IMODIUM INSTANT MELTS

The orodispersible tablet should be placed on the tongue. The tablet will dissolve and is to be swallowed with saliva. No liquid intake is needed for the orodispersible tablet.

Adults and children 12 years and over:

Acute diarrhoea Two tablets (4 mg) initially followed by 1 tablet (2 mg) after every loose stool. The usual dose is 3-4 tablets (6 mg-8 mg) daily; the maximum daily dose should not exceed 6 tablets (12 mg). Symptomatic treatment of acute episodes of diarrhoea associated with irritable bowel syndrome in adults aged 18 years and over Two tablets (4 mg) initially, followed by 1 tablet (2 mg) after every loose stool, or as previously advised by your doctor.

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

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, Imodium Instant Melts should be used with caution in such patients because of reduced first pass metabolism. (see

8 Undesirable effects 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) Glossodyniaa 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. Allow the tablet to disintegrate on the tongue and swallow the medication. 3 Contraindications Imodium Instant Melts is contraindicated: • in patients with a known hypersensitivity to loperamide hydrochloride or to any of the excipients.

• 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. Imodium Instant Melts 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.

Imodium Instant Melts must be discontinued promptly when ileus, constipation or abdominal distension develop. 4 Special warnings and precautions for use Treatment of diarrhoea with Imodium Instant Melts 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 Imodium Instant Melts does not preclude the administration of appropriate fluid and electrolyte replacement therapy.

Since persistent diarrhoea can be an indicator of potentially more serious conditions, Imodium Instant Melts 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 Imodium Instant Melts should be discontinued and patients should be advised to consult their doctor.

Imodium Instant Melts is contraindicated: • in patients with a known hypersensitivity to loperamide hydrochloride or to any of the excipients. • 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.

Imodium Instant Melts 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. Imodium Instant Melts must be discontinued promptly when ileus, constipation or abdominal distension develop.