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LOPERAMIDE 2 MG TABLETS

Active substance(s): LOPERAMIDE HYDROCHLORIDE

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Read all of this leaflet carefully because it contains
important information for you.
This medicine is available without prescription. However, you
still need to use Loperamide Tablets carefully to get the best
results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or
advice.
- You must contact a doctor if your symptoms worsen or
do not improve after 24 hours in case of acute diarrhoea
and 14 days in case of diarrhoea associated with Irritable
Bowel Syndrome (IBS).
- If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Loperamide Tablets are and what they are used for
2. Before you take Loperamide
3. How to take Loperamide
4. Possible side effects
5. How to store Loperamide
6. Further information.

1. WHAT LOPERAMIDE TABLETS ARE AND
WHAT THEY ARE USED FOR
The name of your medicine is Loperamide 2 mg Tablets. In
the rest of this leaflet your medicine is called Loperamide.
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 2 mg 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.

BEFORE YOU TAKE LOPERAMIDE

3.

Always take Loperamide 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.
- Swallow the correct number of tablets whole with a drink
of water.
- Do not take more than 8 tablets in any 24 hour period.
- This medicine is not recommended for children under
12 years old. Other pharmaceutical forms/strengths (e.g.
syrup) are available for children aged 4 years and over.

PHARMACODE
AREA

Loperamide 2 mg
Tablets

Loperamide 2 mg
Tablets

PHARMACODE
AREA

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POSSIBLE SIDE EFFECTS

Like all medicines, Loperamide 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:
Very rarely: (less than 1 in 10,000 people are affected)
- 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.
If you experience any of the following, stop using the
medicine and talk to your doctor:
Very rarely: (less than 1 in 10,000 people are affected)
- Itchiness or hives.
- Difficulties passing water.
- Stomach pain or swollen stomach.
- Severe constipation.
Other effects which may occur include:
Very rarely: (less than 1 in 10,000 people are affected)
- Dizziness or drowsiness.
- Feeling sick, vomiting, indigestion, constipation or wind.
Other effects reported include:
- Tiredness.
- Dry mouth.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your
doctor or pharmacist.

HOW TO TAKE LOPERAMIDE

XXXXX

DO NOT TAKE Loperamide
- if you are allergic (hypersensitive) to loperamide
hydrochloride or any other ingredient of Loperamide
- if it is for a child under 12 years old
- 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 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.

4.

5.

HOW TO STORE LOPERAMIDE

Keep out of the reach and sight of children.
Do not use Loperamide after the expiry date which is stated
on the label or carton. 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.
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.

FURTHER INFORMATION

What Loperamide 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 looks like and contents of the pack
Loperamide 2 mg Tablets are light green coloured capsule
shaped, biconvex uncoated tablets with Â2Êdebossed 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 8, 12 or
18 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Cipla (EU) Limited, Hillbrow House,
Hillbrow Road, Esher, Surrey, KT10 9NW.
Manufacturer:
APC Pharmaceuticals & Chemicals (Europe) Limited,
9th floor, CP House,
97-107 Uxbridge Road, Ealing,
London W5 5TL
Distributed By:
APC Pharmaceuticals & Chemicals (Europe) Limited,
9th Floor, CP House,
97-107 Uxbridge Road, Ealing,
London W5 5TL
This leaflet was last revised in November 2012.

Cipla Inventory Code

(Loperamide hydrochloride)

Short-lived (acute) diarrhoea
Adults and children 12 years and over:
- Swallow two tablets initially, followed by one tablet
after each loose bowel movement.
- Do not take more than 8 tablets in any 24 hour period.
- 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:
- Swallow two tablets initially. Further loose bowel
movements may be controlled by taking one or two
tablets depending on the severity of your symptoms.
- Do not take more than 8 tablets in any 24 hour period.
- If your symptoms change, or if your diarrhoea persists
for more than 2 weeks, talk to your doctor.
If you take more Loperamide than you should
If you or anyone else takes too many Loperamide tablets,
contact your doctor or go to the nearest accident and
emergency department (casualty) straight away taking this
leaflet with you.
If you forget to take Loperamide
- 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 product,
ask your doctor or pharmacist.

XXXXX

Loperamide 2 mg Tablets

Take special care with Loperamide
If any of the following points apply to you now or in the
past, talk to a doctor or pharmacist:
- if you have AIDS and your stomach becomes swollen,
stop taking the tablets immediately and contact your doctor
- if you suffer from liver problems
- if your diarrhoea lasts for more than 24 hours (or 2
weeks if your diarrhoea is related to IBS)
- if you have severe diarrhoea as your body loses more
fluid, sugars and salts than normal.
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.
Taking other medicines
Please tell your doctor if you are taking or have recently
taken any other medicines, including medicines obtained
without a prescription.
In particular, tell your doctor or pharmacist if you are
takingany of the following:
- ritonavir (used to treat HIV)
- quinidine (used to treat abnormal heart rhythms or malaria)
- oral desmopressin (used to treat excessive urination)
- any other antidiarrhoeal preparations (except for oral
rehydration therapy)
Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine if
you are pregnant, think you might be pregnant or are
planning to become pregnant.
Do not take Loperamide 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
Loperamide. You may also lose consciousness, feel faint or
less alert. If affected do not drive or operate machinery.
Important information about some of the ingredients of
Loperamide
This medicine 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.

Cipla Inventory Code

PACKAGE LEAFLET: INFORMATION FOR THE USER

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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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