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IMODIUM® Original 2mg Capsules, Loperamide, Product Information

Presentation: Opaque green cap and grey body, hard gelatin capsule imprinted with 'Imodium' on cap and 'Janssen' on body containing loperamide hydrochloride 2mg. Uses: 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 following initial diagnosis by a doctor. Dosage: Capsules should be taken with liquid. Acute Diarrhoea: Adults and children over 12 years old: 2 capsules initially followed by 1 capsule after every loose stool. The maximum daily dose should not exceed 6 capsules. Symptomatic treatment of acute episodes of diarrhoea associated with Irritable Bowel Syndrome (IBS) in adults aged 18 years and over: 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. Contraindications: Hypersensitivity to loperamide or any excipient. Children under 12 years of age. Acute dysentery, characterized by blood in stools and high fever. Acute ulcerative colitis. Bacterial enterocolitis caused by invasive organisms. Pseudomembranous colitis associated with broad spectrum antibiotics. Conditions when inhibition of peristalsis is to be avoided due to the possible risk of ileus, megacolon or toxic megacolon. Discontinue promptly when ileus, constipation or abdominal distension develop. Precautions: Treatment with IMODIUM® capsules is symptomatic; give specific treatment when appropriate. The priority in acute diarrhoea is the prevention or reversal of fluid and electrolyte depletion, particularly in young children and in frail and elderly patients. Use of IMODIUM® capsules 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® capsules should not be used for prolonged periods until the underlying cause of the diarrhoea has been investigated. If symptoms persist for more than 48 hours, consult a doctor. Patients with AIDS should stop therapy with IMODIUM® capsules if abdominal distension develops. Use with caution in hepatic impairment. Patients with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine as it contains lactose. If IMODIUM® capsules are being used to control episodes of diarrhoea REF-PI-IM-0041 associated with Irritable Bowel Syndrome, consult a doctor if clinical improvement is not seen within 48 hours, for any changes in the pattern of symptoms or if there is a need for continuous treatment of more than 2 weeks. Consult a doctor if patients have recently travelled abroad, are vomiting, having difficulty or pain passing urine, or have a loss of appetite. Cardiac events have been reported in association with overdose. Some cases with extremely high doses had a fatal outcome. Loss of consciousness, depressed level of consciousness, tiredness, dizziness, or drowsiness may occur when diarrhoea is treated with this medicine. Therefore, it is advisable to use caution when driving a car or operating machinery. Cardiac events including QT interval and QRS complex prolongation and torsades de pointes have been reported in association with overdose. Overdose can unmask existing Brugada syndrome. Patients should not exceed the recommended dose and/or the recommended duration of treatment. Pregnancy and lactation: Not recommended. Side Effects: Common: headache, constipation, nausea and flatulence. Uncommon: dizziness, somnolence, abdominal pain, abdominal discomfort, dry mouth, abdominal pain upper, vomiting, dyspepsia and rash. Rare: Hypersensitivity reaction, anaphylactic reaction (including anaphylactic shock), anaphylactoid reaction, loss of consciousness, stupor, depressed level of consciousness, hypertonia, coordination abnormality, miosis, ileus (including paralytic ileus), megacolon (including toxic megacolon), abdominal distension, bullous eruption (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme), angioedema; urticaria; pruritis; urinary retention; fatigue. RRP (ex-VAT): 6 capsules, £3.38 Legal Category: GSL PL Holder: McNeil Products Ltd., 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG PL Number: 15513/0310 Date of Prep: 13 January 2020

