Trosyl 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 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.
1) WHAT TROSYL® IS AND WHAT IT IS USED FOI
2) WHAT YOU NEED TO KNOW BEFORE YOU USE|
3) HOW TO USE TROSYL
|4) POSSIBLE SIDE EFFECTS|
®
500762/PLic Trosyl Nail Solution (tioconazole)
Patient Information Leaflet
The name of your medicine is Trosyl® Nail Solution. Throughout this leaflet it will be referred to as Trosyl®.
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 T rosyl®
4) Possible side effects
5) How to store T rosyl®
6) Contents of the pack and other information
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.
Do not take 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.
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.
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.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month.
• Do not store above 25°C.
• Avoid flame and heat.
• Do not refrigerate.
If you notice any signs of discolouration or deterioration of your medicine, please tell your pharmacist immediately.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Trosyl® contains
Each 1 ml of solution contains 283 mg of tioconazole.
The other ingredients are ethyl acetate and undecylenic acid.
What Trosyl® looks like and contents of the pack
Trosyl® is a non viscous, free-flowing, clear liquid with a characteristic odour and free from any visible contaminants, and comes in a small amber glass bottle with a plastic screw cap, fitted with an applicator.
Each bottle contains 12 ml of solution.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova Ltd and repackager Ginova UK Ltd both at St James' House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer
Farmasierra Manufacturing S.L., Carretera de Irun, Km. 26.200, San Sebastian de los Reyes, E-28700, Spain.
Trosyl® Nail Solution |POM|
PL No: 18067/0286
Trosyl® is a registered trademark of Pfizer Limited.
Leaflet last updated: 7th February 2014.
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.
1) WHAT TIOCONAZOLE IS AND WHAT IT IS USED FOI
|3) HOW TO USE TIOCONAZOLEl
|4) POSSIBLE SIDE EFFECTS|
500762/PLic Tioconazole Nail Solution
Patient Information Leaflet
The name of your medicine is Tioconazole Nail Solution. Throughout this leaflet it will be referred to as Tioconazole.
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
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) WHAT YOU NEED TO KNOW BEFORE YOU USE|
TIOCONAZOLE^^^^^^^^^^^^^H
Do not take 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 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.
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.
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.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month.
• Do not store above 25°C.
• Avoid flame and heat.
• Do not refrigerate.
If you notice any signs of discolouration or deterioration of your medicine, please tell your pharmacist immediately.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Tioconazole contains
Each 1 ml of solution contains 283 mg of tioconazole.
The other ingredients are ethyl acetate and undecylenic acid.
What Tioconazole looks like and contents of the pack
Tioconazole is a non viscous, free-flowing, clear liquid with a characteristic odour and free from any visible contaminants, and comes in a small amber glass bottle with a plastic screw cap, fitted with an applicator.
Each bottle contains 12 ml of solution.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova Ltd and repackager Ginova UK Ltd both at St James' House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer
Farmasierra Manufacturing S.L., Carretera de Irun, Km. 26.200, San Sebastian de los Reyes, E-28700, Spain.
Tioconazole Nail Solution |POM|
PL No: 18067/0286
Leaflet last updated: 7th February 2014.
500762/PL1c