Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Tioconazole 283 mg/ml medicated nail lacquer
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Tioconazole may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for The name of this medicine is Tioconazole 283 mg/ml Medicated Nail Lacquer (called Tioconazole throughout this leaflet). 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.
What you need to know before you take it
e Tioconazole Do not use Tioconazole:
- If you are allergic to: ° Tioconazole or any of the other ingredients of this medicine (listed in section 6) ° Other imidazole antifungal 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 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. Tioconazole is not for ophthalmic use. 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.
How to take it
Tioconazole Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
- Apply the medicated nail lacquer thinly to cover the whole of the affected nail(s) and surrounding skin using the brush provided. Apply the lacquer every 12 hours.
- Leave the lacquer to dry for 10-15 minutes after application.
- The lacquer 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. 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 anyone accidentally swallows this medicine: If you accidentally take this medicine by your mouth, contact your doctor or accident and emergency department straight away.
Possible side effects
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)
- Allergic reaction
- Paresthesia (tingling sensations in the hands or feet)
- Blistering of the skin, contact dermatitis, dry skin, swelling around the eyes, nail disorder (including discolouration, inflammation or pain), itch, skin irritation, peeling of the skin, hives and pain. If you get these symptoms, stop using Tioconazole and tell your doctor or pharmacist. Reporting of side effects 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 via the Yellow Card Scheme at: 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.
How to store it
Tioconazole Flammable. 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.
Contents of the pack and other information
What Tioconazole contains The active substance is tioconazole. One ml of product 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 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 Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom Manufacturer Doppel Farmaceutici S.r.L. Via Martiri delle Foibe, 1 29016 Cortemaggiore (PC) Italy This leaflet was revised in December 2025 1065047758
Frequently asked questions about Tioconazole 283 mg/ml medicated nail lacquer
What is the active substance in Tioconazole 283 mg/ml medicated nail lacquer?
The active substance in Tioconazole 283 mg/ml medicated nail lacquer is tioconazole.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Tioconazole 283 mg/ml medicated nail lacquer, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Tioconazole 283 mg/ml medicated nail lacquer without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: tioconazole
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Tioconazole is indicated for the topical treatment of nail infections due to susceptible fungi (dermatophytes and yeasts) and bacteria.
4.2. Posology and method of administration
Route of administration: Cutaneous use.
Posology
Adults: The solution should be applied to the affected nails and immediately surrounding skin every twelve hours using the applicator brush supplied.
The duration of treatment depends on the severity of the infection, the infectious microorganism and the location of the area to be treated.
Usually, the duration of treatment is up to six months, but may be extended to twelve months.
Use in the elderly: No special precautions are required. Use the adult dose.
Paediatric population: No special precautions are required. Use the adult dose.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Tioconazole is contra-indicated in individuals who have been shown to be hypersensitive to imidazole antifungal agents
Use is contra-indicated during pregnancy (see section 4.6).
4.4. Special warnings and precautions for use
Tioconazole is not for ophthalmic use.
4.5. Interaction with other medicinal products and other forms of interaction
None known.
4.6. Fertility, pregnancy and lactation
Pregnancy
In animal studies tioconazole was not teratogenic. At high doses it increased the incidence of renal abnormalities in rat embryos, but this effect was minor and transient and was not evident in weaned animals.
There is insufficient evidence as to the drug's safety in human pregnancy although absorption after topical administration is negligible. Because of the extensive duration of treatment required for nail infections, the use of Tioconazole is contra-indicated throughout pregnancy.
In case pregnancy is diagnosed for the person receiving the medicine, its use should be immediately discontinued.
Breast-feeding
It is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, nursing should be temporarily discontinued while Tioconazole is administered.
4.7. Effects on ability to drive and use machines
Tioconazole has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Tioconazole is well tolerated upon local application. The most common effect is local irritation (including local allergic reactions), usually seen during the first week of treatment and are transient and mild. Systemic allergic reactions are uncommon.
However, if a sensitivity reaction develops with the use of Tioconazole, treatment should be discontinued and appropriate therapy instituted.
The undesirable effects listed below were reported with frequencies corresponding to Common ( ≥1/100, ≤1/10), Uncommon ( ≥1/1000, <1/100), Rare ( ≥1/10,000 to <1/1,000), or Very rare (<1/10,000), Not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
System Organ Class
Frequency
Frequency
Immune system disorders
Unknown
Allergic reaction
Nervous system disorders
Unknown
Paresthesia
Skin and subcutaneous tissue disorders
Unknown
Bullous eruption, dermatitis contact, dry skin, edema periorbital, nail disorder (including nail discoloration, periungual inflammation and nail pain), pruritis,skin irritation, skin exfoliation, urticaria
Uncommon
Dermatitis, rash,
General disorders and administration site conditions
Common
Oedema peripheral
Unknown
Pain
Anaphylactoid reactions have been reported in patients treated with other formulations than the dermatological preparation.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
No cases of overdosage with Tioconazole have been reported. Overdosage by topical application of tioconazole is unlikely because of negligible systemic absorption. In cases of overdose, treatment should be discontinued and symptomatic therapy instituted. In the event of excessive oral ingestion, gastrointestinal symptoms may occur. Appropriate means of gastric lavage should be considered.
💬 Ask about this leaflet
Ask anything about Tioconazole 283 mg/ml medicated nail lacquer. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.