LOPERAMIDE HYDROCHLORIDE

Posology ACUTE DIARRHOEA Adults and children over 12:

Two capsules initially, followed by one capsule after each loose stool. The usual dose is 3-4 capsules a day. The total daily dose should not exceed 8 capsules. CHRONIC DIARRHOEA Studies have shown that patients may need widely differing amounts of Loperamide Hydrochloride capsules.

The starting dose should be between two and four capsules per day in divided doses, depending on severity. If required, this dose can be adjusted according to result up to a maximum of eight capsules daily. Having established the patient's daily maintenance dose, the capsules may be administered on a twice daily regimen.

Tolerance has not been observed and therefore subsequent dosage adjustment should be unnecessary. Paediatric population Loperamide Hydrochloride capsules is contraindicated in children less than 12 years of age. Elderly No dose adjustment is required for the elderly.

Renal impairment No dose adjustment is required for patients with renal impairment. Hepatic impairment Although no pharmacokinetic data are available in patients with hepatic impairment, Loperamide Hydrochloride capsules should be used with caution in such patients because of reduced first pass metabolism.

(see

Adults and children aged ≥ 12 years The safety of loperamide HCl 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); very rare (<1/10,000); not known (cannot be estimated from the available data).

Table 1:

Adverse Drug Reactions Indication System 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 Dyspepsiaa Ileusa (including paralytic ileus) Megacolona (including toxic megacolonb) Abdominal distension Acute pancreatitis 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 HCl.

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 HCl (acute and chronic), including trials in children ≤ 12 years (N=3683).

4 Special warnings and special precautions for use). Method of administration Oral use. The capsules should be taken with liquid. 1. • in children less than 12 years of age. • 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 Hydrochloride capsules 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 Hydrochloride capsules must be discontinued promptly when ileus, constipation or abdominal distension develops.

4 Special warnings and precautions for use Treatment of diarrhoea with loperamide hydrochloride is only symptomatic. Whenever an underlying etiology can be determined, specific treatment should be given when appropriate. 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 capsules should be discontinued and patients should be advised to consult their doctor. Patients with AIDS treated with this medicine for diarrhoea should have therapy stopped at the earliest signs of abdominal distension.

1. • in children less than 12 years of age. • 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 Hydrochloride capsules 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 Hydrochloride capsules must be discontinued promptly when ileus, constipation or abdominal distension develops.