Topionic 100 mg/ml cutaneous solution
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Topionic 100 mg/ml cutaneous solution
Povidone iodine
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you. Always follow exactly the instructions for taking this medicine as described in this leaflet or as your doctor, pharmacist, or nurse has instructed you.
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Package leaflet contents:
- What Topionic is and what it is used for
- What you need to know before using Topionic
- How to use Topionic
- Possible side effects
- Storage of Topionic
- Contents of the pack and other information
1. What Topionic is and what it is used for
Topionic is a topical antiseptic medicine. The active substance, povidone iodine, belongs to a group of medicines called iodine compounds.
Topionic is used as a general antiseptic for the skin in minor wounds and superficial cuts, mild burns, or abrasions.
2. What you need to know before using Topionic
Do not use Topionic
- If you are allergic to povidone-iodine, iodine, iodine-containing medicines, or any of the other ingredients of this medicine (listed in section 6).
- If you are using other products containing mercury derivatives.
- If you have hyperthyroidism or other acute thyroid diseases.
- In newborns from 0 to 1 month of age.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before using Topionic cutaneous solution.
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Do not use this product for prolonged periods or over large areas of skin without consulting your doctor, especially if you have kidney disease, burns affecting more than 20% of your body surface, large or open wounds, thyroid disorders, or are being treated with lithium.
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When prolonged use of povidone-iodine is required, or when it must be applied to burns or extensive skin areas, thyroid function tests should be performed.
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Patients with goiter, thyroid nodules, or other non-acute thyroid diseases are at risk of developing hyperthyroidism when exposed to high amounts of iodine. In these patients, prolonged application over large skin areas should be avoided unless strictly indicated. Even after treatment ends, early symptoms of possible hyperthyroidism should be monitored, and thyroid function should be checked if necessary.
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Do not use before or after radioactive iodine scintigraphy or radioactive iodine treatment for thyroid carcinoma.
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This product is for external use only, on the skin.
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Avoid contact with eyes, ears, and other mucous membranes.
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If used as a preoperative preparation, avoid pooling under the patient. This may cause irritation and, rarely, severe skin reactions. Chemical burns of the skin may occur due to accumulation. In such cases, discontinue use.
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Do not heat the product before application.
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Topionic may stain skin and clothing. Use water to remove stains from the skin. To remove stains from clothing, wash the garment with water and soap.
Interference with diagnostic tests
This medicine may interfere with diagnostic test results for thyroid function and may lead to errors in tests using toluidine or guaiacol for detecting hemoglobin or glucose in feces or urine. Therefore, inform your doctor before undergoing these tests.
Inform your doctor if you are scheduled for any type of diagnostic test.
Children
- Do not administer to children under 30 months of age without consulting a doctor.
- Use in children under 30 months of age, if absolutely necessary, should be limited to brief and limited application, followed by rinsing with sterile water.
- Due to the presence of terpene derivatives, and in cases where patients do not adhere to recommended doses, there is a risk of seizures in children and infants.
Other medicines and Topionic
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
Do not apply Topionic at the same time as other products containing mercury derivatives, silver, hydrogen peroxide, or taurolidine (antiseptics), as these react with iodine to form irritating compounds.
If you are taking lithium (a medicine used to treat certain types of depression), you should avoid prolonged use of Topionic without first consulting your doctor.
When used simultaneously or after antiseptics containing octenidine, transient dark discoloration of the affected areas may occur.
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.
Use only if strictly indicated; its use should be kept to the absolute minimum. Avoid prolonged use.
Its use could cause transient hypothyroidism in fetuses and newborns. Thyroid monitoring in infants may be necessary.
Driving and use of machines
No effects on the ability to drive or use machines have been reported.
Topionic contains polyoxethylated hydrogenated castor oil
This medicinal product may cause skin reactions as it contains polyoxethylated hydrogenated castor oil.
This medicinal product contains niaouli essence and eucalyptus essential oil, which contain d-limonene. d-limonene may cause allergic reactions. The terpene derivatives of this excipient may lower the epileptogenic threshold and lead to neurological events such as seizures in infants and children if excessive doses are used.
3. How to use Topionic
Follow exactly the instructions for use provided in this leaflet or those given by your doctor. If in doubt, consult 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 daily.
Use in children
Use in children under 30 months of age, if absolutely necessary, should be limited to brief and limited application, followed by rinsing with sterile water.
If you use more Topionic than you should
If an excessive amount of the product is applied and skin irritation occurs, wash the affected area thoroughly with abundant water. If irritation persists, consult your doctor.
Symptoms may include abdominal pain, anuria (suppression or reduction of urine), circulatory, respiratory, and metabolic disorders. Excess iodine may cause goiter, hypothyroidism, and hyperthyroidism.
In case of accidental ingestion, go to a medical center or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.
Although povidone-iodine is less irritating than iodine, local skin reactions such as local irritation, itching or stinging may occasionally occur. In such cases, treatment should be discontinued and the affected area washed with water.
Rare adverse effects (may affect between 1 and 10 out of 10,000 people) include hypersensitivity and contact dermatitis, which manifests as red skin, small blisters and itching.
Very rarely (may affect fewer than 1 in 10,000 people), anaphylactic reactions (severe allergic reaction), hyperthyroidism with tachycardia and agitation, and angioedema (swelling due to allergy) have been observed.
Other adverse effects of unknown frequency include hypothyroidism, electrolyte imbalance, metabolic acidosis, acute renal failure, hepatic failure, abnormal blood osmolarity, exfoliative dermatitis, dry skin, and chemical burn on the skin.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.
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: www.notificaRAM.es
By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. Ask your pharmacist how to properly discard containers and medicines you no longer need. This way, you will help protect the environment.
6. Contents of the pack and other information
Composition of Topionic
- The active substance 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, polyoxyethylene oleyl alcohol, polyoxyethylene hydrogenated castor oil, hydrophilic glyceryl caprylocaprate, glyceryl caprylocaprate, isopropyl myristate, niaouli essence (containing d-limonene), eucalyptus essential oil (containing d-limonene), and purified water.
Appearance of the product and contents of the pack
The solution is dark brown in colour. It is supplied in 25 ml, 100 ml and 500 ml polypropylene bottles.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 most recent review of this leaflet: March 2022