Last Updated on eMC 17-05-2017 View medicine  | Ferring Pharmaceuticals Ltd Contact details

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.

Reasons for adding or updating:

  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

Date of revision of text on the SPC:23-08-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



For alignment and consistency, some changes in the safety section were incorporated.

Post-marketing safety surveillance activities support an update of theimmune system disorder SOC.

The pharmacokinetic sections were revised ensuring alignment with the recommendations from the QRD template.

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:30-04-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

section 4.8 - How to report ADR

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration

Date of revision of text on the SPC:19-08-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.2: Once daily administration dose of 4g mesalazine added.

Reasons for adding or updating:

  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data

Date of revision of text on the SPC:13-06-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.6: Replace embryonic/fetal to embryo/foetal.

Section 5.1: Addition -
The risk of colorectal cancer (CRC) is slightly increased in ulcerative colitis.
Observed effects of mesalazine in experimental models and patient biopsies support the role of mesalazine in prevention of colitis-associated CRC, with down regulation of both inflammation dependent and non-inflammation dependent signalling pathways involved in the development of colitis-associated CRC. However data from meta-analyses, including both referral and non-referral populations, provide inconsistent clinical information regarding the benefit of mesalazine in the carcinogenesis risk associated with ulcerative colitis.

Section 5.3: Addition -
Animal studies on oral mesalazine do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryo-foetal development, parturition or postnatal development.

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC:27-07-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 4.8 - Following rare side effects added; Dizziness, Flatulence
                      Following very rare side effects added: Neutropenia, Allergic exanthema, Pancolitis, cholestasis 
                      parameters, Oligospermia (reversible)

Reasons for adding or updating:

  • Change to MA holder contact details

Date of revision of text on the SPC:27-06-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

New MAH address: Drayton Hall, Church Road, West Drayton, UB7 7PS

Reasons for adding or updating:

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 5 - Nature and Contents of Container

Date of revision of text on the SPC:10-09-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 3: Change in colour of the granules to, White-grey to pale white-brown granules

Section 6.1: The excipient Microcrystalline Cellulose is replaced to Povidone

Section 6.5: A pack size of 120 sachets introduced

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration

Date of revision of text on the SPC:07-04-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Addition of paediatric use.

4.2       Posology and method of administration

 

Ulcerative colitis

 

Paediatric population:

There is only limited documentation for an effect in children (age 6-18 years).

 

Children 6 years of age and older:

Active disease: To be determined individually, starting with 30-50 mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day in divided doses. The total dose should not exceed 4 g/day (maximum adult dose).

Maintenance treatment: To be determined individually, starting with 15-30 mg/kg/day in divided doses. The total dose should not exceed 2 g/day (recommended adult dose).

 

It is generally recommended that half the adult dose may be given to children up to a body weight of 40 kg; and the normal adult dose to those above 40 kg.

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC:10-12-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

section 4.8: An update to the undesirable effects section.

A section for Gastrointestinal side effects was left out in the last version submitted, it was a typo error.

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration

Date of revision of text on the SPC:10-12-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.2: amended dosing for maintenance treatment to once daily dose;

Maintenance treatment

Individual dosage. Recommended dosage, 2 g mesalazine once daily.

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects
  • 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 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:06-08-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



4.4 - Special warnings & precautions for use, addition of the following;

In case of acute symptoms of intolerance, i.e. cramps, abdominal pain, fever, severe headache and rash, the treatment should be discontinued immediately.

4.5 - Interaction with other medicines,

No specific interaction studies have been performed. Concomitant treatment with mesalazine can increase the risk of blood dyscrasia in patients receiving azathioprine or 6-mercaptopurine.

4.8 - Undesirable effects - Additional side effects added in a table format.


Reasons for adding or updating:

  • New SPC for new product

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): NO