Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Loperamide 2mg Capsules (GSL)

⚠ This medicine appears to have been discontinued

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.

Active substance: Loperamide hydrochloride

Equivalent medicines (same active substance, strength and form)

and 8 more with the same active substance, strength and form

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

FOR

nausea, vomiting, which may be symptoms of inflammation of the pancreas (acute pancreatitis).

  • Keep this leaflet. You may need to read it again.
  • Ask your pharmacist if you need more information or advice.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
  • You must talk to a doctor if you do not feel better or if you feel worse after 24 hours.
  • This medicine is used for two different types of diarrhoea. They have different age limits. See Section 1

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)

What you need to know before you take it

e Loperamide Capsules 5. How to store Loperamide Capsules 3. How to take Loperamide Capsules

How to take it

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)

  • Swallow the correct number of capsules whole with a
  • Itchiness or hives. drink of water. For oral use only.
  • Stomach pain or swollen stomach.
  • Do not use more than the dose shown in the tables
  • The capsules are not for long-term treatment. Rare: (may affect up to 1 in 1,000 people) Short-term diarrhoea
  • Difficulties passing water. Age Dose
  • Severe constipation.
  • Miosis (narrowing of the pupils of the eye). Adults and children Take two capsules to start aged 12 and over treatment. If you notice any of the above, stop using the medicine Take one capsule after each and talk to a doctor. loose bowel movement. Other effects that may occur
  • Do not take for attacks lasting longer than 48 hours. Common: (may affect up to 1 in 10 people)
  • Do not take more than six capsules in a 24-hour period. • Feeling sick, constipation or wind.
  • Headache.
  • Replace lost fluid by drinking more liquid than usual.
  • Not for children aged under 12. Uncommon: (may affect up to 1 in 100 people)
  • Dizziness or drowsiness. How long to take Loperamide Capsules
  • Vomiting, indigestion. for short-term diarrhoea
  • Dry mouth. You can use this medicine for up to 48 hours. If your attack lasts longer than 48 hours, stop taking Rare: (may affect up to 1 in 1,000 people) Loperamide Capsules and talk to your doctor.
  • Tiredness. IBS diarrhoea Reporting of side effects Age Dose If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed Adults aged Take two capsules to start treatment. in this leaflet. You can also report side effects directly via 18 and over Take one capsule after each loose bowel the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard movement (or as advised by your doctor). or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help
  • You can use this medicine for up to 2 weeks for repeated provide more information on the safety of this medicine. attacks, but do not take for any one attack lasting longer

Possible side effects

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)

  • Allergic reactions including unexplained wheezing, shortness 38 Springfield Way, Anlaby, Hull, of breath, passing out or swelling of face and throat. HU10 6RJ, United Kingdom.
  • Skin rashes, which may be severe and include blistering or peeling skin. If you would like this leaflet in different format
  • Loss of consciousness or reduced level of information or want to report any side effects, please consciousness (passing out, feeling faint or contact marketing authorization holder listed above. less alert), uncoordinated movements. This leaflet was last revised in 04/2022. Not known: (frequency cannot be estimated from the available data) GSL
  • Upper abdominal pain, abdominal pain that radiates to back, MPLLLOP0002CPCOMFPLXXX035V07 tenderness when touching the abdomen, fever, rapid pulse, PL 43461/0036
  • Do not take this medicine:
  • There are some people who should not use this medicine. To find out if you are one of them, see Section 2
  • If you have ever had a bad reaction to any of the ingredients. For the list of ingredients, see Section 6

How to store it

LOPERAMIDE CAPSULES than 48 hours.

  • Do not take more than six capsules in a 24-hour period. Keep this medicine out of the sight and reach of children. Store below 25°C. Store in the original package.
  • Replace lost fluid by drinking more liquid than usual. Do not use this medicine after the date shown as the
  • Not for children and young people aged under 18. expiry date on the packaging. Talk to your doctor and stop taking this medicine: Medicines should not be disposed of via wastewater or
  • If you have been using this medicine continuously for household waste. Ask your pharmacist how to dispose 48 hours. of medicines no longer required. These measures will
  • If you develop new IBS symptoms. help to protect the environment.
  • If your IBS symptoms get worse.
  • If your IBS symptoms have not improved after 2 weeks. 6. CONTENTS OF THE PACK AND OTHER INFORMATION How long to take Loperamide Capsules for IBS diarrhoea What Loperamide Capsules contains You can use this medicine for up to 2 weeks for repeated attacks of IBS diarrhoea. But if any one attack The active ingredient in Loperamide Capsules is: lasts for longer than 48 hours, stop taking Loperamide Loperamide hydrochloride 2 mg per capsule. The other ingredients are lactose monohydrate, microcrystalline Capsules and talk to your doctor. cellulose, maize starch, colloidal anhydrous silica, purified If you take more Loperamide than you should talc, magnesium stearate. The capsule is made up of If you have taken too many Loperamide 2mg Capsules, Hard, immediately contact a doctor or hospital for advice. gelatin, water, sodium lauryl sulfate, patent blue V (E131), quinoline yellow (E104), brilliant blue FCF (E133), iron Symptoms may include: increased heart rate, irregular heartbeat, changes to your heartbeat (these symptoms can oxide red (E172) and titanium dioxide (E171). The printing have potentially serious, life-threatening consequences), ink contains shellac (E904), propylene glycol (E1520), muscle stiffness, uncoordinated movements, drowsiness, black iron oxide (E172) and potassium hydroxide (E525). difficulty urinating, or weak breathing. What Loperamide Capsules looks like and contents Children react more strongly to large amounts of of the pack Loperamide 2mg Capsules, Hard than adults. If a child Loperamide Capsules are Size '4' Hard gelatin capsule takes too much or shows any of the above symptoms, with Green cap imprinted with 'L' in black ink and grey call a doctor immediately. body imprinted with '2mg' in black ink, containing white If you forget to take Loperamide to off-white powder. You should only take this medicine as you need it, Loperamide Capsules are available in blister packs of 2, following the dosage instructions above carefully. 4 and 6 capsules (not all pack sizes may be marketed). If you forget to take a dose, take a dose after the next loose stool (bowel movement). Marketing Authorization Holder Do not take a double dose. Flamingo Pharma (UK) Ltd. 1st Floor, Kirkland House, 11-15 Peterborough Road,

Contents of the pack and other information

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.

