Curadona 100 mg/g gel
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Curadona 100 mg/g gel
Povidone iodine
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.
- 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 adverse reactions, 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 if you do not improve after 7 days.
Leaflet contents
- What Curadona is and what it is used for
- What you need to know before using Curadona
- How to use Curadona
- Possible side effects
- How to store Curadona
- Contents of the pack and other information
1. What Curadona is and what it is used for
It is a general antiseptic for skin use in minor wounds and superficial cuts, mild burns, or abrasions.
You should consult a doctor if the condition worsens or does not improve after 7 days.
2. What you need to know before using Curadona
Do not use Curadona:
- If you are allergic (hypersensitive) to iodine-containing products or medicines or to any of the other ingredients of this medicine (listed in section 6).
- In newborns (from 0 to 1 month of age).
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Curadona.
Do not use this medicine for long periods or on large areas of skin without consulting your doctor, especially if:
- you have burns affecting more than 20% of your 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.
Do not heat the product before applying it.
This medicine is for external use only, on the skin.
Avoid contact with eyes, ears, and other mucous membranes.
Children
Curadona is contraindicated in children under 1 month of age. Do not use in children under 30 months of age without consulting your doctor.
Using Curadona with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
In particular, 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 medicine may interfere with thyroid function tests and with tests for detecting occult blood in feces and urine. Therefore, you must inform your doctor that you are using Curadona before undergoing these tests, due to povidone-iodine contamination.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you might 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 that occurs when the activity of the thyroid gland decreases) in the fetus or infant.
Driving and using machines
No effects of this medicine on the ability to drive or operate machinery have been reported.
3. How to use Curadona
Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in 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 advisable to cover the treated area with gauze.
For topical use only.
If you use more Curadona than you should
If an excessive amount of the product is applied and irritation occurs, wash the affected area thoroughly with abundant water, discontinue treatment, and if irritation persists, consult a doctor.
In cases of ingestion of large amounts of povidone iodine, symptoms may include: abdominal pain, diarrhea, fever, nausea, vomiting, metabolic acidosis, and hypernatremia, as well as impairment of kidney, liver, and thyroid function.
In such cases, if the patient is conscious, they should drink milk every 15 minutes to soothe stomach irritation. In addition, to eliminate any povidone iodine remaining in the stomach, 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 induction of vomiting must not be performed.
In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the product and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine may have adverse effects, although not everyone experiences 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 burning sensation. 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 prolonged periods or is applied to large wounds or extensive burns, mainly metabolic acidosis, hypernatremia (excess sodium in the blood), and disturbances in kidney, liver, and thyroid function (especially in children).
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Curadona
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Curadona
- The active substance is povidone iodine. Each gram of gel contains 100 mg of povidone iodine.
- The other components (excipients) are: macrogol 400, macrogol 4000, macrogol 6000 and purified water.
Appearance of the product and contents of the pack
Curadona is a brown-colored gel for cutaneous use supplied in polyethylene tubes with polypropylene caps, in the following pack sizes: box containing 1 tube of 30 g, box containing 1 tube of 100 g, and box containing 5 tubes of 5 g.
Only some pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer:
LAINCO, S.A.
Av. Bizet, 8-12
08191 RUBÍ (Barcelona)
Spain
Date of the most recent revision of this leaflet: May 2018
Other sources of information
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/