Imodium Plus Caplets (P) - Summary of Product Characteristics (SPC) - History

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McNeil Products Ltd
Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG Medical Information Direct Line: 01344 864042 Medical Information e-mail: medinfo@its.jnj.com 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: 11/10/2011

SPC	Imodium Plus Caplets (P)

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 11/10/2011 and displayed until Current

Reasons for adding or updating:
Change to section 3 - Pharmaceutical form Change to section 4.2 - Posology and method of administration Change to section 4.3 - Contraindications 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 4.6 - Pregnancy and Lactation Change to section 10 date of revision of the text
Date of revision of text on the SPC: 21-Sep-2011
Legal Category: P
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
· To update SPC sections 4.2 (Posology and method of administration), 4.3 (Contraindications), 4.4 (Special warnings and precautions for use), 4.5 (Interaction with other medicinal products and other forms of interaction) & 4.6 (Pregnancy and lactation) in line with the agreed CSP following a PSUR procedure. Additionally, the pharmaceutical form in section 3 of the SPC (Pharmaceutical form) is being corrected.

Updated on 21/09/2011 and displayed until 11/10/2011

Reasons for adding or updating:
Change to section 5.1 - Pharmacodynamic Properties Change to section 5.2 - Pharmacokinetic Properties Change to section 10 date of revision of the text Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC: 02-Sep-2011
Legal Category: P
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
Update section 5.2 of the SPC (Pharmacokinetic properties) in line with revisions to the January 2008 Company Core Data Sheet, with consequential updates to section 5.1 (Pharmacodynamic properties). A related change regarding clinical pharmacology is being made to section 4.5 (Interaction with other medicinal products and other forms of interaction).

Updated on 25/01/2011 and displayed until 21/09/2011

Reasons for adding or updating:
Change to section 3 - Pharmaceutical form Change to section 10 date of revision of the text
Date of revision of text on the SPC: 08-Dec-2010
Legal Category: P
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
Change to Section 3. Description of the tablet markings.

Updated on 29/01/2009 and displayed until 25/01/2011

Reasons for adding or updating:
Change of Marketing Authorisation Holder
Date of revision of text on the SPC: 01-Sep-2007
Legal Category: P
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
Change of ownership approval from McNeil Ltd, Saunderton, High Wycombe, to McNeil Products Limited, Maidenhead. Artwork change combined with MRP licence renewal approved 12 January 2009.

Updated on 11/08/2008 and displayed until 29/01/2009

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 4.8 - Undesirable Effects Change to section 5.3 - Preclinical Safety Data Change to section 6.1 - List of Excipients Change to section 6. 4 - Special Precautions for Storage Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC: 22-Jul-2008
Legal Category: P
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
To update section 2 'Qualitatitive and quantitative', 4.2 'Posology', 4.8 'Undesirable effects', 5.3 'Preclinical safety', 6.1 'Excipients', 6.4 'Special storage' and 6.5 'Container' of the SPC