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LOPERAMIDE HYDROCHLORIDE 2 MG HARD CAPSULES

Active substance(s): LOPERAMIDE HYDROCHLORIDE

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Package leaflet: Information for the user

DIAQUITTE CAPSULES
(loperamide hydrochloride)

Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet.
You must talk to a doctor if you do not feel better or if you feel worse after 24 hours.

What is in this leaflet
1.
What DiaQuitte is and what it is used for
2.
What you need to know before you take DiaQuitte
3.
How to take DiaQuitte
4.
Possible side effects
5.
How to store DiaQuitte
6.
Contents of the pack and other information

1.

What DiaQuitte is and what it is used for

DiaQuitte 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.
DiaQuitte are used to treat sudden, short lived (acute) attacks of diarrhoea in adults and children over 12
years of age

2.

What you need to know before you take DiaQuitte

Do not take DiaQuitte:
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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 12
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

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Warnings and precautions:
Talk to your doctor or pharmacist before taking DiaQuitte:
! 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
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 there is no improvement in your diarrhoea within 24 hours, or you have a fever or your stool contain
blood, stop taking DiaQuitte and consult your doctor. Prolonged diarrhoea may be a symptom of a more
serious illness and you should not take DiaQuitte for a long period of time unless your doctor has
investigated the cause of your diarrhoea and has then prescribed DiaQuitte to be taken for a prolonged
period of time
Other medicines and DiaQuitte
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.
DiaQuitte 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 DiaQuitte.
DiaQuitte 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 DiaQuitte

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
Check with your doctor or pharmacist if you are not sure.
The dose of DiaQuitte that you will need will depend on whether your diarrhoea is a sudden, short-lived
attack (acute) or a long-lasting condition (chronic).

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Swallow the capsule whole (do not chew) with some liquid. It is important to drink more fluids than you
normally would during treatment with DiaQuitte to replace the fluids and salts lost because of the diarrhoea.
The recommended dose is:
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 6 capsules in one day (24 hours).
If there is no improvement within 24 hours of starting treatment, further investigation of the cause of the
diarrhoea should be considered.
Children (under age of 12)
DiaQuitte is not recommended
Patients with liver problems
Your doctor will advise you.
If you take more DiaQuitte 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 DiaQuitte
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 DiaQuitte
You should take DiaQuitte 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, DiaQuitte can cause side effects, although not everybody gets them.
If any of the following happen, stop taking DiaQuitte 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
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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 DiaQuitte

Keep out of the sight and reach of children.
Do not store above 250C.
Do not use DiaQuitte 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 DiaQuitte contains
The active substance is loperamide hydrochloride
Each capsule contains:
Lactose Monohydrate
Maize Starch
Magnesium Stearate
The capsule cap contains:
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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 DiaQuitte looks like and contents of the pack
Your medicine comes as a hard mauve and green capsule marked “LOPERA-MIDE 2”.
DiaQuitte is available in blisters or plastic bottles of 4 or 6 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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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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