This medicine is available without prescription to treat a minor condition. However, you still need to take it carefully to get the best results from it.

• Keep this leaflet, you may need to read it again
• Ask your pharmacist if you need more information or advice

• If you are allergic to or have ever had a bad reaction to loperamide or to any of the ingredients in this medicine (see “What is in this medicine”)
• If it is for a child aged under 12 (or under 18 for an IBS patient)
• If you are having a flare up of an inflammatory bowel condition, such as ulcerative colitis
• If you have very smelly stools, blood or pus in your stools, stomach pain, or a fever
• If you have dysentery (a disease caused by eating and drinking contaminated food and water) – you may have a fever and blood in your stools
• If you have severe diarrhoea after taking antibiotics
• If you have a swollen stomach (especially in children with severe dehydration)
• If you are constipated, or have any condition which may cause constipation or where constipation should be avoided
• If you have paralysis (non movement) of the bowel muscles, or an obstruction of the bowel
• If you are breastfeeding

• If you are pregnant, think you are pregnant or planning a pregnancy
• If you have liver problems
• If you have AIDS (you may be more likely to experience some of the side effects - if your stomach becomes swollen stop taking the capsules and talk to your doctor)
• If you have IBS but have not had this condition previously diagnosed by a doctor
• If you have diarrhoea that lasts for more than 48 hours
• If you have severe diarrhoea as your body loses more fluid, sugars and salts than normal
• If you have been told by your doctor that you have an intolerance to some sugars
• If you have IBS, which has previously been diagnosed by a doctor, but you notice any of the following new symptoms:
  • If you are 40 years or over and it is some time since your last attack of IBS, or if the symptoms are different this time
  • If you have recently passed blood from the bowel
  • If you have severe constipation
  • If you are feeling sick or being sick
  • If you have lost your appetite or lost weight, especially if losing weight without trying
  • If you have difficulty or pain on passing urine
  • If you have a fever
  • If you have recently travelled abroad

Diarrhoea is a common symptom of a number of serious stomach and bowel conditions. If your diarrhoea continues or keeps coming back talk to your doctor.

Dehydration may be a complication of diarrhoea, as large amounts of fluid are lost in the stools. This medicine acts only to make the stools more solid and less frequent and does not replace lost fluids. Therefore it is important to drink more fluid than usual.

When your body loses fluid, the amount of salts (electrolytes) in your body may also change and this can cause a condition called electrolyte imbalance. To help balance the fluid and salt levels in your body to the right levels your pharmacist may recommend that you also take a “rehydration treatment” if you have diarrhoea, this is especially important in children and the elderly.

Consult with a doctor if you have a history of drug abuse. Loperamide is a type of opioid that acts directly on the gut when used as recommended but can cause other opioid effects when misused at high doses. Addiction is observed with opioids as a class.

Abuse and misuse of loperamide, the active ingredient in this medicine, have been reported. Do not take this product for anything other than its intended use (see section 'What this medicine is for') and never take more than the recommended amount (see section 'How to take this medicine').

Serious heart problems (symptoms of which include fast or irregular heartbeat) have been reported in patients who have taken too much loperamide, the active ingredient in this medicine.

Driving and using machines: Diarrhoea or this medicine may cause people to feel tired, sleepy or dizzy. You may feel less alert, feel faint or pass out. If you are affected, you should not drive or use machines.

Information about some of the ingredients in this medicine: The colour ponceau 4R (E124) in this medicine may cause allergic reactions.

This medicine contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Before you take these capsules, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

• Ritonavir (used to treat HIV)
• Quinidine (for heart rhythm problems or malaria), gemfibrozil (for reducing blood fat levels)
• Itraconazole, ketoconazole (for fungal infections)
• Desmopressin (for treating excessive urination or bed wetting)
• Other medicines for diarrhoea, constipation, or for other stomach and bowel conditions

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

Rare: (may affect up to 1 in 1,000 people)

• Allergic reactions including unexplained wheezing, shortness of breath, passing out or swelling of the face, neck, tongue or throat (severe allergic reactions)
• Skin rashes, which may be severe and include peeling, swelling, blistering and lesions of the skin
• Loss or decreased levels of consciousness (passing out, feeling faint or less alert), muscle stiffness, lack of coordination, lack of response to stimulation

Not known: (frequency cannot be estimated from the available data):

• Upper abdominal pain, abdominal pain that radiates to back, tenderness when touching the abdomen, fever, rapid pulse, nausea, vomiting, which may be symptoms of inflammation of the pancreas (acute pancreatitis).

Uncommon side effects:

(less than 1 in every 100 people are affected)

• Itchiness or hives
• Stomach pain or swollen stomach

Rare side effects:

(less than 1 in every 1000 people are affected)

• Obstruction of the bowel, dilation of the bowel, paralysis (non movement) of the bowel muscles which may stop bowel movements
• Difficulty passing urine,
• Hypertonia (tensing of the muscles)
• Severe constipation
• Miosis (narrowing of the pupils of the eye)
• Coordination abnormality (uncoordinated movements)

Common side effects:

(less than 1 in every 10 people are affected)

• Headache
• Feeling sick, constipation, wind

Uncommon side effects:

(less than 1 in every 100 people are affected)

• Dizziness or drowsiness
• Dry mouth, being sick, indigestion

Rare side effects:

(less than 1 in every 1000 people are affected)

• Feeling very tired, sleepy or wanting to sleep

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.