TROSID 280 mg/ml MEDICINAL NAIL POLISH

Introduction

Package Leaflet: Information for the User

Trosid 280 mg/ml Medicinal Nail Varnish

Tioconazole

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What is Trosid and what is it used for

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

1. What is Trosid and what is it used for

Trosid contains tioconazole. It belongs to a group of medicines called antifungals used to treat various fungal infections. Trosid acts by eliminating or inhibiting the growth of fungi that cause these infections.

Trosid is indicated for the topical treatment of fungal infections of the nails (produced by sensitive fungi, dermatophytes, and Candida).

2. What you need to know before you use Trosid

Do not use Trosid

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medicine.

This medicine should only be applied to the affected nails with the supplied brush. Avoid contact with the eyes.

Children

Due to the type of components of this medicine, it should be used with caution in small children with a tendency to suck their fingers and nails.

Using Trosid with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

No interactions with other medicines have been reported.

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.

Although it has been shown that systemic absorption is insignificant after application to the skin, there is not enough data on the use of tioconazole in pregnant women. For this reason, tioconazole will only be used during pregnancy if your doctor considers that the possible benefit justifies the potential risk to the fetus.

It is not known whether this medicine is excreted in breast milk, but since many medicines are excreted in breast milk, it is recommended to temporarily interrupt breastfeeding while using tioconazole.

Driving and using machines

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

3. How to use Trosid

Follow exactly the administration instructions of this medicine 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) to the entire affected nail and the surrounding area, using the brush applicator included in the pack.

The duration of treatment to achieve healing is variable for each patient, depending on the causative microorganism and the location of the infection. Your doctor will indicate 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

Overdose by topical application of tioconazole is unlikely, as its systemic absorption is insignificant. At the indicated dose and route, no cases of intoxication have been reported. If the solution is accidentally ingested, go immediately to a healthcare center, where possible gastrointestinal irritation and/or central nervous system depression will be treated, and the need for a gastric lavage will be assessed.

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

If you forget to use Trosid

If you forget to apply a dose, do so as soon as you can.

If you stop using Trosid

Do not stop using Trosid without consulting your doctor, even if you notice an improvement.

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

4. Possible side effects

Like all medicines, Trosid can cause side effects, although not everybody gets them.

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

However, if a hypersensitivity reaction occurs during use, interrupt treatment and consult your doctor.

Side effects, ordered by frequency of occurrence, are:

• Frequent(may affect more than 1 in 100 patients):swelling of the limbs.
• Uncommon(may affect more than 1 in 1,000 patients):swelling and/or redness of the skin (dermatitis, rash).
• Frequency not known:abnormal sensation like cramp or tingling, swelling and/or redness of the skin with blisters (bullous rash), contact dermatitis, dry skin, nail disorder (including nail color change, inflammation around the nail, and nail pain), itching, skin irritation, scaling (exfoliation) of the skin, pain, allergic reaction, and urticaria (elevated red patches that itch).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System, https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Trosid

Do not store above 30°C.

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

Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the pack and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the pack and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition ofTrosid

• The active substance 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 pack contents

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

Marketing authorization holder and manufacturer

Marketing authorization holder: Pfizer, S.L. Avda. de Europa, 20-B. Parque Empresarial La Moraleja. 28108, Alcobendas (Madrid). Spain

Manufacturer: 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 medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/