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.
Loperamide 2 mg Capsules (POM)
⚠ 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.
What you need to know before you take it
e Loperamide Capsules 3.How to take Loperamide Capsules 4.Possible side effects 5.How to store Loperamide Capsules
How to take it
LOPERAMIDE CAPSULES
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The dose of Loperamide capsules that you will need will depend on whether your diarrhoea is a sudden, short lived attack (acute) or a long-lasting condition Do not take this product for anything other than its (chronic). intended use (see section 1) and never take more • Take this medicine by mouth. than the recommended amount (see section 3). Serious heart problems (symptoms of which include • Swallow the correct number of capsules whole with a drink of water. fast or irregular heartbeat) have been reported in patients who have taken too much loperamide, the Short-lived (acute) diarrhoea active ingredient in Loperamide Capsules. Adults and children over 12 years: Replacing fluid and salts
- Take two capsules to begin with and then one capsule after each episode of diarrhoea Loperamide capsules only treats the symptoms of for up to 5 days. diarrhoea. Your body can lose large amounts of
Talk to a doctor as soon as possible
POM
Uncommon: (may affect up to 1 in 100 people)
- Itchiness or hives.
- Stomach pain or swollen stomach.
PL 43461/0011
Code : MPLLLOP0002CPCOMFPLXXX071V06
Customer / Livery : FPL UK
Colour Scheme : Black
Ref. Artwork : MPLLLOP0002CPCOMFPLXXX071V05
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Reviewed & Checked By Regulatory
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MPLLLOP0002CPCOM FPLXXX071V06
Children aged 9-12 years:
- Take one capsule 4 times daily until diarrhoea is controlled or for up to 5 days.
- Never take more than this dose.
Rare: (may affect up to 1 in 1,000 people)
- Difficulties passing water.
- Severe constipation.
- Miosis (narrowing of the pupils of the eye). If you notice any of the above, stop using the medicine and talk to a doctor.
- Never take more than 8 capsules in any 24 hour period.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- 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.
PACKAGE LEAFLET: INFORMATION FOR THE USER Loperamide 2 mg Capsules, Hard (loperamide hydrochloride)
How to store it
LOPERAMIDE CAPSULES
- Never take more than 8 capsules in any 24 hour period. Keep this medicine out of the sight and reach If you take more Loperamide capsules than of children. you should Store below 25°C. Store in the original package. If you have taken too many Loperamide Capsules, Do not use this medicine after the date shown immediately contact a doctor or hospital for advice. as the expiry date on the packaging. Symptoms may include: increased heart rate, Do not throw away any medicines via wastewater or irregular heartbeat, changes to your heartbeat household waste. Ask your pharmacist how to throw (these symptoms can have potentially serious, away medicines no longer required. These life-threatening consequences), muscle stiffness, measures will help to protect the environment. uncoordinated movements, drowsiness, difficulty 6. CONTENTS OF THE PACK AND OTHER urinating, or weak breathing. Children react more strongly to large amounts of INFORMATION Loperamide capsules than adults. If a child takes too much or shows any of the above symptoms, call What Loperamide Capsules contains The active ingredient in Loperamide Capsules is: a doctor immediately. Loperamide hydrochloride 2 mg per capsule. If you forget to take Loperamide capsules The other ingredients are lactose monohydrate,
- You should only take this medicine as required, microcrystalline cellulose, maize starch, colloidal following the dosage instructions above carefully. anhydrous silica, purified talc, magnesium stearate.
- If you forget to take a dose, take a dose after the The capsule is made up of gelatin, water, sodium next loose stool (bowel movement). lauryl sulfate, patent blue V (E131), quinoline yellow
- Do not take a double dose to make up a (E104), brilliant blue FCF (E133), iron oxide red forgotten dose. (E172) and titanium dioxide (E171). If you have any further questions on the use of this The printing ink contains shellac (E904), propylene glycol (E1520), black iron oxide (E172) and medicine, ask your doctor or pharmacist. potassium hydroxide (E525).
4. POSSIBLE SIDE EFFECTS
What Loperamide Capsules looks like and Loperamide Capsules can have side-effects, like all contents of the pack medicines, although these don't affect everyone and Loperamide Capsules are Size '4' Hard gelatin capsule with Green cap imprinted with 'L' in black most are usually mild. ink and grey body imprinted with '2mg' in black ink, Get medical help at once containing white to off-white powder. Rare: (may affect up to 1 in 1,000 people)
- Allergic reactions including unexplained wheezing, Loperamide Capsules are available in blister packs of 2, 4, 6, 8, 12, 18 and 30 capsules (not all pack shortness of breath, passing out or swelling of sizes may be marketed). face and throat.
