What Is Lamisil Used For

What is Lamisil and how is it used?

Lamisil is a prescription medicine used to treat symptoms of fungus (Onychomycosis) of the toenail or fingernail. Lamisil may be used alone or with other medications.

Lamisil belongs to a course of drugs called Antifungals, Systemic.

It is non known if Lamisil is safe and effective in children.

What are the possible side effects of Lamisil?

Lamisil may cause serious side furnishings including:

changes in your sense of taste or smell,
depressed mood,
slumber problems,
lack of interest in daily activity,
feeling anxious or restless,
pale peel,
easy bruising,
unusual bleeding (nose, mouth, vagina or rectum),
purple or red pinpoint spots under your skin
,
swelling,
rapid weight proceeds,
little or no urinating,
claret in your urine or stools,
weight loss due to sense of taste changes or loss of appetite,
nausea,
upper tum pain,
vomiting,
tiredness,
nighttime urine,
clay-colored stools,
yellowing of the peel or optics (jaundice),
skin sores, and
butterfly-shaped skin rash on your cheeks or nose that worsens in sunlight

Get medical help right abroad, if you accept any of the symptoms listed to a higher place.

The most common side effects of Lamisil include:

diarrhea,
nausea,
gas,
stomach hurting or upset,
rash,
headache, and
aberrant liver function tests

Tell your doctor if you have whatever side event that bothers y'all or that does not go away.

These are not all the possible side effects of Lamisil. For more information, enquire your physician or pharmacist.

Telephone call your medico for medical advice about side effects. You may report side effects to FDA at i-800-FDA-1088.

DESCRIPTION

Lamisil Tablets contain the synthetic allylamine antifungal compound terbinafine hydrochloride. Chemically, terbinafine hydrochloride is (E)-N-(6,6-dimethyl-2-hepten-4-ynyl)-Due north-methyl-ane- naphthalenemethanamine hydrochloride. The empirical formula C₂₁H₂₆CIN with a molecular weight of 327.ninety, and the following structural formula:

LAMISIL® (terbinafine hydrochloride) Structural Formula Illustration

Terbinafine hydrochloride is a white to off-white fine crystalline pulverization. It is freely soluble in methanol and methylene chloride, soluble in ethanol, and slightly soluble in water.

Each tablet contains:

Active Ingredients: terbinafine hydrochloride (equivalent to 250 mg base of operations)

Inactive Ingredients: colloidal silicon dioxide NF, hydroxypropyl methylcellulose USP, magnesium stearate NF, microcrystalline cellulose NF, and sodium starch glycolate NF.

DOSAGE AND ADMINISTRATION

Fingernail onychomycosis: One 250 mg tablet one time daily for half-dozen weeks.

Toenail onychomycosis: One 250 mg tablet once daily for 12 weeks.

The optimal clinical event is seen some months subsequently mycological cure and cessation of treatment. Thisis related to the period required for outgrowth of good for you nail.

HOW SUPPLIED

Dosage Forms And Strengths

Tablet, 250 mg white to yellowish-tinged white circular, bi-convex, beveled tablets imprinted with "LAMISIL" in circular form on one side and code "250" on the other side.

Storage And Treatment

Lamisil Tablets are supplied as white to xanthous-tinged white circular, bi-convex, askew tablets containing 250 mg of terbinafine imprinted with "LAMISIL" in circular grade on i side and lawmaking "250" on the other.

Bottles of 100 tablets NDC 0078-0179-05
Bottles of 30 tablets NDC 0078-0179-fifteen

Shop Lamisil Tablets below 25°C (77°F); in a tight container. Protect from light.

Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. Revised: February 2015

SIDE Furnishings

Clinical Trials Experience

Considering clinical trials are conducted nether widely varying conditions, adverse reaction rates in the clinical trials of a drug cannot exist direct compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The most frequently reported adverse events observed in the iii US/Canadian placebo-controlled trials are listed in the table below. The adverse events reported encompass gastrointestinal symptoms (including diarrhea, dyspepsia, and abdominal hurting), liver test abnormalities, rashes, urticaria, pruritus, and gustatory modality disturbances. Changes in the ocular lens and retina take been reported following the apply of Lamisil Tablets in controlled trials. The clinical significance of these changes is unknown. In general, the adverse events were mild, transient, and did not lead to discontinuation from study participation.

