Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland
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).
Trosyl Nail Solution is not for ophthalmic use.
None known.
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.
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.
None known.
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.
Anaphylactoid reactions have been reported in patients treated with other formulations than the dermatological preparation.
| 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 | Uncommon Dermatitis, rash | |
| General disorders and administration site conditions | Common | Oedema peripheral |
| Unknown | Pain |
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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
Not applicable.
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