TOPIONIC 100 mg/ml CUTANEOUS SOLUTION

Introduction

Leaflet: Information for the user

Topionic 100 mg/ml cutaneous solution

Povidone iodine

Contents of the leaflet:

1. What is Topionic and what is it used for
2. What you need to know before starting to use Topionic
3. How to use Topionic
4. Possible side effects
5. Storage of Topionic
6. Package contents and additional information

1. What is Topionic and what is it used for

Topionic is a cutaneous antiseptic medicine. The active ingredient, povidone iodine, belongs to the group of drugs called iodine products.

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

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

Do not use Topionic

• If you are allergic to povidone iodine, iodine, iodine-containing medicines, or any of the other components of this medicine (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 cutaneous solution.

• Do not use this product for a prolonged period 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 is necessary or it must be applied to burns or large areas of the skin, thyroid function tests should be performed.

• Patients with goiter, thyroid nodules, or other non-acute thyroid diseases are at risk of developing hyperthyroidism with the administration of high amounts of iodine. In these patients, it should not be applied for prolonged periods or on large areas of skin unless strictly indicated. Even after treatment, you should be alert to early symptoms of possible hyperthyroidism and, if necessary, have your thyroid function checked.

• It should not be used before or after a radioactive iodine scan or treatment of thyroid carcinoma with radioactive iodine.

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

• Contact with the eyes, ears, and other mucous membranes should be avoided.

• If used in preparation before an operation, avoid accumulation under the patient. It can cause irritation and rarely severe reactions on the skin. Chemical burns on the skin can occur due to accumulation. In that case, suspend its 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 medicine may interfere with the results of diagnostic tests for thyroid function and may lead to errors in test results with toluidine or guaiacol for the determination of hemoglobin or glucose in feces or urine, so you should 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
• The use in children under 30 months, if indispensable, will be limited to a brief and not extensive application, followed by a rinse with sterile water
• Due to the presence of terpene derivatives and in case patients do not comply with the recommended doses, there is a risk of convulsions in children and babies.

Other medicines and Topionic

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

Topionic should not be applied at the same time as other products that contain mercury derivatives, silver, hydrogen peroxide, or taurolidine (antiseptics), as they react with iodine to form compounds that are irritants.

If you are taking lithium (a medicine used to treat some types of depression), you should avoid continuous use of Topionic without first consulting your doctor.

When used at the same time or after antiseptics with octenidine, a transient dark discoloration of the involved areas may appear.

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.

Use only if strictly indicated, and its use should be kept to a minimum. Avoid continuous use.

Its use could produce transient hypothyroidism in fetuses and newborns. Thyroid control may be necessary in children.

Driving and using machines

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

Topionic contains hydrogenated polyoxyethylene castor oil

This medicine may cause skin reactions because it contains hydrogenated polyoxyethylene castor oil.

This medicine contains niauli essence and eucalyptus essential oil, which contain d-limonene. D-limonene may cause allergic reactions. The terpene derivatives of this excipient may decrease the epileptogenic threshold and lead to neurological accidents such as convulsions in infants and children in excessive doses.

3. How to use Topionic

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor. In case of doubt, ask your doctor or pharmacist.

Topionic is a solution for cutaneous use.

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

Use in children

The use in children under 30 months, if indispensable, will be limited to a brief and not extensive application, followed by a rinse with sterile water.

If you use more Topionic than you should

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

The symptoms could be abdominal pain, anuria (suppression or reduction of urine), circulatory, respiratory, and metabolic problems. Excess iodine can produce goiter, hypothyroidism, and hyperthyroidism.

In case of accidental ingestion, go to a medical center or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

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

Very rare side effects (may affect less than 1 in 10,000 people) include anaphylactic reactions (severe allergic reaction), hyperthyroidism with tachycardia and agitation, and angioedema (swelling caused by allergy).

Other side effects of unknown frequency have been hypothyroidism, electrolyte imbalance, metabolic acidosis, acute kidney failure, liver failure, abnormal blood osmolality, exfoliative dermatitis, dry skin, and chemical burns on the skin.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Topionic

Keep this medicine out of the sight and reach of children.

Store in a cool place.

Do not use this medicine after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition ofTopionic

• The active ingredient is povidone iodine. Each ml of cutaneous solution contains 100 mg of povidone iodine.
• The other components are povidone, potassium iodate, sodium citrate (E-331), sodium hydroxide, oleic acid polyoxyethylene, hydrogenated polyoxyethylene castor oil, hydrophilic glycerol caprylate, glycerol caprylate, isopropyl myristate, niauli essence (contains d-limonene), eucalyptus essential oil (contains d-limonene), and purified water.

Appearance of the product and package contents

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

Marketing authorization holder and manufacturer

Marketing authorization holder:

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona (Spain)

Manufacturer:

Reig Jofré, S.A.

C/ Gran Capità, 10

08970 Sant Joan Despí

Barcelona (Spain)

Date of the last revision of this leaflet: March 2022