Curadona Scrub 75 mg/ml cutaneous solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Curadona scrub 75 mg/ml cutaneous solution

Povidone iodine

Read the entire leaflet carefully before you start using this medicine, as 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 effects, consult your doctor or pharmacist, even if they are adverse effects 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

1. What Curadona scrub is and what it is used for
2. What you need to know before using Curadona scrub
3. How to use Curadona scrub
4. Possible side effects
5. How to store Curadona scrub
6. Contents of the pack and other information

1. What Curadona scrub 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 scrub is indicated as a general antiseptic for:

• Skin (for minor wounds and superficial cuts, mild burns, or abrasions).
• Surgical sites, puncture areas, wounds, burns, and surgical instruments.
• Microbial and mycotic dermatitis.
• Irrigation of septic areas of the body (peritoneum, pleura, bones).

You should consult a doctor if you get worse or do not improve after 7 days.

2. What you need to know before using Curadona scrub

Do not use Curadona scrub

• 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 newborn infants (from 0 to 1 month of age).

Warnings and precautions

Consult your doctor or pharmacist before using Curadona scrub.

Do not use this medicine for prolonged periods or over 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.

Other medicines and Curadona scrub

Tell 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 scrub 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 types of depression)

Interference with diagnostic tests:

This medicine may interfere with thyroid function tests and with tests for occult blood in feces and urine. Therefore, inform your doctor that you are using Curadona scrub 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 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 resulting from decreased activity of the thyroid gland) in the fetus or breastfed infant.

Driving and using machines

The use of this medicine does not affect your ability to drive and/or operate machinery.

3. How to use Curadona scrub

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.

Recommended dose: Apply a small amount directly to the affected area, 2 to 3 times daily.

Method of administration

For topical use only.

After application, rub for approximately 2–5 minutes until foam forms. Rinse thoroughly with plenty of water or with a sterile gauze soaked in water.

This medicine may stain skin and clothing. If this occurs, apply 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, consult your doctor.

If you use more Curadona scrub than you should

If you have used more Curadona scrub 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 name of the medicine and the amount ingested.

If an excessive amount of product has been applied and skin irritation occurs, wash the affected area thoroughly with water, discontinue treatment, and if irritation persists, seek medical advice.

In cases of ingestion of large amounts of povidone-iodine, the following may occur: 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 relieve gastric 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 oesophageal injury, gastric lavage or induction of vomiting must not be performed.

Other supportive measures to maintain vital functions may be applied, such as administration of oxygen to maintain respiration, and administration of 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 can cause 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 precisely determined: occasionally 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 severe if the product is used for prolonged periods, or applied to large wounds or extensive burns, potentially leading to systemic adverse effects such as mainly metabolic acidosis, hypernatraemia (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 scrub

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 is the last day of the month indicated.

Medicines should 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 containers and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Curadona scrub

• The active substance is povidone iodine. Each millilitre of solution contains 75 mg of povidone iodine.
• The other components (excipients) are: glycerol (E-422), PEG-7 glyceryl cocoate, sodium laureth sulfate, potassium iodate, sodium hydroxide (E-524) (for pH adjustment), and purified water.

Appearance of the product and contents of the container

Aqueous brown solution for cutaneous use, supplied in polyethylene bottles with a screw cap. Available in single packages of 100 ml, 250 ml, and 500 ml, and in clinical packs containing 10 bottles of 250 ml and 10 bottles of 500 ml.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

LAINCO, S.A. – Avda. Bizet, 8-12 - 08191 Rubí (Barcelona), Spain

Date of the most recent revision of this leaflet: September 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/