TIOCONAZOLE Medicated nail lacquer (2018)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
Tioconazole 283 mg/ml medicated nail lacquer.
Qualitative and quantitative composition
One ml of product contains 283 mg of tioconazole. For the full list of excipients, see section 6.1.
Pharmaceutical form
Medicated nail lacquer. Tioconazole is a clear pale yellow solution for topical application.
Therapeutic indications
Tioconazole is indicated for the topical treatment of nail infections due to susceptible fungi (dermatophytes and yeasts) and bacteria.
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 ...
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 ...
Special warnings and precautions for use
Tioconazole is not for ophthalmic use.
Interaction with other medicinal products and other forms of interaction
None known.
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 ...
Effects on ability to drive and use machines
Tioconazole has no or negligible influence on the ability to drive and use machines.
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 ...
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 ...
Pharmacodynamic properties
Pharmacotherapeutic group: Imidazole and triazole derivatives ATC-code: D01AC07 Tioconazole is an imidazole derivative. Its chemical name is (RS)1[2-[(2-Chloro-3-thienyl)methoxy]2(2,4-dichlorophenyl)ethyl]-1H-imidazole ...
Pharmacokinetic properties
Absorption Absorption is rapid and extensive on oral administration to rats, monkeys and man, the major metabolite being a glucuronide conjugate of tioconazole. Tissue uptake in rat and monkey was highest ...
Preclinical safety data
Tioconazole cream applied on rat and rabbit skin did not result in systemic toxicity in these animals. Mild topical reaction was observed. Oral doses (200 mg/kg) did not affect behaviour in rats but 25 ...
List of excipients
Undecylenic acid Ethyl acetate
Incompatibilities
Not applicable.
Shelf life
36 months. After first opening: 6 months.
Special precautions for storage
Inflammable. Avoid heat and flame. Do not refrigerate. Keep the bottle tightly closed.
Nature and contents of container
Tioconzole is contained in an amber type III soda-lime silica glass bottle with a HDPE/LDPE screw cap fitted with a CE nylon brush applicator containing 12 ml.
Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Creo Pharma Limited, Felsted business Centre, Felsted, Essex, CM6 3LY, United Kingdom
Marketing authorization number(s)
PL 31862/0006
Date of first authorization / renewal of the authorization
27/08/2015
Date of revision of the text
21/12/2018
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