Boots Diarrhoea Relief 2 mg Capsules (P) (12 or 18 Capsules)

Patient Leaflet Updated 17-Jul-2024 | THE BOOTS COMPANY PLC

Boots Diarrhoea Relief 2 mg Capsules (P) (12 or 18 Capsules)

Information for the user

Boots Diarrhoea Relief 2 mg Capsules

(Loperamide Hydrochloride)

Read all of this leaflet carefully because it contains important information for you.

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

What this medicine is for

This medicine contains Loperamide Hydrochloride which belongs to a group of medicines called antidiarrhoeals, which act to relieve the symptoms of sudden, short term diarrhoea (“acute” diarrhoea). It works by making the stools (“poo”) more solid and less frequent. It can be used to relieve short term diarrhoea in adults and children aged 12 years and over. It can also be used by adults of 18 years and over who have irritable bowel syndrome (IBS), which has been previously diagnosed by a doctor, to relieve short term diarrhoea associated with it.

Before you take this medicine

This medicine can be taken by adults and children of 12 years and over. However, diarrhoea is a common symptom of a number of serious stomach and bowel conditions and therefore some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

Do not take:
  • 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

Talk to your pharmacist or doctor:
  • 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 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 but have not had this condition previously diagnosed by a doctor
  • 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

Other important information

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.

If you take other medicines

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.

How to take this medicine

Check the foil is not broken before use. If it is, do not take that capsule.

Adults and children of 12 years and over for short term diarrhoea: Take two capsules to start with. After that, take one capsule after each loose bowel movement. Don’t take more than 6 capsules in any 24 hours. Don’t take for more than 48 hours.

Adults only (18 years and over) for diarrhoea associated with irritable bowel syndrome, which has been diagnosed by a doctor: Take two capsules to start with. After that, take one capsule after each loose bowel movement (or as advised by your doctor). Don’t take more than 6 capsules in any 24 hours. You can use this medicine for up to 14 days for repeated attacks, but don’t take for any one attack lasting longer than 48 hours. Don’t take for more than 14 days.

Swallow each capsule with water. For oral use only.

Do not give to children under 12 years.

Do not take more than the amount recommended above.

Replace lost fluid by drinking more liquid than usual.

This medicine is not for long-term treatment. If your short term diarrhoea does not go away within 48 hours talk to your doctor.

If you need to take this medicine for diarrhoea associated with IBS for more than 14 days, or if you notice new symptoms, or symptoms worsen, talk to your doctor.

If you take too many capsules: If you have taken too many Boots Diarrhoea Relief 2 mg Capsules, immediately contact a doctor or hospital for advice. Symptoms may include: increased heart rate, irregular heartbeat, changes to your heartbeat (these symptoms can have potentially serious, life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, or weak breathing. Children react more strongly to large amounts of this medicine than adults. If a child takes too much or shows any of the above symptoms, call a doctor immediately. Take your medicine and this leaflet with you.

If you forget to take the medicine: You should only take this medicine as you need it, following the dosage instructions above carefully. If you forget to take a dose, take a dose after the next loose stool (bowel movement). Do not take a double dose..

Possible side effects

Most people will not have problems, but some may get some.

If you get any of these serious side effects, stop taking the capsules. See a doctor at once:

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).

If you get any of the following side effects see your pharmacist or doctor.

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)

Other effects that may occur

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

Reporting of side effects

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.

How to store this medicine

Do not store above 30°C.

Store in the original package.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton.

What is in this medicine

Each capsule contains Loperamide Hydrochloride 2 mg, which is the active ingredient.

As well as the active ingredient, the capsules also contain lactose monohydrate, pregelatinised maize starch, magnesium stearate. The capsule shell contains gelatin, ponceau 4R (E124), indigo carmine (E132), titanium dioxide (E171), yellow and black iron oxides (E172), printing ink (containing black iron oxide (E172), shellac, propylene glycol).

The pack contains 12 or 18 hard, green/grey capsules with “0611” printed on them. Not all pack sizes may be marketed.

Who makes this medicine

Manufactured for the Marketing Authorisation holder

The Boots Company PLC
Nottingham
NG2 3AA

by

Famar AVE
Anthoussa
Attiki
15349
Greece

Leaflet prepared May 2024.

If you would like any further information about this medicine, please contact

The Boots Company PLC
Nottingham
NG2 3AA

Other formats

To request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name: Boots Diarrhoea Relief 2 mg Capsules (12 or 18 capsules)

Reference number: 00014/0611

This is a service provided by the Royal National Institute of Blind People.

31055688

Company Contact Details
THE BOOTS COMPANY PLC
Address

1 Thane Road West, Beeston, Nottingham, NG2 3AA

Fax

+44 (0)1159 592 565

Telephone

+44 (0)1159 595 165