LOPERAMIDE HYDROCHLORIDE

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

Acute diarrhoea:

Adults: two capsules initially, followed by 1 capsule after every loose stool, for up to 5 days. The usual dosage is 3 to 4 capsules a day; the maximum daily dose should not exceed 8 capsules. Children: 9-12 years: the maximum dose is 1 capsule 4 times daily until diarrhoea is controlled, for up to 5 days.

4-8 years: Loperamide hydrochloride capsules 2mg cannot be divided and are therefore not recommended for use in children aged 4-8 years. A suitable alternative presentation of loperamide should be used in these patients. If there is no improvement within 2 days of starting treatment further investigation of the cause of diarrhoea should be considered.

Chronic diarrhoea:

Adults: studies have shown that patients may need widely differing amounts of loperamide hydrochloride. The starting dose should be between 2 and 4 capsules per day in divided doses, depending on severity. If required, this dose can be adjusted according to response.

The maximum recommended daily dose is 8 capsules. 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.

Children: loperamide is not recommended for treatment of chronic diarrhoea in children Use in elderly: acute and chronic diarrhoea - as for adults Renal impairment No dose adjustment is required for patients with renal impairment. 4 special warnings and special precautions for use).

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 diarrhea) 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 Urinary retentiona Disorders 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 ≤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 diarrhoea, especially in children, 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 aged 2 to 6 years without medical prescription and supervision. 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.

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 overdose leading to CNS toxicity.

Caution is needed in patients with a history of drug abuse. 9). Loperamide is an opioid with low bioavailability and limited potential to penetrate the blood brain barrier at therapeutic doses. However, addiction is observed with opioids as a class.

Excipients Contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Loperamide is contraindicated: • in patients with known hypersensitivity to loperamide hydrochloride or to any of the excipients • in children aged less than 4 years Loperamide should not be used as the primary therapy: • in patients with acute dysentery which is characterised by blood in stools and elevated body temperature.

• 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 should be discontinued promptly when ileus or constipation are present or when abdominal distension develops, especially in severely dehydrated children.