Lamisil 125mg. 250mg Tablet

Adults: Fungal infections of the skin caused by dermatophytes such dermatophytes such as Trychophyton (e.g. T. rubrum, T. mentagrorophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum) Oral LAMISIL u00ae is indicated in the treatment of ringworm (Tinea corporis, Tinea cruris and Tinea pedis) and yeast infections of the skin caused by Candida (e.g., Candida albicans) where topical treatment is considered inappropriate owing to the site, severity, or extent of the infection. Onychomycosis (fungal infection of the nail) caused by dermatophyte fungi.

Children: Tinea capitis. Note: In contrast to topical LAMISIL u00ae, oral LAMISIL u00ae is not effective in pityriasis versicolor and also not in gastro - intestinal and vaginal candidiasis.

Prior to initiating treatment, appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained from the nail bed to confirm the diagnosis of onychomycosis. The duration of treatment varies according to the indication and the severity of the infection:

Posology

Adults: 250 mg once a day. Skin infections Recommended duration of treatment: Tinea pedis (interdigital, plantar/moccasin type): 2 to 6 weeks. Tinea corporis, T. cruris: 2 to 4 weeks. Cutaneous candidiasis: 2 to 4 weeks. Complete resolution of the signs and symptoms of infection may not occur until several weeks after mycological cure.

Hair and scalp infections Recommended duration of treatment: Tinea capitis: 4 weeks. Tinea capitis occurs primarily in children. Onychomycosis For most patients the duration of successful treatment is 6 - 12 weeks.

• Fingernail onychomycosis: Six weeks of therapy is sufficient for fingernail infections in most cases.
• Toenail onychomycosis: Twelve weeks of therapy is sufficient for toenail infections in most cases. Some patients with poor nail outgrowth may require longer treatment. The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.

Special populations

Liver impairment LAMISIL u00ae tablets are not recommended for patients with chronic or active liver disease (see Section 4.4). Renal impairment In patients with renal impairment (creatinine clearance less than 50mL /min or serum creatinine of more than 300 u03bcmol/L) the use of LAMISIL u00ae tablets has not been adequately studied, and therefore, is not recommended in this population (see Section 5.2). Elderly: There is no evidence that elderly patients require different dosages or experience different side - effects than younger patients. When prescribing LAMISILu00ae tablets for patients in this age group, the possibility of pre - existing impairment of liver or kidney function should be considered (see above). Paediatric population No data are available in children under two years of age (usually < 12 kg).

• Children weighing under 20 kg: 62,5 mg once daily (the use of Lamisil 250 mg tablets is not recommended)
• Children weighing 20 - 40 kg: 125 mg (half 250 mg tablet) once daily
• Children weighing more than 40 kg: 250 mg once daily

Method of administration The scored tablets are taken orally with water. They should preferably be taken at the same time each day and can be taken on an empty stomach or after a meal.

• Hypersensitivity to terbinafine and any of the excipients of LAMISIL u00ae tablets.
• Impaired liver function.
• Breastfeeding (see Section 4.6).

Cutaneous and mucosal Candida infection, pityriasis versicolor Orally administered terbinafine is not active or is insufficiently active against skin infections caused by Candida spp. or Pityrosporum ovale (pityriasis versicolor) or against mucosal infections caused by Candida spp. (including vaginal candidosis).

Liver function LAMISIL u00ae tablets are not recommended for patients with chronic or active liver disease. Before prescribing LAMISIL u00ae tablets, pre - existing liver disease should be assessed. Hepatotoxicity may occur in patients with and without pre - existing liver transplant) have been reported in patients treated with LAMISIL u00ae tablets. Therefore, periodic monitoring (after 4 - 6 weeks of treatment) of the liver function is recommended. In the majority of liver failure cases the patients had serious underlying systemic conditions and a causal association with the intake of LAMISIL u00ae tablets was uncertain (see Section 4.9). Patients prescribed LAMISIL u00ae tablets should be warned to report immediately any symptoms of unexplained persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain, or jaundice, dark urine or pale stools. Patients with these symptoms should discontinue taking oral LAMISIL u00ae and the patientu2019s liver function should be immediately evaluated.

Dermatological effects Serious skin reactions (e.g., Stevens - Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms) have been very rarely reported in patients taking LAMISIL u00ae tablets. If progressive skin rash occurs, LAMISIL u00ae tablets treatment should be discontinued. Caution is recommended in the use of terbinafine in patients with existing psoriasis or lupus erythematosus, given that very rare cases of cutaneous and systemic lupus erythematosus and psoriasiform eruptions or exacerbation of psoriasis have been reported.

Haematological effects Cases of blood dyscrasias (neutropenia, agranulocytosis, thrombocytopenia, pancytopenia) have been reported in patients treated with LAMISIL u00ae tablets. The etiology of every blood disorder that occurs in patients who are treated with Lamisil tablets must be evaluated and a possible adjustment of the medication schedule must be considered, including discontinuation of the treatment with Lamisil tablets. It is recommended to monitor blood cells frequently.

