithium-containing medicines.
If your doctor indicates that it is necessary to use this medicine for a prolonged period or on burns or extensive skin areas, you should consult your doctor about the need for thyroid function tests.
Do not heat the product before applying it.
This product is for external use only, on the skin.
Avoid contact with eyes, ears, and other mucous membranes.
Children
Do not administer this medicine to children under 30 months of age without first consulting a doctor.
Interference with diagnostic tests:
This medicine may interfere with the results of thyroid function tests and tests for detecting occult blood in feces or urine. Inform your doctor before undergoing these tests.
Use of Normovidona with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Do not apply povidone-iodine at the same time as products containing mercury derivatives, as these react with iodine to form irritating compounds.
Patients receiving lithium treatment should avoid prolonged use of this product without first consulting their doctor.
Consult your doctor if you are using this medicine concurrently with sodium thiosulfate (used for the treatment of fungal infections).
Use of Normovidona with food and drink
No interaction between the use of this medicine and food or drink has been reported.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnant or breastfeeding women should avoid using this medicine, as it may cause transient hypothyroidism (a condition caused by reduced activity of the thyroid gland) in the fetus or breastfed infant.
Driving and using machines
Normovidona does not affect the ability to drive or operate machinery.
3. How to use Normovidona
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult 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 skin and clothing. If this occurs, use water to remove the stain from the skin. 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
If an excessive amount of the product is applied and skin irritation occurs, wash the affected area thoroughly with plenty of water, discontinue treatment, and if irritation persists, consult 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), hypernatremia (elevated sodium levels in the blood), as well as disturbances in kidney, liver, and thyroid function.
In case of accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount taken.
In cases of accidental ingestion, if the patient is conscious, they should drink milk every 15 minutes to help relieve stomach irritation. In addition, to eliminate any remaining povidone iodine, a starch solution should be administered, prepared by adding 15 mg of corn starch or 15 mg of flour to 500 ml of water. If the patient has esophageal damage, gastric lavage or emesis (induced vomiting) must not be performed.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause 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 cannot be accurately determined: rarely, skin disorders such as local irritation, itching, or stinging. In such cases, treatment should be discontinued and the affected area washed with water.
However, adverse effects may become more serious if the product is used for a prolonged period or applied to large wounds or extensive burns, potentially leading to systemic adverse effects such as metabolic acidosis (excessive acidity in the blood), hypernatremia (elevated blood sodium levels), and disturbances in kidney, liver, and thyroid function (especially in children).
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not mentioned in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Normovidona
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage temperature. Keep the bottle tightly closed. Store the container in the outer packaging to protect it from light.
Do not use this medicine after the expiry date stated on the bottle after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Normovidona
The active substance is povidone-iodine. Each millilitre of solution contains 100 mg of povidone-iodine.
The other components (excipients) are: disodium phosphate and purified water.
Appearance of the product and contents of the container
Normovidona is supplied 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 most recent review of this leaflet: April 2009
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/