Skip to Content

UK Edition. Click here for US version.

LOPERAMIDE 2 MG TABLETS

Active substance(s): LOPERAMIDE HYDROCHLORIDE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

Package leaflet: Information for the user
Loperamide 2 mg Tablets
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 has 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. See section 4.
- You must talk to a doctor if you do not feel better or if
you feel worse.
What is in this leaflet
1. What Loperamide Tablet is and it is used for
2. What you need to know before you use
Loperamide Tablets
3. How to use Loperamide Tablets
4. Possible side effects
5. How to store Loperamide Tablets
6. Contents of the pack and other information
1. What Loperamide Tablet is and it is used for
Loperamide hydrochloride is the active ingredient of
Loperamide Tablets. The tablets are available in one
strength.
Loperamide is one of a group of medicines called "antidiarrhoeals" which are used to treat diarrhoea.
Loperamide Tablets are used to treat sudden short-lived
(acute) attacks of diarrhoea in adults and children aged 12
years and over.
It can also be used to treat diarrhoea associated with Irritable
Bowel Syndrome (IBS) in adults aged 18 years and over
after your doctor has diagnosed you are suffering from this
condition.
The tablets help reduce diarrhoea by slowing down an
overactive bowel, which helps the body to absorb water and
salts from this organ, making the stools more solid and less
frequent.
2.

What you need to know before you use
Loperamide Tablets

21066311

PHARMACODE
AREA

21066311

Loperamide 2 mg
Tablets

PHARMACODE
AREA

21066311

Loperamide 2 mg
Tablets

Do not use Loperamide Tablets
- if you are allergic to loperamide hydrochloride or any of
the other ingredients of this medicine (listed in section 6)
- if you have severe diarrhoea after taking antibiotics
- if you are having a flare up of an inflammatory bowel
condition like ulcerative colitis
- if you are constipated or your stomach appears swollen
(particularly in children with severe dehydration)
- if you have acute dysentery, the symptoms of which may
include blood in your stools and a high temperature.
Do not give this medicine to a child under 12 years old.
Do not use this medicine if any of the above applies to
you. If you are not sure, talk to your doctor or pharmacist before taking Loperamide Tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking Loperamide
Tablets
- if you have AIDS and your stomach becomes swollen,
stop taking the tablets immediately and contact your doctor
- if you suffer from liver problems
- This medicine only treat the symptoms of diarrhoea. In
some cases, the cause of your diarrhoea may require
treatment, if symptoms persist or worsen, please contact
your doctor.

if you have severe diarrhoea as your body loses more
fluid, sugars and salts than normal.
- if you have diarrhoea that lasts for more than 48 hours.
If you are unsure about any of the medicines you are taking,
show the bottle or pack to your pharmacist.
Special warnings:
- Loperamide only treats the symptoms of diarrhoea.
When you have diarrhoea, your body can lose large
amounts of fluids and salts. You will need to replace
the fluid by drinking more liquid than usual. Ask your
pharmacist about special powders (known as oral
rehydration therapy) which replace fluids and salts lost
during diarrhoea. The prevention of fluid depletion
(dehydration) is of particular importance in infants,
children and frail and elderly people with acute diarrhoea.
- You can use Loperamide for diarrhoea associated with
IBS which has been diagnosed by your doctor. If your
symptoms change or you are concerned about anything
you should talk to your doctor.
- If your IBS related diarrhoea continues for longer than
2 weeks you should talk to your doctor.
Do not take this product for anything other than its intended
use (see section 1) and never take more than the
recommended amount (see section 3). 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 Loperamide.
Special warnings about use in Irritable Bowel Syndrome
(IBS)
If any of the following apply, do not use the product without
first consulting your doctor, even if you know you have IBS:
- if you are aged 40 or over and it is some time since your
last IBS attack.
- if you are aged 40 or over and your IBS symptoms are
different this time.
- if you have recently passed blood from the bowel
- if you suffer from severe constipation
- if you are feeling sick or vomiting
- if you have lost your appetite or lost weight
- if you have difficulty or pain passing urine
- if you have a fever
- if you have recently travelled abroad
- you can use this medicine for up to 2 weeks for
repeated attacks, but if any one attack lasts continuously
for longer than 48 hours, talk to your doctor.
Consult your doctor if you develop new symptoms, if
your symptoms worsen, or your symptoms have not
improved over two weeks.
Other medicines and Loperamide Tablets
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines, including
medicines obtained without a prescription.
In particular, tell your doctor or pharmacist if you are taking
any of the following:
- ritonavir (used to treat HIV)
- quinidine (used to treat abnormal heart rhythms or malaria)
- itraconazole, ketoconazole (used to treat fungal infections)
- gemfibrozil (used to reduce levels of cholesterol)
- oral desmopressin (used to treat excessive urination)
- other drugs that slow down or speed up movement in the
gut
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Do not take this medicine if you are breast-feeding as small
amounts may get into your milk. Talk to your doctor about
suitable treatment.
Driving and using machines
Do not drive if you feel dizzy, tired or sleepy after taking
this medicine. You may also lose consciousness, feel faint or
less alert. If affected do not drive or operate machinery.
-

