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.
Trosyl 283 mg/ml Nail Solution
⚠ 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 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.
What you need to know before you take it
e Trosyl Do not use 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.
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How to take it
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 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.
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How to store it
Trosyl 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 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. Replace cap securely after use.
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.
Contents of the pack and other information
What Trosyl contains The active substance in Trosyl is tioconazole. The other ingredients are ethyl acetate and undecylenic acid. What Trosyl looks like and contents of the pack Trosyl is a clear, pale yellow nail solution. It is provided in a glass bottle with a screw cap fitted with an applicator, containing 12 ml of solution. Marketing Authorisation Holder: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Manufacturer: Farmasierra Manufacturing S.L., Carretera de Irun, Km. 26,200, 28700 San Sebastian de los Reyes, Madrid, Spain Company Contact Address: For further information on your medicine, please contact Medical Information at Pfizer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS Telephone 01304 616161 This leaflet was last revised in 06/2013. Ref: TY7_1
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Frequently asked questions about Trosyl 283 mg/ml Nail Solution
How do I take Trosyl 283 mg/ml Nail Solution?
Trosyl 283 mg/ml Nail Solution comes as solution containing 283mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Trosyl 283 mg/ml Nail Solution?
The active substance in Trosyl 283 mg/ml Nail Solution is tioconazole.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Trosyl 283 mg/ml Nail Solution, 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 Trosyl 283 mg/ml Nail Solution 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 a broad spectrum imidazole antifungal agent. Trosyl Nail Solution 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: Topical.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 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.Use in children 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.Trosyl Nail Solution is contraindicated in individuals who have been shown to be hypersensitive to imidazole antifungal agents.Use is contraindicated during pregnancy (see section 4.6).
4.4. Special warnings and precautions for use
Trosyl Nail Solution 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 Trosyl Nail Solution is contra-indicated throughout pregnancy. 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 Trosyl is administered.
4.7. Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
Trosyl Nail Solution is well tolerated following local application. Symptoms of local irritation have been reported by some patients, but are 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 Trosyl Nail Solution, 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 Undesirable effects
Immune system disorders Unknown Allergic reaction
Nervous system disorders Unknown Paraesthesia
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, burning sensation
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 at: www.mhra.gov.uk/yellowcard
4.9. Overdose
No cases of overdosage with Trosyl Nail Solution have been reported. Overdosage by topical application of tioconazole is unlikely because of negligible systemic absorption. In the event of excessive oral ingestion by mistake, gastrointestinal symptoms may occur. Appropriate means of gastric lavage should be considered.
💬 Ask about this leaflet
Ask anything about Trosyl 283 mg/ml Nail Solution. 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.