Pentasa Sachet 4g prolonged release granules

*
Pharmacy Only: Prescription
  • Company:

    Ferring Ireland Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

Updated on 18 January 2024

File name

Pentasa Sachet combined PR granules_Leaflet_nov2023.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

To update section 2.0 & 4.0 of the leaflet

Updated on 04 January 2024

File name

Pentasa Sachet 4g prolonged release granules_SmPC_Nov2023.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Drug reaction with eosinophilia and systemic symptoms (DRESS) is moved from ‘Very rare’ to ‘Not known’ in section 4.8 SmPC in line with the PRAC recommendation. In the ADR table in section 4.8 SmPC a footnote is added to urine discolouration with reference to the new warning re urine discolouration in section 4.4 SmPC. 

Updated on 13 July 2021

File name

Pentasa Sachet 4g SPC_clean_approved July 2021.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 28 January 2020

File name

Pentasa Sachet 4g SPC__in line with license dated 27 01 2020.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to Section 4.4, to add sentence 'Cases of nephrolithiases have been reported with the use of mesalazine including stones with a 100% mesalazine content. It is recommended to ensure adequate fluid intake during treatment.'

Update to Section 4.8, to add column for 'Not known (cannot be estimated from the available data' and include 'Nephrolithiasis' in the Renal and Urinary disorders row

Updated on 18 September 2019

File name

Pentasa Sachet 4g SPC_in line with licence dated 18 09 2019.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to Section 4.2, to add sentence 'Alternatively the entire content of the sachet can be taken with yogurt and consumed immediately.'

Updated on 07 August 2019

File name

Pentasa Sachet 4g SPC_in line with license dated 13 5 2019.pdf

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

SmPC Section 9 update - Added date of last renewal

Updated on 03 August 2018

File name

Pentasa Sachet 4g SPC_in line with license dated 19 7 2018.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8

Photosensitivity” added as a rare side effect with the footnote “More severe reactions are reported in patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema.

 

Other minor updates in the table in Section 4.8:

-          blood disorders” updated to “altered blood counts”

-          allergic exanthema” reworded to “dermatitis allergic” and relocated to section for skin and subcutaneous tissue disorders

-          “drug fever” moved to section for general disorders and administration site conditions.

Updated on 05 July 2016

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 05 July 2016

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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
  • Change to section 4.6 - Pregnancy and lactation

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.6:

Sentence update: “Mesalazine is known to cross the placental barrier and its concentration in umbilical cord plasma is lower than the concentration in maternal plasma.  The metabolite acetyl-mesalazine is found at similar concentrations in umbilical cord and maternal plasma. “

New sentence: “The underlying condition itself (Inflammatory bowel disease (IBD) may increase risks for adverse pregnancy outcome.”

New text:  “There are no adequate and well controlled studies of Pentasa use in pregnant women. Limited published human data on mesalazine show no increase in the overall rate of congenital malformations.  Some data show an increased rate of preterm birth, stillbirth, and low birth weight; however, these adverse pregnancy outcomes are also associated with active inflammatory bowel disease. “

 

Section 4.8

Adverse events updated, see SPC for full updated list.

 

Section 4.9

New sentences:

“Since Pentasa is an amino salicylate, symptoms of salicylate toxicity may occur.  Symptoms of salicylate over dosage are well described in the literature.  “

“There is no specific antidote and the management of overdose is supportive and symptomatic. The treatment at hospital includes close monitoring of renal function.”

 

Deleted text:

“There is no specific antidote and treatment is symptomatic and supportive.”

Management of overdose in man:

Symptomatic treatment at hospital. Close monitoring of renal function. Intravenous infusion of electrolytes may be used to promote diuresis.”

 

Section 5.1

New sections:

“It has been established that mesalazine is the active component of sulphasalazine which is used for the treatment of ulcerative colitis and Crohn’s disease.  Based on clinical results, the therapeutic value of mesalazine after oral as well as rectal administration appears to be due to local effect on the inflamed intestinal tissue, rather than to systemic effect.  There is information suggesting that severity of colonic inflammation in ulcerative colitis patients treated with mesalazine is inversely correlated with mucosal concentrations of mesalazine. “

 

The mechanism of action of mesalazine is not fully understood although mechanisms such as activation of the γ-form of peroxisome proliferator-activated receptors (PPAR-γ) and inhibition of nuclear factor-kappa B (NF-κB) in the intestinal mucosa has been implicated. “

 

“It is currently unknown which, if any, of these mechanisms play a predominant role in the clinical efficacy of mesalazine.”

 

Sections 5.2 and 5.3

Full updates, see SPC for text.

Updated on 05 July 2016

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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
  • Change to section 4.6 - Pregnancy and lactation

Free text change information supplied by the pharmaceutical company

Section 4.6:

Sentence update: “Mesalazine is known to cross the placental barrier and its concentration in umbilical cord plasma is lower than the concentration in maternal plasma.  The metabolite acetyl-mesalazine is found at similar concentrations in umbilical cord and maternal plasma. “

New sentence: “The underlying condition itself (Inflammatory bowel disease (IBD) may increase risks for adverse pregnancy outcome.”

New text:  “There are no adequate and well controlled studies of Pentasa use in pregnant women. Limited published human data on mesalazine show no increase in the overall rate of congenital malformations.  Some data show an increased rate of preterm birth, stillbirth, and low birth weight; however, these adverse pregnancy outcomes are also associated with active inflammatory bowel disease. “

 

Section 4.8

Adverse events updated, see SPC for full updated list.

 

Section 4.9

New sentences:

“Since Pentasa is an amino salicylate, symptoms of salicylate toxicity may occur.  Symptoms of salicylate over dosage are well described in the literature.  “

“There is no specific antidote and the management of overdose is supportive and symptomatic. The treatment at hospital includes close monitoring of renal function.”

 

Deleted text:

“There is no specific antidote and treatment is symptomatic and supportive.”

Management of overdose in man:

Symptomatic treatment at hospital. Close monitoring of renal function. Intravenous infusion of electrolytes may be used to promote diuresis.”

 

Section 5.1

New sections:

“It has been established that mesalazine is the active component of sulphasalazine which is used for the treatment of ulcerative colitis and Crohn’s disease.  Based on clinical results, the therapeutic value of mesalazine after oral as well as rectal administration appears to be due to local effect on the inflamed intestinal tissue, rather than to systemic effect.  There is information suggesting that severity of colonic inflammation in ulcerative colitis patients treated with mesalazine is inversely correlated with mucosal concentrations of mesalazine. “

 

The mechanism of action of mesalazine is not fully understood although mechanisms such as activation of the γ-form of peroxisome proliferator-activated receptors (PPAR-γ) and inhibition of nuclear factor-kappa B (NF-κB) in the intestinal mucosa has been implicated. “

 

“It is currently unknown which, if any, of these mechanisms play a predominant role in the clinical efficacy of mesalazine.”

 

Sections 5.2 and 5.3

Full updates, see SPC for text.

Updated on 02 March 2015

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 02 March 2015

Reasons for updating

  • New SPC for new product

Free text change information supplied by the pharmaceutical company

None provided