Imoboston

Method of administration

Oral use. The capsules should be taken with liquid.

Posology

Acute Diarrhoea 

- Adults and children over 12: Two capsules (4 mg) initially, followed by 1 capsule after every 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). 

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, IMOBOSTON should be used with caution in such patients because of reduced first pass metabolism. 

4. CONTRAINDICATIONS 

- Hypersensitivity to loperamide hydrochloride 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.

- IMOBOSTON 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. IMOBOSTON must be discontinued promptly when ileus, constipation or abdominal distension develop.

WARNINGS AND PRECAUTIONS 

- Treatment of diarrhea with IMOBOSTON is only symptomatic. Whenever an underlying etiology can be determined, specific treatment should be given when appropriate. The priority in acute diarrhea 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 diarrhea. Use of this medicine does not preclude the administration of appropriate fluid and electrolyte replacement therapy.

- Since rersistent diarrhea can be an indicator of potentially more serious conditions, this medicine should not be used for prolonged periods until the underlying cause of the diarrhea has been investigated.

- In acute diarrhea, if clinical improvement is not observed within 48 hours, the administration of loperamide HCI should be discontinued and patients should be advised to consult their doctor.

- Patients with AIDS treated with loperamide for diarrhea 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.

-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.

- Imoboston contains lactose.   Patients with rare hereditary problems of galactose intolerance e.g. galactosaemia or glucose-galactose malabsorption should not take this medicine.

- 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.

- 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. 

- Special Warnings: Only take IMOBOSTON 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 traveled 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: Although from animal studies there are no indications that loperamide HCl possesses any teratogenic or embryotoxic properties. As with other drugs, it is not advisable to administer this medicine in pregnancy, especially during the first trimester. 

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

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 IMOBOSTON.  Therefore, it is advisable to use caution when driving a car or operating machinery.

SHELF-LIFE 

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

Box of 10 blisters x 10 hard capsules.