- Skin rashes, which may be severe and include Marketing Authorisation Holder: blistering or peeling skin. Flamingo Pharma (UK) Ltd.
- Loss of consciousness or reduced level of 1st Floor, Kirkland House, 11-15 Peterborough consciousness (passing out, feeling faint or less Road, Harrow, Middlesex, HA1 2AX, alert), uncoordinated movements. United Kingdom. Not known: (frequency cannot be estimated from Manufacturer: the available data) Flamingo Pharma (UK) Limited
- Upper abdominal pain, abdominal pain that The Bloc, 38 Springfield Way, radiates to back, tenderness when touching the Anlaby, Hull, HU10 6RJ, United Kingdom abdomen, fever, rapid pulse, nausea, vomiting, If you would like this leaflet in different format which may be symptoms of inflammation of the information or want to report any side effects please pancreas (acute pancreatitis). contact marketing authorization holder listed above. If you get any of these, stop using the medicine This leaflet was last revised in 04/2022. and get medical help at once.
Contents of the pack and other information
Loperamide capsule is used
- To treat sudden short-lived (acute) attacks of diarrhoea in adults and in children over 9 years of age.
- To treat long lasting (chronic) diarrhoea in adults
Other medicines and Loperamide Capsules Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without 2. WHAT YOU NEED TO KNOW BEFORE a prescription. YOU TAKE LOPERAMIDE CAPSULES In particular, tell your doctor or pharmacist if Consult a doctor before use if you have a history of you are taking any of the following: drug abuse; loperamide is an opioid and addiction is – ritonavir (used to treat HIV). observed with opioids as a class.
- quinidine (used to treat abnormal heart rhythms or malaria). Do not take Loperamide capsules
- If you are allergic to loperamide hydrochloride or
- Oral desmopressin (used to treat excessive any of the ingredients of this medicine (listed in urination). section 6).
- Itraconazole, ketoconazole (used to treat
- If you have severe diarrhoea after taking fungal infections). antibiotics.
- gemfibrozil (used to treat high cholesterol).
- If you are having a flare-up of an inflammatory
- other drugs that slow down or speed up bowel condition like ulcerative colitis. movement in the gut
- If you are constipated or your stomach appears swollen (especially in children with severe Pregnancy and breast-feeding dehydration). If you are pregnant, think you may be pregnant or
- for a child less than 9 years old. planning to have a baby, ask your doctor or
- If you have acute dysentery, the symptoms of pharmacist for advice before taking this medicine. which may include blood in your stools and a high Do not take this medicine if you are breast-feeding temperature as small amounts may get into your milk. Talk to your doctor about a suitable treatment. Do not use this medicine if any of these applies to Driving and using machines you. If you are not sure, talk to your doctor or Do not drive if you feel dizzy, tired or sleepy. You pharmacist before taking Loperamide Capsules. may feel less alert, feel faint or pass out. If you're Warnings and precautions affected do not drive or use machines. Talk to your doctor before taking Loperamide Loperamide capsules contains lactose Capsules if
- You have acute dysentery, the symptoms of which If you have been told by your doctor that you have an intolerance to some sugars contact your doctor may include blood in your stools and a high temperature. You will also need to be given other before taking this medicinal product. medicines to treat this
- You have AIDS and your stomach becomes swollen, stop taking the capsules immediately and contact your doctor.
- You suffer from liver problems. You may still be able to use Loperamide capsules, but you should discuss this with your doctor first.
295 mm
295 mm
Loperamide capsules contain loperamide hydrochloride, a substance that helps reduce diarrhoea by slowing down an overactive bowel. This allows water and salts that are usually lost in diarrhoea to be absorbed by the body.
fluids and salts when you have diarrhoea. You need to replace the fluid by drinking more liquid than usual. This is especially important for children. Your doctor may also give you a special powder containing sugar and salts (known as oral rehydration therapy) to help your body replace the fluid and salts lost during diarrhoea. The prevention of fluid depletion (dehydration) is particularly important in infants, children, and frail and elderly people with acute diarrhoea.
