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TIOCONAZOLE 28% NAIL SOLUTION

Active substance(s): TIOCONAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Revision date: 19.12.2014
Leaflet reference: TRO12ML

Trosyl® Nail Solution
(tioconazole)
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 of 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® 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

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 shortlived and mild.
Not known (frequency cannot be estimated from the available date)
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

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.

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.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE TROSYL® NAIL
SOLUTION

5. HOW TO STORE 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 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.
®

Do not store above 25°C. Protect from flame and heat. Do not
refrigerate.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date (This is printed on both
the carton and bottle).
If your doctor tells you to stop using this medicine, return any unused
medicine to your pharmacist for safe disposal. Only keep this
medicine, if your doctor tells you to.
If the solution shows signs of deterioration or discolouration, 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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Trosyl® Nail Solution looks like and contents of the pack

3. HOW TO USE TROSYL NAIL SOLUTION

Each ml contains 283mg tioconazole as the active ingredient.

Always use this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.

Also contains undecylenic acid and ethyl acetate.
It is a clear pale yellow solution for topical application.

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.

Trosyl® Nail Solution is available in bottles containing 12ml.



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.

Manufactured by Farmasierra Manufacturing S.L., Carretera de Irun,
Km 26, 200, 28700 San Sebastian de los Reyes, Madrid, Spain and is
procured from within the EU and repackaged by Product Licence Holder:
Beachcourse Limited, 20 Alliance, Alliance Road, London W3 0RB.



The film should be left intact as long as possible. This allows the
antifungal agent to have maximum effect.

PL



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.

Revision date: 19.12.2014
Leaflet reference: TRO12ML



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.

Who manufactured your medicine

16378/0417

POM

Trosyl® is a trademark of Pfizer Ltd

PACKAGE LEAFLET: INFORMATION FOR THE USER
Revision date: 19.12.2014
Leaflet reference: TIO12ML

Tioconazole 28.3 % Nail Solution
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 of 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 Tioconazole 28.3% Nail Solution is and what it is used for
2. What you need to know before you use Tioconazole 28.3% Nail
Solution
3. How to use Tioconazole 28.3% Nail Solution
4. Possible side effects
5. How to store Tioconazole 28.3% Nail Solution
6. Contents of the pack and other information
1. WHAT TIOCONAZOLE 28.3% NAIL SOLUTION IS AND WHAT IT IS
USED FOR
This medicine contains tioconazole, which is one of a group of medicines
called antifungals.
Tioconazole 28.3% 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 TIOCONAZOLE
28.3% NAIL SOLUTION
Do not use Tioconazole 28.3% 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 Tioconazole 28.3% Nail
Solution:


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 shortlived and mild.
Not known (frequency cannot be estimated from the available date)
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 TIOCONAZOLE 28.3% NAIL SOLUTION









If you are breast-feeding as you may be told to stop during treatment.

Do not store above 25°C. Protect from flame and heat. Do not
refrigerate.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date (This is printed on both
the carton and bottle).
If your doctor tells you to stop using this medicine, return any unused
medicine to your pharmacist for safe disposal. Only keep this
medicine, if your doctor tells you to.
If the solution shows signs of deterioration or discolouration, 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.

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 TIOCONAZOLE 28.3% NAIL SOLUTION
Always use this medicines 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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Tioconazole 28.3% Nail Solution looks like and contents of the
pack
Each ml contains 283mg tioconazole as the active ingredient.
Also contains undecylenic acid and ethyl acetate.
It is a clear pale yellow solution for topical application.
Tioconazole 28.3% Nail Solution is available in bottles containing 12ml.
Who manufactured your medicine
Manufactured by Farmasierra Manufacturing S.L., Carretera de Irun,
Km 26, 200, 28700 San Sebastian de los Reyes, Madrid, Spain and is
procured from within the EU and repackaged by Product Licence Holder:
Beachcourse Limited, 20 Alliance, Alliance Road, London W3 0RB.
PL

16378/0417

Revision date: 19.12.2014
Leaflet reference: TIO12ML

POM

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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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