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TIOCONAZOLE 283 MG/ML NAIL SOLUTION

Active substance(s): TIOCONAZOLE

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Trosyl® Nail Solution /
Tioconazole 283 mg/ml Nail Solution
(tioconazole)
Package leaflet: Information for the patient
This product is available as any of the above names but will be
referred to as Trosyl throughout the following 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, 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.
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 hours.
• 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 months.

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 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.
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 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
• Keep 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.
• Do not store above 25°C. Do not refrigerate. Avoid flame and
heat.
• Replace cap securely after use.
• 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 your medicine becomes discoloured or shows signs of any
deterioration, should ask your doctor or pharmacist for advice.
6. Contents of the pack and other information
What Trosyl contains
The active substance in Trosyl is tioconazole.
Each ml solution contains 283mg 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 in an amber glass bottle with
a screw cap fitted with an applicator.
Trosyl is supplied in bottles containing 12ml of solution.
PL: 15814/1130 POM
Manufacturer:
Trosyl is manufactured by Farmasierra Manufacturing, S.L., Ctra.
N-I, Km 26,200. 28700, San Sebastian de los Reyes, Madrid,
Spain.
Procured from within the EU and repackaged by the Product
Licence holder: O.P.D. Laboratories Ltd., Unit 6 Colonial Way,
Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 04.03.2015.
Trosyl is a trademark of Pfizer Limited, UK.
To request a copy of this leaflet in Braille, large print or audio
please call 01923 332 796.

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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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