Curadona 100 mg/ml vaginal solution
SpainTable of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Curadona 100 mg/ml vaginal 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 administration of this medicine as provided 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 further information, consult your pharmacist.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if these adverse reactions 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 of treatment.
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
It is an antiseptic used for washing the external vaginal area (vulvovaginal) and for relief of symptoms associated with vaginal infections.
You should consult a doctor if symptoms worsen or do not improve after 7 days.
2. What you need to know before starting to use 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
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 a thyroid disorder
- you are being treated with lithium-containing medicines.
Do not heat the product before applying it.
This medicine is for external vaginal use only (vulvovaginal).
Avoid contact with eyes, ears, and other mucous membranes apart from the vaginal mucosa.
Children
Curadona is contraindicated in girls under 1 month of age. Do not use in children under 30 months of age without consulting a doctor.
Use of Curadona with other medicines
Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use 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 contamination with povidone iodine.
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 women or those who are breastfeeding should avoid using this medicine, as it may cause transient hypothyroidism (a condition that occurs when thyroid gland activity decreases) in the fetus or breastfed 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 administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose is:
Adult women and girls from 1 month of age: Wash the affected area 1 or 2 times a day with a dilution of 20 ml of product (measured with the dosing cup) per liter of boiled and lukewarm water.
Vaginal use.
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, the following may occur: abdominal pain, diarrhea, fever, nausea, vomiting, metabolic acidosis, hypernatremia, and disturbances in kidney, liver, and thyroid function.
In such cases, if the patient is conscious, they should drink milk every 15 minutes to relieve stomach irritation. Additionally, 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 esophageal damage.
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 will experience them.
During the period of use of povidone iodine, the following adverse effects have been observed, whose frequency cannot be precisely 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 applied to large wounds or extensive burns, mainly metabolic acidosis, hypernatremia (excess sodium in 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 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 have any doubts, 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: macrogol lauril ether and purified water.
Appearance of the medicine and contents of the pack
Curadona is a brown-coloured solution for vaginal use, supplied in high-density polyethylene bottles containing 125 ml and 250 ml, and in clinical packs containing 25 bottles of 125 ml each.
A polypropylene dosing cup is included.
Only certain 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 review of this leaflet: June 2018
Other sources of information
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/