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TROSYL 280MG/ML NAIL SOLUTION

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PACKAGE LEAFLET: INFORMATION FOR THE USER

PP2/1322/V2

Trosyl™ 280 mg/ml
Nail Solution
(tioconazole)
Read all of this leaflet carefully before you
use 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.
The name of your medicine is Trosyl 280mg/ml
Nail Solution, but will be referred to as Trosyl
throughout the remainder of the leaflet.
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.

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.

6. Further Information
What Trosyl contains
The active ingredient is tioconazole.
Each 1 ml of solution contains 280 mg
tioconazole.
Also contains ethyl acetate and undecylenic
acid.
Trosyl is a nail solution contained in a amber
coloured glass bottle with a white screw cap
fitted with an applicator containing 12 ml of a
clear, pale yellow solution for topical
application.
Manufactured by Farmasierra Manufacturing
S.L., Carretera de Irun, Km. 26,200, 28700
San Sebastian de los Reyes, Madrid, Spain.
Procured from within the EU. Product Licence
Holder: Quadrant Pharmaceuticals Ltd,
Lynstock House, Lynstock Way, Lostock,
Bolton, BL6 4SA. Repackaged by Maxearn
Ltd, Bolton, BL6 4SA
PLPI 20774/1322
Trosyl 280 mg/ml Nail Solution
POM

Date of preparation 6th December 2013
Trosyl is a registered trademark of Pfizer
Limited

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 Trosyl after the expiry date
which is stated on the carton. The expiry
date refers to the last day of the month.
Do not store above 30°C.
Avoid flame and heat.
Do not refrigerate.
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.
If the solution shows any signs of
discolouration or deterioration consult your
pharmacist for advice.

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

PP2/1322/V2

PP2/1322/V2

If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
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.
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.
3.
4.
5.
6.

In this leaflet:
1. What Trosyl is and what it is used for
2. What you need to know before you use
Trosyl
How to use Trosyl
Possible side effects
How to store Trosyl
Contents of the pack and other information
Read all of this leaflet carefully before you
use 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.
The name of your medicine is Trosyl 280mg/ml
Nail Solution, but will be referred to as Trosyl
throughout the remainder of the leaflet.

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.
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.
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.
Make sure you do not put this medicine in your
eyes.
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.

Trosyl™ 280 mg/ml
Nail Solution
(tioconazole)
PACKAGE LEAFLET: INFORMATION FOR THE USER

PP2/1322/V2

5. How to store Trosyl
Keep out of the sight and reach of children.
Do not use Trosyl after the expiry date
which is stated on the carton. The expiry
date refers to the last day of the month.
Do not store above 30°C.
Avoid flame and heat.
Do not refrigerate.
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.
If the solution shows any signs of
discolouration or deterioration consult your
pharmacist for advice.
By reporting side effects you can help provide
more information on the safety of this
medicine.
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.
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.
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.
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.
Common side effects (may affect up to 1 in 10
people).
Swelling of hands and feet.
4. Possible side effects
Like all medicines this medicine can cause
side effects, although not everybody gets
them.

Trosyl is a registered trademark of Pfizer
Limited
Date of preparation 6th December 2013
POM

PLPI 20774/1322
Trosyl 280 mg/ml Nail Solution
Manufactured by Farmasierra Manufacturing
S.L., Carretera de Irun, Km. 26,200, 28700
San Sebastian de los Reyes, Madrid, Spain.
Procured from within the EU. Product Licence
Holder: Quadrant Pharmaceuticals Ltd,
Lynstock House, Lynstock Way, Lostock,
Bolton, BL6 4SA. Repackaged by Maxearn
Ltd, Bolton, BL6 4SA
Trosyl is a nail solution contained in a amber
coloured glass bottle with a white screw cap
fitted with an applicator containing 12 ml of a
clear, pale yellow solution for topical
application.
6. Further Information
What Trosyl contains
The active ingredient is tioconazole.
Each 1 ml of solution contains 280 mg
tioconazole.
Also contains ethyl acetate and undecylenic
acid.

