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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: 02/11/2009
SPC Pancrease HL Capsules

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 02/11/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   01-Aug-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change

eMC - Summary of Change Details Per Section

Change to section 9 – Date of Renewal of Authorisation

Renewal date updated to 26 March2008
Updated on 06/08/2009 and displayed until 02/11/2009
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Aug-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 6.1 – List of Excipients

Updated excipients

Change to section 10 – Date of revision of the text

August 2009
Updated on 08/04/2008 and displayed until 06/08/2009
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:   04/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to section 7 – Marketing Authorisation Holder
Change of address to new site

Change to section 10 – Date of revision of the text

April 2008
Updated on 31/03/2008 and displayed until 08/04/2008
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   03/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to section 4.3 – Contra-indications

Pancrease HL Capsules are contra-indicated in patients known to be hypersensitive to pork protein or any other component of this product.

Children aged 15 or under with cystic fibrosis.
Updated on 26/03/2008 and displayed until 31/03/2008
Reasons for adding or updating:
  • 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:   03/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to section 4.8 – Undesirable effects

Updated into medra format

Change to section 10 – Date of revision of the text

March 2008
Updated on 24/12/2007 and displayed until 26/03/2008
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   12/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to section 6.1 – List of Excipients

Change to ink composition

Change to section 10 – Date of revision of the text

December 2007
Updated on 22/11/2007 and displayed until 24/12/2007
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   11/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to section 2 – quantitative and qualitative composition

Remove reference to BP units

Change to section 10 – Date of revision of the text

November 2007
Updated on 28/08/2007 and displayed until 22/11/2007
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   08/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to section 4.6 – Pregnancy and Lactation

Talk to your doctor before using Pancrease HL if you are pregnant, think you may be pregnant or might become pregnant.

You may still be able to use Pancrease HL if your doctor thinks you need to.

Ask your doctor or pharmacist for advice before taking any             medicine if you are pregnant or breast-feeding.

Change to section 6.4 – Special Precautions for Storage

Do not store above 25°C . Keep bottle tightly closed. Do not refrigerate or freeze.

Change to section 10 – Date of revision of the text

August 2007
Updated on 30/07/2007 and displayed until 28/08/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   07/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to section 4.4 – Special Warnings and Precautions for Use

Contact of the minitablets with food or liquid having a pH higher than 5.0 can dissolve the protective coating and will reduce efficacy of the product.

Cases of fibrotic strictures in the colon have been reported primarily in cystic fibrosis patients with the use of enzyme supplements, generally at dosages above the recommended range. If symptoms suggestive of gastrointestinal obstruction occur, the possibility of bowel strictures should be considered. In some cases surgery including resection of the bowel is required and the need for this should also be considered.

Any change in pancreatic enzyme replacement therapy (e.g., dose or brand of medication) should be made cautiously and only under medical supervision.

 
Updated on 05/07/2007 and displayed until 30/07/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   06/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to section 4.2 – Posology and |Method of Administration

Additional Paragraphs

Change to section 10 – Date of revision of the text

July 2007
Updated on 19/02/2007 and displayed until 05/07/2007
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to section 6.1 – List of Excipients

Addition of Methacrylic acid- ethyl acrylate copolymer (1:1).

Dimethylpolysiloxane relaced with Antifoam DC 1510

Change to section 10 – Date of revision of the text

February 2007
Updated on 23/08/2001 and displayed until 19/02/2007
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  pancreatin