Source: Web Search Revision Year: 2015 Publisher: Recordati Ireland Ltd., Raheens East, Ringaskiddy, Co. Cork, Ireland
Hypersensitivity to the active substance or to any of the excipients.
When applied to the lesion, a slight burning sensation may be felt which disappears rapidly.
Avoid contact with the eyes; should this happen, rinse thoroughly with water.
The use, especially if extended, of products for topical use, may give rise to sensitization.
In such case, interrupt the treatment and consult a physician to commence an appropriate therapy.
There are no known interactions with other medicines.
No human studies of the effects of fenticonazole on fertility have been conducted, however animal studies have not demonstrated any effects of the drug on fertility (see Section 5.3).
There are limited amount of data from the use of fenticonazole in pregnant women. Studies in animals have shown no teratogenic effects, but embriotoxic and fetotoxic effects have been observed only at very high doses administered orally (see Section 5.3). Entirely negligible absorption occurs by the transcutaneous route (see Section 5.2). Fenticonazole should be used in pregnancy under the supervision of a physician.
Animal studies via the oral route have shown that fenticonazole and/or its metabolites can be excreted in the milk (see Section 5.3). Even if no data are available showing that dermatological administration of fenticonazole in humans causes its and /or its metabolites excretion into the milk, a risk for the baby cannot be excluded. Fenticonazole should be used during lactation under the supervision of a physician.
Lomexin has no influence on ability to drive and use machines.
When used as recommended, Lomexin is only poorly absorbed and systemic undesirable reactions are not expected. Prolonged use of topical products can cause sensitisation (see section 4.4).
In the table below, adverse reactions are reported and listed by MedDRA system organ class and frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (frequency cannot be estimated from available data).
| System Organ Class | Frequency | Preferred Terms |
|---|---|---|
| Skin and subcutaneous tissue disorders | very rare | Erythema Pruritus Rash Rash Erythematous Skin irritation Skin burning sensation |
None.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
