Imodium Instants 2 mg Orodispersible Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Loperamide hydrochloride

Available from:

PCO Manufacturing Ltd.

ATC code:

A07DA; A07DA03

INN (International Name):

Loperamide hydrochloride

Dosage:

2 milligram(s)

Pharmaceutical form:

Orodispersible tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Antipropulsives; loperamide

Authorization status:

Authorised

Authorization date:

2012-08-31

Patient Information leaflet

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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 any of

Summary of Product characteristics

Health Products Regulatory Authority
25 April 2023
CRN00DHKT
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(s) with known effect: Aspartame (E951) and the Mint
flavouring contains traces of Sulphites
For the full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Orodispersible tablet.
_Product imported from Greece and Poland._
White to off-white, circular, freeze-dried tablets.
4 CLINICAL PARTICULARS
As per PA0330/045/001
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 flavor
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
Do not store above 30 °C. Store in the original container.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs of 6 or 12 tablets in a printed cardboard carton.
Not all pack sizes may be marketed.
Health Products Regulatory Authority
25 April 2023
CRN00DHKT
Page 2 of 2
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
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/001/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 31
st
August 2012
10 DATE OF REVISION OF THE TEXT
April 2023