Loperamide 2mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Loperamide hydrochloride

Available from:

Alliance Healthcare (Distribution) 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

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LOPERAMIDE HYDROCHLORIDE 2MG TABLETS
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 after 48 hours (short term
diarrhoea) or 14 days (irritable bowel syndrome)
WHAT IS IN THIS LEAFLET
1.
What Loperamide Hydrochloride 2mg Tablets is and what it is used for
2.
What you need to know before you take Loperamide Hydrochloride 2mg
Tablets
3.
How to take Loperamide Hydrochloride 2mg Tablets
4.
Possible side effects
5.
How to store Loperamide Hydrochloride 2mg Tablets
6.
Contents of the pack and other information
1.
WHAT LOPERAMIDE HYDROCHLORIDE 2MG TABLETS IS AND WHAT IT IS USED FOR
These tablets contain Loperamide Hydrochloride a substance which helps
reduce diarrhoea (loose
bowels), by slowing down the movements of your intestine to prevent
loose bowels. This allows water
and salts that are usually lost in diarrhoea to be absorbed by the
body.
Loperamide Hydrochloride 2mg Tablets can be used to treat two types of
diarrhoea with different age
limits:
The tablets can be used to relieve short term sudden attacks of
diarrhoea in adults and children aged 12
years and over. To treat attacks that last up to 48 hours. If the
condition does not get better within 48
hours, please speak to your doctor or pharmacist.
These tablets can also be used by adults of 18 years and over who have
irritable bowel syndrome (IBS)
diarrhoea, which has been previously diagnosed by a doctor, to Treat
attacks that last up to 48 hours.
This medicine can be used for up to 2 weeks for repea

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: 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
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 taken with liquid.
4.3
CONTRAINDICATIONS
Loperamide 2mg Tablets are co