Package Insert: Information for the User

Topionic 100 mg/ml Topical Solution

Povidone-Iodine

Topionic is a topical antiseptic medication. The active ingredient, povidone iodine, belongs to the group of drugs known as iodated products.

Topionic is used as a general-purpose skin antiseptic for small wounds and superficial cuts, minor burns, or scrapes.

No use Topionic

• If you are allergic to povidone iodine, iodine, iodinated medications, or any of the other components of this medication (listed in section 6).
• If you are using other products that contain mercury derivatives.
• If you have hyperthyroidism or other acute thyroid diseases.
• In newborns from 0 to 1 month.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before using Topionic skin solution.

• Do not use this product for a long time or on large areas of the skin without consulting your doctor, especially if you have kidney disease, burns that affect more than 20% of your body, large or open wounds, thyroid disorders, or are being treated with lithium.

• In cases where prolonged use of povidone iodine or application on burns or large areas of the skin is necessary, thyroid function tests should be performed.

• Patients with goiter, thyroid nodules, or other non-acute thyroid diseases have a risk of developing hyperthyroidism with the administration of high doses of iodine. In these patients, do not apply for prolonged periods of time and on large areas of skin unless strictly indicated. Even at the end of treatment, be aware of early symptoms of possible hyperthyroidism and, if necessary, control thyroid function.

• Do not use before or after radioactive iodine scintigraphy or treatment of thyroid cancer with radioactive iodine.

• This product is for external use, on the skin.

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

• If used in preparation before surgery, avoid accumulation under the patient. It may cause irritation and rarely severe skin reactions. Chemical burns may occur on the skin due to accumulation. In that case, discontinue use.

• Do not heat the product before applying it.

• Topionic may stain the skin and clothing. Apply water to remove the stain from the skin. To remove stains from clothing, wash the garment with water and soap.

Interactions with diagnostic tests

This medication may interfere with thyroid function tests and may lead to errors in results of tests with toluidine or guaiacol for hemoglobin or glucose determination in stool or urine, so inform your doctor before undergoing these tests.

Inform your doctor when you need to undergo any type of diagnostic test.

Children

• Do not administer to children under 30 months without consulting a doctor
• Use in children under 30 months, if necessary, should be limited to a brief and limited application, followed by a rinse with sterile water
• Due to the presence of terpenic derivatives and in case patients do not comply with recommended doses, there is a risk of seizures in children and infants.

Other medications and Topionic

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

Do not apply Topionic at the same time as other products that contain mercury derivatives, silver, hydrogen peroxide, or taurolidina (antisetics), as these react with iodine to form irritating compounds.

If you are taking lithium (medication used to treat certain types of depression) avoid continuous use of Topionic without consulting your doctor.

When used simultaneously or after antisetics with octenidina, dark transitory discoloration of the involved areas may appear.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Use only if strictly indicated, and maintain use to the absolute minimum. Avoid continuous use.

Use may cause transient hypothyroidism in fetuses and newborns. Thyroid control may be necessary in children.

Driving and operating machines

No effects on the ability to drive or operate machines have been described.

Topionic contains hydrogenated polyoxylated ricin oil

This medication may cause skin reactions because it contains hydrogenated polyoxylated ricin oil.

This medication contains niauli essence and eucalyptus essential oil that contain d-limonene

d-limonene may cause allergic reactions.The terpenic derivatives of this excipient may decrease the epileptogenic threshold and lead to neurological accidents such as seizures in infants and children in excessive doses.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor. If in doubt, ask your doctor or pharmacist.

Topionic is a topical solution.

After washing and drying, apply a small amount directly to the affected area 2 to 3 times a day.

Use in children

Use in children under 30 months, if necessary, will be limited to a brief and limited application, followed by a rinse with sterile water.

If you use more Topionic than you should

In case an excessive amount of product is applied and skin irritation occurs, wash the affected area with plenty of water and, if the irritation continues, consult your doctor.

The symptoms may be abdominal pain, anuria (suppression or decrease in urine), circulatory, respiratory, and metabolic problems. Excessive iodine may cause goiter, hypothyroidism, and hyperthyroidism.

In case of accidental ingestion, consult a medical center or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Although povidone-iodine is less irritating than iodine, rare skin reactions may occur, such as local irritation, itching, or stinging. In these cases, treatment should be discontinued and the affected area washed with water.

Rare adverse effects (may affect between 1 and 10 of every 10,000 people) are hypersensitivity and contact dermatitis, which manifests with red skin, small blisters, and itching.

Very rarely (may affect fewer than 1 of every 10,000 people), severe allergic reactions (anaphylaxis), hyperthyroidism with tachycardia and agitation, and angioedema (allergic swelling) have been observed.

Other adverse effects of unknown frequency have been hypothyroidism, electrolyte imbalance, metabolic acidosis, acute renal insufficiency, liver insufficiency, abnormal blood osmolarity, exfoliative dermatitis, dry skin, and chemical burns on the skin.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: 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.

Store in a cool place.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition ofTopionic

• The active ingredient is povidone iodine. Each milliliter of topical solution contains 100 mg of povidone iodine.
• The other components are povidone, potassium iodate, sodium citrate (E-331), sodium hydroxide, oleic polyoxethylene glycol, hydrogenated ricinoleic polyoxethylene glycol, caprylic capryl glycerol hydrophilic, caprylic capryl glycerol, isopropyl myristate, niauli essence (contains d-limonene), eucalyptus essential oil (contains d-limonene), and purified water.

Appearance of the product and contents of the packaging

The solution is dark brown in color. It is presented in polypropylene bottles of 25 ml, 100 ml, and 500 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona (Spain)

Responsible for manufacturing:

Reig Jofré, S.A.

C/ Gran Capità, 10

08970 Sant Joan Despí

Barcelona (Spain)

Last review date of this leaflet: March 2022