LOPERAMIDE

Loperamide hydrochloride 2mg capsules are for oral administration. The capsules should be taken with liquid.

Adults and children aged 12 years and over Acute diarrhoea:

Two capsules initially (4mg), followed by 1 capsule (2mg) after every loose stool. The maximum daily dose should not exceed 6 capsules (12 mg). Symptomatic treatment of acute episodes of diarrhoea associated with irritable bowel syndrome in adults aged 18 years and over Two capsules (4 mg) to be taken initially, followed by 1 capsule (2 mg) after every loose stool, or as previously advised by your doctor.

The maximum daily dose should not exceed 6 capsules (12 mg).

Elderly:

No dose adjustment is required for the elderly.

Renal impairment:

No dose adjustment is required for patients with renal impairment. 4). Method of administration Oral use.

Adults and children aged ≥ 12 years The safety of loperamide hydrochloride was evaluated in 2755 adults and children aged ≥ 12 years who participated in 26 controlled and uncontrolled clinical trials of loperamide HCl used for the treatment of acute diarrhoea.

e. 1%). Table 1 displays ADRs that have been reported with the use of loperamide HCl from either clinical trial (acute diarrhoea) or post-marketing experience. The frequency categories use the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); and very rare (<1/10,000); not known (cannot be estimated from the available data).

Table 1:

Adverse Drug Reactions IndicationSystem Organ Class Common Uncommon Rare Not known Immune System Disorders Hypersensitivity reactiona Anaphylactic reaction (including Anaphylactic shock)a Anaphylactoid reactiona Nervous System Disorders Headache Dizziness Somnolencea Loss of consciousnessa Stupora Depressed level of consciousnessa Hypertoniaa Coordination Abnormalitya Eye Disorders Miosisa Gastrointestinal Disorders Constipation Nausea Flatulence Abdominal pain Abdominal discomfort Dry mouth Abdominal pain upper Vomiting Ileusa (including paralytic ileus) Megacolona (including toxic megacolonb) Abdominal distension acute pancreatitis IndicationSystem Organ Class Common Uncommon Rare Not known Dyspepsiaa Skin and Subcutaneous Tissue Disorders Rash Bullous eruptiona (including Stevens- Johnson syndrome, Toxic epidermal necrolysis and Erythema multiforme) Angioedemaa Urticariaa Pruritusa Renal and Urinary Disorders Urinary retentiona General Disorders and Administration Site Conditions Fatiguea a: Inclusion of this term is based on post-marketing reports for loperamide hydrochloride.

As the process for determining post marketing ADRs did not differentiate between chronic and acute indications or adults and children, the frequency is estimated from all clinical trials with loperamide hydrochloride (acute and chronic), including trials in children ≤ 12 years (N=3683).

Treatment of diarrhoea with loperamide hydrochloride is only symptomatic. Whenever an underlying etiology can be determined, specific treatment should be given when appropriate. Cardiac events including QT interval and QRS complex prolongation and torsades de pointes have been reported in association with overdose.

9). Overdose can unmask existing Brugada syndrome. Patients should not exceed the recommended dose and/or the recommended duration of treatment. The priority in acute diarrhoea is the prevention or reversal of fluid and electrolyte depletion.

This is particularly important in young children and in frail and elderly patients with acute diarrhoea. Use of this medicine does not preclude the administration of appropriate fluid and electrolyte replacement therapy. Since persistent diarrhoea can be an indicator of potentially more serious conditions, this medicine should not be used for prolonged periods until the underlying cause of the diarrhoea has been investigated.

In acute diarrhoea, if clinical improvement is not observed within 48 hours, the administration of loperamide hydrochloride should be discontinued and patients should be advised to consult their doctor. Patients with AIDS treated with loperamide for diarrhoea should have therapy stopped at the earliest signs of abdominal distension.

There have been isolated reports of obstipation with an increased risk for toxic megacolon in AIDS patients with infectious colitis (viral or bacterial pathogens) treated with loperamide hydrochloride. Although no pharmacokinetic data are available in patients with hepatic impairment, loperamide should be used with caution in such patients because of reduced first pass metabolism as it may result in a relative over dosage leading to CNS toxicity.

Excipients Contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. If patients are taking this medicine to control episodes of diarrhoea associated with Irritable Bowel Syndrome (IBS) previously diagnosed by their doctor, and clinical improvement is not observed within 48 hours, the administration of loperamide HCl should be discontinued and they should consult with their doctor.

Loperamide hydrochloride 2mg capsule is contraindicated: • in patients with known hypersensitivity to loperamide hydrochloride or to any of the excipients • in children aged less than 12 years • in patients with acute dysentery which is characterised by blood in stools and high fever • in patients with acute ulcerative colitis • in patients with bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella and Campylobacter • in patients with pseudomembranous colitis associated with the use of broad spectrum antibiotics Loperamide must not be used when inhibition of peristalsis is to be avoided due to the possible risk of significant sequelae including ileus, megacolon and toxic megacolon.

Loperamide must be discontinued promptly when ileus or constipation are present or when abdominal distension develops.