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TROSYD NAIL SOLUTION

Active substance(s): TIOCONAZOLE

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Trosyl® Nail Solution
(tioconazole)
PATIENT INFORMATION LEAFLET
The name of your medicine is Trosyl Nail Solution bit it will be referred to as Trosyl in this 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.

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.

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.

Page 1 of 2

5.

HOW TO STORE TROSYL

Keep out of the sight and reach of children.
Do not store above 25°C.
Avoid flame and heat.
Do not refrigerate.
Do not use after the expiry date printed on the carton and on the bottle label. The expiry date refers to
the last day of the month.
If your doctor tells you to stop using the medicine or when you need to dispose of them, please take
them back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
If the medicine becomes discoloured or shows signs of deterioration, you should seek the advice of your
pharmacist.
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

Your nail solution is called Trosyl. Each ml of solution contains 283mg of tioconazole as the active
ingredient in a topical solution for cutaneous use.
Trosyl also contains ethyl acetate and undecylenic acid.

What Trosyl looks like and contents of the pack
Trosyl is a clear pale yellow solution for topical application.
Each bottle contains 12ml of solution.

Manufacturer:

The manufacturer of your medicine is:
Pfizer Italia S.R.L.S.S. 156. KM 50 - 04010 Borgo San Michele, Italy.
Or
Farmasierra Manufacturing S.L., Carretera de Irun, km 26200, 28700 San Sebastian de los Reyes,
Madrid, Spain.
Or
Doppel Farmaceutici, Via Martiri delle Foibe, 1 29016 Cortemaggiore (PC).
Your medicine is procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., 6 Kirk Sandall Industrial Estate, Doncaster DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX
PL No: 21828/0171

POM

Leaflet revision and issue date (Ref): 16.09.15
Trosyl® is the registered trademark of Pfizer Ltd.

Page 2 of 2

Trosyd® Nail Solution
(tioconazole)
PATIENT INFORMATION LEAFLET
The name of your medicine is Trosyd Nail Solution bit it will be referred to as Trosyd in this 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 Trosyd is and what it is used for
2. What you need to know before you use Trosyd
3. How to use Trosyd
4. Possible side effects
5. How to store Trosyd
6. Contents of the pack and other information
1.

WHAT TROSYD IS AND WHAT IT IS USED FOR

This medicine contains tioconazole, which is one of a group of medicines called antifungals.
Trosyd is used in adults and children to treat nail infections caused by certain fungi.

2.

WHAT YOU NEED TO KNOW BEFORE YOU USE TROSYD

Do not use Trosyd:

3.

HOW TO USE TROSYD

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.



If you have ever had an allergic reaction to tioconazole or any of the other ingredients of this

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.



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.

Reporting of side effects



medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using Trosyd:

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

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.

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.

Page 1 of 2

5.

HOW TO STORE TROSYD

Keep out of the sight and reach of children.
Do not store above 25°C.
Avoid flame and heat.
Do not refrigerate.
Do not use after the expiry date printed on the carton and on the bottle label. The expiry date refers to
the last day of the month.
If your doctor tells you to stop using the medicine or when you need to dispose of them, please take
them back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
If the medicine becomes discoloured or shows signs of deterioration, you should seek the advice of
your pharmacist.
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 Trosyd contains

Your nail solution is called Trosyd. Each ml of solution contains 283mg of tioconazole as the active
ingredient in a topical solution for cutaneous use.
Trosyd also contains ethyl acetate and undecylenic acid.

What Trosyd looks like and contents of the pack
Trosyd is a clear pale yellow solution for topical application.
Each bottle contains 12ml of solution.

Manufacturer:

The manufacturer of your medicine is:
Pfizer Italia S.R.L.S.S. 156. KM 50 - 04010 Borgo San Michele, Italy.
Or
Farmasierra Manufacturing S.L., Carretera de Irun, km 26200, 28700 San Sebastian de los Reyes,
Madrid, Spain.
Or
Doppel Farmaceutici, Via Martiri delle Foibe, 1 29016 Cortemaggiore (PC).
Your medicine is procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., 6 Kirk Sandall Industrial Estate, Doncaster DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX
PL No: 21828/0171

POM

Leaflet revision and issue date (Ref): 16.09.15
Trosyd® is the registered trademark of Pfizer Ltd.

Page 2 of 2

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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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