Leaflet: information for the user

Trosid 280 mg/ml nail varnish medicamentoso

Tioconazol

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms of illness as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet.

1. What you need to know before you start using Trosid
2. How to use Trosid
3. Possible side effects
4. Storage of Trosid
5. Contents of the pack and additional information

Trosid contains tioconazole. It belongs to a group of medications called antifungals used to treat various fungal infections. Trosidacts by eliminating or inhibiting the growth of fungi causing these infections.

Trosid is indicated for the topical treatment of fungal infections of the nails caused by sensitive fungi (dermatophytes andCandida).

Do not use Trosid

• if you are allergic to tioconazole, other imidazoles, or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medication

This medication should only be applied to the affected nails with the provided brush. Avoid contact with the eyes.

Children

Due to the type of components in this medication, it should be used with caution in small children who tend to suck their fingers and nails.

Use of Trosid with other medications

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

No interactions with other medications have been described.

Pregnancy and breastfeeding

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

Although systemic absorption has been shown to be insignificant after application to the skin, there are insufficient data on the use of tioconazole in pregnant women. Therefore, tioconazole should only be used during pregnancy if your doctor considers that the potential benefit justifies the potential risk to the fetus.

The excretion of this drug in breast milk is unknown, but since many drugs are excreted in breast milk, it is recommended to temporarily stop breastfeeding while using tioconazole.

Driving and operating machines

No effects on the ability to drive and operate machines are known.

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.

Trosid is applied twice a day (every 12 hours) over the entire affected nail and surrounding area, using the applicator brush included in the packaging.

The duration of treatment to achieve cure is variable for each patient, depending on the causative microorganism and the location of the infection. Your doctor will inform you of the duration of treatment with Trosid. Do not interrupt treatment before your doctor tells you to, even if your symptoms have improved.

Generally, the duration of treatment is approximately 6 months, although in some patients it may be extended to 12 months.

If you use more Trosid than you should

It is unlikely that a topical overdose of tioconazole will occur, as its systemic absorption is insignificant. At the indicated dose and route, no cases of intoxication have been described. If the solution is ingested by accident, seek immediate medical attention, where gastrointestinal irritation and/or central nervous system depression will be treated, and an appropriate gastric lavage will be evaluated.

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

If you forget to use Trosid

If you forget to apply a dose, do it as soon as possible.

If you interrupt treatment with Trosid

Do not interrupt treatment with Trosid without consulting your doctor, even if you notice improvement.

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

Like all medications, Trosid may produce adverse effects, although not all people will experience them.

Tioconazole is well tolerated after local application. The most frequent adverse effects are local irritation symptoms (including local allergic reactions) and these generally appear during the first week of treatment, being mild and transient. Systemic allergic reactions are rare.

However, if any hypersensitivity reaction occurs during its use, discontinue treatment and consult with your doctor.

The adverse effects, listed in order of their frequency of appearance are:

• Frequent(may affect more than 1 in 100 patients):Swelling of the extremities.
• Rare(may affect more than 1 in 1,000 patients):Swelling and/or redness of the skin (dermatitis, rash).
• Unknown frequency:Abnormal sensation like numbness or tingling, swelling and/or redness of the skin with blisters (vesicular eruption), contact dermatitis, dry skin, nail disorder (including nail color change, inflammation around the nail, and nail pain), itching, skin irritation, skin peeling (exfoliation), pain, allergic reaction, and urticaria (raised red itchy patches).

Reporting Adverse Effects

If you experience any type of adverse effect, consult with your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of human use medicines, https://www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication

Do not store at a temperature above 86°F (30°C).

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

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 unused medication at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medication. By doing so, you will help protect the environment.

Composition ofTrosid

• The active ingredient is tioconazole. Each ml of solution contains 280 mg of tioconazole.
• The other components are: undecylenic acid and ethyl acetate.

Appearance of the product and contents of the packaging

Trosid is presented in amber glass containers containing 12 ml of yellow or very pale yellow solution with characteristic odor. The containers are provided with an applicator brush.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization: Pfizer, S.L. Avda. de Europa, 20-B. Parque EmpresarialLa Moraleja.28108, Alcobendas (Madrid). Spain

Responsible for manufacturing:Farmasierra Manufacturing, SL.Ctra. Irún, Km 26,200. 28709, San Sebastián de los Reyes. Madrid. Spain

This leaflet was last revised in April 2017.

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