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TROSYL NAIL SOLUTION

Active substance(s): TIOCONAZOLE

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Package leaflet: Information for the patient
UNITED KINGDOM

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

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, 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 fungi.

• 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.
• A pply 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 hours.
• Leave the solution to dry for 10-15 minutes after application.
• T he 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.
• T he film should be left intact as long as possible. This allows the antifungal agent to
have maximum effect.
• T ry 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 months.

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).

Continued overleaf...

You will find more about TROSYL on the back of this leaflet

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If anyone accidentally swallows this medicine

• Replace cap securely after use.

If you accidentally take this medicine by your mouth, contact your doctor or accident
and emergency department straight away.

Do not throw away medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect the
environment.

If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines this medicine can cause side effects, although not everybody gets
them.
Common side effects (may affect up to 1 in 10 people).
Swelling of hands and feet.

6. Contents of the pack and other information
What Trosyl contains
The active substance in Trosyl is tioconazole.
The other ingredients are ethyl acetate and undecylenic acid.

What Trosyl looks like and contents of the pack

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.

Trosyl is a clear, pale yellow nail solution. It is provided in a glass bottle with a screw
cap fitted with an applicator, containing 12 ml of solution.

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.

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

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 skin.

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: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Trosyl

Marketing Authorisation Holder:
Manufacturer:
Farmasierra Manufacturing S.L., Carretera de Irun, Km. 26,200, 28700 San Sebastian de
los Reyes, Madrid, Spain

Company Contact Address:
For further information on your medicine, please contact Medical Information at Pfizer
Limited, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS
Telephone 01304 616161
This leaflet was last revised in 06/2013.


Ref: TY7_1

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 carton after EXP.
The expiry date refers to the last day of the month.

2013-0006742/1

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• Do not store above 25°C.
• Avoid flame and heat.
• Do not refrigerate.

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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.

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