PACKAGE LEAFLET: INFORMATION FOR THE USER

PP2/1322/V2

Trosyl™ 280 mg/ml
Nail Solution
(tioconazole)
Read all of this leaflet carefully before you
use 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.
The name of your medicine is Trosyl 280mg/ml
Nail Solution, but will be referred to as Trosyl
throughout the remainder of the leaflet.
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.

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.

6. Further Information
What Trosyl contains
The active ingredient is tioconazole.
Each 1 ml of solution contains 280 mg
tioconazole.
Also contains ethyl acetate and undecylenic
acid.
Trosyl is a nail solution contained in a amber
coloured glass bottle with a white screw cap
fitted with an applicator containing 12 ml of a
clear, pale yellow solution for topical
application.
Manufactured by Farmasierra Manufacturing
S.L., Carretera de Irun, Km. 26,200, 28700
San Sebastian de los Reyes, Madrid, Spain.
Procured from within the EU. Product Licence
Holder: Quadrant Pharmaceuticals Ltd,
Lynstock House, Lynstock Way, Lostock,
Bolton, BL6 4SA. Repackaged by Maxearn
Ltd, Bolton, BL6 4SA
PLPI 20774/1322
Trosyl 280 mg/ml Nail Solution
POM

Date of preparation 6th December 2013
Trosyl is a registered trademark of Pfizer
Limited

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 Trosyl after the expiry date
which is stated on the carton. The expiry
date refers to the last day of the month.
Do not store above 30°C.
Avoid flame and heat.
Do not refrigerate.
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.
If the solution shows any signs of
discolouration or deterioration consult your
pharmacist for advice.

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

PP2/1322/V2

PP2/1322/V2

If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
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.
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.
3.
4.
5.
6.

In this leaflet:
1. What Trosyl is and what it is used for
2. What you need to know before you use
Trosyl
How to use Trosyl
Possible side effects
How to store Trosyl
Contents of the pack and other information
Read all of this leaflet carefully before you
use 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.
The name of your medicine is Trosyl 280mg/ml
Nail Solution, but will be referred to as Trosyl
throughout the remainder of the leaflet.

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.
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.
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.
Make sure you do not put this medicine in your
eyes.
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.

Trosyl™ 280 mg/ml
Nail Solution
(tioconazole)
PACKAGE LEAFLET: INFORMATION FOR THE USER

PP2/1322/V2

5. How to store Trosyl
Keep out of the sight and reach of children.
Do not use Trosyl after the expiry date
which is stated on the carton. The expiry
date refers to the last day of the month.
Do not store above 30°C.
Avoid flame and heat.
Do not refrigerate.
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.
If the solution shows any signs of
discolouration or deterioration consult your
pharmacist for advice.
By reporting side effects you can help provide
more information on the safety of this
medicine.
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.
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.
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.
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.
Common side effects (may affect up to 1 in 10
people).
Swelling of hands and feet.
4. Possible side effects
Like all medicines this medicine can cause
side effects, although not everybody gets
them.

Trosyl is a registered trademark of Pfizer
Limited
Date of preparation 6th December 2013
POM

PLPI 20774/1322
Trosyl 280 mg/ml Nail Solution
Manufactured by Farmasierra Manufacturing
S.L., Carretera de Irun, Km. 26,200, 28700
San Sebastian de los Reyes, Madrid, Spain.
Procured from within the EU. Product Licence
Holder: Quadrant Pharmaceuticals Ltd,
Lynstock House, Lynstock Way, Lostock,
Bolton, BL6 4SA. Repackaged by Maxearn
Ltd, Bolton, BL6 4SA
Trosyl is a nail solution contained in a amber
coloured glass bottle with a white screw cap
fitted with an applicator containing 12 ml of a
clear, pale yellow solution for topical
application.
6. Further Information
What Trosyl contains
The active ingredient is tioconazole.
Each 1 ml of solution contains 280 mg
tioconazole.
Also contains ethyl acetate and undecylenic
acid.

+ Expand Transcript

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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