IMODIUM PLUS 2MG/125MG CHEWABLE TABLETS 2 mg/125mg Milligram Tablets Chewable

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LOPERAMIDE HYDROCHLORIDE DIMETICONE

Available from:

McNeil Healthcare (Ireland) Ltd

INN (International Name):

LOPERAMIDE HYDROCHLORIDE DIMETICONE

Dosage:

2 mg/125mg Milligram

Pharmaceutical form:

Tablets Chewable

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

TOP
PLEASE R
EAD ALL OF THIS LEAFLET CAR
EFULLY BECAUSE IT CONTAINS IMPOR
TANT 
INF
ORMATION F
OR Y
OU.

This medicine is a
vailable without pr
escription.
 Ho
w
ev
er
, y
ou still need 
to tak
e Imodium Plus Che
w
able tablets car
efully to get the best r
esults
.
■
 K
eep this leaflet.
 You ma
y need to r
ead it again.
■
 Ask y
our pharmacist if y
ou need mor
e inf
ormation or advice
.
■
 Y
ou must contact a doctor if y
our s
ymptoms w
orsen or do not impr
ov
e 
after tw
o da
ys
.
■
 If an
y of the side-e
ffects get serious
, or if y
ou notice an
y side-e
ffects not 
listed in this leaflet, please tell y
our doctor or pharmacist.
IN THIS LEAFLET:
1.
What Imodium Plus Che
w
able 
Tablets ar
e, and what the
y ar
e used f
or
2.
Be
for
e y
ou use Imodium Plus Che
w
able 
Tablets
3.
Ho
w to tak
e Imodium Plus Che
w
able 
Tablets
4.
Possible side e
ffects
5.
Ho
w to stor
e Imodium Plus Che
w
able 
Tablets
6.
Fur
ther inf
ormation
1
  WHAT THE MEDICINE IS F
OR
The tablets ar
e used to tr
eat a shor
t-liv
ed attack of diarrhoea when it 
occurs with stomach cr
amps
, bloating and wind.
The tablets contain tw
o activ
e ingr
edients:

■
 L
oper
amide h
ydr
ochloride which helps r
educe diarrhoea b
y slo
wing do
wn 
an o
ver
activ
e bo
w
el.
 It also helps the body to absorb mor
e w
ater and 
salts fr
om the bo
w
el.

■
 Simeticone
, which br
eak
s up the gas bubbles in the bo
w
el that causes 
cr
amps and bloating.
2
  BE
FOR
E TAKING THIS MEDICINE
This medicine is suitable f
or most adults and childr
en aged 12 y
ears and 
ov
er
, but a f
ew people should not use it.
 If y
ou ar
e in an
y doubt, talk to y
our 
doctor or pharmacist.

DO NOT TAK
E THIS MEDICINE…
■
 If the patient is a child less 
THAN 12 Y
EARS OLD
.
■
  If y
ou ar
e 
ALLER
GIC
 (h
ypersensitiv
e) to loper
amide h
ydr
ochloride
, 
simeticone or an
y of the other ingr
edients of the tablets (see 
section 6).
■
  If y
ou ha
ve a 
HIGH TEMPER
ATUR
E (e
.g.
 abo
ve 38° C) or 
BLOOD IN Y
O

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imodium Plus 2mg/125mg Chewable Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains loperamide hydrochloride 2 mg and simeticone equivalent to 125 mg dimeticone.
Excipients: include 300 mg sorbitol (E420) and approximately 50 mg sucrose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet.
Whhite, round, flat-faced tablets wiht a vanilla-mint odour debossed with "IMO" on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Imodium Plus is 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
Adults over 18 years:
Chew 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:
Chew 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.
Use in children:
Imodium Plus must not be used in children under 12 years.
Use in the elderly:
No dosage adjustments are required for the elderly.
Renal impairment:
No dosage adjustment is necessary in renal impairment.
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 4.4 Special warnings and special
precautions for use).
IRISH MEDICINES BOARD
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