Loperamide Hydrochloride 2mg Capsules
PATIENT INFORMATION LEAFLET
Loperamide Hydrochloride 2mg and is referred to as Loperamide throughout this leaflet.
Loperamide should not be taken with the following:
Loperamide Hydrochloride Capsules belong to a group of medicines called 'antidiarrhoeals' which are used to treat diarrhoea.
Loperamide is used to treat sudden short lived (acute) attacks of diarrhoea in adults and children over 12 years of age.
It reduces diarrhoea by slowing down an overactive bowel. It also helps the body to absorb more water and salts from the bowel.
What you need to know before you take Loperamide
Do not take Loperamide if:
■ you are allergic (hypersensitive) to Loperamide, other antidiarrhoeals or any of the other ingredients of this medicine (see section 6 "Contents of the pack and other information”)
■ you need to keep the bowel movements normal to avoid complications such as blockage of the bowel and abnormal or rapid widening of the colon
■ you have constipation, blockage of the bowel or a bloated tummy (in particular, in children with severe dehydration)
■ you have acute ulcerative colitis (a form of inflammatory bowel disease) which can cause abdominal pain, bloody diarrhoea, fever and weight loss
■ you have a bacterial infection of the small intestine and colon (caused by bacteria such as salmonella, shigella and campylobacter)
■ you have inflammation of the colon after taking antibiotics the symptoms of which may include watery or bloody diarrhoea
■ you have dysentery the symptoms of which may include blood in your stools and a high temperature
Warnings and precautions
Talk to your doctor before taking Loperamide
if:
■ you have or think you may have lost body fluids and salts through diarrhoea. Particularly important for children and frail or elderly patients with severe diarrhoea (see 'Replacing fluids and salts', section 3)
■ you have liver disease. You should consult your doctor or pharmacist before taking Loperamide as it may cause side effects
■ you are taking Loperamide to control episodes of diarrhoea associated with Irritable Bowel Syndrome. See your doctor if the pattern of your symptoms changes
■ you have inflammatory bowel disease (inflammation of the intestines), which can cause abdominal pain and bloody diarrhoea
■ you have a bloated tummy and you have AIDS. You should stop taking the capsules immediately and contact your doctor
Other medicines and Loperamide
Loperamide may interact with other medicines.
■ Other antidiarrhoea preparations, except for oral rehydration therapy (see "Replacing fluids and salts" in section 3)
Loperamide may cause serious side effects if
taken with the following:
■ Quinidine, for abnormal and increased heart rhythm
■ Digoxin, for heart failure
■ Ritonavir or Tipranavir, for HIV infection and AIDS
■ Itraconazole and ketoconazole, for fungal infections
■ Gemfibrozil, used to lower levels of cholesterol and other lipids (fats) in the blood.
Loperamide increases the blood levels of the
following:
■ Oral desmopressin, for reducing urine production (antidiuretic).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.
Pregnancy
It is not known if Loperamide is safe to take, especially during the first 3 months of pregnancy.
Breast-feeding
If you are breast-feeding, you should not take Loperamide, as small amounts of this medicine get into your breast milk.
Driving and using machines
This medicine may make you feel tired, dizzy or drowsy. If affected, you are advised not to drive or operate machinery.
Loperamide contains lactose
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
Loperamide contains colouring agent Sunset Yellow FCF (E110)
May cause allergic reactions.
How to take Loperamide
Always take this medicine exactly as described in this leaflet. Check with your doctor or pharmacist if you are not sure.
■ Loperamide is for oral use only
■ Swallow the capsules whole with some liquid
Adults and children over 12 years:
To treat sudden, short-lived (acute) attacks of diarrhoea.
■ Adults: 2 capsules (4mg) initially followed by 1 capsule (2mg) after each loose stool (bowel movement), for up to 5 days
continued.
Till-Asd-V.2s
■ The usual dosage is 3 to 4 capsules (6 - 8mg) a day
■ The maximum daily dose for adults is 8 capsules (16mg)
■ Children over 12 years: 1 capsule (2mg) initially followed by 1 capsule (2mg) after each loose stool (bowel movement), for up to 5 days
■ The usual dosage is 3 to 4 capsules (6 - 8mg) a day
■ The maximum daily dose for children is related to body weight (3 capsules per 20kg) but should not exceed 8 capsules (16mg) a day
Children under 12 years:
This medicine should not be given to children under 12 years of age.