	Agin Event		Discontinuation
	Lamisil Tablets (%) n=465	Placebo (%) n=137	Lamisil Tablets (%) n=465	Placebo (%) n=137
Headache	12.9	9.v	0.2	0.0
Gastrointestinal Symptoms:
Diarrhea	5.vi	ii.ix	0.six	0.0
Dyspepsia	four.iii	2.9	0.iv	0.0
Abdominal Hurting	2.4	1.5	0.4	0.0
Nausea	2.vi	2.9	0.two	0.0
Flatulence	2.2	2.2	0.0	0.0
Dermatological Symptoms:
Rash	5.six	2.2	0.9	0.7
Pruritus	2.8	one.5	0.ii	0.0
Urticaria	1.1	0.0	0.0	0.0
Liver Enzyme Abnormalities*	iii.3	1.4	0.2	0.0
Taste Disturbance	2.8	0.7	0.ii	0.0
Visual Disturbance	1.1	ane.v	0.9	0.0
*Liver enzyme abnormalities ≥ 2x the upper limit of normal range.

Postmarketing Experience

The following agin events have been identified during postapproval employ of Lamisil Tablets. Considering these events are reported voluntarily from a population of uncertain size, information technology is not ever possible to reliably judge their frequency or establish a causal relationship to drug exposure.

Claret and lymphatic system disorders: Pancytopenia, agranulocytosis, astringent neutropenia, thrombocytopenia, anemia [meet WARNINGS AND PRECAUTIONS]

Immune system disorders: Serious hypersensitivity reactions e.m., angioedema and allergic reactions (including anaphylaxis), precipitation and exacerbation of cutaneous and systemic lupus erythematosus [see WARNINGS AND PRECAUTIONS], serum sickness-like reaction

Psychiatric disorders: Anxiety and depressive symptoms contained of sense of taste disturbance have been reported with use of Lamisil Tablets. In some cases, depressive symptoms accept been reported to subside with discontinuance of therapy and to recur with reinstitution of therapy [see WARNINGS AND PRECAUTIONS].

Nervous arrangement disorders: Cases of gustation disturbance, including sense of taste loss, have been reported with the apply of Lamisil Tablets. Information technology can be severe plenty to result in decreased nutrient intake, weight loss, anxiety, and depressive symptoms. Cases of smell disturbance, including aroma loss, have been reported with the use of Lamisil Tablets [see WARNINGS AND PRECAUTIONS]. Cases of paresthesia and hypoesthesia take been reported with the use of Lamisil Tablets.

Centre disorders: Visual field defects, reduced visual acuity

Ear and labyrinth disorders: Hearing impairment, vertigo, tinnitus

Vascular disorders: Vasculitis

Gastrointestinal disorders: Pancreatitis, airsickness

Hepatobiliary disorders: Cases of liver failure some leading to liver transplant or death [see WARNINGS AND PRECAUTIONS], idiosyncratic and symptomatic hepatic injury. Cases of hepatitis, cholestasis, and increased hepatic enzymes [run into WARNINGS AND PRECAUTIONS] have been seen with the use of Lamisil Tablets.

Pare and subcutaneous tissue disorders: Serious skin 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] [come across WARNINGS AND PRECAUTIONS], astute generalized exanthematous pustulosis, psoriasiform eruptions or exacerbation of psoriasis, photosensitivity reactions, hair loss

Musculoskeletal and connective tissue disorders: Rhabdomyolysis, arthralgia, myalgia

General disorders and administration site conditions: Malaise, fatigue, influenza-similar illness, pyrexia

Investigations: Altered prothrombin time (prolongation and reduction) in patients concomitantly treated with warfarin and increased claret creatine phosphokinase take been reported

DRUG INTERACTIONS

Drug-Drug Interactions

In vivo studies have shown that terbinafine is an inhibitor of the CYP450 2D6 isozyme. Drugs predominantly metabolized by the CYP450 2D6 isozyme include the following drug classes: tricyclic antidepressants, selective serotonin reuptake inhibitors, beta-blockers, antiarrhythmics class 1C (e.thousand., flecainide and propafenone) and monoamine oxidase inhibitors Blazon B. Coadministration of Lamisil Tablets should exist done with conscientious monitoring and may require a reduction in dose of the 2D6- metabolized drug. In a study to appraise the effects of terbinafine on desipramine in salubrious volunteers characterized as normal metabolizers, the administration of terbinafine resulted in a 2-fold increase in Cmax and a five-fold increase in area nether the curve (AUC). In this study, these furnishings were shown to persist at the concluding ascertainment at 4 weeks after discontinuation of Lamisil Tablets. In studies in good for you subjects characterized as extensive metabolizers of dextromethorphan (antitussive drug and CYP2D6 probe substrate), terbinafine increases the dextromethorphan/dextrorphan metabolite ratio in urine by xvi- to 97-fold on average. Thus, terbinafine may convert extensive CYP2D6 metabolizers to poor metabolizer condition.

