Tioconazole 283 Mg/Ml Nail Solution
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Trosyl® 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® Nail Solution, but it will be referred as Trosyl throughout this leaflet.
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
Do not use Trosyl:
• If you have ever had an allergic reaction to Trosyl 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
Talkto 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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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 10 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.qov.uk/vellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
Do not use this medicine after the expiry date shown on the carton or label.
• Keep this medicine out of the sight and reach of children.
• Do not store above 25°C. Avoid flame and heat.
• Do not refrigerate.
Medicines should not be disposed via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.
If your medicine becomes discoloured or shows any other signs of deterioration, consult your pharmacist who will tell you what to do.
6. Further information
What Trosyl looks like and content of the pack
What Trosyl contains
Each ml of solution contains 283mg of Tioconazole.
Your medicine also contains the following inactive ingredients: Ethyl acetate and undecylenic acid.
Each bottle contains 12 ml of clear, slightly yellow solution. Manufactured by: Farmasierra Manufacturing S.L., Carretera de Irun, Km. 26200, 28700 San Sebastian de los Reyes, Madrid,
Spain
Procured from within the ELI and repackaged by Product Licence holder:
POM
Kosei Pharma UK Limited, 956 Buckingham Avenue, Slough Trading Estate, Slough, SL1 4NL, UK
Trosyl® Nail Solution, PL: 39352/0152 Trosyl® is a registered trademark of Pfizer Limited.
Tioconazole 283mg/ml Nail Solution
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 Tioconazole 283mg/ml Nail Solution, but it will be referred as Tioconazole throughout this leaflet.
What is in this leaflet:
1. What Tioconazole is and what it is used for
2. What you need to know before you use Tioconazole
3. How to use Tioconazole
4. Possible side effects
5. How to store Tioconazole
6. Contents of the pack and other information
1. What Tioconazole is and what it is used for
This medicine contains tioconazole, which is one of a group of medicines called antifungals.
Tioconazole is used in adults and children to treat nail infections caused by certain fungi.
2. Before you use Tioconazole
Do not use Tioconazole:
• 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:
• 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 Tioconazole
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 10 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.qov.uk/vellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
Do not use this medicine after the expiry date shown on the carton or label.
• Keep this medicine out of the sight and reach of children.
• Do not store above 25°C. Avoid flame and heat.
• Do not refrigerate.
Medicines should not be disposed via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.
If your medicine becomes discoloured or shows any other signs of deterioration, consult your pharmacist who will tell you what to do.
6. Further information
What Tioconazole looks like and content of the pack
What Tioconazole contains
Each ml of solution contains 283mg of Tioconazole.
Your medicine also contains the following inactive ingredients: Ethyl acetate and undecylenic acid.
Each bottle contains 12ml of clear, slightly yellow solution. Manufactured by: Farmasierra Manufacturing S.L., Carretera de Irun, Km. 26200, 28700 San Sebastian de los Reyes, Madrid,
Spain.
Procured from within the EU and repackaged by Product Licence holder:
POM
Kosei Pharma UK Limited, 956 Buckingham Avenue,
Slough Trading Estate, Slough, SL1 4NL, UK
Tioconazole 280mg/ml Nail Solution, PL: 39352/0152
LEAFLET DATE: 14.04.2015