Terbinafine is an inhibitor of CYP2D6. An interaction is possible with medications that are primarily metabolized via CYP2D6 such as tricyclic antidepressants, beta blockers, selective serotonin reuptake inhibitors (SSRI), antiarrhythmic drugs (including class 1A, 1B and 1C) and type B monoamino - oxidase inhibitors (MAOI). Patients must be monitored, especially if the therapeutic window for these medications is small (see Section 4.5). Checking of the blood count for immunodeficient patients who have been under treatment for longer than 6 weeks.

Effect of other medicines on LAMISIL u00ae: The plasma clearance of LAMISIL u00ae may be accelerated by medicines, which induce metabolism and may be inhibited by medicines, which inhibit cytochrome P450. Where co - administration of such medicines is necessary, the dosage of LAMISIL u00ae tablets may need to be adjusted accordingly. The following medicines may increase the effect or plasma concentration of LAMISIL u00ae Cimetidine decreased the clearance of LAMISIL u00ae by 33%. Fluconazole increased the C max and AUC of LAMISIL u00ae by 52% and 69% respectively, due to inhibition of both CYP2C9 and CYP3A4 enzymes. Similar increase in exposure may occur when other medicines which inhibit both CYP2C9 and CYP3A4 such as ketoconazole and amiodarone are concomitantly administered with LAMISIL u00ae.

Renal function In patients with renal impairment (creatinine clearance less than 50mL /min or serum creatinine of more than 300 u03bcmol/L) the use of LAMISILu00ae tablets has not been adequately studied, and therefore, is not recommended in this population (see Section 5.2).

The following medicines may decrease the effect or plasma concentration of LAMISIL u00ae Rifampicin increased the clearance of LAMISILu00ae by 100%. Effect of LAMISILu00ae on other medicines: According to the results from studies undertaken in vitro and in healthy volunteers, LAMISILu00ae shows negligible potential for inhibiting or enhancing the clearance of medicines that are metabolised via the cytochrome P - 450 system (e.g., terfenadine, triazolam, tolbutamide or oral contraceptives). LAMISIL u00ae does not interfere with the clearance of antipyrine or digoxin. LAMISIL u00ae has no effect on the pharmacokinetics of fluconazole. There is no clinically relevant interaction between LAMISIL u00ae and cotrimoxazole (trimethoprim and sulfamethoxazole), zidovudine or theophylline. Cases of menstrual irregularities have been reported in patients taking LAMISILu00ae tablets concomitantly with oral contraceptives. LAMISILu00ae may increase the effect or plasma concentration of the following medicines: Terbinafine decreased the clearance of caffeine administered intravenously by 21%. Compounds predominantly metabolised by CYP2D6: In vitro and in vivo studies have shown however, that LAMISILu00ae inhibits the CYP2D6 - mediated metabolism. This finding may be of clinical relevance for compounds predominantly metabolised by CYP2D6, such as tricyclic antidepressants (TCAs), beta - blockers, selective serotonin reuptake inhibitors (SSRIs), antidysrhythmics (including class 1A, 1B and 1C) and monoamine oxidase inhibitors (MAO - Is) Type B, especially if they also have a narrow therapeutic window. (See Section 4.4) LAMISIL u00ae decreased the clearance of desipramine by 82%. LAMISILu00ae increased the dextromethorphan metabolic ratio in urine by 16 - to 97 - fold on average in studies in healthy subjects characterised as extensive metabolisers of dextromethorphan (antitussive medicines). Thus, LAMISILu00ae may convert extensive CYP2D6 metabolisers to poor metaboliser status.

LAMISILu00ae may decrease the effect or plasma concentration of the following medicines LAMISILu00ae increased the clearance of ciclosporin by 15%. Drug - food/drink interactions The bioavailability of terbinafine is moderately affected by food (increase in the AUC of less than 20%), but not sufficiently to require dose adjustments.

Pregnancy In an observational, registry - based cohort study, there was no increase in the risk of major malformations or spontaneous abortion in pregnancies exposed to oral terbinafine in comparison to those not exposed to oral terbinafine (see Clinical Data). In animal reproduction studies, terbinafine did not cause reproductive toxicity in rats and rabbits at oral doses up to 12 and 23 times the maximum recommended human dose (MRHD) based on body surface (BSA), respectively (see Non - clinical Data). The use of terbinafine may be considered during pregnancy, if necessary.

Data Clinical data A nationwide, observational, registry - based cohort study was conducted in a cohort of 1,650,649 pregnancies. Pregnancies were matched on propensity scores comparing pregnancies exposed to oral terbinafine versus those not exposed to oral terbinafine in a 1:10 ratio to evaluate the risk of major malformations (522 versus 5220) and spontaneous abortions (891 versus 8910). The prevalence odds ratio for the risk of major malformations was 1.01 (95% CI, 0.63 - 1.62) for pregnancies exposed versus not exposed to oral terbinafine. The hazard ratio for the risk of spontaneous abortion was 1.06 (95% CI, 0.86 - 1.32) for the same comparison. No increased risk of major malformations or spontaneous abortion was identified among pregnancies exposed to oral terbinafine.

