Lamifen 125 mg 14 tablets

Lamifen 125 mg 14 tablets

Composition:

Active Ingredient: Terbinafine — 125 mg per tablet.
Excipients: Hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, silicon dioxide, calcium stearate.

Product Description:

• Systemic antifungal agent belonging to the allylamine class with a broad spectrum of antimycotic activity.
• The medication exerts a fungicidal effect on dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Trichophyton verrucosum, Trichophyton violaceum), Microsporum canis, Epidermophyton floccosum, mold fungi, and certain yeast species (Candida albicans). 
• Its mechanism of action involves inhibiting the enzyme squalene epoxidase, thereby disrupting an early step in the biosynthesis of ergosterol, a vital component of the fungal cell membrane. 
• When administered orally, the drug is ineffective against pityriasis versicolor caused by Pityrosporum ovale, Pityrosporum orbiculare, or Malassezia furfur.

Indications for Use:

• Treatment of fungal infections of the skin, hair, and nails caused by terbinafine-sensitive microorganisms:
• Fungal scalp infections (tinea capitis, trichophytosis, microsporosis);
• Fungal infections of the skin and nails (onychomycosis);
• Severe, widespread dermatomycoses of the trunk and limbs requiring systemic therapy;
• Cutaneous and mucosal candidiasis.

Method of Administration and Dosage:

• How to use: Oral administration, regardless of meal times, swallowed whole with an adequate volume of water.
• Standard dosage for adults: 250 mg per day (taken as one 125 mg tablet twice daily, or two 125 mg tablets once daily).
• Treatment duration: Determined individually based on the localization and severity of the infection:
  Tinea pedis (athlete's foot): 2 to 6 weeks.
  Tinea corporis / tinea cruris, cutaneous candidiasis: 2 to 4 weeks.
  Tinea capitis: approximately 4 weeks.
  Onychomycosis: 6 to 12 weeks (fingernail onychomycosis: 6 weeks; toenail onychomycosis: 12 weeks).

Contraindications:

• Acute or chronic liver disease with significant functional impairment
• Lactation (breastfeeding) period
• Children under 2 years of age
• Known hypersensitivity or allergy to terbinafine or any inactive excipients

Precautions:

• Use with caution in patients with renal impairment, alcoholism, bone marrow depression, tumors, metabolic disorders, or occlusive vascular disease of the limbs, as well as during pregnancy.
• Irregular administration or premature discontinuation of treatment increases the risk of disease recurrence.
• If no clinical improvement is observed after 2 weeks of skin infection treatment, re-identification of the pathogen and its sensitivity is recommended.
• Systemic therapy for onychomycosis is justified in cases of total nail involvement, pronounced subungual hyperkeratosis, or failure of prior topical treatment. Clinical response in onychomycosis aligns with the growth rate of healthy nails and may become apparent several months after mycological cure and treatment completion.

Adverse Reactions / Side Effects:

• Central Nervous System: Frequently — headache, dizziness.
• Gastrointestinal System: Frequently — abdominal fullness, nausea, abdominal pain, diarrhea, dyspepsia, decreased appetite, taste disturbances (ageusia, dysgeusia).
• Skin and Subcutaneous Tissue: Frequently — skin rash, urticaria; very rarely — psoriasiform eruptions, exacerbation of psoriasis, Stevens-Johnson syndrome, toxic epidermal necrolysis, alopecia (hair loss), acute generalized exanthematous pustulosis.
• Musculoskeletal System: Frequently — arthralgia, myalgia.
• Hematologic System: Very rarely — neutropenia, agranulocytosis, thrombocytopenia.
• Immune System: Infrequently — anaphylactoid reactions, angioedema, exacerbation of systemic lupus erythematosus.
• General: Very rarely — fatigue.

Pregnancy and Lactation:

Use during pregnancy is permissible only if the potential benefit to the mother outweighs the potential risk to the fetus.
Use during breastfeeding is contraindicated (terbinafine is excreted in human breast milk).

Storage Conditions:

Store at a temperature not exceeding 30 °C in a dry place.
Keep out of reach of children.

Packaging:

Cardboard box containing 2 blisters of 7 tablets each (14 tablets total).