Imodium Instants 2 mg Orodispersible Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Loperamide hydrochloride

Available from:

IMED Healthcare Ltd.

ATC code:

A07DA; A07DA03

INN (International Name):

Loperamide hydrochloride

Pharmaceutical form:

Orodispersible tablet

Therapeutic area:

Antipropulsives; loperamide

Authorization date:

2023-07-07

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IMODIUM
® INSTANTS 2 MG ORODISPERSIBLE TABLETS
loperamide hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor, pharmacist or nurse has told you.

This medicine is available without prescription and is used to treat
sudden short-lived (acute) attacks of diarrhoea in adults and
children aged 12 years and over.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
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 24 hours.
WHAT IS IN THIS LEAFLET
1.
What IMODIUM
®
Instants is and what it is used for
2.
What you need to know before you take IMODIUM
®
Instants
3.
How to take IMODIUM
®
Instants
4.
Possible side effects
5.
How to store IMODIUM
®
Instants
6.
Contents of the pack and other information
1.
WHAT IMODIUM
®
INSTANTS IS AND WHAT IT IS USED 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.
You must talk to a doctor if you do not feel better or if you feel
worse
after 24 hours in case of acute diarrhoea.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE IMODIUM
®
INSTANTS
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 IMODIUM
® INSTANTS…

If you are allergic to loperamide or an

Summary of Product characteristics

Health Products Regulatory Authority
07 July 2023
CRN00DFR7
Page 1 of 2
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.
Excipient with known effect – Each tablet contains Aspartame (E951)
and it contains Mint flavour which contains benzyl alcohol.
The Mint flavouring contains traces of Sulphites. The Mint flavouring
also contains glucose.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Orodispersible tablet.
_Product imported from Poland:_
White to off-white, circular, freeze-dried tablets.
4 CLINICAL PARTICULARS
As per PA0330/045/001
Product imported from Poland _contains glucose:_
This medicinal product contains glucose which is a component of
maltodextrin contained in the composition mint flavour.
Patients with glucose-galactose malabsorption should not take this
medicinal product.
5 PHARMACOLOGICAL PROPERTIES
As per PA0330/045/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Gelatin
Mannitol (E421) Aspartame (E951)
Sodium hydrogen carbonate
Mint flavour
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store in the original packaging.
6.5 NATURE AND CONTENTS OF CONTAINER
Health Products Regulatory Authority
07 July 2023
CRN00DFR7
Page 2 of 2
PVC/OPA/Al/OPA/PVC foil blisters in a cardboard box.
The pack contains 12 orodispersible tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/207/001
9 DATE OF FIRST AUTHORISATION/RENEWA