Imodium Hard Capsules 2mg

Valsts: Malta

Valoda: angļu

Klimata pārmaiņas: Medicines Authority

Aktīvā sastāvdaļa:

LOPERAMIDE HYDROCHLORIDE

Pieejams no:

Johnson & Johnson Hellas Consumer AE Aegialias & Epidavrou 4, Maroussi, 15125, Athens, Greece

ATĶ kods:

A07DA03

SNN (starptautisko nepatentēto nosaukumu):

LOPERAMIDE HYDROCHLORIDE 2 mg

Zāļu forma:

HARD CAPSULE

Kompozīcija:

LOPERAMIDE HYDROCHLORIDE 2 mg

Receptes veids:

OTC

Ārstniecības joma:

ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS

Autorizācija statuss:

Authorised

Autorizācija datums:

2007-01-30

Lietošanas instrukcija

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PACKAGE LEAFLET: INFORMATION FOR THE USER
IMODIUM HARD CAPSULES
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 OR NURSE HAS 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 or
nurse. This
includes any possible side effects not listed in this leaflet. See
section 4.
•
You must talk to your doctor if you do not feel better or if you feel
worse after
2 days.
WHAT IS IN THIS LEAFLET
1.
What Imodium is and what it is used for
2.
What you need to know before you take Imodium
3.
How to take Imodium
4.
Possible side effects
5.
How to store Imodium
6.
Contents of the pack and other information
1
WHAT IMODIUM IS AND WHAT IT IS USED
FOR
The name of your medicine is Imodium capsules.
WHAT IMODIUM IS USED FOR
Imodium is used:
•
To treat sudden short-lived (acute) attacks of diarrhea in adults and
children
age 12 and over.
If your child is aged 12 years and above the ‘you’ stated
everywhere below should be
read as ‘your child’.
HOW IMODIUM WORKS
Imodium contain a medicine called loperamide hydrochloride. It belongs
to a group of
medicines which helps reduce diarrhoea by slowing down an overactive
bowel. It also
helps the body to absorb more water and salts from the bowel.
2
WHAT YOU NEED TO KNOW
BEFORE YOU TAKE IMODIUM
DO NOT TAKE IMODIUM IF:
•
You are allergic to anything in Imodium (listed in section 6 below)
•
You have severe diarrhea after taking antibiotics
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•
You are having a flare up of ulcerative colitis
•
You are constipated or your stomach appears swollen
•
For a child less than 12 years old
•
If you have acute dysentery, the symptoms of which may include blood
in your stools
and a high temperature. You will also need to be given oth

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Imodium™ Hard Capsules.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Loperamide hydrochloride (HCl) 2 mg per capsule.
Excipient with known effect: lactose
For a full list of excipients, see Section 6.1
3.
PHARMACEUTICAL
FORM
Capsule, hard.
Opaque green cap and grey body, hard gelatin capsule imprinted with
‘Imodium’ on cap and ‘Janssen’ on body containing white
powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic treatment of acute diarrhoea of any aetiology for
periods of up to 2 days in adults and children age 12 and over.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children age 12 and over:
2 capsules initially, followed by 1 capsule after every loose stool.
The
usual dose is 3-4 capsules/day; the maximum daily dose should not
exceed 6 capsules.
_Paediatric population _
There is limited data available regarding use in children below 12
years of
age. Please refer to Section 4.8 Undesirable effects.
Imodium is not recommended for children under 12 years of age.
Further investigation into the cause of the diarrhoea should be
considered
if there is no improvement within two days of starting treatment with
Imodium.
_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 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 use. The capsules should be taken with liquid.
4.3
CONTRAINDICATIONS
Imodium is contra-indicated in:
•
patients with a known hypersensitivity to loperamide hydrochloride or
to any of the excipients listed in section 6.1.
•
children age 12 and under (for the capsules).
•
when inhibition of peristalsis is to be avoided due to the possible
risk of
significant sequelae i