IMODIUM INSTANTS 2mg Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LOPERAMIDE HYDROCHLORIDE

Available from:

McNeil Healthcare (Ireland) Ltd

ATC code:

A07DA03

INN (International Name):

LOPERAMIDE HYDROCHLORIDE

Dosage:

2mg Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Antipropulsives

Authorization status:

Authorised

Authorization date:

2009-06-25

Patient Information leaflet

Orodispersible
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AW_117787.pdf - Page 1 of 3 - April 6, 2017 - 07:14:14
_Instants _
2mg
T
ablets
_Loperamide _
_Hydrochloride_
■
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
su
ff
er
from any of the conditions mentioned in _Section 2 _
▶
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 like ULCERATIVE COLITIS
.
■
If you are CONSTIPATED or your STOMACH APPEARS SWOLLEN
(particularly in children with severe dehydration).
■
If you have ACUTE DYSENTERY, the symptoms of which may
include BLOOD IN YOUR STOOLS and a HIGH TEMPERATURE
.
■
If
you
have
had a BACTERIAL INFECTION of the
small intestine
or colon.
■
If you have a BLOCKAGE OF THE BOWEL, including a blockage
due to paralysis of the bowel wall.
■
If you have an ENLARGEMENT OF THE COLON, particularly if
this enlargement is very rapid.
If any of these apply to you, GET ADVICE FROM A DOCTOR OR
®
If you are unsure about any of the medicines you are taking,
show the bottle or pack to your pharmacist.
If any of these bullet points apply to you now or in the past,
TALK TO A DOCTOR OR PHARMACIST.
IF YOU ARE PREGNANT OR BREAST-FEEDING
■
Ask your doctor or pharmacist for advice before taking this
medicine if you are pregnant, think you are pregnant or
planning to become pregnant.
■
Do not take this medicine if you are breast-feeding as small
amounts may get into your
milk.
Talk to your d

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imodium Instants 2 mg Orodispersible Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Loperamide hydrochloride 2 mg per tablet.
Excipients:
Each tablet contains 750 micrograms of Aspartame (E951) and the Mint
flavouring contains traces of Sulphites.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Orodispersible tablet.
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.
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