Imodium 1mg/5ml oral solution

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Loperamide hydrochloride

제공처:

Janssen-Cilag Ltd

ATC 코드:

A07DA03

INN (국제 이름):

Loperamide hydrochloride

복용량:

200microgram/1ml

약제 형태:

Oral solution

관리 경로:

Oral

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 01040200; GTIN: 5012674040485

환자 정보 전단

- 1 -
PACKAGE LEAFLET: INFORMATION FOR THE USER
IMODIUM
® 1 MG/5 ML
ORAL SOLUTION
Loperamide hydrochloride
Imodium is a registered trademark
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again
•
If you have any further questions, ask your doctor or pharmacist
•
This medicine has been prescribed for you. 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 effects talk to your doctor or pharmacist. This
includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1 What Imodium oral solution is and what it is used for
2 What you need to know before you use Imodium oral solution
3 How to use Imodium oral solution
4 Possible side effects
5 How to store Imodium oral solution
6 Contents of the pack and other information
1 WHAT IMODIUM ORAL SOLUTION IS AND WHAT IT IS USED FOR
The name of your medicine is Imodium 1mg/5ml oral solution. It is
called
Imodium oral solution in this leaflet.
WHAT IMODIUM ORAL SOLUTION IS USED FOR
Imodium oral solution is used:
•
To treat sudden short-lived (acute) attacks of diarrhoea in adults and
children over 4 years of age
•
To treat long-lasting (chronic) diarrhoea in adults
If your child is using Imodium oral solution, the ‘you’ stated
everywhere below
should be read as ‘your child’.
HOW IMODIUM ORAL SOLUTION WORKS
Imodium oral solution contains 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 USE IMODIUM ORAL SOLUTION
DO NOT USE IMODIUM ORAL SOLUTION:
•
If you are allergic to anything in Imodium oral solution (listed in
section 6
below)
- 2 -
•
If you have severe diarrhoea after taking antibiotics
•
If you are having a flare up of ul

제품 특성 요약

OBJECT 1
IMODIUM 1 MG/5 ML ORAL SOLUTION
Summary of Product Characteristics Updated 05-Apr-2018 | Janssen-Cilag
Ltd
1. Name of the medicinal product
Imodium 1 mg/5 ml oral solution
2. Qualitative and quantitative composition
Each 5 ml of oral solution contains 1 mg loperamide hydrochloride.
Excipients with known effect:
Each 5 ml of oral solution contains
3.78g of Glycerol
0.365 mg of Ethanol
3.6 mg of Methyl parahydroxybenzoate (E218)
0.4 mg of Propyl parahydroxybenzoate (E216)
0. 5 mg Cochineal Red A (E124)
4.85 mg Sodium
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Oral solution for oral administration.
A clear, red, slightly viscous fruit-flavoured oral solution.
4. Clinical particulars
4.1 Therapeutic indications
For the symptomatic treatment of acute diarrhoea of any aetiology
including acute exacerbations of
chronic diarrhoea for periods of up to 5 days in adults and children
over 4 years. For the symptomatic
treatment of chronic diarrhoea in adults.
4.2 Posology and method of administration
Acute diarrhoea
Adults:
Four 5 ml doses initially, followed by two 5 ml doses after each loose
stool. The
total daily dose should not exceed sixteen 5 ml doses.
Children:
The following doses should not be exceeded.
Children over 8 years:
Two 5 ml doses four times daily with the duration limited to 5 days.
Children 4 - 8 years:
One 5 ml dose three or four times daily with the duration limited to 3
days.
Not recommended for children under 4 years of age.
There is limited data available regarding use in children below 12
years of age. Please refer to Section 4.8
Undesirable effects.
Further investigation into the cause of the diarrhoea should be
considered if there is no improvement
within two days of starting treatment with Imodium.
Chronic diarrhoea
Adults:
Patients may need widely differing amounts of Imodium. The starting
dose should be
between four and eight 5 ml doses per day in divided doses, depending
on severity. If
required this dose can be adjusted up to a maximum of sixteen 5 ml
dose