Imodium Instants 2 mg Orodispersible Tablets

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Loperamide hydrochloride

Dostupné s:

Johnson & Johnson (Ireland) Limited

ATC kód:

A07DA; A07DA03

INN (Mezinárodní Name):

Loperamide hydrochloride

Dávkování:

2 milligram(s)

Léková forma:

Orodispersible tablet

Druh předpisu:

Product not subject to medical prescription

Terapeutické oblasti:

Antipropulsives; loperamide

Stav Autorizace:

Marketed

Datum autorizace:

2003-10-03

Informace pro uživatele

_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 the other ingredients of
this medicine (

Charakteristika produktu

Health Products Regulatory Authority
21 December 2023
CRN00DX4W
Page 1 of 6
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 0.750 mg of
Aspartame (E951) which is equivalent to 0.055 mg/mg and Mint
flavour, which contains less than 0.00066 mg of benzyl alcohol, less
than 0.24 mg of maltodextrin (which contains glucose) and
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.
4.3 CONTRAINDICATIONS
Health Products Regulatory Authority
21 December 2023
CRN00DX4W
Page 2 of 6

Imodium use is contraindicated in patients under 12 years of age.

Imodium Instants are contraindicated in patients with a known
hypersensitivity to loperamide hydrochloride or to
any of the excipients.

Imodium should not be used as the primary therapy:
- In patients with acute dysen