LOMODINE

The capsules should be taken with liquid.

Acute diarrhoea:

Adults and children over 12 years: two capsules (4mg) initially, followed by 1 capsule (2mg) after every loose stool. The usual dosage is 3 to 4 capsules (6mg-8mg) a day; the maximum daily dose should not exceed 6 capsules (12mg). Symptomatic treatment of acute episodes of diarrhoea associated with Irritable Bowel Syndrome in adults and children aged 18 years and over: Two capsules (4mg) to be taken initially, followed by 1 capsule (2mg) after every loose stool, or as previously advised by your doctor.

The maximum daily dose should not exceed 6 capsules (12mg). If symptoms persist for more than 48 hours consult your doctor.

Use in elderly:

No dose adjustment is required for the elderly. Renal impairment No dose adjustment is required for patients with renal impairment. 4 special warnings and special precautions for use). Method of administration Oral use

e. 1%). Table 1 displays ADRs that have been reported with the use of loperamide HCl from either clinical trial (acute diarrhea or both) or post-marketing experience. 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 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 combined, including trials in children :≤12years (N=3683).

4 Special Warnings and Special Precautions for use. 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.

Treatment of diarrhoea with Loperamide 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. In patients with acute diarrhoea, especially in children, and in the frail and elderly fluid and electrolyte depletion may occur.

In such cases administration of appropriate fluid and electrolyte replacement therapy is the most important measure. Loperamide should not be given to children under 12 years without medical prescription and supervision. Use of this product 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 should be discontinued and patients should be advised to consult their doctor.

If patients are taking this medicine to control episodes of diarrhoea associated with Irritable Bowel Syndrome 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 their doctor.

Patients should also return to their doctor if the pattern of their symptoms changes or if the repeated episodes of diarrhoea continue for more than two weeks. Patients with AIDS treated with Loperamide for diarrhoea should have therapy stopped at the earliest signs of abdominal distension.

LoModine 2mg capsules are 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 elevated body temperature.

• when ileus or constipation are present or when abdominal distension develops, especially 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 should 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 constipation, abdominal distension or ileus develop.