Loperal Loperamide 2mg Anti-Diarrhoeal, 10 Capsules

Product Name & Strength: Loperal Capsules 2 mg (Loperamide Hydrochloride BP 2 mg), 1 x 10's.

Indications (Approved Uses): Indicated as an adjunct in the management of acute diarrhoea, to be used together with appropriate fluid and electrolyte replacement. It is also used for the symptomatic control of diarrhoea associated with chronic inflammatory bowel disease (such as Crohn's disease and ulcerative colitis) and for the adjunctive short-term control of post-surgical diarrhoea, including ileostomy. In children, it may be used occasionally for the control of intractable diarrhoea under specialist supervision.

Contraindications (Safety Warnings): Contraindicated in patients under 4 years of age and in individuals with a known hypersensitivity to loperamide hydrochloride or any of the excipients. It must not be used as primary therapy for patients with acute dysentery (characterised by blood in the stools and high fever), acute ulcerative colitis, bacterial enterocolitis (caused by invasive organisms including Salmonella, Shigella, and Campylobacter), or pseudomembranous colitis associated with the use of broad-spectrum antibiotics. It must absolutely not be used when the inhibition of peristalsis is to be avoided due to the possible risk of significant sequelae, including ileus, megacolon, and toxic megacolon. Treatment must be discontinued promptly if constipation, abdominal distension, or ileus develop. It should be used with caution in patients with hepatic impairment. It contains lactose and should not be taken by patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption. Concomitant use with P-glycoprotein inhibitors (such as quinidine, ritonavir, itraconazole, and ketoconazole) may significantly increase loperamide plasma levels. It is not recommended for use during pregnancy or whilst breast-feeding.

Side Effects (Adverse Reactions): Known common adverse reactions include constipation, flatulence, headache, and nausea. Other reported side effects include dizziness, somnolence, loss of consciousness, stupor, depressed level of consciousness, hypertonia, coordination abnormality, miosis, abdominal pain or discomfort, dry mouth, vomiting, dyspepsia, ileus (including paralytic ileus), megacolon (including toxic megacolon), acute pancreatitis, urinary retention, and fatigue. Allergic reactions such as rash, bullous eruption (including Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme), angioedema, urticaria, pruritus, anaphylactic reactions, and anaphylactic shock have also been reported. Overdose may lead to severe central nervous system depression and serious cardiac events (such as QT interval prolongation and Torsades de Pointes).

Nutritional Information (per 1 Capsule): Loperamide Hydrochloride BP 2 mg, dibasic calcium phosphate, colloidal silicon dioxide, purified talc, croscarmellose sodium, maize starch, sodium lauryl sulphate, and approved colours used in the capsule shell.

Instructions for Use / Dosage: For oral administration. For acute diarrhoea in adults, the initial dose is 4 mg followed by 2 mg after each motion, up to a maximum of 16 mg in 24 hours. For acute diarrhoea in children aged 5 to 12 years, the dose is 2 mg followed by 2 mg after every motion, up to a maximum of 6 mg per 20 kg of body weight per day. It is not recommended for children under 4 years of age. For the symptomatic treatment of chronic bowel disorders in adults, the starting dosage is between 4 to 8 mg per day in divided doses depending on severity, which can be adjusted to a twice-daily maintenance regimen. No dose adjustment is required for the elderly or patients with renal impairment. Do not exceed the recommended dose or duration of treatment.

Regulatory Information: NAFDAC Registration Number: A4-4462. Manufactured by: Lesanto Laboratories.