Tioconazole Nail Solution 28%
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TIOCONAZOLE NAIL SOLUTION 28% / TROSYD® NAIL SOLUTION / TROSYL® NAIL SOLUTION
(tioconazole)
Your medicine is called by any of the above names but will be referred to as Tioconazole.
Read all of this leaflet carefully before you use this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1 What Tioconazole is and what it is used for
2 Before you use Tioconazole
3 How to use Tioconazole
4 Possible side effects
5 How to store Tioconazole
6 Further information
1. What Tioconazole is and what it is used for
Tioconazole is one of a group of medicines called antifungals. The active ingredient is tioconazole.
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:
• Any of the ingredients of Tioconazole (see Section 6 for details).
• Other medicines you have taken to treat a fungal infection. The symptoms may include itching, reddening of the skin or difficulty in breathing.
• If you are pregnant.
Take special care with Tioconazole:
Tell your doctor or pharmacist if:
• You are breast-feeding as you may be told to stop during your treatment.
3. How to use Tioconazole
• 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 you have any further questions on the use of this product, ask
your doctor or pharmacist.
4. Possible side effects
Like all medicines Tioconazole can cause side effects, although not everybody gets them.
Common side effects (occurs in more than 10 out of every 1,000 patients).
These includes: Swelling of soft skin areas.
Uncommon side effects (occurs in fewer than 10 out of every 1,000 patients).
These include: 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 (cannot be estimated from the available data).
Allergic reaction which includes itching, swelling or blistering of the skin or face.
If you get these symptoms, stop using Tioconazole and tell your doctor or pharmacist.
You may also experience nail discolouration, inflammation or pain. You may also feel tingling sensations in the hands or feet or have peeling of the skin.
If you get any of the above side effects, or notice any other unusual side effects not listed in this leaflet, tell your doctor at once.
5. How to store Tioconazole
• Do not use after the expiry date printed on the bottle or carton label.
• Do not store above 25°C. Do not refrigerate. Avoid flame and heat.
• Keep out of the sight and reach of children.
• If your doctor tells you to stop using the nail solution, please take it back to the pharmacist for safe disposal. Only keep the nail solution if your doctor tells you to.
• If the nail solution becomes discoloured or shows signs of any 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. Further information
What Tioconazole looks like and contents of the pack What Tioconazole contains
Each ml of solution contains 283mg of the active ingredient tioconazole.
The other ingredients are ethyl acetate and undecylenic acid. Tioconazole is a clear slightly yellow solution Each bottle contains 12ml of solution.
Manufacturer:
Farmasierra Manufacturing S.L., Madrid, Spain and Doppel Farmaceutici, Cortemaggiore, Italy.
Procured from within the EU. Product Licence Holder and repackaged by: S.C.A.C. Ltd., Unit 2a, Bandeath Industrial Estate, Throsk, Stirling, FK7 7NP.
PL No: 30984/0181 |POM|
Tioconazole Nail Solution 28% /
Trosyd® Nail Solution /
Trosyl ® Nail Solution
Company contact address:
For further information on your medicine please contact Medical Information at:
Pfizer Limied, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS.
Telephone: 01304 616161 Leaflet last updated: 27.08.2012
Trosyd® and Trosyl® are registered trademarks of Pfizer Ltd.