ASDA ANTI-DIARRHOEA

Adults, the elderly and adolescents 12 years and over:

GSL status: Two capsules to be taken initially, followed by one capsule after each loose motion, up to a maximum of six capsules in any 24 hours. Not recommended for children under 12 years of age. USE IN 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 should be used with caution in such patients because of reduced first pass metabolism.

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Adults and adolescents 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); and very rare (<1/10,000).

Not known (cannot be estimated from 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 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. A number of the adverse events reported during the clinical investigations and post-marketing experience with loperamide are frequent symptoms of the underlying diarrhoeal syndrome (abdominal pain/discomfort, nausea, vomiting, dry mouth, tiredness, drowsiness, dizziness, constipation, and flatulence).

These symptoms are often difficult to distinguish from undesirable drug effects. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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4 Special warnings and special precautions for use). When no clinical change is observed in the acute diarrhoea within 48 hours, the administration of loperamide must be interrupted and the patient must be advised to consult their doctor.

Loperamide should not be used for more than 5 days without consulting a doctor. Method of administration Oral use. 3 Contraindications Patients with a known hypersensitivity to loperamide hydrochloride or to any of the excipients. Children under 12 years of age When inhibition of peristalsis is to be avoided due to the possible risk of significant sequelae including ileus, megacolon, toxic megacolon and certain poisonings, in particular: • When ileus or constipation are present or when abdominal distension develops, particularly in severely dehydrated children.

• 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 should not be used alone in acute dysentery, which is characterised by blood in stools and elevated body temperatures. g. in cases of severe hepatic disturbance), as this might result in a relative overdose leading to CNS toxicity.

Loperamide relieves the symptoms of diarrhoea only and is not a substitute for rehydration therapy. 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. 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.

Patients with a known hypersensitivity to loperamide hydrochloride or to any of the excipients. Children under 12 years of age When inhibition of peristalsis is to be avoided due to the possible risk of significant sequelae including ileus, megacolon, toxic megacolon and certain poisonings, in particular: • When ileus or constipation are present or when abdominal distension develops, particularly in severely dehydrated children.

• 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 should not be used alone in acute dysentery, which is characterised by blood in stools and elevated body temperatures.