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BOOTS DIARRHOEA RELIEF is a brand name for Loperamide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: P and GSL: For the symptomatic treatment of acute diarrhoea, in adults and children 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.
Verbatim from this product's MHRA label. Tap a section to expand.
The capsules should be taken with liquid. For oral administration.
Acute diarrhoea:
Adults and children of 12 years of age and over: The initial dose is 2 capsules (4 mg) followed by 1 capsule (2 mg) after every subsequent loose stool. The usual dose is 3-4 capsules (6 mg – 8 mg) a day. The maximum daily dose should not exceed 6 capsules (12 mg).
If symptoms persist for more than 24 hours consult your doctor. 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: 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). Consult your doctor if you develop new symptoms, or if your symptoms worsen, or if your symptoms have not improved over two weeks. Children under 12 years Loperamide HCl capsules should not be used in children under 12 years of age.
Elderly No dose adjustment is required for the elderly. Renal impairment No dose adjustment is required for patients with renal impairment. 4 special warnings and special precautions for use).
8 Undesirable effects 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.
e. 1%). 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 (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Table 1 Adverse Drug Reactions System Organ Class Indication Common Uncommon Rare Not known 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 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 HCl.
As the process for determining post marketing ADRs did not differentiate between chronic and acute indications for adults and children, the frequency is estimated from all clinical trials with loperamide HCl combined, including trials in children ≤12 years (N=3683).
Treatment of diarrhoea with loperamide HCl is only symptomatic. Whenever an underlying aetiology can be determined, specific treatment should be given when appropriate. In patients with diarrhoea, especially in children, frail and elderly patients, fluid and electrolyte depletion may occur.
In such cases administration of appropriate fluid and electrolyte replacement therapy is the most important measure. 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, since persistent diarrhoea can be an indicator of potentially more serious conditions.
This medicine should not be used for prolonged periods until an underlying cause for persistent diarrhoea has been investigated and diagnosed by a doctor. 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.
This medicine must be used with caution in patients with hepatic impairment as it may result in a relative overdose leading to CNS toxicity. This medicine contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This medicine contains Ponceau 4R (E124) which can cause allergic-type reactions including asthma. Allergy is more common in those people who are allergic to aspirin. 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.
Loperamide HCl is contraindicated:
In patients with known hypersensitivity to loperamide HCl or to any of the excipients. Loperamide HCl is contraindicated: : • in children under 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.
Loperamide HCl should 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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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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, torsade de pointes have been reported in association with overdose.
9). Overdose can unmask existing Brugada syndrome. Patients should not exceed the recommended dose and/or the recommended duration of treatment. Caution is needed in patients with a history of drug abuse. 9). Loperamide is an opioid with low bioavailability and limited potential to penetrate the blood brain barrier at therapeutic doses.
However, addiction is observed with opioids as a class.
Warnings to be included in the leaflet:
For acute diarrhoea If symptoms persist for more than 24 hours, consult your doctor. For acute episodes of diarrhoea associated with irritable bowel syndrome Only take loperamide HCl to treat acute episodes of diarrhoea associated with irritable bowel syndrome (IBS) 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 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 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, or if your symptoms worsen, or if your symptoms have not improved over two weeks.
Keep all medicines out of the reach of children. This medicine contains Ponceau 4R (E124) which can cause allergic-type reactions including asthma. Allergy is more common in those people who are allergic to aspirin. This medicine contains lactose monohydrate.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.