In vitro studies with homo liver microsomes showed that terbinafine does not inhibit the metabolism of tolbutamide, ethinylestradiol, ethoxycoumarin, cyclosporine, cisapride and fluvastatin. In vivo drug-drug interaction studies conducted in good for you volunteer subjects showed that terbinafine does not touch on the clearance of antipyrine or digoxin. Terbinafine decreases the clearance of caffeine by 19%. Terbinafine increases the clearance of cyclosporine by xv%.

The influence of terbinafine on the pharmacokinetics of fluconazole, cotrimoxazole (trimethoprim and sulfamethoxazole), zidovudine or theophylline was not considered to be clinically pregnant.

Coadministration of a single dose of fluconazole (100 mg) with a unmarried dose of terbinafine resulted in a 52% and 69% increment in terbinafine Cmax and AUC, respectively. Fluconazole is an inhibitor of CYP2C9 and CYP3A enzymes. Based on this finding, information technology is likely that other inhibitors of both CYP2C9 and CYP3A4 (e.g., ketoconazole, amiodarone) may also lead to a substantial increase in the systemic exposure (Cmax and AUC) of terbinafine when concomitantly administered.

In that location have been spontaneous reports of increase or decrease in prothrombin times in patients concomitantly taking oral terbinafine and warfarin, however, a causal relationship between Lamisil Tablets and these changes has non been established.

Terbinafine clearance is increased 100% by rifampin, a CYP450 enzyme inducer, and decreased 33% by cimetidine, a CYP450 enzyme inhibitor. Terbinafine clearance is unaffected by cyclosporine. In that location is no information available from acceptable drug-drug interaction studies with the following classes of drugs: oral contraceptives, hormone replacement therapies, hypoglycemics, phenytoins, thiazide diuretics, and calcium aqueduct blockers.

Food Interactions

An evaluation of the effect of nutrient on Lamisil Tablets was conducted. An increase of less than 20% of the AUC of terbinafine was observed when Lamisil Tablets were administered with food. Lamisil Tablets can be taken with or without nutrient.

WARNINGS

Included every bit part of the PRECAUTIONS section.

PRECAUTIONS

Hepatotoxicity

Cases of liver failure, some leading to liver transplant or decease, 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. The severity of hepatic events and/or their event may be worse in patients with active or chronic liver disease. Treatment with Lamisil Tablets should be discontinued if biochemical or clinical evidence of liver injury develops.

Lamisil Tablets are non recommended for patients with chronic or active liver disease. Before prescribing Lamisil Tablets, liver function tests should be performed since hepatotoxicity may occur in patients with and without pre-existing liver disease. Periodic monitoring of liver function tests is recommended. Lamisil should be immediately discontinued in case of elevation of liver office tests. Patients prescribed Lamisil Tablets should be warned to report immediately to their physician any symptoms of persistent nausea, anorexia, fatigue, vomiting, right upper intestinal pain or jaundice, night urine, or pale stools. Patients with these symptoms should discontinue taking oral terbinafine, and the patientâ€™s liver function should be immediately evaluated.

Sense of taste Disturbance Including Loss of Taste

Gustatory modality disturbance, including taste loss, has been reported with the employ of Lamisil Tablets. It can be severe enough to result in decreased food intake, weight loss, anxiety, and depressive symptoms. Taste disturbance may resolve inside several weeks afterwards discontinuation of treatment, but may exist prolonged (greater than 1 year), or may be permanent. If symptoms of a taste disturbance occur, Lamisil Tablets should be discontinued.

Smell Disturbance Including Loss Of Smell

Scent disturbance, including loss of smell, has been reported with the use of Lamisil Tablets. Smell disturbance may resolve after discontinuation of treatment, just may be prolonged (greater than 1 twelvemonth), or may be permanent. If symptoms of a aroma disturbance occur, Lamisil Tablets should be discontinued.

