Tablet:

For all indications, the dose of Elvina® Tablet is 250 mg once daily. The duration of treatment varies based on the indication and severity of the infection.

For onychomycosis, the optimal clinical effect may be seen after mycological cure and cessation of treatment, as this is related to the period required for the regrowth of healthy nails.

Cream:

Elvina® Cream can be applied once or twice daily. The duration of treatment depends on the indication and the severity of the infection.

Clean and dry the affected areas thoroughly before application.

Apply the cream to the affected skin and surrounding areas in a thin layer and rub gently.

Relief of clinical symptoms usually occurs within a few days. Treatment must be used regularly for an adequate length of time. Irregular use or premature discontinuation may lead to recurrence.

If no improvement is observed after two weeks, the diagnosis should be re-evaluated.

Known hypersensitivity to terbinafine or any of the excipients in Terbinafine tablets or cream.

Chronic or active hepatic disease.

Elvina® Tablets and Cream are contraindicated in patients with chronic or active hepatic disease.

Before prescribing Terbinafine Tablets, liver function tests should be performed, and any pre-existing liver disease should be assessed.

Patients prescribed Terbinafine Tablets should immediately report signs of liver dysfunction, such as pruritus, persistent nausea, decreased appetite, anorexia, jaundice, vomiting, fatigue, right upper abdominal pain, dark urine, or pale stools. Treatment should be discontinued if these symptoms occur, and liver function should be evaluated.

Serious skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia, and systemic symptoms) have been very rarely reported. If a progressive skin rash occurs, discontinue Terbinafine Tablets.

Use with caution in patients with pre-existing psoriasis, as very rare cases of exacerbation have been reported.

Very rare cases of blood dyscrasias (e.g., neutropenia, agranulocytosis, thrombocytopenia, pancytopenia) have been reported. Blood dyscrasias should be evaluated, and a possible change in the treatment regimen should be considered.

In patients with renal impairment (creatinine clearance <50 mL/min or serum creatinine >300 µmol/L), Terbinafine Tablets and Cream have not been adequately studied and are not recommended.

Side effects are generally mild to moderate and transient. The most frequently reported adverse effects include:

Gastrointestinal symptoms: Feeling of fullness, abdominal distension, dyspepsia, nausea, abdominal pain, and diarrhea.

Dermatological reactions: Rash and urticaria.

Musculoskeletal reactions: Arthralgia and myalgia.

Pregnancy: As clinical experience in pregnant women is very limited, Elvina® should not be used during pregnancy.

Lactation: Elvina® is excreted in breast milk and should not be used by breastfeeding mothers.

Animal studies suggest no adverse effects on fertility.

Children:

Due to limited data, use in children is not recommended.

Geriatric Patients:

There is no evidence suggesting that elderly patients (65 years or older) require different dosages or experience different side effects compared to younger patients. However, liver or kidney function should be assessed in this age group.

Elvina® inhibits the CYP450 2D6 isozyme and can affect the metabolism of desipramine, cimetidine, fluconazole, cyclosporine, rifampin, and caffeine.

A few cases of overdose (up to 5 g) have been reported, with symptoms including headache, nausea, upper abdominal pain, and dizziness.

Elvina® Tablet 250 mg: Store below 30 °C in a dry place. Protect from light and moisture.

Elvina® Cream 1%: Store below 30 °C in a dry place. Protect from light and moisture.

Elvina® Tablet 250 mg: Each tablet contains Terbinafine Hydrochloride EP equivalent to Terbinafine 250 mg.

Elvina® Cream 1%: Each gram of cream contains Terbinafine Hydrochloride EP equivalent to Terbinafine 10 mg.

Terbinafine Hydrochloride (Elvina®) is a synthetic allylamine antifungal. It is highly lipophilic and tends to accumulate in the skin, nails, and fatty tissues. Like other allylamines, terbinafine inhibits ergosterol synthesis by blocking fungal squalene monooxygenase (squalene 2,3-epoxidase), an enzyme critical to the fungal cell wall synthesis pathway.

Elvina® Tablet

Onychomycosis of the toenail or fingernail due to dermatophytes.

Ringworm (Tinea corporis, Tinea cruris, and Tinea pedis) when oral therapy is appropriate due to the site, severity, or extent of the infection.

Elvina® Cream

Yeast infections of the skin, principally caused by the genus Candida (e.g., Candida albicans).

Pityriasis (Tinea) versicolor caused by Pityrosporum orbiculare (also known as Malassezia furfur).