Loperamide 2mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Loperamide hydrochloride

Available from:

Morningside Healthcare Ltd

ATC code:

A07DA03

INN (International Name):

Loperamide hydrochloride

Dosage:

2mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01040200; GTIN: 5055132712180

Patient Information leaflet

•
This medicine is used for two different
types of diarrhoea. They have
different age limits._ See Section 1._
•
Do not take this medicine:
o
There are some people who
should not use this medicine.
_To find out if you are one of then,_
_see section 2._
o
If you have ever had a bad reaction
to any of the ingredients. For the list
of ingredients, see Section 6.
•
Speak to your doctor:
o
If you suffer from any of the
conditions mentioned in Section 2.
o
If you are taking any other
medicines. See Section 2.
•
If you have Irritable Bowel
Syndrome (IBS)
_See also Section 2_ Extra warnings
for IBS patients.
•
Follow the dosage instructions
carefully.
See Section 3.
Always take this medicine exactly as
described in this leaflet or as your
doctor or pharmacist has told you.
Now read this whole leaflet carefully
before you use this medicine. Keep
the leaflet: you might need it again.
1.
WHAT LOPERAMIDE TABLETS
ARE FOR
Loperamide 2mg Tablets are used to
treat two types of diarrhoea. The
two types have different age limits.
Short-term diarrhoea
•
For adults and children aged 12 and
over.
•
To treat attacks that last up to
48 hours.
•
If your attack lasts longer than
48 hours, talk to your doctor.
IBS diarrhoea
•
For adults and young people
aged 18 and over who have been
diagnosed with IBS (Irritable Bowel
Syndrome).
•
To treat attacks that last up to
48 hours.
•
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.
The tablets contain_ loperamide_
_hydrochloride_, a substance that helps
reduce diarrhoea by slowing down
an overactive bowel. This allows
water and salts that are usually lost in
diarrhoea to be absorbed by the body.
2.
BEFORE YOU TAKE
LOPERAMIDE TABLETS
Warnings for everyone
This medicine is suitable for most people,
but a few people should not use it:
Do not take this medicine:
•
If you have ever had a bad reaction
to any of the ingredients.
•
If it is for a child aged under 12
(or under

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Loperamide 2mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2mg loperamide hydrochloride.
Excipients
with
known
effect:
each
tablet
contains
100mg
of
lactose
monohydrate.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Light green coloured capsule shaped, biconvex uncoated tablets, plain
on one side
and score line on other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide
into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic treatment of acute diarrhoea in adults and
children aged
12 years and over.
For the symptomatic treatment of acute episodes of diarrhoea
associated with
Irritable Bowel Syndrome in adults aged 18 years and over following
initial
diagnosis by a doctor.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
ACUTE DIARRHOEA
Adults and children over 12:
Two tablets (4 mg) initially, followed by one tablet (2 mg) after each
loose stool. The
usual dose is 3-4 tablets (6 mg – 8 mg) a day. The total daily dose
should not exceed
6 tablets (12 mg).
SYMPTOMATIC TREATMENT OF ACUTE EPISODES OF DIARRHOEA
ASSOCIATED WITH IRRITABLE BOWEL SYNDROME IN ADULTS
AGED 18 YEARS AND OVER
Two tablets (4 mg) to be taken initially, followed by 1 tablet (2 mg)
after every loose
stool, or as previously advised by your doctor. The maximum daily dose
should not
exceed 6 tablets (12 mg).
_Paediatric population_
Lopramide is contraindicated in children less than 12 years of age.
_Elderly_
No dose adjustment is required for the elderly.
_Renal impairment_
No dose adjustment is required for patients with renal impairment.
_ _
_Hepatic impairment_
Although no pharmacokinetic data are available in patients with
hepatic impairment,
Lopramide should be used with caution in such patients because of
reduced first pass
metabolism. (see 4.4 Special warnings and special precautions for
use).
Method of administration
Oral use. The tablets should be