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CARE DIARRHOEA RELIEF is a brand name for Loperamide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For symptomatic treatment of acute diarrhoea in adolescents from 12 years of age and adults, unless causative treatment is available. Treatment with loperamide hydrochloride for more than 2 days may only be carried out under medical advice and follow-up monitoring.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults Two orodispersible tablets (equivalent to 4 mg of loperamide hydrochloride) as initial dose for treatment of acute diarrhoea followed by one 1 orodispersible tablet (equivalent to 2 mg of loperamide hydrochloride) after every subsequent loose stool.
A daily dose of 6 orodispersible tablets (equivalent to 12 mg of loperamide hydrochloride) must not be exceeded. Paediatric population Adolescents from 12 years of age One orodispersible tablet (equivalent to 2 mg of loperamide hydrochloride) at the beginning of treatment of acute diarrhoea and after every subsequent loose stool.
A daily dose of 4 orodispersible tablets (equivalent to 8 mg of loperamide hydrochloride) must not be exceeded. Children under 12 years Care Diarrhoea Relief is not suitable for children below 12 years of age due to the high content of active substance.
For this purpose other preparations are available on medical prescription. Special populations Renal impairment As the majority of the active substance is metabolised and the metabolites or the unchanged active substance are excreted with the faeces, no dose adjustment is necessary in patients with renal impairment.
4). Method of administration Care Diarrhoea Relief is placed on the tongue. The orodispersible tablet disintegrates immediately on the tongue and is swallowed with the saliva. No further fluid intake is required. The duration of treatment with Care Diarrhoea Relief is limited to 2 days.
If diarrhoea persists after two days of treatment with Care Diarrhoea Relief, the patient is advised to see a doctor. If necessary, further diagnostic measures can be considered. Note For this pharmacy-only medicine, patients are told in the package leaflet not to exceed the recommended dosage and duration of use of 2 days, as severe constipation may occur.
Treatment with loperamide hydrochloride for more than 2 days may only be administered following medical advice and follow-up monitoring.
In this section frequencies of undesirable effects are defined as follows:
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); very rare (< 1/10,000), not known (cannot be estimated from the available data). Adolescents aged ≥ 12 years and adults The safety of loperamide hydrochloride was evaluated in 3,076 adolescents aged ≥ 12 years and adults who participated in 31 controlled and uncontrolled clinical trials of loperamide hydrochloride used for the treatment of diarrhoea.
Of these, 26 trials were in acute diarrhoea (n = 2,755) and 5 trials were in chronic diarrhoea (n = 321). 1 %). 2 %). The table below displays adverse drug reactions from either clinical trial or post marketing experience. Side effects classified according to system organ class Acute diarrhoea (n = 2,755) Chronic diarrhoea (n = 312) Acute and chronic diarrhoea following post marketing experience Immune system disorders Hypersensitivity reactions a, anaphylactic reactions (including anaphylactic shock) a, anaphylactoid reactions a.
Rare Nervous system disorders Headache. Common Uncommon Common Dizziness. Uncommon Common Common Somnolence a. Uncommon Loss of consciousness a, stupor a, depressed level of consciousness a, hypertonia a, coordination abnormality a. Rare Eye disorders Miosis a.
Rare Gastrointestinal disorders Constipation, nausea, Common Common Common Side effects classified according to system organ class Acute diarrhoea (n = 2,755) Chronic diarrhoea (n = 312) Acute and chronic diarrhoea following post marketing experience flatulence.
Abdominal pain and discomfort, dry mouth. Uncommon Uncommon Uncommon Abdominal pain upper, vomiting. Uncommon Uncommon Dyspepsia. Uncommon Uncommon Ileus a (including paralytic ileus), megacolon a (including toxic megacolon b), glossodynia a.
Treatment of diarrhoea with loperamide hydrochloride is symptomatic only. Whenever an underlying aetiology can be determined, the cause should be treated if possible. Diarrhoea can lead to large losses of fluid and electrolytes. Therefore, the most important therapeutic measure for diarrhoea is to replace the fluid and electrolytes.
This is particularly important in children. In acute diarrhoea, if clinical improvement is not observed within 48 hours, the administration of loperamide hydrochloride should be discontinued and patients should be advised to consult their doctor.
Patients with AIDS treated with loperamide hydrochloride 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 hydrochloride should be used with caution in such patients because of reduced first pass metabolism. Patients with liver dysfunction should be closely monitored for signs of CNS toxicity.
9). Cardiac events including QT interval and QRS complex prolongation, and torsades 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.
Excipients Contains aspartame which is a source of phenylalanine and may be harmful for patients with phenylketonuria.
1 • children less than 12 years of age. (Children less than 2 years of age must not be treated with loperamide. Children between 2 and 12 years of age must be treated with loperamide only after medical prescription) • conditions in which an inhibition of peristalsis is to be avoided due to possible risks of sequelae including ileus, megacolon and toxic megacolon.
Loperamide hydrochloride must be discontinued promptly when constipation, abdominal distension or ileus develop. g. Salmonella, Shigella, and Campylobacter) • chronic diarrhoea. ) • acute exacerbation of ulcerative colitis Loperamide should only be taken after medical advice if liver disease is present or persisted because the breakdown of loperamide may be delayed in severe hepatic impairment.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Rare Abdominal distension. Rare Rare Acute pancreatitis. Not known Skin and subcutaneous tissue disorders Rash. Uncommon Uncommon Bullous eruption a (including Stevens- Johnson syndrome, Toxic epidermal necrolysis and erythema multiforme), angioedema a, urticaria a, pruritus a.
Rare Renal and urinary disorders Urinary retention a. Rare General disorders and administration site conditions Fatigue a. Rare a Inclusion of this term is based on post-marketing reports for loperamide hydrochloride. As the process for determining post marketing ADRs did not differentiate 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 = 3,683).
4. In the case of adverse reactions from clinical studies without frequency data, the adverse event was either not observed or was not considered as a side-effect for this indication. Paediatric population The safety of loperamide hydrochloride was evaluated in 607 patients aged 10 days to 13 years who participated in 13 controlled and uncontrolled clinical trials of loperamide hydrochloride used for the treatment of acute diarrhoea.
In general, the ADR profile in this patient population was similar to that seen in clinical trials of loperamide hydrochloride in adolescents aged 12 years and over and adults. Note Some adverse events reported during clinical trials and after marketing of loperamide hydrochloride are often symptoms of the underlying diarrhoea (stomach pain, discomfort, nausea, vomiting, dry mouth, drowsiness, fatigue, dizziness, constipation and flatulence).
These symptoms are often difficult to distinguish from the side effects of the drug. Immediately after taking loperamide hydrochloride orodispersible tablets, some patients reported a temporary, burning or prickling sensation on the tongue.
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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.