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DIOCALM ULTRA CAPSULES

Active substance(s): LOPERAMIDE HYDROCHLORIDE / LOPERAMIDE HYDROCHLORIDE

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Reckitt Benckiser

0004 PL 17905 0049 SmPC Update

Diocalm ULTRA CAPSULES
Loperamide Hydrochloride 2mg
PATIENT INFORMATION LEAFLET
Please read this leaflet carefully before using Diocalm Ultra Capsules.
• Keep this leaflet, you may wish to read it again.
• Ask your pharmacist if you need more information or advice.
What are these capsules used for?
Diocalm Ultra Capsules are used to treat the symptoms of acute (sudden, short-term)
diarrhoea in adults and children aged 12 years and over.
Loperamide hydrochloride reduces the movement of the gut and stomach.
Before taking these capsules
Do not take…
• If you are allergic to any of the ingredients in this product.
See 'What these capsules contain' for the full list of ingredients.
• If you have constipation (reduced frequency of bowel movements),
diverticular disease (inflamed intestine) or ulcerative colitis (inflammatory
bowel disease) - if in doubt consult your doctor.
• If you suffer from irritable bowel syndrome.
• If you have acute dysentery (a disease caused by eating and drinking
contaminated food and water), the symptoms of which may include blood
in your stools and high temperature
• 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.
Do not take this product for anything other than its intended use (see “what are the
capsules used for”) and never take more than the recommended amount (see “how to take
these capsules”). 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 Diocalm Ultra Capsules.
Take special care…
• If you have impaired liver function (liver problems).
• If you are pregnant or breastfeeding, speak to your doctor before using this product.
• This medicine is for the relief of the symptoms of diarrhoea and is not
a substitute for oral rehydration therapy. It is important to replace body
fluids and salts lost during diarrhoea, particularly if you are frail or elderly.
• If you have AIDS and your stomach becomes swollen, stop taking the
capsules immediately and contact your doctor.
• If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.
• Speak to your pharmacist or doctor

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If your diarrhoea lasts for more than 24 hours.
If you are taking other medicines including oral desmopressin (used to treat
excessive urination), itraconazole (to treat fungal infections), gemfibrozil (to
control levels of cholesterol) or co-trimoxazole (an antibiotic).
If you are taking treatment for any condition affecting your stomach.
• When driving or using machines as this medicine may make you feel tired or drowsy.
How to take these capsules
Swallow the capsules whole with water.
Adults and children 12 years and over:
• Two capsules initially, followed by one capsule after each further bout
of diarrhoea up to a maximum of 6 capsules in any 24 hours.
Children under 12 years:
• Not to be given to children under 12 years.
Do not take more medicine than the label tells you to.
Speak to your doctor if symptoms persist for more than 24 hours.
If you take too many of the capsules…
If you have taken too many Diocalm Ultra 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 Diocalm Ultra Capsules than adults. If a
child takes too much or shows any of the above symptoms, call a doctor immediately.
Possible side effects
As with all medicines these capsules can have side effects in some people.
If you experience any of the following, stop using the medicine and seek immediate
medical help:
Rare: (affects less than 1 in 1000 but 1 or more in 10000 people)
• Allergic reactions including unexplained wheezing, shortness of breath, passing out
or swelling of face and throat.
• Skin rashes which may be severe and include blistering or peeling of the skin.
• Loss of consciousness or reduced level of consciousness (feeling faint or less alert),
uncoordinated movements.
If you experience any of the following, stop using the medicine and talk to your doctor:
Common: (affects less than 1 in 10 but 1 or more in 100 people)
• Headache, constipation, nausea and flatulence
Uncommon: (affects less than 1 in 100 but 1 or more in 1000 people)
• Dizziness, vomiting, abdominal pain or discomfort, dry mouth, rash.
Rare: (affects less than 1 in 1000 but 1 or more in 10000 people)
• Abdominal distension
• Somnolence (drowsiness), indigestion, swollen stomach, tiredness
• Difficulties passing water
• Itchiness or hives, burning or prickling sensation of the tongue
• Miosis (narrowing of the pupils of the eye).

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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 these capsules
• Keep out of the sight and reach of children.
• Do not use after the expiry date shown on the carton.
• If you find that you still have this medicine after its expiry date, return it
to your local pharmacist who will dispose of it properly.
What these capsules contain
Diocalm Ultra Capsules contain 2mg per capsule of the active ingredient loperamide
hydrochloride.
They also contain lactose (DMV), maize starch (dried), microcrystalline cellulose (Avicel
PH101), pregelatinised starch (dried), croscarmellose sodium and dimeticone. The shell cap
contains yellow iron oxide (E172), black iron oxide (E172), indigo carmine (E132), titanium
dioxide (E171) and gelatin. The shell body contains titanium dioxide (E171) and gelatin. The
capsules come in cartons containing 6 blister packed capsules
for oral use.
MA Holder: SSL International PLC, 103-105 Bath Road, Slough, SL1 3UH, UK.
Manufactured by: Wrafton Laboratories Ltd, Braunton, North Devon,
EX33 2DL, UK.
Date of revision: June 2017.
Diocalm is a trade mark of the RB Group.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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