IMODIUM 2mg Milligram Capsule

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:

Capsule

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Antipropulsives

Authorization status:

Authorised

Authorization date:

2009-10-30

Patient Information leaflet

FACE 1
– 1 –
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
■
IMODIUM
®
2mg Capsules is used to treat
sudden, shortlived (acute) attacks of diarrhoea
in adults and children 4 years and over and
long-lasting (chronic) diarrhoea in adults.
■
DO NOT TAKE THIS MEDICINE:
■
There are some people who should not use
this medicine. _To fi nd 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 suff er from any of the conditions
mentioned in _Section 2 _
_▶_
■
If you are taking any OTHER MEDICINES. _See _
_Section 2 _
_▶_
■
FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY.
These are shown in the dosage table. _See _
_Section 3 _
_▶_
NOW READ THIS WHOLE LEAFL ET CAREFULLY
BEFORE YOU USE THIS MEDICINE.
■
Keep this leafl et. You may need to read it
again.
■
If you have any further questions, ask your
doctor, pharmacist or nurse.
■
This medicine has been prescribed for YOU
ONLY. DO NOT PASS IT ON TO OTHERS. It may
harm them, even if their signs of illness are
the same as yours.
■
If you get any side eff ects, talk to your doctor,
pharmacist or nurse. This includes any
possible side eff ects not listed in this leafl et.
_See Section 4 _
_▶_
WHAT IS IN THIS LEAFL ET
1. What IMODIUM
®
2mg Capsules are, and
what they are used for.
2. What you need to know before you take
IMODIUM
®
2mg Capsules.
3. How to take IMODIUM
®
2mg Capsules.
4. Possible side eff ects.
5. How to store IMODIUM
®
2mg Capsules.
6. Contents of the pack and other information.
1
WHAT IMODIUM
® 2MG
CAPSULES ARE AND WHAT
THEY ARE USED FOR
IMODIUM
®
2mg Capsules is used to treat
sudden, shortlived (acute) attacks of diarrhoea
in adults and children 4 years and over and
long-lasting (chronic) diarrhoea in adults,
such as diarrhoea associated with Crohn's
disease and ulcerative coliti

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imodium 2 mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 2 mg of loperamide hydrochloride.
Excipient: Each capsule contains 127 mg Lactose.
For a full list of excipients, see 6.1
3 PHARMACEUTICAL FORM
Capsule, hard. (capsule)
Gelatin capsules with an opaque green cap and an opaque dark grey
body, containing white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults
As an adjunct in the management of acute diarrhoea, together with
appropriate fluid and electrolyte replacement.
In the symptomatic control of diarrhoea associated with chronic
inflammatory bowel disease, eg., Crohn’s disease and
ulcerative colitis, as an adjunct to specific measures such as
corticosteroids and sulphasalazine. Use in these conditions
should be under specialist supervision.
In the adjunctive short-term, control of post-surgical diarrhoea,
including ileostomy.
Children
For the occasional use in the control of intractable diarrhoea under
specialist supervision.
Since persistent diarrhoea can be an indicator of potentially serious
conditions, the underlying cause must always be
investigated.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.The capsules should be taken with water.
As an adjunct in the management of acute diarrhoea
Adults and children 9-12 years
1 to 2 capsules (2 to 4 mg) is the usual initial dose, followed by 1
capsule (2 mg) three times daily.
The maximum
daily dose should not exceed 10 mg.
Children 4-8 years
A total maximum daily dose of 4 mg in divided doses (see 4.4 Special
warnings and precautions for use).
Under 4 years
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