Curadona 100 mg/ml cutaneous solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Curadona 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.
Always follow exactly the instructions for use of this medicine as described in this leaflet or as given 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 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 if you do not improve after 7 days.
Contents of the leaflet
- What Curadona is and what it is used for
- What you need to know before using Curadona
- How to use Curadona
- Possible adverse effects
- How to store Curadona
- Contents of the pack and other information
1. What Curadona is and what it is used for
Povidone iodine, the active substance in this medicine, is an antiseptic and disinfectant (a substance that prevents the growth of microorganisms) containing iodine.
Curadona is indicated as a general antiseptic for use on:
- Skin (for minor wounds and superficial cuts, mild burns, or abrasions).
- Surgical fields, puncture sites, wounds, burns, and surgical instruments.
- Microbial and mycotic dermatitis.
- Irrigation of septic body areas (peritoneum, pleura, bones).
You should consult a doctor if your 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 to povidone iodine, to other 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
Consult 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 any 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.
Other medicines and Curadona
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 (a medicine used to treat certain depressive disorders).
Interference with diagnostic tests:
This medicine may interfere with tests of thyroid function and with tests for detecting occult blood in feces and urine. Therefore, you must inform your doctor that you are using Curadona before undergoing such tests.
Use in children
Do not administer this medicine to children under 30 months of age without first consulting a doctor.
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 medicine.
Pregnant or breastfeeding women should avoid using this medicine, as it may cause transient hypothyroidism (a condition occurring when thyroid gland activity decreases) in the fetus or infant.
Driving and using machines
The use of this medicine does not affect the ability to drive and/or operate machinery.
3. How to use Curadona
Follow exactly the instructions for administering this medicine provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose: Apply a small amount directly to the affected area, 2 to 3 times daily.
Method of administration
For topical use only.
Wash and dry the affected area before applying the product.
If symptoms worsen or persist after 7 days, consult your doctor.
If you use more Curadona than you should
If you have used more Curadona than recommended, consult your doctor or pharmacist. In case of overdose or accidental ingestion, contact the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If an excessive amount of the product has been applied and skin irritation occurs, wash the affected area thoroughly with water, discontinue treatment, and if irritation persists, seek medical advice.
Ingestion of large amounts of povidone iodine may cause: abdominal pain, diarrhea, fever, nausea, vomiting, metabolic acidosis, and hypernatraemia (excess sodium in the blood), as well as impairment of kidney, liver, and thyroid function. Excess iodine may also cause goitre, hypothyroidism, or hyperthyroidism.
In such cases, if the patient is conscious, milk should be administered 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. Gastric lavage or induction of vomiting must not be performed if the patient has oesophageal injury.
Other supportive measures to maintain vital functions may be applied, such as administration of oxygen to support respiration, and antihistamines, epinephrine, or corticosteroids for the treatment of anaphylaxis.
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 produce adverse effects, although not everyone will experience them.
During the period of use of povidone-iodine, the following adverse effects have been observed, although their frequency could not be established accurately: occasionally skin disorders such as local irritation, itching, or burning sensation. In these 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 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 via 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
No special storage conditions are required.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, 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 millilitre of solution contains 100 mg of povidone iodine.
- The other components (excipients) are: glycerol (E-422), polyethylene glycol alkyl ether, sodium phosphate, citric acid, sodium hydroxide (E-524) and purified water.
Nature of the product and pack contents
Brown-coloured solution for cutaneous use, available in plastic bottles with dropper and cap. Available in single packs of 30, 60 and 250 ml, and in clinical packs containing 10 bottles of 250 ml, 10 bottles of 500 ml, and 25 bottles of 125 ml.
Only some pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
LAINCO, S.A. – Avda. Bizet, 8-12 - 08191 Rubí (Barcelona), Spain
Date of the most recent revision of this summary: September 2024
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.gob.es/