Depressive Symptoms

Depressive symptoms accept occurred during postmarketing utilise of Lamisil Tablets. Prescribers should be alert to the evolution of depressive symptoms, and patients should be instructed to study depressive symptoms to their physician.

Hematologic Effects

Transient decreases in accented lymphocyte counts (ALCs) have been observed in controlled clinical trials. In placebo-controlled trials, viii/465 subjects receiving Lamisil Tablets (ane.vii%) and 3/137 subjects receiving placebo (ii.2%) had decreases in ALC to beneath thou/mm³ on ii or more occasions. In patients with known or suspected immunodeficiency, physicians should consider monitoring complete blood counts if treatment continues for more than than vi weeks. Cases of severe neutropenia have been reported. These were reversible upon discontinuation of Lamisil Tablets, with or without supportive therapy. If clinical signs and symptoms suggestive of secondary infection occur, a complete blood count should be obtained. If the neutrophil count is ≤ 1000 cells/mm³, Lamisil Tablets should be discontinued and supportive management started.

Serious Skin/Hypersensitivity Reactions

There have been postmarketing reports of serious pare/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]. Manifestations of DRESS syndrome may include cutaneous reaction (such equally rash or exfoliative dermatitis), eosinophilia, and one or more organ complications such every bit hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis. If progressive peel rash or signs/symptoms of the to a higher place drug reactions occur, treatment with Lamisil Tablets should exist discontinued.

Lupus Erythematosus

During postmarketing experience, atmospheric precipitation and exacerbation of cutaneous and systemic lupus erythematosus have been reported in patients taking Lamisil Tablets. Lamisil Tablets should be discontinued in patients with clinical signs and symptoms suggestive of lupus erythematosus.

Laboratory Monitoring

Measurement of serum transaminases (ALT and AST) is brash for all patients before taking Lamisil Tablets.

Patient Counseling Information

Run into FDA-Canonical Patient Labeling (PATIENT Data)

Patients taking Lamisil Tablets should receive the post-obit information and instructions:

Advise patients to immediately study to their physician or get emergency assist if they experience whatsoever of the following symptoms: hives, mouth sores, blistering and peeling of peel, swelling of face up, lips, tongue, or pharynx, difficulty swallowing or breathing. Lamisil Tablets treatment should be discontinued.
Advise patients to immediately study to their physician any symptoms of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain, jaundice, dark urine, or pale stools. Lamisil Tablets treatment should be discontinued.
Advise patients to report to their physician any signs of taste disturbance, odour disturbance and/or depressive symptoms, fever, skin eruption, lymph node enlargement, erythema, scaling, loss of paint, and unusual photosensitivity that can result in a rash. Lamisil Tablets handling should be discontinued.
Suggest patients to minimize exposure to natural and artificial sunlight (tanning beds or UVA/B handling) while using Lamisil Tablets.
Advise patients that if they forget to take Lamisil Tablets, to accept their tablets as soon as they think, unless it is less than iv hours earlier the side by side dose is due. Advise patients to call their md if they take too many Lamisil Tablets.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

In a 28-calendar month oral carcinogenicity written report in rats, an increase in the incidence of liver tumors was observed in males at the highest dose tested, 69 mg/kg/solar day (2x the MRHD based on AUC comparisons of the parent terbinafine); however, fifty-fifty though dose-limiting toxicity was not achieved at the highest tested dose, higher doses were not tested.

The results of a diverseness of in vitro (mutations in E. coli and Due south. typhimurium, DNA repair in rat hepatocytes, mutagenicity in Chinese hamster fibroblasts, chromosome abnormality, and sister chromatid exchanges in Chinese hamster lung cells), and in vivo (chromosome aberration in Chinese hamsters, micronucleus test in mice) genotoxicity tests gave no prove of a mutagenic or clastogenic potential.

Oral reproduction studies in rats at doses up to 300 mg/kg/mean solar day (approximately 12x the MRHD based on BSA comparisons) did not reveal whatsoever specific effects on fertility or other reproductive parameters. Intravaginal application of terbinafine hydrochloride at 150 mg/solar day in significant rabbits did non increase the incidence of abortions or premature deliveries nor affect fetal parameters.

