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TIOCONAZOLE 283MG/ML NAIL SOLUTION

Active substance(s): TIOCONAZOLE

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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.

CODE: 06464/3030

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.

CUSTOMER: WAYMADE
PRODUCT: Trosyl naul solution









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.

PROOF HISTORY:v.2 - waymade - 16/12/13

This product is known by both of the above names but will be referred to as Trosyl throughout this leaflet.

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
BRIDGED TO CRESTOR 6464/2069 2070

Trosyl® nail solution/
Tioconazole 283mg/ml nail solution
(tioconazole)
Patient Information Leaflet

Leaflet Flat Size = 148 x 210

REF:
ARTWORKER: DT

DATE OF PROOF: 14/12/13

QA APPROVED
DATE:

000-0000

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.

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.







CODE: 06464/3030




5. How to store Trosyl
Do not store above 25°C. Replace cap securely after use.
Do not refrigerate.
Avoid flame and heat.
Do not use after the expiry date printed on the carton or bottle label. The expiry date refers to the
last day of the month.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
If your doctor tells you to stop using the solution, please take it back to the pharmacist for safe
disposal. Only keep the solution if your doctor tells you to.
If the solution becomes discoloured or shows any other sign of deterioration, you should ask your
pharmacist for advice.
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 Trosyl contains
Contains 283 mg tioconazole per ml of solution.
Trosyl also contains ethyl acetate and undecylenic acid.

CUSTOMER: WAYMADE
PRODUCT: Trosyl naul solution

What Trosyl looks like and contents of the pack
Trosyl is a clear to pale yellow liquid.
Trosyl Nail Solution is available in a 12 ml amber glass bottle with a white screw (fitted with an applicator).
POM

PL No: 06464/3030

This product is manufactured by Farmasierra Manufacturing S.L., Carretera de Irun, km 26,200, 28700 San
Sebastián de los Reyes, Madrid, Spain and is procured from within the EU and repackaged by the Product
Licence Holder:
Waymade Plc Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 16.12.2013
Trosyl is a registered trademark of PFIZER LIMITED

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
BRIDGED TO CRESTOR 6464/2069 2070

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.

Leaflet Flat Size = 148 x 210

REF:
ARTWORKER: DT

DATE OF PROOF: 16/12/13

QA APPROVED
DATE:

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

PROOF HISTORY:v.2 - waymade - 16/12/13

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.

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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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