Imodium Plus Caplets diarrhoea, cramps, wind and bloating-Hyperdrug

Imodium Plus Caplets are uniquely formulated with dual action to stop diarrhoea and calm additional symptoms such as stomach cramps, wind and bloating. Adults over 18 years: Two Imodium Plus Caplets initially followed, if necessary, by one caplet after each loose bowel movement. Young adults 12-18 years: One caplet initially, followed by one caplets after eac You should make sure that you carefully read all product packaging and labels prior to use. Imodium Plus Caplets contains loperamide hydrochchloride 2mg and simethicone equivalent to polymethylsiloxane 125mg

Loperamide hydrochloride 2 mg Excipient: lactose Therapeutic indications POM For the symptomatic treatment of acute diarrhoea of any aetiology including acute exacerbations of chronic diarrhoea for periods of up to 5 days in adults and children over 8 years. For the symptomatic treatment of chronic diarrhoea in adults. P and GSL For the symptomatic treatment of acute diarrhoea in adults and children aged 12 years and over. For the symptomatic treatment of acute episodes of diarrhoea associated with Irritable Bowel Syndrome in adults aged 18 years and over following initial diagnosis by a doctor.

Posology and method of administration ACUTE DIARRHOEA P and POM Adults and children over 12: Two capsules initially, followed by one capsule after each loose stool. The usual dose is 3-4 capsules a day. The total daily dose should not exceed 8 capsules. POM Children 4-8 years: Use Syrup. Children 9 to12 years: One capsule four times daily until diarrhoea is controlled (up to 5 days). This dose should not be exceeded. Not recommended for children under 4 years of age. Further investigation into the cause of the diarrhoea should be considered if there is no improvement within two days of starting treatment with Imodium. GSL Adults and children over 12: 2 capsules initially followed by 1 capsule after every loose stool. The maximum daily dose should not exceed 6 capsules. CHRONIC DIARRHOEA (POM) Adults: Studies have shown that patients may need widely differing amounts of Imodium. The starting dose should be between two and four capsules per day in divided doses, depending on severity. If required, this dose can be adjusted according to result up to a maximum of eight capsules daily. 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. SYMPTOMATIC TREATMENT OF ACUTE EPISODES OF DIARRHOEA ASSOCIATED WITH IRRITABLE BOWEL SYNDROME IN ADULTS AGED 18 YEARS AND OVER P Two capsules to be taken initially. The usual dose is between 2 and 4 capsules per day in divided doses, depending on severity. If required, this dose can be adjusted according to result, up to a maximum of 8 capsules daily. GSL Two capsules to be taken initially, followed by 1 capsule after every loose stool, or as previously advised by your doctor. The maximum daily dose should not exceed 6 capsules. USE IN 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, Imodium should be used with caution in such patients because of reduced first pass metabolism (see 4.4 Special warnings and precautions for use). Method of administration Oral use.

Contraindications Imodium is contraindicated in: • patients with a known hypersensitivity to loperamide hydrochloride or to any of the excipients. • children less than 4 years of age. • when inhibition of peristalsis is to be avoided due to the possible risk of significant sequelae including ileus, megacolon and toxic megacolon, in particular: - when ileus or constipation are present or when abdominal distension develops, particularly 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. Imodium should not be used alone in acute dysentery, which is characterised by blood in stools and elevated body temperatures. Special warnings and precautions for use 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 Imodium does not preclude the administration of appropriate fluid and electrolyte replacement therapy. Since persistent diarrhoea can be an indicator of potentially more serious conditions, Imodium should not be used for prolonged periods until the underlying cause of the diarrhoea has been investigated. Imodium must be used with caution when the hepatic function necessary for the drug's metabolism is defective (eg in cases of severe hepatic disturbance), as this might result in a relative overdose leading to CNS toxicity. Patients with AIDS treated with Imodium for diarrhoea should have therapy stopped at the earliest signs of abdominal distension. There have been isolated reports of toxic megacolon in AIDS patients with infectious colitis from both viral and bacterial pathogens treated with loperamide hydrochloride. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine because it contains lactose. Also for P and GSL use In cases of acute diarrhoea, if symptoms persist for more than 24 hours, consult your doctor. If you are taking Imodium to control episodes of diarrhoea associated with Irritable Bowel Syndrome previously 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 diarrhoea continue for more than two weeks or there is a need for continued treatment of more than two weeks. Special Warnings to be included on the GSL leaflet Only take Imodium to treat acute episodes of diarrhoea associated with Irritable Bowel Syndrome if your doctor has previously diagnosed IBS. If any of the following apply, do not use the product without first consulting your doctors, even if you know you have IBS: • If you are 40 years or over and it is some time since your last attack of IBS or the symptoms are different this time • If you have recently passed blood from the bowel • If you suffer from severe constipation • If you are 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, or if your symptoms worsen, or your symptoms have not improved over two weeks.

Interaction with other medicinal products and other forms of interaction Non-clinical data have shown that loperamide is a P-glycoprotein substrate. Concomitant administration of loperamide (16 mg single dose) with quinidine, or ritonavir, which are both P-glycoprotein inhibitors, resulted in a 2 to 3-fold increase in loperamide plasma levels. The clinical relevance of this pharmacokinetic interaction with P-glycoprotein inhibitors, when loperamide is given at recommended dosages (2 mg, up to 16 mg maximum daily dose), is unknown. Pregnancy and lactation Safety in human pregnancy has not been established although studies in animals have not demonstrated any teratogenic effects. As with other drugs, it is not advisable to administer Imodium in pregnancy. Small amounts of loperamide may appear in human breast milk. Therefore, Imodium is not recommended during breast-feeding. Women who are pregnant or breast feeding infants should therefore be advised to consult their doctor for appropriate treatment.

Imodium Plus Caplets (pack of 6)