IMODIUM® Instants (loperamide) Product Information

Presentation: White/off-white, circular, orodispersible tablet containing loperamide hydrochloride 2mg. Excipients with known effect: Each tablet contains 0.750 mg of Aspartame (E951) which is equivalent to 0.055 mg/mg and it contains less than 0.00066mg of benzyl alcohol. The Mint flavouring contains traces of Sulphites. Uses: Symptomatic treatment of acute diarrhoea in adults and children aged 12 years and over. 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. Dosage: Acute Diarrhoea: Adults and children over 12 years old: Two tablets initially followed by 1 tablet after every loose stool. Total daily dose should not exceed 6 tablets. Symptomatic treatment of acute episodes of diarrhoea associated with Irritable Bowel Syndrome in adults aged 18 years and over: Two tablets to be taken initially, followed by 1 tablet after every loose stool, or as previously advised by your doctor. Total daily dose should not exceed 6 tablets. Method of administration: Allow the tablet to disintegrate on the tongue and swallow; no liquid is needed. Contraindications: Hypersensitivity to loperamide or any excipient. Children under 12 years of age. Acute dysentery, characterised by blood in stools and high fever. Acute ulcerative colitis. Bacterial enterocolitis caused by invasive organisms. Pseudomembranous colitis associated with broad spectrum antibiotics. Conditions when inhibition of peristalsis is to be avoided due to the possible risk of ileus, megacolon or toxic megacolon. Discontinue promptly when ileus, constipation or abdominal distension develop. Precautions: Treatment with IMODIUM® Instants is symptomatic; give specific treatment when appropriate. The priority in acute diarrhoea is the prevention or reversal of fluid and electrolyte depletion, particularly in young children and in frail and elderly patients. Use of IMODIUM® Instants 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® Instants should not be used for prolonged periods until the underlying cause of the diarrhoea has been investigated. If symptoms persist for more than 48 hours, consult a doctor. Patients with AIDS should stop therapy with IMODIUM® Instant Melts if abdominal distension develops. Contains benzyl alcohol, which may cause allergic reactions- Use with caution in hepatic or renal impairment, or in patients who are pregnant or breast feeding, because of the risk of accumulation and REF-PI-IM-0027 toxicity (metabolic acidosis). If IMODIUM® Instants are being used to control episodes of diarrhoea associated with Irritable Bowel Syndrome, consult a doctor if clinical improvement is not seen within 48 hours, for any changes in the pattern of symptoms or if there is a need for continuous treatment of more than 2 weeks. Patients should consult a doctor if aged 40 or over where it is some time since their last IBS attack or if symptoms differ to previous episodes; in cases of severe constipation; weight loss or loss of appetite; pain passing urine; blood is present in stools; episode after recent travel abroad. Some cases with extremely high doses had a fatal outcome. Cardiac events have been reported in association with overdose. Some cases with extremely high doses had a fatal outcome. Loss of consciousness, depressed level of consciousness, tiredness, dizziness, or drowsiness may occur when diarrhoea is treated with loperamide. Therefore, it is advisable to use caution when driving a car or operating machinery. Cardiac events including QT interval and QRS complex prolongation and torsades de pointes have been reported in association with overdose. Overdose can unmask existing Brugada syndrome. Patients should not exceed the recommended dose and/or the recommended duration of treatment. Pregnancy and lactation: Not recommended. Side Effects: Common: headache, constipation, nausea and flatulence. Uncommon: dizziness, somnolence, abdominal pain, abdominal discomfort, dry mouth, abdominal pain upper, vomiting, dyspepsia and rash. Rare: Hypersensitivity reaction, anaphylactic reaction (including anaphylactic shock), anaphylactoid reaction, loss of consciousness, stupor, depressed level of consciousness, hypertonia, coordination abnormality, miosis, ileus (including paralytic ileus), megacolon (including toxic megacolon), abdominal distension, bullous eruption (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme), angioedema; urticaria; pruritis; urinary retention; fatigue. RRP (ex-VAT): 6 tablets £4.35; 12 tablets £6.74 Legal Category: GSL PL Holder: McNeil Products Ltd, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG PL Number: 15513/0345 Date of Preparation: 19 August 2020

IMODIUM® IBS Relief 2mg Capsules Soft, Loperamide Product Information

Presentation: Clear blue, oval, soft gelatin capsule containing Loperamide hydrochloride 2mg. Excipient with known effect: each capsule contains 115.31 mg Propylene Glycol which is equivalent to 0.65 mg/mg, also contains 0.06 micrograms of soya lecithin. Uses: Symptomatic treatment of acute diarrhoea in adults and children aged 12 years and over. 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. Dosage: Acute Diarrhoea: Adults and children over 12 years old: 2 capsules initially followed by 1 capsule after every loose stool. Total daily dose should not exceed 6 capsules. Symptomatic treatment of acute episodes of diarrhoea associated with Irritable Bowel Syndrome in adults: Adults 18 years and over: 2 capsules to be taken initially, followed by 1 capsule after every loose stool, or as previously advised by your doctor. Total daily dose should not exceed 6 capsules. Contraindications: Hypersensitivity to Loperamide or any excipient. Patients with allergies to soya or peanuts. Children under 12 years of age. Acute dysentery, characterised by blood in stools and high fever. Acute ulcerative colitis. Bacterial enterocolitis caused by invasive organisms. Pseudomembranous colitis associated with broad spectrum antibiotics. Conditions when inhibition of peristalsis is to be avoided due to the possible risk of ileus, megacolon or toxic megacolon. Discontinue promptly when ileus, constipation or abdominal distension develop. Precautions: Treatment with IMODIUM® IBS Relief 2mg Capsules Soft is symptomatic; give specific treatment when appropriate. The priority in acute diarrhoea is the prevention or reversal of fluid and electrolyte depletion, particularly in young children and in frail and elderly patients. Use of IMODIUM® IBS Relief 2mg Capsules Soft 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® IBS Relief 2mg Capsules Soft should not be used for prolonged periods until the underlying cause of the diarrhoea has been investigated. If symptoms persist for more than 48 hours, consult a doctor. Patients with AIDS should stop therapy with IMODIUM® IBS Relief 2mg Capsules Soft if abdominal distension develops. Use with caution in hepatic impairment. If IMODIUM® IBS Relief 2mg Capsules Soft are being used to control episodes of diarrhoea associated with Irritable Bowel Syndrome, consult a doctor if clinical REF-PI-IM-0003 V2.0 improvement is not seen within 48 hours. If the pattern of symptoms changes or if repeated episodes of diarrhoea continue for more than 2 weeks consult doctor. Cardiac events have been reported in association with overdose. Some cases with extremely high doses had a fatal outcome. Loss of consciousness, depressed level of consciousness, tiredness, dizziness, or drowsiness may occur when diarrhoea is treated with this medicine. Therefore, it is advisable to use caution when driving a car or operating machinery. Cardiac events including QT interval and QRS complex prolongation and torsades de pointes have been reported in association with overdose. Overdose can unmask existing Brugada syndrome. Patients should not exceed the recommended dose and/or the recommended duration of treatment. Pregnancy and lactation: Not recommended. Side Effects: Common: headache, constipation, nausea and flatulence. Uncommon: dizziness, somnolence, abdominal pain, abdominal discomfort, dry mouth, abdominal pain upper, vomiting, dyspepsia and rash. Rare: Hypersensitivity reaction, anaphylactic reaction (including anaphylactic shock), anaphylactoid reaction, loss of consciousness, stupor, depressed level of consciousness, hypertonia, coordination abnormality, miosis, ileus (including paralytic ileus), megacolon (including toxic megacolon), abdominal distension, bullous eruption (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme), angioedema; urticaria; pruritis; urinary retention; fatigue. RRP (ex-VAT): 6's: £3.98 Legal Category: GSL PL Holder: McNeil Products Ltd, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG PL Number: 15513/0367 Date of Preparation: 13 January 2020