Date: 27/11/2017

Loperamide Tablets 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 use Loperamide Tablets

Always take this medicine exactly as your doctor has told
you. You should check with your doctor or pharmacist if you
are not sure.
- Take this medicine by mouth.
- The score line is only there to help you break the tablet if
you have difficulty swallowing it whole.
- Do not take more than 8 tablets in any 24 hour period.
- This medicine should not be given to children under 12
years old. Other pharmaceutical forms/strengths (e.g.
syrup) are available for children aged 4 years and over.
Short-lived (acute) diarrhoea
Adults and children 12 years and over:
- Take two tablets initially, followed by one tablet
after each loose bowel movement.
- If symptoms persist for more than 24 hours, talk to your
doctor.
Diarrhoea associated with Irritable Bowel Syndrome
already diagnosed by a doctor
Adults aged 18 years and over:
- Take two tablets initially, followed if required, by
one tablet after every further loose bowel movement
depending on the severity of your symptoms, or as
advised previously by your doctor.
- If your symptoms change, or if your diarrhoea persists
for more than 2 weeks, talk to your doctor.
If you take more Loperamide Tablets than you should
If you have taken too many Loperamide tablets,
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
Loperamide than adults. If a child takes too much or shows
any of the above symptoms, call a doctor immediately.
If you forget to take Loperamide Tablets
- You should only take this medicine as required following
the dosage instructions above carefully.
- If you forget to take a dose, take a dose after the next loose
stool (bowel movement).
- Do not take a double dose to make up for a forgotten
dose.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4.

Possible side effects

21066311

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If you experience any of the following, stop using the
medicine and seek immediate medical help:
- Sudden swelling of the face lips, or throat, hives (also
known as nettle rash or urticaria), Severe irritation,
reddening or blistering of your the skin. These may be
signs of a severe allergic reaction
- Blistering of your skin, mouth, eyes or genitals
- Stomach pain or severe swollen stomach
- Severe constipation
- Loss of consciousness or reduced level of consciousness
(feeling faint)
Common side effects (may affect up to 1 in 10 people)
- Headache
- Feeling sick (nausea)
- Constipation
- Wind

Uncommon side effects (may affect up to 1 in 100 people)
- Feeling sleepy or drowsy
- Dry mouth
- Feeling dizzy
- Being sick (vomiting), indigestion (dyspepsia)
- Rash
- Abdominal pain or discomfort
Rare side effects (affects fewer than 1 in 1000 patients)
- Tiny pupils
- Itchy skin
- Difficulty passing water
- Feeling tired
- Problems with co-ordination
- Unusually stiff muscles causing poor control of
movement
- Burning, tingling mouth (glossodynia)
Some of the listed side effects may be due to the diarrhoea,
such as discomfort around the middle, feeling sick or being
sick, dry mouth, feeling tired, drowsy or dizzy and wind.
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 or
search for MHRA Yellow Card in the Google Play or Apple
App Store
By reporting side effects you can help provide more
information on the safety of this medicine
5.

How to store Loperamide Tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the label or carton after 'EXP'. The expiry date
refers to the last day of that month.
Store in the original package.
If the tablets become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you
what to do.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.
6.

Contents of the pack and other information

What Loperamide Tablets contains
The active substance is loperamide hydrochloride. Each
tablet contains 2 mg loperamide hydrochloride.
The other ingredients are maize starch, lactose
monohydrate, povidone (K-30), Brilliant Blue FCF
(E133), quinoine yellow (E104), magnesium stearate,
talc, colloidal anhydrous silica and sodium starch
glycolate and purified water.
What Loperamide Tablets looks like and contents of the
pack
Loperamide Tablets are light green coloured capsule shaped,
biconvex uncoated tablets with ‘2’debossed on one side and
scoreline on other side.
The score line is only to facilitate breaking for ease of
swallowing and not to divide into equal doses
Loperamide is presented in a blister pack of 6 tablets.
Marketing Authorisation Holder:
Cipla (EU) Limited,
Hillbrow House, Hillbrow Road, Esher, Surrey,
KT10 9NW, United Kingdom.
Manufacturer:
Cipla (EU) Limited,
4th Floor, 1 Kingdom Street, London, W2 6BY,
United Kingdom
This leaflet was last revised in 11/2017

Date: 27/11/2017

GSL

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide