Imolieve 2 mg orodispersible tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Loperamide hydrochloride

Available from:

Clonmel Healthcare Ltd

ATC code:

A07DA; A07DA03

INN (International Name):

Loperamide hydrochloride

Dosage:

2 milligram(s)

Pharmaceutical form:

Orodispersible tablet

Therapeutic area:

Antipropulsives; loperamide

Authorization status:

Not marketed

Authorization date:

2019-09-27

Patient Information leaflet

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
Imolieve 2mg orodispersible tablet
For adolescents from 12 years of age and adults
Loperamide hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist have told
you.
•
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 or pharmacist. 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 2 days.
WHAT IS IN THIS LEAFLET
1. What Imolieve is and what it is used for
2. What you need to know before you use Imolieve
3. How to take Imolieve
4. Possible side effects
5. How to store Imolieve
6. Contents of the pack and other information
1. WHAT IMOLIEVE IS AND WHAT IT IS USED FOR
Imolieve is a medicine for the symptomatic treatment of acute
diarrhoea in adolescents from 12 years
of age and adults, unless the cause of the diarrhoea can be treated.
Loperamide must not be used for longer than 2 days except after
medical advice and with medical
monitoring.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE IMOLIEVE
DO NOT USE IMOLIEVE IF:
•
you are allergic to loperamide hydrochloride or any of the other
ingredients of this medicine (listed
in section 6)
•
your child is less than 12 years old (see also “Children” below)
•
you are suffering from conditions in which slowing of intestinal
passage must be avoided, e.g.
abdominal distensions, constipation and intestinal obstruction
Imolieve must be stopped immediately in the event of constipation,
abdominal distension or intestinal
obstruction (ileus).
•
you are suffering from diarrhoea with fever and/or bloody stool
•
you are suffering from diarrhoea occurring during or after the use of
antibiotics
•
you are suffering from c

Summary of Product characteristics

Health Products Regulatory Authority
10 November 2023
CRN00DHZ9
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imolieve 2 mg orodispersible tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg loperamide hydrochloride.
Excipient with known effect
Each tablet contains 3 mg aspartame.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Orodispersible tablet
Imolieve are white to off-white, circular, flat face, bevelled edge,
uncoated orodispersible tablets, plain on both sides with a
diameter of 7 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For symptomatic treatment of acute diarrhoea in adolescents from 12
years of age and adults, unless causative treatment is
available.
Treatment with loperamide hydrochloride for more than 2 days may only
be carried out under medical advice and follow-up
monitoring.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults
Two orodispersible tablets (equivalent to 4 mg of loperamide
hydrochloride) as initial dose for treatment of acute diarrhoea
followed by one 1 orodispersible tablet (equivalent to 2 mg of
loperamide hydrochloride) after every subsequent loose stool.
A daily dose of 6 orodispersible tablets (equivalent to 12 mg of
loperamide hydrochloride) must not be exceeded.
_PAEDIATRIC POPULATION_
Adolescents from 12 years of age
One orodispersible tablet (equivalent to 2 mg of loperamide
hydrochloride) at the beginning of treatment of acute diarrhoea
and after every subsequent loose stool.
A daily dose of 4 orodispersible tablets (equivalent to 8 mg of
loperamide hydrochloride) must not be exceeded.
Children under 12 years
Imolieve is not suitable for children below 12 years of age due to the
high content of active substance. For this purpose other
preparations are available on medical prescription.
_Special populations_
Renal impairment
Health Products Regulatory Authority
10 November 2023
CRN00DHZ9
Page 2 of 8
As the majority of the active substance is metabolised and the
metabolites or