IMODIUM® Dual Action Relief Tablets (Formerly IMODIUM® Plus Comfort Tablets) (loperamide & simeticone) Product Information:

Presentation: White, capsule-shaped tablet containing loperamide hydrochloride 2mg and simeticone equivalent to 125mg dimeticone. Indications: Symptomatic treatment of acute diarrhoea in adults and adolescents over 12 years when acute diarrhoea is associated with gas-related abdominal discomfort including bloating, cramping or flatulence. Dosage and Administration: Swallow the correct number of caplets whole with a drink of water. Adults over 18 years: Take 2 caplets initially, followed by 1 caplet after every loose stool. Adolescents aged 12-18 years: Take 1 caplet initially followed by 1 caplet after each loose stool. Not more than 4 caplets should be taken in 24 hours, limited to no more than 2 days. Contraindications: Not to be used in children under 12 years of age, or patients with: hypersensitivity to the active substances or to any of the excipients listed in SPC section 6.1; acute dysentery (characterised by blood in stool and high fever); acute ulcerative colitis; pseudomembranous colitis associated with broad spectrum antibiotics; bacterial enterocolitis caused by invasive organisms. Must not be used when inhibition of peristalsis is to be avoided. Therapy must be discontinued if constipation, ileus and/or abdominal distension develop. Precautions: Treatment of diarrhoea with loperamide-simeticone is only symptomatic; give specific treatment when appropriate. In patients with severe diarrhoea, attention should be paid to appropriate fluid and electrolyte replacement. If clinical improvement is not seen within 48 hours, stop treatment and consult a doctor. Patients with AIDS should stop therapy if abdominal distension develops. Use under medical supervision in patients with severe hepatic dysfunction. Use with caution in patients with renal or hepatic impairment. Tiredness, dizziness and drowsiness may occur in the setting of diarrheal syndromes treated with loperamide HCl, therefore use caution when driving a car or operating machinery. Cardiac events including QT interval and QRS complex prolongation and torsades de pointes have been reported in association with overdose. Some cases with extremely high doses had a fatal outcome. Overdose can unmask existing Brugada syndrome. This medicine contains less than 0.026mg of benzyl alcohol, which may cause allergic reactions and this medicine contains maltodextrin which contains glucose. Patients with rare glucose-galactose malabsorption should not take this medicine. Fertility, pregnancy and lactation: Should not be given during pregnancy, especially during the first trimester, unless clinically justified. Not recommended during breast-feeding. The effect on human fertility has not been evaluated. Side Effects: The most commonly reported adverse drug reactions in clinical trials were: dysgeusia (2.6%) and nausea (1.6%). Additionally, adverse drug reactions reported with the use of loperamide-simeticone from either clinical trial or post-marketing experience and with the use of loperamide HCl are: Common: Headache. Uncommon: Somnolence, dizziness, abdominal pain, abdominal discomfort, abdominal pain upper, vomiting, constipation, abdominal distension, dyspepsia, flatulence, dry mouth, rash and asthenia. Rare: Hypersensitivity reaction, anaphylactic reaction (including anaphylactic shock), anaphylactoid reaction, loss of consciousness, depressed level of consciousness, stupor, hypertonia, coordination abnormality, miosis, ileus (including paralytic ileus), megacolon (including toxic megacolon), bullous eruption (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme), angioedema, urticaria, pruritus, urinary retention and fatigue. Not Known: Acute pancreatitis. RRP (ex-VAT): 6 tablets, £4.51 Legal Category: GSL PL Holder: McNeil Products Ltd, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG PL Number: 15513/0343 Date of Preparation: 19 May 2022