Employ In Specific Populations

Pregnancy

Pregnancy Category B

There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, and because treatment of onychomycosis can be postponed until after pregnancy is completed, it is recommended that Lamisil Tablets non be initiated during pregnancy.

Oral reproduction studies accept been performed in rabbits and rats at doses up to 300 mg/kg/day [12x to 23x the maximum recommended human dose (MRHD), in rabbits and rats, respectively, based on body surface surface area (BSA) comparisons] and have revealed no evidence of dumb fertility or harm to the fetus due to terbinafine.

Nursing Mothers

Afterward oral administration, terbinafine is present in breast milk of nursing mothers. The ratio of terbinafine in milk to plasma is 7:1. Treatment with Lamisil Tablets is not recommended in women who are nursing.

Pediatric Utilize

The safety and efficacy of Lamisil Tablets take non been established in pediatric patients with onychomycosis.

Geriatric Use

Clinical studies of Lamisil Tablets did non include sufficient numbers of subjects aged 65 years and over to determine whether they answer differently from younger subjects. Other reported clinical feel has not identified differences in responses between the elderly and younger patients. In general, dose pick for an elderly patient should be cautious, unremarkably starting at the depression stop of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac office, and of concomitant illness or other drug therapy.

Renal Impairment

In patients with renal impairment (creatinine clearance less than or equal to 50 mL/min) the employ of Lamisil Tablets has not been fairly studied.

Overdosage & Contraindications

OVERDOSE

Clinical experience regarding overdose with oral terbinafine is limited. Doses up to v grams (xx times the therapeutic daily dose) have been taken without inducing serious adverse reactions. The symptoms of overdose included nausea, vomiting, abdominal pain, dizziness, rash, frequent urination, and headache.

CONTRAINDICATIONS

Lamisil Tablets are contraindicated in individuals with a history of allergic reaction to oral terbinafine because of the risk of anaphylaxis.

CLINICAL PHARMACOLOGY

Mechanism Of Action

Terbinafine is an allylamine antifungal [see Microbiology].

Pharmacodynamics

The pharmacodynamics of Lamisil Tablets is unknown.

Pharmacokinetics

Following oral administration, terbinafine is well absorbed ( > seventy%) and the bioavailability of Lamisil Tablets equally a event of get-go-pass metabolism is approximately xl%. Pinnacle plasma concentrations of ane μg/mL announced within ii hours after a unmarried 250 mg dose; the AUC is approximately 4.56 μg&bu;ll;h/mL. An increase in the AUC of terbinafine of less than twenty% is observed when Lamisil Tablets are administered with food.

In plasma, terbinafine is > 99% bound to plasma proteins and at that place are no specific binding sites. At steady-country, in comparison to a unmarried 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 consequent with an effective one-half-life of ~36 hours. Terbinafine is distributed to the sebum and skin. A last half-life of 200-400 hours may stand for the slow elimination of terbinafine from tissues such every bit skin and adipose. Prior to excretion, terbinafine is extensively metabolized by at least vii CYP isoenzymes with major contributions from CYP2C9, CYP1A2, CYP3A4, CYP2C8, and CYP2C19. No metabolites have been identified that have antifungal activeness like to terbinafine. Approximately 70% of the administered dose is eliminated in the urine.

In patients with renal damage (creatinine clearance ≤ fifty mL/min) or hepatic cirrhosis, the clearance of terbinafine is decreased by approximately 50% compared to normal volunteers. No effect of gender on the blood levels of terbinafine was detected in clinical trials. No clinically relevant historic period-dependent changes in steady-state plasma concentrations of terbinafine take been reported.

Microbiology

Terbinafine, an allylamine antifungal, inhibits biosynthesis of ergosterol, an essential component of fungal cell membrane, via inhibition of squalene epoxidase enzyme. This results in fungal cell death primarily due to the increased membrane permeability mediated by the accumulation of high concentrations of squalene only not due to ergosterol deficiency. Depending on the concentration of the drug and the fungal species test in vitro, terbinafine hydrochloride may be fungicidal. However, the clinical significance of in vitro data is unknown.

