Leaflet: information for the user

Curadona 100 mg/ml vaginal 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 your symptoms worsen or do not improve after 7 days of treatment.

1. What is Curadona and what it is used for

2. What you need to know before starting to use Curadona

3. How to use Curadona

4. Possible side effects

5. Storage of Curadona

6. Contents of the pack and additional information

It is an antiseptic used for the washing of the external vaginal area (vulvovaginal) and for the relief of symptoms associated with vaginal infections.

Consult a doctor if it worsens or does not improve after 7 days.

No use Curadona:

• If you are allergic (hypersensitive) to iodine-containing products or medications or to any of the other components of this medication(listed in section 6).
• In newborns (0 to 1 month).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Curadona.

Do not use this medication 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.

Do not heat the product before applying it.

This medication is for external vaginal use only (vulvovaginal).

Avoid contact with the eyes, ears, and other mucous membranes other than the vagina.

Children

Curadona is contraindicated in girls under 1 month. Do not use in girls under 30 months without consulting a doctor.

Use of Curadona with other medications

Inform your doctor or pharmacist if you are using, have used recentlyor may need to use any other medication.

In particular, you should consult your doctor if you are usingCuradonaat the same time as:

• Other products containing mercury derivatives, as these react with iodine to form irritating compounds
• Sodium thiosulfate (used to treat fungal infections)
• Lithium.

Interference with diagnostic tests:

This medication may interfere with thyroid function tests and tests for blood in stool and urine, so you should inform your doctor that you are usingCuradonabefore these tests are performed,due to povidone iodine contamination.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become 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 is less active) in the fetus or infant.

Driving and operating machinery

No effects of this medication on the ability to drive and operate machinery have been described.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adult women and girls over 1 month: Wash the affected area 1 or 2 times a day with a dilution of 20 ml of product (measured with a dosing cup) per liter of boiled and warm water.

Vaginal route.

If you use more Curadona than you should

In the event of applying an excessive amount of product and irritation occurs, wash the affected area with plenty of water, discontinue treatment, and if irritation continues, see 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 alterations in kidney, liver, and thyroid function.

In these cases, if the patient is conscious, they should drink milk every 15 minutes to alleviate stomach irritation. Additionally, to eliminate povidone iodine that may remain in the stomach, 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 stomach lavage or inducing vomiting cannot be performed.

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the product and the amount ingested.

Like all medications, this medicationmay 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 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, mainly metabolic acidosis, hypernatremia (excess sodium in the blood) and disorders of kidney, liver, and thyroid function (especially in children).

Reporting Adverse Effects:

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

No special storage conditions are required.

Do not use this medication after the expiration date indicated on the packaging 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 packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Curadona

• The active principle is povidone iodide. Each milliliter of solution contains 100 mg of povidone iodide.
• The other components (excipients) are: lauryl macrogol ether and purified water.

Appearance of the product and contents of the packaging

Curadonais a brown-colored solution for vaginal use, presented in high-density polyethylene bottles containing 125 and 250 ml and in clinical containers of 25 bottles containing 125 ml.

Includesa polypropylene dosing vial.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

LAINCO, S.A.

Avenida Bizet, 8-12

08191 RUBÍ (Barcelona)

Spain

Last review date of this leaflet:June2018

Other sources of information

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