Imodium Plus 2mg/125mg Tablets

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Dimethicone; Loperamide Hydrochloride

MAH:

Imbat Limited

ATC_code:

A07DA; A07DA03

INN:

Dimethicone; Loperamide Hydrochloride

dosage:

2 mg/125 milligram(s)

pharmaceutical_form:

Tablet

prescription_type:

Product not subject to medical prescription

therapeutic_area:

Antipropulsives; loperamide

authorization_status:

Authorised

authorization_date:

2009-07-24

PIL

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
IMODIUM
® PLUS 2MG/125MG TABLETS
(loperamide hydrochloride/simeticone)
Your medicine is imported from the UK under the name of
‘Imodium plus caplets’ but is marketed as ‘Imodium Plus
2mg/125mg Tablets’ in Ireland.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Your medicine is available using the above name, but will be
referred to as ‘Imodium Plus’ throughout this leaflet.
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 is, and what it is used for.
2.
What you need to know before you take Imodium Plus.
3.
How to take Imodium Plus.
4.
Possible side effects.
5.
How to store Imodium Plus.
6.
Contents of the pack and other information.
1.
WHAT IMODIUM PLUS IS, AND WHAT IT IS 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 is used in adults and adolescents aged 12 years
and above, 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
DO NOT TAKE IMODIUM PLUS:

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 temperatur

SPC

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 2mg and simeticone
equivalent to 125mg dimeticone.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet, uncoated
_Product imported from the United Kingdom_
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
As per PA0330/050/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0330/050/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Calcium hydrogen phosphate anhydrous
Microcrystalline cellulose
Acesulfame potassium
Artificial vanilla flavour (includes propylene glycol, maltodextrin
and benzyl alcohol)
Sodium starch glycolate (Type A)
Stearic acid.
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
blister strips and outer carton of the product as
marketed in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
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6.5 NATURE AND CONTENTS OF CONTAINER
Overlabelled outer cardboard carton containing blister strips
Pack size:12
6.6 SPECIAL PRECA