IMOBOSTON

ADMINISTRATION AND DOSAGE

Administration

Oral administration with water.

Dosage

Acute Diarrhoea

Adults and children aged 12 years and over:

The initial dose is 2 capsules (4 mg), followed by 1 capsule after every subsequent loose stool. The usual dose is 3-4 capsules (6-8 mg) a day. The total daily dose should not exceed 6 capsules (12 mg).

Not recommended for children under 12 years of age.

Symptomatic treatment of acute episodes of diarrhoea associated with irritable bowel syndrome in adults aged 18 years and over

Two capsules (4 mg) to be taken initially, followed by 1 capsule (2 mg) after every loose stool, or as previously advised by your doctor. The maximum daily dose should not exceed 6 capsules (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, loperamide should be used with caution in such patients because of reduced first pass metabolism. 

CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients.

Children under the age of 12 years old.

Patients with acute dysentery, which is characterised by blood in stools and high fever.

Patients with acute ulcerative colitis.

Patients with bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella and Campylobacter.

Patients with pseudomembranous colitis associated with the use of broad-spectrum antibiotics.

Loperamide 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. Loperamide HCl must be discontinued promptly when constipation, abdominal distension or ileus develop.

WARNINGS AND PRECAUTIONS

Warnings

Treatment of diarrhoea with loperamide HCl 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 this medicine does not preclude the administration of appropriate fluid and electrolyte replacement therapy.

Persistent diarrhoea can be an indicator of potentially more serious conditions and as such loperamide 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 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 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. This medicine must be used with caution in patients with hepatic impairment as it may result in a relative overdose leading to CNS toxicity.

Loperamide capsules contain lactose. Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Cardiac events including QT prolongation and torsades de pointes have been reported in association with overdose. Some cases had a fatal outcome. Patients should not exceed the recommended dose and/or the recommended duration of treatment.

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 with 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.

SPECIAL WARNINGS TO BE INCLUDED ON THE LEAFLET:

Only take Loperamide to treat acute episodes of diarrhoea associated with Irritable Bowel Syndrome if your doctor has previously diagnosed IBS.

If any of the following now apply, do not use the product without first consulting your doctor, even if you know you have IBS:

If you are aged 40 or over and it is some time since your last IBS attack.

If you are aged 40 or over and your IBS symptoms are different this time.

If you have recently passed blood from the bowel.

If you suffer from severe constipation.

If you are feeling sick or vomiting.

If you have lost your appetite or lost weight.

If you have difficulty or pain passing urine.

If you have a fever.

If you have recently travelled abroad.

Consult your doctor if you develop new symptoms, if your symptoms worsen, or your symptoms have not improved over two weeks.

PREGNANCY AND LACTATION

Pregnancy 

Safety in human pregnancy has not been established. Although from animal studies there are no indications that loperamide HCL possess any teratogenic or embryotoxic properties. As with other drugs, it is not advisable to administer this medicine in pregnancy, especially during the first trimester.

Lactation

Small amounts of loperamide may appear in human breast milk. Therefore, this medicine is not recommended during breastfeeding.

Women who are pregnant or breast-feeding should therefore be advised to consult their doctor for appropriate treatment.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

Loss of consciousness, depressed level of consciousness, tiredness, dizziness or drowsiness may occur when diarrhoea is treated with loperamide HCl. Therefore, it is advisable to exercise caution when operating machinery or driving a car following administration of loperamide HCl.

SHELF-LIFE

36 months from the manufacturing date. Do not use after the expiry date.