  • For adults and children aged 12 and over. If any of these applies to you (now or in the past),
  • To treat attacks that last up to 48 hours. talk to a doctor or pharmacist.
  • If your attack lasts longer than 48 hours, talk to your doctor. Pregnancy, breast-feeding and fertility
  • If you are pregnant, think you are pregnant or ¡¡. IBS diarrhoea planning a pregnancy: ask your doctor or pharmacist
  • For adults and young people aged 18 and over who have been diagnosed with IBS for advice before taking this medicine. (Irritable Bowel Syndrome).
  • If you are breast-feeding do not take this medicine.
  • To treat attacks that last up to 48 hours. Small amounts may get into your milk. Talk to your
  • You can use this medicine for up to 2 weeks for doctor about a suitable treatment. repeated attacks, but if any one attack lasts Driving and using machines continuously for longer than 48 hours,
  • This medicine may make you feel dizzy, tired or sleepy. talk to your doctor. You may feel less alert, feel faint or pass out. If you're The capsules contain loperamide hydrochloride, a affected do not drive or use machines. substance that helps reduce diarrhoea by slowing down Warnings and precautions an overactive bowel.This allows water and salts that are • Your body can lose large amounts of fluids and salts usually lost in diarrhoea to be absorbed by the body. when you have diarrhoea. You need to replace the fluid by drinking more liquid than usual. Ask your pharmacist 2. WHAT YOU NEED TO KNOW BEFORE YOU about rehydration therapy to replace lost salts. TAKE LOPERAMIDE CAPSULES This is especially important for children, and frail or Consult a doctor before use if you have a history of drug older people. abuse; loperamide is an opioid and addiction is observed • Do not take this product for anything other than its with opioids as a class. intended use (see section 1) and never take more than Warnings for everyone the recommended amount (see section 3). Serious heart This medicine is suitable for most people, but a few problems (symptoms of which include fast or irregular people should not use it: heartbeat) have been reported in patients who have Do not take this medicine if you… taken too much loperamide, the active ingredient in
  • have ever had a bad reaction to any of the ingredients. Loperamide 2mg Capsules, Hard.
  • have severe diarrhoea after taking antibiotics. Loperamide contains:
  • are having a flare-up of an inflammatory bowel condition This medicine contains lactose. If you have been told by like ulcerative colitis. your doctor that you have an intolerance to some sugars
  • are constipated, or your stomach appears swollen contact your doctor before taking this medicinal product. (especially in children with severe dehydration).
  • have acute dysentery, the symptoms of which may include Extra warnings for IBS patients blood in your stools and a high temperature. Use only if your doctor has previously diagnosed IBS.
  • If it is for a child aged under 12 Check the following: (or under 18 for an IBS patient). If any of these applies to you, talk to a doctor or Do not take this medicine… pharmacist and do not take Loperamide Capsules.
  • If you are aged under 18. Other medicines and Loperamide Talk to your doctor first if you… Talk to your doctor first if you…
  • have AIDS and your stomach becomes swollen, stop
  • are aged 40 or over and it is some time since taking the capsules immediately and contact your doctor your last IBS attack.
  • suffer from liver disease.
  • are aged 40 or over and your IBS symptoms are
  • have diarrhoea that lasts for more than 48 hours. different this time.
  • have been told by your doctor that you have an • have recently passed blood from the bowel. intolerance to some sugars.
  • suffer from severe constipation.
  • have severe diarrhoea as your body loses more fluid,
  • are feeling sick or vomiting. sugars and salts than normal.
  • have lost your appetite or lost weight.
  • are taking any other medicines, including:
  • have difficulty or pain passing urine. ritonavir (used to treat HIV).
  • have a fever. quinidine (used to treat abnormal heart rhythms or
  • have recently travelled abroad. malaria).

Code : MPLLLOP0002CPCOMFPLXXX035V07

Customer / Livery : FPL UK

Colour Scheme : BLACK

Ref. Artwork : MPLLLOP0002CPCOMFPLXXX035V06

Prepared By Artwork

Approved by

Reviewed & Checked By Pkg. Development

Regulatory

Marketing

MAH

CQA

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Date :

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If you get any of these, stop using the medicine and get medical help at once.

Frequently asked questions about Loperamide 2mg Capsules (GSL)

How do I take Loperamide 2mg Capsules (GSL)?

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.

What is the active substance in Loperamide 2mg Capsules (GSL)?

The active substance in Loperamide 2mg Capsules (GSL) is loperamide hydrochloride.

Are there equivalent medicines to Loperamide 2mg Capsules (GSL)?

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.

Where does this information come from?

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.

Can I get Loperamide 2mg Capsules (GSL) without a prescription?

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.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Loperamide hydrochloride (22 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

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.

4.2. Posology and method of administration

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.

4.3. Contraindications

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.

4.4. 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 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.

4.5. Interaction with other medicinal products and other forms of interaction

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.

4.6. Fertility, pregnancy and lactation

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.

4.7. Effects on ability to drive and use machines

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.

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.

4.9. Overdose

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 about this leaflet

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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