Advise patients with these symptoms to discontinue taking oral terbinafine, and immediately evaluate the patient’s liver function.

In placebo-controlled trials, 8/465 subjects receiving Lamisil Tablets (1.7%) and 3/137 subjects receiving placebo (2.2%) had decreases in ALC to below 1000/mmThere have been postmarketing reports of serious skin/hypersensitivity reactions [e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, bullous dermatitis, and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome]. If progressive skin rash or signs/symptoms of the above drug reactions occur, treatment with Lamisil Tablets should be discontinued. Do not take extra medicine to make up the missed dose.Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.Overdose symptoms may include headache, dizziness, vomiting, stomach pain, rash, and increased urination.Avoid coffee, tea, cola, energy drinks or other sources of caffeine while taking this medicine. Transient decreases in absolute lymphocyte counts (ALCs) have been observed in controlled clinical trials. Follow all directions on your prescription label. The ratio of terbinafine in milk to plasma is 7:1. Cases of liver failure, some leading to liver transplant or death, have occurred with the use of Lamisil Tablets in individuals with and without preexisting liver disease.In the majority of liver cases reported in association with use of Lamisil Tablets, the patients had serious underlying systemic conditions. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.Some people taking Lamisil have developed severe liver damage leading to liver transplant or death. Cases of thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, some fatal, have been reported with terbinafine. If symptoms of a smell disturbance occur, Lamisil Tablets should be discontinued.Depressive symptoms have occurred during postmarketing use of Lamisil Tablets. In the first toenail trial, for subjects evaluated at least 6 months after achieving clinical cure and at least 1 year after completing therapy with Lamisil Tablets, the clinical relapse rate was approximately 15%.Advise the patient to read the FDA-Approved Medication Guide.Patients taking Lamisil Tablets should receive the following information and instructions:Advise patients to immediately report to their physician or get emergency help if they experience any of the following symptoms: hives, mouth sores, blistering and peeling of skin, swelling of face, lips, tongue, or throat, difficulty swallowing or breathing.

Skipping doses may also increase your risk of further infection that is resistant to antifungal medicine. If symptoms of a taste disturbance occur, Lamisil Tablets should be discontinued.Smell disturbance, including loss of smell, has been reported with the use of Lamisil Tablets. Carcinogenesis, Mutagenesis, Impairment of FertilityIn a 28-month oral carcinogenicity study in rats, an increase in the incidence of liver tumors was observed in males at the highest dose tested, 69 mg/kg/day (2x the MRHD based on AUC comparisons of the parent terbinafine); however, even though dose-limiting toxicity was not achieved at the highest tested dose, higher doses were not tested.The efficacy of Lamisil Tablets in the treatment of onychomycosis is illustrated by the response of subjects with toenail and/or fingernail infections who participated in 3 US/Canadian placebo-controlled clinical trials.Results of the first toenail trial, as assessed at week 48 (12 weeks of treatment with 36 weeks follow-up after completion of therapy), demonstrated mycological cure, defined as simultaneous occurrence of negative KOH plus negative culture, in 70% of subjects.

The pathogenic role of the nondermatophytes cultured in the presence of dermatophytic onychomycosis has not been established. At steady-state, in comparison to a single dose, the peak concentration of terbinafine is 25% higher and plasma AUC increases by a factor of 2.5; the increase in plasma AUC is consistent with an effective half-life of ~36 hours. Lamisil tablets are used to treat infections caused by fungus that affect the fingernails or toenails . Lamisil Tablets are contraindicated for patients with chronic or active liver disease [see Contraindications (4) and Warnings and Precautions (5.1)]. Inactive ingredients in 5 mg and 10 mg tablets are lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropyl cellulose, and magnesium stearate. Do not save the mixture for later use.Lamisil is usually taken for 6 weeks to treat scalp or fingernail infections, and for 12 weeks to treat a toenail infection.Use this medicine for the full prescribed length of time. Terbinafine clearance is unaffected by cyclosporine. Donepezil (Aricept) is a medication prescribed for the treatment of mild, moderate, or severe dementia associated with Alzheimer's disease. Indicated for onychomycosis of the toenail or fingernail owing to dermatophytes (tinea unguium 250 mg (1 tablet) PO daily for 6 weeks (fingernail) or 12 weeks (toenail) Fingernail onychomycosis: One 250 mg tablet once daily for 6 weeks.Toenail onychomycosis: One 250 mg tablet once daily for 12 weeks.The optimal clinical effect is seen some months after mycological cure and cessation of treatment.

Lamisil may prolong the effects of caffeine.Avoid exposure to sunlight or tanning beds.