IMODIUM LIQUIRELIEF 2 Milligram Capsules, Soft

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

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PIL PIL (PIL)
21-07-2017
SPC SPC (SPC)
21-07-2017

active_ingredient:

LOPERAMIDE HYDROCHLORIDE

MAH:

McNeil Healthcare (Ireland) Ltd

ATC_code:

A07DA03

INN:

LOPERAMIDE HYDROCHLORIDE

dosage:

2 Milligram

pharmaceutical_form:

Capsules, Soft

prescription_type:

Product not subject to medical prescription

therapeutic_area:

Antipropulsives

authorization_status:

Authorised

authorization_date:

2011-04-01

PIL

                                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.
n
This medicine is used to treat the sudden short-lived (acute) attacks
of
diarrhoea in adults and children aged 12 years and over.
n
Do not take this medicine:
n
There are some people who should not use this medicine. To find out if
you are one of them. _See Section 2_
n
I f you have ever had a bad reaction to any of the ingredients. For
the
list of ingredients. _See Section 6_
n
Speak to your doctor:
n
If you suffer from any of the conditions mentioned in _Section 2_
n
If you are taking any other medicines. See _Section 2_
n
Follow the dosage instructions carefully. These are shown in the
dosage tables. _See Section 3_
Now read this whole leaflet carefully before you use this medicine.
n
Keep this leaflet. You may need to read it again.
n
Ask your pharmacist if you need more information or advice.
n
If you get any side effects, talk to your pharmacist. This includes
any
possible side effects not listed in this leaflet. _See Section 4_
n
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 IMODIUM
®
LiquiRelief Capsules are, and what they are used for.
2. What you need to know before you take IMODIUM
®
LiquiRelief Capsules.
3. How to take IMODIUM
®
LiquiRelief Capsules.
4. Possible side effects.
5. How to store IMODIUM
®
LiquiRelief Capsules.
6. Contents of the pack and other information.
1 What IMODIUM
®
LiquiRelief Capsules are and
what they are used for
IMODIUM
®
LiquiRelief Capsules is a medicine which is used to treat sudden
short-lived (acute) attacks of diarrhoea in adults and children aged
12 years
and over. The capsules contain loperamide hydrochloride which helps
reduce diarrhoea by slowing down an overactive bowel to its normal
rhythm,
which helps the body to absorb water and salts from the bowel.
2 
                                
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SPC

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imodium LiquiRelief 2mg Soft Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 2 mg Loperamide hydrochloride.
Contains trace amounts of soya lecithin.
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Capsule, soft (Capsules)
A clear blue size 2, oval soft gelatin capsule
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic treatment of acute diarrhoea in adults and
children aged 12 years and over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ACUTE DIARRHOEA
Adults and children aged 12 years and over:
2 capsules initially followed by 1 capsule after every loose stool.
The capsules should be taken with water.
The maximum daily dose should not exceed 5 capsules.
USE IN 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, Imodium LiquiRelief 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.
4.3 CONTRAINDICATIONS
Imodium LiquiRelief must not be used in:
Children less than 12 years of age
Patients with a known hypersensitivity (allergy) to any component of
the product
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