Terbinafine has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections:

Trichophyton mentagrophytes
Trichophyton rubrum

The following in vitro information are available, only their clinical significance is unknown. In vitro, terbinafine exhibits satisfactory MIC'southward against most strains of the post-obit microorganisms; however, the safe and efficacy of terbinafine in treating clinical infections due to these microorganisms have non been established in adequate and well-controlled clinical trials:

Candida albicans
Epidermophyton floccosum
Scopulariopsis brevicaulis

Fauna Toxicology And/Or Pharmacology

A broad range of in vivo studies in mice, rats, dogs, and monkeys, and in vitro studies using rat, monkey, and human hepatocytes advise that peroxisome proliferation in the liver is a rat-specific finding. However, other effects, including increased liver weights and APTT, occurred in dogs and monkeys at doses giving Css trough levels of the parent terbinafine 2-3x those seen in humans at the MRHD. Higher doses were not tested.

Clinical Studies

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 starting time toenail trial, equally assessed at week 48 (12 weeks of handling with 36 weeks follow-up later completion of therapy), demonstrated mycological cure, divers as simultaneous occurrence of negative KOH plus negative culture, in 70% of subjects. Fifty-nine percent (59%) of subjects experienced effective handling (mycological cure plus 0% nail involvement or > 5mm of new unaffected smash growth); 38% of subjects demonstrated mycological cure plus clinical cure (0% nail involvement).

In a 2nd toenail trial of dermatophytic onychomycosis, in which nondermatophytes were also cultured, similar efficacy against the dermatophytes was demonstrated. The pathogenic office of the nondermatophytes cultured in the presence of dermatophytic onychomycosis has not been established. The clinical significance of this association is unknown.

Results of the fingernail trial, as assessed at week 24 (vi weeks of treatment with 18 weeks follow-up after completion of therapy), demonstrated mycological cure in 79% of subjects, effective handling in 75% of the subjects, and mycological cure plus clinical cure in 59% of the subjects.

The mean time to overall success was approximately 10 months for the first toenail trial and 4 months for the fingernail trial. In the offset toenail trial, for subjects evaluated at to the lowest degree vi months after achieving clinical cure and at least one year afterwards completing therapy with Lamisil Tablets, the clinical relapse rate was approximately 15%.

PATIENT Data

Lamisil
(Lam-i-sil)
(terbinafine hydrochloride) Tablets

What are Lamisil Tablets ?

Lamisil Tablets is a prescription antifungal medicine used to treat fungal infections of the fingernails and toenails (onychomycosis).

Your doctor should practice tests to cheque y'all for fungal infection of your nails before y'all start Lamisil Tablets.

Information technology is non known if Lamisil Tablets are safe and constructive in children for the handling of onychomycosis.

Who should not take Lamisil Tablets ?

Do not accept Lamisil Tablets if you are allergic to terbinafine hydrochloride when taken by oral fissure.

What should I tell my md before taking Lamisil Tablets ?

Before you have Lamisil Tablets , tell your doctor if y'all:

have or had liver problems
have a weakened allowed organization (immunocompromised)
take lupus (an autoimmune disease)
have any other medical weather condition
are meaning or plan to get pregnant. It is not known if Lamisil Tablets will harm your unborn baby. You lot should non commencement taking Lamisil Tablets during pregnancy without talking with your doc.
are breastfeeding or plan to breastfeed. Lamisil can pass into your chest milk and may impairment your infant. Talk to your md about the best way to feed your babe if yous take Lamisil Tablets.

Tell your doctor nearly all the medicines yous have, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Lamisil Tablets may affect the way other medicines work and other medicines may affect how Lamisil Tablets work. Especially tell your physician if y'all take:

a medicine for low
a medicine for loftier blood pressure
a medicine for heart problems
desipramine (Norpramin)
caffeine
cyclosporine (Gengraf, Neoral, Sandimmune)
fluconazole (Diflucan)
rifampin (Rifater, Rifamate, Rimactane, Rifadine)
cimetidine (Tagamet)

If you are not sure if your medicine is one listed higher up, ask your doctor or pharmacist.

Know the medicines you take. Keep a list of them to bear witness your doc and pharmacist when you get a new medicine.

How should I take Lamisil Tablets ?

Take Lamisil Tablets exactly as your physician tells you to take information technology.
Lamisil comes equally a tablet that you accept by oral cavity.
Lamisil Tablets are normally taken:
- one time each day for 6 weeks to care for fungal infections of your fingernail, or
- 1 time each day for 12 weeks to treat fungal infections of your toenail
Lamisil Tablets tin can exist taken with or without food.
If you lot miss a dose of Lamisil Tablets, take it as before long as you remember. If it is less than 4 hours before your next dose, skip the missed dose. But take the adjacent dose at your regular time.