Older people and patients with kidney problems
Same dose as for adults
Patients with liver problems
See 'Warnings and precautions' (section 2)
Do not take Loperamide for longer than 5 days.
If your symptoms do not improve within 24 hours, please contact your doctor.
Also see your doctor if your episodes of sudden, short lived (acute) attacks of diarrhoea continue for more than 2 weeks or you need continuous treatment for more than 2 weeks.
Replacing fluids and salts
When you have diarrhoea your body loses large amounts of fluid and salts. In addition to your medicine, you should take more liquids which contain sugar and salts, than normal.
■ Drink plenty of clear fluids containing salt and sugar (special oral rehydration powders are available from pharmacists), unsweetened fruits juices or clear soups
■ Avoid excessive plain water
■ Do not drink alcohol or milk
■ Do not eat fruit, green vegetables or fatty foods
■ Two or three days after symptoms have disappeared you may return to your normal diet
If you take more Loperamide than you should
If you accidentally take too many capsules, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining capsules with you.
Symptoms of an overdose include:
Constipation, difficulty passing urine, feeling bloated, stupor, difficulty co-ordinating movements, pupils of the eyes become smaller, increased muscle tension, difficulty sleeping, breathing problems or abnormally slow breathing.
If you forget to take Loperamide
Take it as soon as you remember unless it is nearly time for your next dose. If you miss a dose, do not take a double up a dose to make up for a forgotten dose.
Possible side effects
Like all medicines Loperamide can cause side
effects, although not everybody gets them.
Seek medical advice immediately if you
develop the following symptoms:
■ Allergic reactions such as swollen face, lips or eyelids and serious reactions such as passing out, difficulty breathing and dizziness
■ Bloated tummy and you have AIDS
■ Serious skin condition with severe blistering of the skin, mouth, nose, eyes, and genital area (Steven-Johnson's syndrome or toxic epidermal necrolysis)
■ Loss of consciousness
■ Reduced ability to respond to stimulation (stupor) or reduced consciousness
■ Blockage of the bowel
■ Enlargement of the large intestine, which may cause constipation, bloating and tenderness of the stomach or fever (megacolon or toxic
megacolon)
Common side effects (may affect up to 1 in 10 people)
■ Headache
■ Constipation
■ Feeling sick (nausea)
■ Stomach wind (flatulence)
Uncommon side effects (may affect up to 1 in
100 people)
■ Dizziness
■ Drowsiness
■ Stomach pain or discomfort
■ Dry mouth
■ Being sick (vomiting)
■ Indigestion
■ Rash
Rare side effects (may affect up to 1 in 1,000 people)
■ Abnormal increase in muscle tension
■ Difficulty co-ordinating movement
■ Pupils of the eyes become smaller
■ Painful or burning feeling of the tongue
■ Bloated tummy
■ Itchy rash (urticaria) or itching (pruritus)
■ Difficulty in urinating (passing water)
■ Tiredness
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the internet at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
51 How to store Loperamide
■ Keep this medicine out of the sight and reach of children.
■ Store this medicine in a dry, cool place (below 25°C) away from the light.
■ Do not use this medicine after the expiry date, which is stated on the carton/blister 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 you no longer use. These measures will help to protect the environment.
Contents of the pack and other information
What Loperamide Capsules contain:
Each 2mg capsules contains Loperamide Hydrochloride 2mg
The other ingredients are: lactose, maize starch, talc, magnesium stearate, gelatin, colouring agents sunset yellow FCF (E110), erythrosine (E127), patent blue (E131), indigotine (E132) and titanium dioxide (E171).
What Loperamide look like and the contents of the pack:
Loperamide capsules have a grey cap body colour and dark green cap hood colour.
Loperamide is available in:
Loperamide capsules are available in packs of 8, 10, 12, 18 or 30 capsules.
Not all pack sizes may be marketed.
Product Licence Number: PL 11311/0151
Marketing Authorisation Holder & Manufacturer
Tillomed Laboratories Ltd,
3 Howard Road,
Eaton Socon, St. Neots,
Cambridgeshire, PE19 8ET UK
Legal category: Pharmacy Medicine This leaflet was last revised in January 2016
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