Patient Leaflet Updated 02-Aug-2021 | Zentiva
Tioconazole 283 mg/ml medicated nail lacquer
Tioconazole 283 mg/ml Medicated Nail Lacquer
Tioconazole
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
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.
The symptoms may include itching, reddening of the skin or difficulty in breathing.
Talk to your doctor or pharmacist before using Tioconazole:
Make sure you do not put this medicine in your eyes.
Tioconazole is not for ophthalmic use.
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.
The dosage and duration of treatment are the same for children and adults.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you accidentally take this medicine by your mouth, contact your doctor or accident and emergency department straight away.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tioconazole is generally well tolerated. You may experience mild and transient local irritation symptoms (including local allergic reactions) during initial treatment. If you experience an allergic reaction, stop the treatment and consult your doctor.
Anaphylactoid reactions have been reported in patients treated with other formulations than the dermatological preparation.
Common side effects (may affect up to 1 in 10 people).
Swelling of hand and feet.
Uncommon side effects (may affect up to 1 in 100 people).
Rash and dermatitis.
Not known (frequency can not be estimated from the available data)
If you get these symptoms, stop using Tioconazole and tell your doctor or pharmacist.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly:
In the UK via the UK Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
Inflammable. Avoid heat and flame. Do not refrigerate. Keep the bottle tightly closed.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the carton and the bottle label after EXP. The expiry date refers to the last day of that month.
The medicated nail lacquer should be used within 6 months after first opening.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help you protect the environment.
The active substance is tioconazole. One ml of product contains 283 mg of tioconazole.
The other ingredients are ethyl acetate and undecylenic acid.
Tioconazole is a clear solution for cutaneous use.
Tioconazole is contained in an amber type III soda-lime silica glass bottle with a HDPE/LDPE screw cap fitted with a nylon brush applicator containing 12 ml.
Marketing Authorisation Holder:
Manufacturer:
This leaflet was revised in November 2020.
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