IMODIUM PLUS 2/125 Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LOPERAMIDE HYDROCHLORIDE, DIMETICONE, ACTIVATED

Available from:

McNeil Healthcare (Ireland) Ltd

ATC code:

A07DA03

INN (International Name):

LOPERAMIDE HYDROCHLORIDE, DIMETICONE, ACTIVATED

Dosage:

2/125 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Antipropulsives

Authorization status:

Authorised

Authorization date:

2009-12-04

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you get any side effects, talk to your 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 2 days.
WHAT IS IN THIS LEAFLET
1.
What IMODIUM
®
Plus 2mg/125mg tablets are, and what they are used for.
2.
What you need to know before you take IMODIUM
®
Plus 2mg/125mg tablets.
3.
How to take IMODIUM
®
Plus 2mg/125mg tablets.
4.
Possible side effects.
5.
How to store IMODIUM
®
Plus 2mg/125mg tablets.
6.
Contents of the pack and other information.
1. WHAT IMODIUM
® PLUS 2MG/125MG TABLETS ARE, AND WHAT THEY ARE USED FOR
The tablets contain two active ingredients:
• Loperamide hydrochloride, which helps reduce diarrhoea by slowing
down an overactive bowel.
It also helps the body to absorb more water and salts from the bowel.
• Simeticone, which breaks up the gas bubbles in the bowel that
causes cramps and bloating.
IMODIUM
®
Plus 2mg/125mg tablets are used to treat a short lived attack of
diarrhoea when it
occurs with stomach cramps, bloating and wind.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IMODIUM
® PLUS 2MG/125MG TABLETS
DO NOT TAKE IMODIUM
® PLUS 2MG/125MG TABLETS:
• In children less than 12 years old.
• If you are allergic (hypersensitive) to loperamide hydrochloride,
simeticone or any of the other
ingredients of the tablets (see section 6).
• If you have a high temperature (e.g. above 38° C) or blood in
your stools.
• If you are having a flare up of an inflammatory bowel condition
like ulcerative colitis.
• If you have severe diarrhoea after taking antibiotics.
• If you are constipated or

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imodium Plus 2mg/125mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains loperamide hydrochloride 2 mg and simeticone
equivalent to 125 mg dimeticone.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet, uncoated.
White, capsule
-
shaped tablets debossed with “IMO” on one side, the other side is
debossed with a line between “2”and
“125”.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Imodium Plus 2mg/125mg Tablets are indicated for the symptomatic
treatment of acute diarrhoea in adults and
adolescents over 12 years when acute diarrhoea is associated with
gas-related abdominal discomfort including bloating,
cramping or flatulence.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults over 18 years_
Take two tablets initially, followed by one tablet after every loose
stool. Not more than 4 tablets should be taken in a
day, limited to no more than 2 days.
_Adolescents between 12 and 18 years_
Take one tablet initially, followed by one tablet after every loose
stool. Not more than 4 tablets should be taken in a
day, limited to no more than 2 days.
_Paediatric population_
Imodium Plus is contraindicated in children under 12 years (see
section 4.3).
_Use in the elderly_
No dosage adjustments are required for the elderly.
_Use in renal impairment_
No dosage adjustment is necessary in patients with renal impairment.
_Use in hepatic impairment_
Although no pharmacokinetic data are available in patients with
hepatic insufficiency, Imodium Plus should be used
with caution in such patients because of reduced first pass metabolism
(see section 4.4).
Method of administration
Swallow the correct number of tablets whole with a drink of water.
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