Lopranest 2 mg 20 orodispersible films

Lopranest 2 mg 20 orodispersible films

Composition:

Each orodispersible film contains:
Loperamide hydrochloride 2 m.
Excipients: film-forming agents, stabilizers, flavoring, and packaging components.

Product Description:

Lopranest is an anti-diarrheal medication in the form of oral films that dissolve on the tongue without water.
This dosage form is convenient for travel, emergencies, and for patients (children or elderly) who have difficulty swallowing tablets.

Indications for Use:

Acute diarrhea (e.g., traveler’s diarrhea, food-related diarrhea).
Chronic diarrhea associated with inflammatory bowel disease (under medical supervision).
Reduction of stool frequency in patients with ileostomy.

Method of Administration and Dosage:

Adults: 2 mg (1 film) after each loose stool.
Maximum: 8 mg/day without prescription; up to 16 mg/day under medical supervision.
Children ≥12 years: 2 mg initially, then 1 film after each loose stool (max 8 films/day).
Children <6 years: Not recommended unless specifically formulated.
Films are placed on the tongue and allowed to dissolve completely.

Contraindications:

Children under 2 years of age.
Acute dysentery (bloody diarrhea, high fever).
Pseudomembranous colitis or bacterial enterocolitis.
Hypersensitivity to loperamide or excipients.

Precautions:

Use with caution in liver impairment (risk of increased systemic exposure).
Avoid exceeding recommended dose - high doses may cause serious cardiac arrhythmias (QT prolongation, torsades de pointes).
Not suitable for diarrhea caused by invasive bacterial infections.

Adverse Reactions:

Common: constipation, nausea, headache, flatulence.
Rare: allergic reactions (rash, urticaria, anaphylaxis), abdominal pain, dizziness.
Serious (rare): severe constipation, toxic megacolon, cardiac arrhythmias at high doses.

Pregnancy and Lactation:

Limited data; use only if benefits outweigh risks.
Not recommended during breastfeeding due to possible excretion in breast milk.

Storage Conditions:

Store below 30°C, in a dry place, away from direct sunlight.

Packaging:

Carton box containing 20 orodispersible films (2 mg each).