IMODIUM INSTANTS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LOPERAMIDE HYDROCHLORIDE

Available from:

Imbat Limited

ATC code:

A07DA03

INN (International Name):

LOPERAMIDE HYDROCHLORIDE

Dosage:

2 Milligram

Pharmaceutical form:

Orodispersible Tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

loperamide

Authorization status:

Authorised

Authorization date:

2014-08-01

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
IMODIUM
® INSTANTS
2MG ORODISPERSIBLE TABLETS
(loperamide hydrochloride)
Your medicine is available using the name Imodium Instants 2mg
Orodispersible Tablets but will be referred to as Imodium Instants
throughout this leaflet.

This medicine is used to treat sudden short-lived (acute)
attacks of diarrhoea in adults and children aged 12 years
and over.

DO NOT TAKE THIS MEDICINE:

There are some people who should not use this
medicine.
_To find out if you are one of them see Section 2 _
_►_

If you are allergic to loperamide or any of the other
ingredients of this medicine.
_For the list of ingredients see Section 6_
_►_

SPEAK TO YOUR DOCTOR:

If you suffer from any of the conditions mentioned in
_Section 2 _
_►_

If you are taking any OTHER MEDICINES.
_See Section 2_
_►_

FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY.
These are shown in the dosage table. _See Section 3_
_►_
NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU USE
THIS MEDICINE.
Keep the leaflet: you might need it again.
1.
WHAT THE MEDICINE IS FOR
Imodium Instants 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 tablets contain loperamide
hydrochloride which helps reduce diarrhoea by slowing down an
overactive bowel, which helps the body to absorb water and salts
from the bowel. Imodium Instants should be used in conjunction
with oral rehydration therapy which replace fluids and salts lost
during diarrhoea.
2.
BEFORE TAKING THIS MEDICINE
This medicine is suitable for most people, but a few people should
not use it. If you are in any doubt, talk to your doctor or
pharmacist.
DO NOT TAKE THIS MEDICINE…

If you are allergic to loperamide or any of the other
ingredients of this medicine (listed in section 6).

If it is for a child UNDER 12 YEARS OLD.

If you have SEVERE DIARRHOEA after taking antibiotics.

If you are having a flare up of an INFLAMMATORY BOWEL
condition l

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imodium Instants 2mg Orodispersible Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2mg loperamide hydrochloride.
Excipient: aspartame (E951), mannitol (E421)
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Orodispersible tablet.
_Product imported from the UK:_
Imodium Instants are white to off-white, circular, freeze-dried
tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an adjunct in the management of diarrhoea together with fluid and
electrolyte replacement.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The orodispersible tablet should be placed on the tongue. The tablet
will dissolve and is to be swallowed with saliva.
No liquid intake is needed for the orodispersible tablet.
Adults and children over 12 years only
The usual dose is 2 tablets initially, followed by 1 tablet after each
further episode of diarrhoea up to a maximum of 5
in 24 hours.
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 Instants should be used
with caution in such patients because of reduced first pass metabolism
(see 4.4 Special warnings and precautions for
use).
Method of administration
Oral.
4.3 CONTRAINDICATIONS
o
Imodium use is contraindicated in patients under 12 years of age.
o
Imodium Instants are contraindicated in patients with a known
hypersensitivity to loperamide hydrochloride or to
any of the excipients.
o
Imodium should not be used as the primary therapy:
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