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Janssen-Cilag Ltd
50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG
Telephone: +44 (0)1494 567 567
Fax: +44 (0)1494 567 568
WWW: http://www.janssen.co.uk
WWW: http://www.janssen-medinfo.co.uk
Medical Information Direct Line: +44 (0)800 731 8450
Medical Information e-mail: medinfo@janssen-cilag.co.uk
Customer Care direct line: +44 (0)800 731 5550

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 27/09/2010
SPC Imodium Syrup

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 27/09/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   22-Sep-2010
Legal Category:   POM, P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Update to 4.7 - Addition of loss of consciousness, depressed level of consciousness.

 

Update to 4.8 - Addition of loss of consciousness, depressed level of consciousness. Change to the format of the section.

Update to 10 – 22 September 2010
Updated on 30/07/2010 and displayed until 27/09/2010
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   27-Jul-2010
Legal Category:   POM, P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 4.5 - Interaction with desmopressin included.
Change to section 10 - 27 July 2010.
Updated on 16/09/2009 and displayed until 30/07/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   10-Sep-2008
Legal Category:   POM, P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 7 – Marketing Authorisation Holder*

Address change

Change to section 10 – Date of revision of the text

Date change

 
Updated on 23/06/2008 and displayed until 16/09/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 1 -Name of the Medicinal product
Date of revision of text on the SPC:   13-Jun-2008
Legal Category:   POM, P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


1.

NAME OF THE MEDICINAL PRODUCT

Update to QRD

 

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Update to QRD excipients

 

3.

PHARMACEUTICAL FORM

Update to QRD, description

 

4.
CLINICAL PARTICULARS

 

4.1

Therapeutic Indications

Update to QRD

4.2

Posology and method of administration

Update to QRD

4.4

Special Warnings and Precautions for Use

Update to QRD

4.5

Interaction with other medicinal products and other forms of interaction

Update to QRD

4.6

Pregnancy and Lactation

Update to QRD

4.7

Effects of ability to drive and use machines

Update to QRD

4.8

Undesirable effects

Update to QRD

 

5.

PHARMACOLOGICAL PROPERTIES

 

5.1

Pharmacodynamic properties

Addition of ATC code and group

5.2

Pharmacokinetic properties

Update to QRD

5.3

Preclinical Safety Data

Update to QRD

 

6.

PHARMACEUTICAL PARTICULARS

 

6.1

List of excipients

Update to QRD

6.4

Special precautions for storage

Update to QRD

6.5

Nature and contents of container

Update to QRD

6.6

Instructions for use, handling and disposal

Update to QRD

 

 

 

10.

DATE OF REVISION OF THE TEXT

 

June 2008

 

Updated on 13/04/2006 and displayed until 23/06/2008
Reasons for adding or updating:
  • Addition of separate SPCs covering individual presentations

Active Ingredients/Generics

 
  loperamide hydrochloride