Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Loperamide hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
FOR
nausea, vomiting, which may be symptoms of inflammation of the pancreas (acute pancreatitis).
If any of these applies to you, talk to your doctor before taking Loperamide Capsules.
PACKAGE LEAFLET : INFORMATION FOR THE USER Loperamide 2mg Capsules, Hard (Loperamide Hydrochloride) Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your pharmacist has told you.
(GSL)
e Loperamide Capsules 5. How to store Loperamide Capsules 3. How to take Loperamide Capsules
LOPERAMIDE CAPSULES Check the tables below to see how much medicine to take. Talk to a doctor as soon as possible Uncommon: (may affect up to 1 in 100 people)
Harrow, Middlesex, HA1 2AX, United Kingdom. Loperamide Capsules can have side-effects, like all medicines, although these don't affect everyone and most are usually mild. Manufacturer: Flamingo Pharma (UK) Limited, Get medical help at once The Bloc, Rare: (may affect up to 1 in 1,000 people)
LOPERAMIDE CAPSULES than 48 hours.
oral desmopressin (used to treat excessive urination). itraconazole or ketoconazole (used to treat fungal infections). gemfibrozil (used to treat high cholesterol).
295 mm
Loperamide capsule is used to treat two types of diarrhoea. The two types have different age limits. If you are unsure about any of the medicines you are ¡. Short-term diarrhoea taking, show the bottle or pack to your pharmacist.
Code : MPLLLOP0002CPCOMFPLXXX035V07
Customer / Livery : FPL UK
Colour Scheme : BLACK
Ref. Artwork : MPLLLOP0002CPCOMFPLXXX035V06
Prepared By Artwork
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If you get any of these, stop using the medicine and get medical help at once.
Loperamide 2mg Capsules (GSL) comes as capsule containing 2mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Loperamide 2mg Capsules (GSL) is loperamide hydrochloride.
Medicines with the same active substance, strength and form include: Boots Diarrhoea Relief 2 mg Capsules (GSL) (6 Capsules), Boots Diarrhoea Relief 2 mg Capsules (P) (12 or 18 Capsules), Imodium Classic 2 mg Capsules. In total there are 13 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Loperamide 2mg Capsules (GSL), as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
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
ACUTE DIARRHOEA
Adults and children over 12:
Two capsules (4 mg) initially, followed by one capsule (2 mg) after each loose stool. 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 2 mg Capsules are 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 pharmacokinetic data are available in patients with hepatic impairment, Loperamide 2 mg Capsules 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.
The capsules should be taken with liquid.
Loperamide 2 mg Capsules are contraindicated:
• in patients with a known hypersensitivity to loperamide hydrochloride or to any of the excipients listed in section 6.1.
• 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.
Loperamide 2 mg Capsules must 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 2 mg Capsules must be discontinued promptly when ileus, constipation or abdominal distension develops.
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 2 mg Capsules is only symptomatic. Whenever an underlying etiology 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 2 mg Capsules 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 HCl 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, torsade de Pointes have been reported in association with overdose. Some cases had a fatal outcome (see section 4.9). Overdose can unmask existing Brugada syndrome.
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 2 mg Capsules 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.
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, is unknown.
The concomitant administration of loperamide (4 mg single dose) and itraconazole, an inhibitor of CYP3A4 and P-glycoprotein, resulted in a 3 to 4- fold increase in loperamide plasma concentrations. In the same study a CYP2C8 inhibitor, gemfibrozil, increased loperamide by approximately 2- fold. The combination of itraconazole and gemfibrozil resulted in a 4-fold increase in peak plasma levels of loperamide and a 13-fold increase in total plasma exposure. These increases were not associated with central nervous system (CNS) effects as measured by psychomotor tests (i.e., subjective drowsiness and the Digit Symbol Substitution Test).
The concomitant administration of loperamide (16 mg single dose) and ketoconazole, an inhibitor of CYP3A4 and P-glycoprotein, resulted in a 5-fold increase in loperamide plasma concentrations. This increase was not associated with increased pharmacodynamic effects as measured by pupillometry.
Concomitant treatment with oral desmopressin resulted in a 3-fold increase of desmopressin plasma concentrations, presumably due to slower gastrointestinal motility.
It is expected that drugs with similar pharmacological properties may potentiate loperamide's effect and that drugs that accelerate gastrointestinal transit may decrease its effect.
Pregnancy
Safety in human pregnancy has not been established, although from animal studies there are no indications that loperamide HCl posseses any teratogenic or embryotoxic properties. As with other drugs, it is not advisable to administer loperamide 2 mg Capsules in pregnancy, especially in the first trimester.
Breast-feeding
Small amounts of loperamide may appear in human breast milk. Therefore, Loperamide 2 mg Capsules 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.
Fertility
The effect on human fertility has not been evaluated.
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. See Section 4.8, 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.
The most commonly reported (i.e. 1% incidence) adverse drug reactions (ADRs) in ≥ clinical trials with loperamide HCl in acute diarrhoea were: constipation (2.7%), flatulence (1.7%), headache (1.2%) and nausea (1.1%).
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 (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and Not known (frequency 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
Somnolence a
Loss of consciousnessa
Stupor a
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
Dyspepsia a
Ileusa (including paralytic ileus)
Megacolona (including toxic megacolonb)
Abdominal distension
acute pancreatitis
Skin and Subcutaneous Tissue Disorders
Rash
Bullous eruption a (including Stevens- Johnson syndrome, Toxic epidermal necrolysis and Erythema multiforme)
Angioedema a
Urticaria a
Pruritus a
Renal and Urinary Disorders
Urinary retention a
General Disorders and Administration Site Conditions
Fatigue a
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 or adults and children, the frequency is estimated from all clinical trials with loperamide HCl (acute and chronic), including trials in children ≤ 12 years (N=3683).
b: See section 4.4 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or by searching for MHRA yellow card in the google play or Apple play store.
Symptoms:
In case of overdose (including relative overdose due to hepatic dysfunction), CNS depression (stupor, coordination abnormality, somnolence, miosis, muscular hypertonia and respiratory depression), constipation, urinary retention and ileus may occur. Children and patients with hepatic dysfunction may be more sensitive to CNS effects.
In individuals who have ingested overdoses of loperamide, cardiac events such as QT interval and QRS complex prolongation, torsade de pointes, other serious ventricular arrhythmias, cardiac arrest and syncope have been observed (see section 4.4). Fatal cases have also been reported. Overdose can unmask existing Brugada syndrome.
Treatment:
In cases of overdose, ECG monitoring for QT interval prolongation should be initiated.
If CNS symptoms of overdose occur, naloxone can be given as an antidote. Since the duration of action of loperamide is longer than that of naloxone (1 to 3 hours), repeated treatment with naloxone might be indicated. Therefore, the patient should be monitored closely for at least 48 hours in order to detect possible CNS depression.
Ask anything about Loperamide 2mg Capsules (GSL). The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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