- loperamide hydrochloride
GSL: General Sales Licence
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL00014/0611 .
Value Health Diarrhoea Relief 2 mg Capsules
Information for the user
Value Health Diarrhoea Relief 2 mg Capsules
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 loperamide or to any of the ingredients in this medicine (see “What is in this medicine”)
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
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 have an intolerance to some sugars, unless your doctor tells you to (this medicine contains lactose)
If you are pregnant or breastfeeding, unless your doctor tells you to
Talk to your pharmacist or doctor:
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 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, especially if you are elderly.
Driving and using machines: Diarrhoea or this medicine may cause people to feel tired, sleepy or dizzy. You should not drive or use machines, until you are sure you are not affected.
Information about some of the ingredients in this medicine: The colour ponceau 4R (E124) in this medicine may cause allergic reactions.
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), 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 24 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 as needed until stools become solid. Don’t take more than 6 capsules in any 24 hours.
Don’t take for more than 14 days.
Swallow each capsule with water.
Do not give to children under 12 years.
Do not take more than the amount recommended above.
If your short term diarrhoea does not go away within 24 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: Talk to a doctor straight away. Take your medicine and this leaflet with you.
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:
Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)
If you get any of the following side effects see your pharmacist or doctor.
Common side effects:
(less than 1 in every 10 people are affected)
Feeling sick, constipation, wind
Uncommon side effects:
(less than 1 in every 100 people are affected)
Dry mouth, being sick, indigestion, stomach discomfort, stomach or upper abdominal pain
Feeling very sleepy or wanting to sleep
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
Swelling of the stomach and abdomen
Allergic skin reactions such as itchy, red, raised rash (which can sometimes be severe and include peeling, swelling, blistering and lesions of the skin)
General feeling of tiredness, loss or decreased levels of consciousness, lack of coordination, lack of response to stimulation
Difficulty passing urine, tensing of the muscles
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. 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 4 hard, green/grey capsules with “0611” printed on them.
Who makes this medicine
Manufactured for the Marketing Authorisation holder
Leaflet prepared June 2015
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: Value Health Diarrhoea Relief 2 mg Capsules
Reference number: 00014/0611
This is a service provided by the Royal National Institute of Blind People.