TEVA DIARRHOEA RELIEF

For oral administration. The capsules should be taken with liquid. Acute diarrhoea Adults and Children 12-17 years The initial dose is 2 capsules (4 mg) for adults and 1 capsule (2 mg) for children; followed by 1 capsule (2 mg) after every subsequent loose stool.

The maximum dose is 6 capsules (12 mg) daily for adults; in children it must be related to the body weight (3 capsules/20 kg) but should not exceed a maximum of 6 capsules per day. Further investigation into the cause of the diarrhoea should be considered if there is no improvement within two days of starting treatment with loperamide hydrochloride.

Symptomatic treatment of acute episodes of diarrhoea associated with Irritable Bowel Syndrome in adults Two capsules to be taken initially. The usual dose is between 2 and 4 capsules per day in divided doses, depending on the severity.

If required, this dose can be adjusted according to result, up to a maximum of 6 capsules daily. Elderly No dose adjustment is required for the elderly. Renal Impairment No dose adjustment is required for patients with renal impairment.

4).

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.

1%). List of adverse reactions 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).

Table 1:

Adverse Drug Reactions IndicationSystem Organ Class Common Uncommon Rare Unknown 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 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. 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 HCl is only symptomatic. Whenever an underlying etiology can be determined, specific treatment should be given when appropriate. In patients with diarrhoea, especially in children, fluid and electrolyte depletion may occur.

The use of loperamide HCl does not preclude the need for appropriate fluid and electrolyte replacement therapy, which is essential in such patients. Loperamide HCl should not be given to children aged 2 to 6 years without medical prescription and supervision.

Since persistent diarrhoea can be an indicator of potentially more serious conditions, loperamide hydrochloride 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 HCl should be discontinued and patients should be advised to consult their physician.

Patients with AIDS treated with loperamide HCl 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 from both viral and bacterial pathogens treated with loperamide HCl.

Although no pharmacokinetic data are available in patients with hepatic impairment, loperamide HCl should be used with caution in such patients because of reduced first pass metabolism. Patients with hepatic dysfunction should be monitored closely for signs of central nervous system (CNS) toxicity.

If symptoms persist for more than 48 hours, consult your doctor. Experience is lacking in patients with hepatic insufficiency. Loperamide HCl should be used with caution in such patients because of reduced first pass metabolism, which may result in overdose leading to CNS toxicity.

If you are taking loperamide hydrochloride to control episodes of diarrhoea associated with Irritable Bowel Syndrome diagnosed by your doctor, you should return to him/her if the pattern of your symptoms changes. You should also return to your doctor if your episodes of acute symptoms continue for more than two weeks or there is a need for continuous treatment of more than two weeks.

1. • Not to be used in children under 12 years of age. • Loperamide HCl should not be used: • 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 HCl should not be used if inhibition of peristalsis is to be avoided due to the possible risk of significant sequelae including ileus, megacolon, toxic megacolon. Loperamide HCl must be discontinued promptly when constipation, abdominal distension or ileus develop.