If yous take besides many Lamisil Tablets call your doc. You may have the following symptoms:

nausea
vomiting
stomach (abdomen) pain
dizziness
rash
frequent urination
headache

What should I avoid while taking Lamisil Tablets ?

Avoid sunlight. Lamisil Tablets can make your pare sensitive to the sun and the lite from sunlamps and tanning beds. You lot can go a severe sunburn. Employ sunscreen and wear a hat and apparel that cover your skin if yous have to be in sunlight. Talk to your medico if you get sunburn.

What are the possible side effects of Lamisil Tablets ?

Lamisil Tablets may cause serious side effects, including:

liver problems that can pb to the need for liver trans plant, or death. Tell your doctor right abroad if you get any of these symptoms of a liver trouble:
- nausea
- upper right stomach-expanse (belly) pain
- poor appetite
- yellowing of your skin or optics (jaundice)
- tiredness
- dark (tea-colored) urine
- vomiting
- stake or calorie-free colored stools

Your doc should do a blood exam to check you for liver problems earlier y'all take Lamisil Tablets.

modify in taste or los due south of taste may happen with Lamisil Tablets and tin can be severe. This may meliorate within several weeks after you stop taking Lamisil Tablets, merely may last for a long fourth dimension or may become permanent. Tell your doctor if y'all accept:
- change in taste or loss of taste
- poor appetite
- unwanted weight loss
- anxiousness
- change in mood or depressive symptoms
change in scent or loss of smell may happen with Lamisil Tablets. This may improve subsequently y'all stop taking Lamisil Tablets, but may last for a long time or may become permanent.
depressive symptoms. Tell your doctor right away if you have any of these signs or symptoms:
- feel lamentable or worthless
- alter in slumber pattern
- loss of free energy or involvement in daily activities
- restlessness
- mood changes
depression white blood cell count. People taking Lamisil Tablets may have a decrease in white blood cells, peculiarly neutrophils. You may have a higher risk of getting an infection when your white blood prison cell count is depression.
serious skin or allergic reactions. Tell your doc right abroad or get emergency aid if yous become any of these symptoms:
- skin rash, hives, sores in your oral cavity, or your skin blisters and peels
- swelling of your face, eyes, lips, tongue or pharynx, problem swallowing or breathing
- drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome – pare rash, fever, bloated lymph glands, interest of internal organs
new or worsening lupus (an autoimmune disease). Finish taking Lamisil Tablets and tell your doctor if you go whatsoever of the post-obit:
- progressive skin rash that is scaly, red, shows scarring, or loss of paint
- unusual sensitivity to the sunday that can lead to a rash

The almost common side effects of Lamisil Tablets include:

headache
diarrhea
rash
upset tummy
abnormal liver function tests
itching
change in taste
nausea
stomach-expanse (abdomen) pain
gas

Tell your md if yous take any side consequence that bothers you or that does not go away.

These are not all of the possible side effects of Lamisil Tablets. For information, ask your physician or chemist.

Call your doctor for medical advice about side effects. You lot may report side effects to FDA at i-800-FDA-1088.

How should I store Lamisil Tablets ?

Store Lamisil Tablets below 77°F (25°C)
Go along Lamisil Tablets in a tightly closed container and continue out of the light.

Go along Lamisil Tablets and all medicines out of the reach of children.

General information about the prophylactic and effective use of Lamisil Tablets .

Medicines are sometimes prescribed for purposes other than those listed in Patient Data. Do not utilise Lamisil Tablets for a status for which it was not prescribed. Do not requite Lamisil Tablets to other people, fifty-fifty if they take the same symptoms that you have. It may harm them.

You tin inquire your pharmacist or dr. for information about Lamisil Tablets that is written for health professionals.

What are the ingredients in Lamisil Tablets ?

Active ingredient: terbinafine hydrochloride

Inactive ingredients: colloidal silicon dioxide, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

This Patient Information has been approved by the U.S. Food and Drug Assistants.

From

FDA Logo

Study Bug to the Food and Drug Administration

Y'all are encouraged to study negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or telephone call 1-800-FDA-1088.