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TIOCONAZOLE NAIL SOLUTION

Active substance(s): TIOCONAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Trosyl® Nail Solution /
Tioconazole Nail Solution 28%
(tioconazole)
This medicine is available as any of the above names but will be referred to as Trosyl
Nail Solution throughout the following:
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 of pharmacist. This includes any side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
What Trosyl Nail Solution is and what it is used for
2. What you need to know before you use Trosyl Nail Solution
3. How to use Trosyl Nail Solution
4. Possible side effects
5. How to store Trosyl Nail Solution
6. Contents of the pack and other information
1.

1. What Trosyl Nail Solution is and what it is used for
This medicine contains tioconazole, which is one of a group of medicines called
antifungals.
Trosyl Nail Solution is used in adults and children to treat nail infections caused by
certain fungi.
2. What you need to know before you use Trosyl Nail Solution
Do not use Trosyl Nail Solution:
• 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 Nail Solution:
• If you are breast- feeding as you may be told to stop during the 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 Nail Solution
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 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 have 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 Nail Solution
Do not store above 25°C. Avoid flame and heat. Do not refrigerate.
Keep out of the sight and reach of children.
Do not use after the expiry date which is stated on the carton or bottle label.
If your doctor tells you to stop using the solution, please take it back to the
pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
If the solution becomes discoloured or show signs of any deterioration, you should
seek the advice of your pharmacist who will advise 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.
6. Contents of the pack and other information
What is your medicine?
The name of this medicine is Trosyl Nail Solution and its active ingredient is
tioconazole.
Each gram of solution contains 280mg of tioconazole.
The solution also contains the following inactive ingredients:
Ethyl acetate and undecylenic acid.
Trosyl Nail Solution is a clear solution supplied in bottles containing 12ml of
solution.
POM

PL No: 17805/0181

This product is manufactured by Farmasierra Manufacturing S.L., Carretera De
Irun, Km 26200 28700 San Sebastian De Los Reyes, Madrid, Spain and procured
from within the EU by the Product Licence holder Delta Pharma (Europe) Ltd, 1
Colonial Way, P.O. Box 233, North Watford, Herts WD24 4EW and repackaged by
O.P.D. Laboratories Ltd, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.) 20.08.2013
Trosyl is a registered Trade Mark of Pfizer Limited.
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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