Other effects that may occur Common: (may affect up to 1 in 10 people) Children aged under 9 years old: This medicine should not be given to children under • Feeling sick, constipation or wind. 9 years old. Other pharmaceutical forms/strengths • Headache. (e.g. syrup) are available for children aged 4 years Uncommon: (may affect up to 1 in 100people) and over.
- Dizziness or drowsiness. If your symptoms are not getting better within 2 days • Vomiting, indigestion. of taking your first dose of this medicine, you should • Dry mouth. see your doctor again, who may want to examine you to further check on the cause of the diarrhoea. Rare: (may affect up to 1 in 1,000 people)
- Tiredness. Long-lasting (chronic) diarrhea Reporting of side effects Adults only: If you get any side effects, talk to your doctor,
- Your doctor will tell you how much Loperamide pharmacist or nurse. This includes any possible side capsules to take.
- The initial dose will probably be between two and effects not listed in this leaflet. You can also report four capsules per day taken in divided doses, but side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for will depend on each individual's needs. When your doctor is satisfied that you are receiving the MHRA Yellow Card in the Google Play or Apple App daily dose that best suits you, he or she will then Store. By reporting side effects you can help provide more information on the safety of this medicine. probably suggest that you take your capsules twice a day.
Frequently asked questions about Loperamide 2 mg Capsules (POM)
How do I take Loperamide 2 mg Capsules (POM)?
Loperamide 2 mg Capsules (POM) 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 2 mg Capsules (POM)?
The active substance in Loperamide 2 mg Capsules (POM) is loperamide hydrochloride.
Are there equivalent medicines to Loperamide 2 mg Capsules (POM)?
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 2 mg Capsules (POM), 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 2 mg Capsules (POM) 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.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: loperamide hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
For the symptomatic treatment of acute diarrhoea of any aetiology including acute exacerbations of chronic diarrhoea for periods of up to 5 days in adults and children over 9 years. For the symptomatic treatment of chronic diarrhoea in adults.
4.2. Posology and method of administration
Posology
ACUTE DIARRHOEA
Adults and children over 12 years:
Two capsules (4 mg) initially, followed by one capsule (2 mg) after each loose stool. The usual dose is 3-4 capsules (6 mg – 8 mg) a day. The total daily dose should not exceed 8 capsules (16 mg).
Children 9 to 12 years
One capsule (2 mg) four times daily until diarrhoea is controlled (up to 5 days). This dose should not be exceeded.
Further investigation into the cause of the diarrhoea should be considered if there is no improvement within two days of starting treatment with loperamide.
CHRONIC DIARROHEA
Adults
Patients may need widely differing amounts of loperamide. The starting dose should be between two and four capsules per day in divided doses, depending on severity. If required, this dose can be adjusted according to result up to a maximum of eight capsules daily.
Having established the patient's daily maintenance dose, loperamide may be administered on a twice daily regimen. Tolerance has not been observed and therefore subsequent dosage adjustment should be unnecessary.
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 9 years of age.
• when inhibition of peristalsis is to be avoided due to the possible risk of significant sequelae including ileus, megacolon and toxic megacolon, in particular:
- when ileus, constipation or abdominal distension develop,
- 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 hydrochloride should not be used alone in acute dysentery, which is characterised by blood in stools and elevated body temperatures.
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 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 (eg in cases of severe hepatic disturbance), as it might result in a relative overdose leading to CNS toxicity.
Treatment with Loperamide must be discontinued promptly when constipation, abdominal distension or ileus develop.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine because it contains lactose.
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.
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 possesses 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 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
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 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 search 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 2 mg Capsules (POM). 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.
Medicines containing Loperamide hydrochloride
- Imodium Classic 2 mg Capsules
- Imodium IBS Relief 2mg Soft Capsules
- Imodium Instant Melts
- Imodium Instants
- Imodium Original 2mg Capsules
- Imodium SoftGels 2mg Capsules, soft
- Lomodine 2mg capsules
- Loperamide 2 mg tablets
- Loperamide 2mg Caps
- Loperamide 2mg Capsules
- Loperamide 2mg Capsules (GSL)
- Loperamide hydrochloride 2 mg Orodispersible tablet
- Loperamide Hydrochloride 2mg capsules, hard
- Loperamide Hydrochloride Capsules 2mg - 0045