Loperamide Hydrochloride 2 Mg Hard Capsules
Package leaflet: Information for the user
LOPERAMIDE HYDROCHLORIDE CAPSULES 2 mg
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.
What is in this leaflet
1. What Loperamide is and what it is used for
2. What you need to know before you take Loperamide
3. How to take Loperamide
4. Possible side effects
5. How to store Loperamide
6. Contents of the pack and other information
1. What Loperamide is and what it is used for
Loperamide is an anti-diarrhoeal agent. It works by slowing down the speed at which food and stomach contents pass through the bowel. This allows your body more time to take up more water from your stool and so reduce diarrhoea. Your doctor will prescribe a short course of Loperamide for the relief of sudden onset diarrhoea in adults and children over 8 years. Your doctor may also prescribe Loperamide for longer periods of time to help relieve the symptoms of chronic diarrhoea.
2. What you need to know before you take Loperamide Do not take Loperamide:
• If you are allergic to loperamide or any of the other ingredients of this medicine. (listed in Section 6)
• If you are under the age of 8
• If you have noticed blood in your stools and have high fever
• If you are constipated (reduced frequency of bowel movements)
• If you know you suffer from inflamed intestine (diverticular disease) or inflammatory bowel disease (ulcerative colitis, Crohn’s disease)
• If you know you suffer from bacterial inflammation of the small intestine and the colon
• If you know you suffer from a blockage in your intestine
• If you suffer from a bloated tummy (particularly in children with severe dehydration)
• If you have been told by your doctor that your abdominal pain, inflammation or diarrhoea is caused by bacteria such as Salmonella, Shigella or Campylobacter
• If you have severe diarrhoea after taking antibiotics
Warnings and precautions:
Talk to your doctor or pharmacist before taking Loperamide:
• If you know you suffer from liver problems
• If you are dehydrated. 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
• If you are an AIDS sufferer and you develop a bloated tummy, treatment should be stopped immediately
If there is no improvement in your diarrhoea within 48 hours, or you have a fever or your stool contain blood, stop taking Loperamide and consult your doctor. Prolonged diarrhoea may be a symptom of a more serious illness and you should not take Loperamide for a long period of time unless your doctor has investigated the cause of your diarrhoea and has then prescribed Loperamide to be taken for a prolonged period of time
Other medicines and Loperamide
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially any of the following:
■ quinidine (used to treat abnormal heart rhythms or malaria)
■ ritonavir (used to treat HIV)
■ itraconazole (used to treat fungal infections) or gemfibrozil (helps reduce cholesterol and triglycerides (fatty acids) in the blood)
■ ketoconazole (used to treat infections caused by a fungus or yeast)
■ desmopressin (used to treat excessive urination)
■ any medicine being taken for any condition affecting your stomach
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.
Loperamide should not be taken if you are pregnant. Do not breastfeed your baby, as small amounts of loperamide can pass into breast milk.
Driving and using machines
Do not drive or operate machinery or equipment if you feel drowsy, dizzy or tired while taking Loperamide. Loperamide contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Loperamide
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The dose of Loperamide that you will need will depend on whether your diarrhoea is a sudden, short-lived attack (acute) or a long-lasting condition (chronic).
Swallow the capsule whole (do not chew) with some liquid. It is important to drink more fluids than you normally would during treatment with Loperamide to replace the fluids and salts lost because of the diarrhoea.
The recommended dose is:
Acute / Short term Diarrhoea
Adults (including Elderly) and children aged 12 years and over
Two capsules initially then one capsule after every loose stool. The recommended dosage is three to four capsules a day. Do not take more than 8 capsules in one day (24 hours).
Children
9-12 years: One capsule four times a day until the diarrhoea is controlled, for up to 5 days.
4-8 years: The 2 mg capsules are not suitable for children under 8 years old and an alternative Loperamide preparation should be used.
If there is no improvement within 24 hours of starting treatment, further investigation of the cause of the diarrhoea should be considered.
Chronic Diarrhoea
Adults (including Elderly)
The recommended starting daily dose is between two and four capsules taken in divided doses (usually two doses) in the day depending on the severity of the diarrhoea, up to a maximum of 8 capsules per day.
Children
Loperamide is not recommended for treatment of chronic diarrhoea in children.
Patients with liver problems
Your doctor will advise you.
If you take more Loperamide than you should
Contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining capsules with you. Symptoms of overdose include constipation, sleepiness or decreased respiratory rate.
If you forget to take Loperamide
Take the next dose as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Loperamide
You should take Loperamide for as long as the doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following happen, stop taking Loperamide and tell your doctor immediately or go to your nearest hospital emergency department:
Rare: (may affect up to 1 in 1,000 people)
• You have an allergic reaction. Such reactions may appear in the form of anaphylaxis (a severe form of allergic reaction) with symptoms such as:
- rash
- swelling of the face, lips, mouth, tongue or throat (angioedema)
- anaphylactic shock (sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties in swallowing)
• Skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with dark ring around the edge) (erythema multiforme)
• A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens Johnson Syndrome).
• A widespread rash with blisters and skin peeling on much of the body surface (toxic epidermal necrolysis).
Loss of consciousness or reduced level of consciousness (feeling faint or less alert), Increased tension of the muscles or arteries and uncoordinated movements.
• Widening of the large intestine (megacolon), this widening can be rapid and the following symptoms could be noticed; abdominal pain/tenderness, fever and rapid heart rate
These side effects are rare but serious. You may need medical attention.
The following side effects may be seen with Loperamide:
Common (may affect up to 1 in 10 people):
• Headache, dizziness
• Constipation, feeling sick, wind
Uncommon (may affect up to 1 in 100 people):
• Sleepiness
• Stomach pain, stomach discomfort, upper stomach pain,
• Vomiting
• Indigestion
• Dry mouth
• Rash
Rare (may affect up to 1 in 1,000 people)
• Bowel blockage (ileus), a condition where the bowel does not work properly
• Burning of the lips, tongue or mouth (glossodynia)
• Stomach discomfort
• Difficulty passing water (urine)
• Tiredness
• Hives
• Itching
• Narrowing of the pupils of the eye (miosis)
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
5. How to store Loperamide
Keep out of the sight and reach of children.
Do not store above 250C.
Do not use Loperamide after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other Information What Loperamide contains
The active substance is loperamide hydrochloride
Each capsule contains:
Lactose Monohydrate Maize Starch Magnesium Stearate
The capsule cap contains:
Quinoline Yellow Oxide (E104)
Indigo Carmine (E132)
Titanium Dioxide (E171)
Gelatin
The capsule body contains:
Erythrosin (E127)
Indigo Carmine (E132)
Black Iron Oxide (E172)
Titanium Dioxide (E171)
Gelatin
Printing ink contains Ammonium hydroxide (E527)
Povidone
Shellac
Simeticone
Sodium Hydroxide
Titanium dioxide (E171)
What Loperamide looks like and contents of the pack
Your medicine comes as a hard mauve and green capsule marked “LOPERA-MIDE 2”.
Loperamide is available in blisters of 4, 6, 8, 10, 12, 16, 18, 20, 24, 28, 30, 60,250 or 500 capsules; and in plastic bottles of 4, 6, 8, 10, 12, 18, 20, 28, 50, 100, 250 or 500 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Generics [UK] Limited
Station Close
Potters Bar
Hertfordshire
EN6 1TL
This leaflet was last revised in 07/2014.
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