DIARRHOMED

Posology Acute Diarrhoea Adults and children over 12:

Two capsules (4 mg) initially, followed by one capsule (2 mg) after each loose stool. The usual dose is 3-4 capsules (6 mg – 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). Paediatric population Loperamide is contraindicated in children less than 12 years of age. 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 pharmacokinetics data is available in patients with hepatic impairment, loperamide should be used with caution in such patients because of reduced first pass metabolism (see

). 8 Undesirable effects Adults and children aged ≥ 12 years The safety of loperamide hydrochloride was evaluated in 2755 adults and children aged ≥ 12 years who participated in 26 controlled and uncontrolled clinical trials of loperamide hydrochloride used for the treatment of acute diarrhoea.

1%). Table 1 display ADRs that have been reported with the use of loperamide hydrochloride 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 Immune System Disorders Hypersensitivity reactiona, Anaphylactic reaction (including Anaphylactic shock)a, Anaphyloactoid reactiona Nervous System Disorders Headache Dizziness, Somnolencea Loss of consciousnessa, stupora, Depressed level of consciousnessa, Hypertoniaa, Coordination abnormality Eye Disorders Miosisa Gastrointestinal Disorders Constipation, Nausea, Flatulence Abdominal pain, Abdominal discomfort, Dry mouth, Abdominal pain upper, Vomiting, Ileusa (including paralytic ileus), Megacolona (including toxic megacolonb), Abdominal distension Dyspepsiaa Skin and subcutaneous Tissue Disorders Rash Bullous eruptiona (including Stevens- Johnson syndrome, Toxic epidermal necrolysis and Erythema multiforme), Angioedemaa, Urticariaa, Pruritusa Renal and Urinary Disorders Urinary retentiona General Disorders and Administration Site Conditions Fatiguea a: Inclusion of this term is based on post-marketing reports for loperamide hydrochloride.

As the process for determining postmarketing ADRs did not differentiated between chronic and acute indications or adults and children, the frequency is estimated from all clinical trials with loperamide hydrochloride (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.

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4 Special warnings and special precautions for use). Method of administration For oral use. The capsules should be taken with liquid. 1. In children less than 12 years of age. 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.

g. constipation, diverticular disease and ulcerative colitis) due to the possible risk of significant sequelae including ileus, megacolon and toxic megacolon. Loperamide must be discontinued promptly when constipation, abdominal distension or ileus develop.

4 Special warnings and precautions for use Caution is needed in patients with a history of drug abuse. Loperamide is an opioid and addiction is observed with opioids as a class. Treatment of diarrhoea with loperamide is only symptomatic.

Whenever an underlying aetiology 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. Since persistent diarrhoea can be an indicator of potentially more serious conditions, this medicine 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 should be discontinued and patients should be advised to consult their doctor. Patients with AIDS treated with this medicine 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, this medicine 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.

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. 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 hydrochloride 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 interval and QRS complex prolongation and torsades de pointes have been reported in association with overdose.

9). Patients should not exceed the recommended dose and/or the recommended duration of treatment.

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.

Excipients Due to the presence of lactose, patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

1. In children less than 12 years of age. 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. g. constipation, diverticular disease and ulcerative colitis) due to the possible risk of significant sequelae including ileus, megacolon and toxic megacolon.

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