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Active substance(s): TIOCONAZOLE

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Trosyl® 283mg/ml Nail Solution / Tioconazole 283mg/ml Nail Solution
Package Leaflet: Information for the User
Your medicine is known by one of the above names but will be referred to as
Trosyl throughout this leaflet.
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 or pharmacist.
 This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, 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 or pharmacist. This
includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1) What Trosyl is and what it is used for
2) What you need to know before you use Trosyl
3) How to use Trosyl
4) Possible side effects
5) How to store Trosyl
6) Contents of the pack and other information

1) What Trosyl is and what it is used for
This medicine contains tioconazole, which is one of a group of medicines
called antifungals.
Trosyl is used in adults and children to treat nail infections caused by certain

2) What you need to know before you use Trosyl
Do not use Trosyl:
 If you have ever had an allergic reaction to tioconazole or any of the other
ingredients of this medicine (listed in section 6).
 If you have ever had an allergic reaction to any other medicines you have
taken or used to treat fungal infection.
 If you are pregnant.

Warnings and precautions
Talk to your doctor or pharmacist before using Trosyl:
 If you are breast-feeding as you may be told to stop during your treatment.
Make sure you do not put this medicine in your eyes.
Pregnancy and breast-feeding
 If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
using this medicine.

3) How to use Trosyl
Always use this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
 Apply the nail solution thinly to cover the whole of the affected nail(s) and
surrounding skin using the brush provided. Apply the solution every 12
 Leave the solution to dry for 10-15 minutes after application.
 The solution does not dry hard. A transparent, slightly greasy film is left
on the nail. This film contains the antifungal agent and it slowly passes
through the nail to reach the site of infection.
 The film should be left intact as long as possible. This allows the
antifungal agent to have maximum effect.
 Try to avoid putting your hands (or feet if your toenails are affected) in
soapy water immediately after applying the solution. Soap or detergent
removes the film. Water alone does not remove the film.
 If you need to wash anything by hand, it is best to wear rubber gloves.
 It is usual for treatment to last for up to six months, and in some cases 12
If anyone accidentally swallows this medicine
If you accidentally take this medicine by your mouth, contact your doctor or
accident and emergency department straight away.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

4) Possible side effects

5) How to store Trosyl

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

 Keep all medicines out of the sight and reach of children.
 Do not use Trosyl after the expiry date which is stated on the bottle label
and the outer carton. The expiry date refers to the last day of that month.
 Keep away from eyes. Replace cap securely after use.
 Do not store above 30°C. Do not refrigerate. Avoid flame and heat.
 If the nail solution becomes discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist who will tell
you what to do.
 Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment

Common side effects (may affect up to 1 in 10 people).
Swelling of hands and feet.
Uncommon side effects (may affect up to 1 in 100 people).
Rash, skin irritation around the nails which have been treated. This usually
occurs during the first week of treatment and tends to be short-lived and mild.
Not known (frequency cannot be estimated from the available data).
Allergic reaction, which includes itching, dry skin, swelling or blistering of the
skin, particularly on the face and around the eyes.
You may also experience nail discolouration, inflammation, pain or burning.
You may also feel tingling sensations in the hands or feet or a peeling of the
Reporting of side effects
If you get any side effects, talk to your doctor pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
By reporting side effects you can help provide more information on the safety
of this medicine.

6) Contents of the pack and other information
What Trosyl contains
The active substance in Trosyl is tioconazole.
Each ml contains 283mg of the active ingredient tioconazole.
The other ingredients are: ethyl acetate and undecylenic acid.
What Trosyl looks like and contents of the pack
Trosyl is a clear pale yellow solution for topical application contained in an
amber glass bottle with a screw cap fitted with an applicator brush.
Each bottle contains 12ml of solution.
PL 10383/2041

Trosyl 283mg/ml Nail Solution /
Tioconazole 283mg/ml Nail Solution


Who makes and repackages your medicine?
Your medicine is manufactured by Farmasierra Manufacturing S.L., Carretera
de Irun, Km. 26,200, 28700 San Sebastian de los Reyes, Madrid, Spain.
Procured from within the EU and repackaged by the Product Licence Holder:
Primecrown Ltd., 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex, UB5 5QS.
Leaflet date: 05.11.2013
Trosyl® is a registered trademark of Pfizer Ltd.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.