Non - clinical data In embryo - foetal development studies in rats and rabbits, terbinafine was administered orally (30, 100, or 300 mg/kg/day) during the period of organogenesis. There were no embryotoxic or teratogenic effects up to the maximum tested dose of 300 mg/kg/day in rats and rabbits (corresponding to 12 and 23 times the MRHD based on BSA, respectively). Subcutaneous administration of terbinafine (10, 30 or 100 mg/kg/day) to rats during the period of organogenesis showed no teratogenic or embryotoxic effect up at doses up to 100 mg/kg/day (corresponding to 4 times the MRHD based on BSA). In a rat peri - and postnatal development study, oral administration of terbinafine (30, 100 or 300 mg/kg/day) had no adverse effects on pregnancy and lactation at doses up to 300 mg/kg/day (corresponding to 12 times the MRHD based on BSA). No treatment related effects in F1 and F2 generations were noted.

Breastfeeding LAMISIL u00ae is excreted in breastmilk. Mothers receiving oral treatment with LAMISIL u00ae tablets should not breastfeed their infants. There are no data on the effects of terbinafine on the breastfed child or on milk production. The maximum ratio of terbinafine in milk to plasma is 7:1, and the maximum amount of terbinafine ingested by the infant is expected to be 16% of the dose administered to the nursing mother. The highest concentration of terbinafine in breast milk was observed within 6 hours after administration, and thereafter the concentration of terbinafine decreased by approximately 70% in the 6 u2013 12 - hour time window after administration.

Fertility There is no relevant information from human experience. Studies regarding fertility in animals did not reveal any toxic effect.

No studies on the effects of Lamisil tablets treatment on the ability to drive and use machines have been performed. Patients who experience dizziness as an undesirable effect should avoid driving vehicles or using machines.

Adverse reactions are ranked under headings of frequency, using the following convention: Very common (u2265 1/10); common (u2265 1/100, < 1/10); uncommon (u2265 1/1,000, < 1/100); rare (u2265 1/10,000, < 1/1,000;); very rare (< 1/10,000), including isolated reports.

Table 1: Adverse reactions form clinical trials and post - marketing experience

Blood and lymphatic system disorders Uncommon: Anaemia. Very rare: Neutropenia, agranulocytosis, thrombocytopenia, pancytopenia

Immune system disorders Very rare: Anaphylactoid reactions (including angioedema), cutaneous and systemic lupus erythematosus Unknown Anaphylactic reactions, serum sickness - like reaction

Psychiatric disorders Common: Depression. Uncommon: Anxiety.

Nervous system disorders Very common: Headache Common: Taste disturbances (Dysgeusia* including ageusia*), dizziness. Uncommon: Paraesthesia and hypoesthesia. Unknown Anosmia including permanent anosmia, hyposmia

Eye disorders Common: Visual impairment. Unknown Vision blurred, visual acuity reduced

Ear and labyrinth disorders Uncommon: Tinnitus. Unknown Hypoacusis

Gastrointestinal disorders Very common: Gastrointestinal symptoms (abdominal distension, decreased appetite, dyspepsia, nausea, mild abdominal pain, diarrhoea). Unknown: Pancreatitis

Hepatobiliary disorders Rare: Hepatobiliary dysfunction liver failure, hepatitis, jaundice, cholestasis, increased liver enzymes

Skin and subcutaneous tissue disorders Very common: Non - serious forms of skin reactions (Rash, urticaria). Uncommon: Photosensitivity reaction. Very rare: Erythema multiforme, Stevens - Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis (AGEP), toxic skin eruption, dermatitis exfoliative, dermatitis bullous. Psoriasiform eruptions or exacerbation of psoriasis Alopecia Unknown Drug rash with eosinophilia and systemic symptoms

Musculoskeletal and connective tissue disorders Very common: Musculoskeletal reactions (arthralgia, myalgia) Unknown Rhabdomyolysis

General disorders and administration site conditions Uncommon: Pyrexia. Common: Fatigue Unknown Illnesses resembling influenza

Tests Uncommon: Weight loss** Unknown Increased blood creatinine phosphokinase * Hypogeusia, including ageusia, which generally recovers within several weeks after treatment with the medication has been discontinued. Isolated cases of long - term hypogeusia have been reported. **Weight loss as a result of dysgeusia.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

See Undesirable effects. Cases of overdosage (up to 5 g) have been reported, giving rise to headache, nausea, epigastric pain, and dizziness. The recommended treatment of overdosage consists of eliminating the medicine primarily by the administration of activated charcoal and giving, symptomatic supportive therapy, if needed.