Imodium Plus 2 mg/125 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Loperamide hydrochloride; Simeticone

Available from:

Johnson & Johnson (Ireland) Limited

ATC code:

A07DA; A07DA53

INN (International Name):

Loperamide hydrochloride; Simeticone

Dosage:

2 mg/125 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Antipropulsives; loperamide, combinations

Authorization status:

Marketed

Authorization date:

2007-04-20

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 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 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 afte

Summary of Product characteristics

Health Products Regulatory Authority
12 April 2023
CRN00CPN7
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imodium Plus 2 mg/125 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains loperamide hydrochloride 2 mg and simeticone
equivalent to 125 mg dimeticone.
_Excipient(s) with known effect_
Each tablet contains less than 0.026 mg of benzyl alcohol and less
than 4.4 mg of maltodextrin (which contains glucose).
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_"_.
The score line is not intended for breaking the tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Imodium Plus 2 mg/125 mg 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).
Health Products Regulatory Authority
12 April 2023
CRN00CPN7
Page 2 o