Mezavant XL

*
Pharmacy Only: Prescription
  • Company:

    Takeda Products Ireland Ltd
  • 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 25 May 2023

File name

ie-pl-mezavantxl-consolidated-035-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 25 May 2023

File name

ie-spc-mezavantxl-consolidated-035-clean.pdf

Reasons for updating

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

In section 4.4, the following highlighted text has been removed:

Severe cutaneous adverse reactions (SCARs), including Drug reaction with eosinophilia and systemic symptoms (DRESS), such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine treatment. 

Date of revision: 15 May 2023

Updated on 14 April 2023

File name

ie-pl-mezavantxl-II-035-approved-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 14 April 2023

File name

ie-spc-mezavantxl-II-035-approved-clean.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

In section 4.4, the following text shown in red has been added : Severe cutaneous adverse reactions (SCARs), including Drug reaction with eosinophilia and systemic symptoms (DRESS), such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine treatment.

In section 4.8, the table has been amended (drug rash with eosinophilia and systemic symptoms (DRESS) has been moved from immune system disorders to skin and subcutaneous tissue disorders) and the following text shown in red has been added: Severe cutaneous adverse reactions (SCARs), including Drug reaction with eosinophilia and systemic symptoms (DRESS), such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine treatment (see section 4.4).

Date of revision of text: 04 April 2023


Updated on 24 March 2023

File name

ie-pl-mezavantxl-IA-037-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

In section 2, the following wording has been added: Mesalazine may produce red-brown urine discoloration after contact with sodium hypochlorite bleach in the toilet water. It concerns a chemical reaction between mesalazine and bleach and is harmless.


Updated on 24 March 2023

File name

ie-spc-mezavantxl-IA-037-clean.pdf

Reasons for updating

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

In section 4.4, the following wording has been added: Mesalazine may produce red-brown urine discoloration after contact with sodium hypochlorite bleach (e.g. in toilets cleaned with sodium hypochlorite contained in certain bleaches).

Date of revision: 17 March 2023


Updated on 24 January 2023

File name

ie-spc-mezavantxl-clean-TypeIA-Jan2023.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

TPI-IB address was updated from Takeda Pharmaceuticals International AG Ireland Branch Block 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, D02 Y754, Ireland to Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland

Updated on 24 January 2023

File name

ie-pl-mezavantxl-clean-TypeIA-Jan2023.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

TPI-IB address was updated from Takeda Pharmaceuticals International AG Ireland Branch Block 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, D02 Y754, Ireland to Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland

Updated on 26 August 2022

File name

ie-spc-mezavantxl-clean.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • 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

The following changes have been made to the SmPC:

4.3 Contraindications

4.4 Special warnings and precautions for use

4.8 Undesirable effects

6.1        List of excipients

Date of Revision: 22nd August 2022

Updated on 10 December 2021

File name

ie-pl-mezavantxl-Oct 2021.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Summary of changes:

  • Removal of United Kingdom reporting details
  • Transfer of the Marketing Authorization Holder (from Shire Pharmaceuticals Ireland Limited to Takeda Pharmaceuticals International AG Ireland Branch).
  • Date of revision of the text: October 2021

Updated on 10 December 2021

File name

ie-spc-mezavantxl-26.11.2021.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • 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

Summary of changes:

  • Transfer of the Marketing Authorization Holder (from Shire Pharmaceuticals Ireland Limited to Takeda Pharmaceuticals International AG Ireland Branch).
  • Update to marketing authorisation numbers to: PA23211/004/001
  • Date of revision of the text: 26 November 2021

Updated on 22 July 2021

File name

ie-pl-mezavantxl-TII-031- June 2021-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

The following changes have been made to the PIL:

Section

Change

2 Warnings and precautions

Added:

If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after using Mezavant

 

Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with Mezavant treatment. Stop using Mezavant and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

 

4 Possible Side Effects

Added:

  • If you notice reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms.

 

Updated:

The following side effects have been reported but it is not known exactly how often they occur:

Severe reduction in blood cells which can cause weakness or bruising; low blood cell counts; allergic reaction (hypersensitivity); serious allergic reaction which causes difficulty in breathing or dizziness; serious illness with blistering of the skin (possibly leading to peeling of the skin and resulting in painful, raw areas),…

10 Date of revision of the text

Updated:

June 2021

Updated on 22 July 2021

File name

ie-spc-mezavantxl-TII-031- June 2021-clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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)

Free text change information supplied by the pharmaceutical company

The following changes have been made to the SmPC:

Section

Change

4.4 Special warnings and precautions for use

Added:

Severe cutaneous adverse reactions (SCARs), such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine treatment. Mesalazine should be discontinued, at the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other sign of hypersensitivity.

4.8 Undesirable effects

Updated:

Stevens Johnson Syndrome has been moved from under Immune System Disorders and Toxic epidermal necrolysis has been added to Skin and subcutaneous tissue disorders as follows:

Not known

Stevens‑Johnson syndrome (SJS)*, Toxic epidermal necrolysis (TEN)*

Added:

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)

Severe cutaneous adverse reactions (SCARs), such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine treatment (see section 4.4).

10 Date of revision of the text

Updated:

30 June 2021

Updated on 08 January 2021

File name

ie-pl-mezavantxl-TII-026-with TIAIN-28 accepted-nov2020-clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

  • Updated the SmPC and PIL: addition of ADR Hepatotoxicity.
  • Minor formatting and spelling corrections.

Please note a new version of the same PIL has been uploaded (with corrected document title). 

Updated on 08 January 2021

File name

ie-spc-mezavantxl-TII-026-21Dec2020-clean.pdf

Reasons for updating

  • 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

  • Updated the SmPC and PIL to align with the Company Core Data Sheet (CCDS) version 22: addition of ADR Hepatotoxicity.
  • Minor formatting and spelling corrections.

Updated on 08 January 2021

File name

uk-pl-mezavantxl-TII-026-with TIAIN-28 accepted-nov2020-clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

  • Updated the SmPC and PIL: addition of ADR Hepatotoxicity.
  • Minor formatting and spelling corrections.

Updated on 20 July 2020

File name

ie-pl-mezavantxl-TII-024-clean-June2020.pdf

Reasons for updating

  • Change to section 2 - use in children and adolescents
  • Change to section 3 - how to take/use
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 20 July 2020

File name

ie-spc-mezavantxl-TII-024-clean-8July2020.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

The HPRA have approved an extension of indication - for use in paediatrics aged 10 years and over (currently indicated in adults aged 18 years and over).

The following major changes have been made to the SmPC. Other minor editorial changes, including update of ‘Mezavant’ to ‘mesalazine’ were made throughout the text.

Section

Change

3 PHARMACEUTICAL FORM

Update:

Red-brown, ellipsoidal, film-coated tablet (dimensions 20.5 × 9.5 × 7.5 mm), debossed on one side with S476.

4.1 Therapeutic Indications

Update:

Adults, including the elderly (>65 years)

For the induction and maintenance of clinical and endoscopic remission in patients with mild to moderate, active ulcerative colitis. For maintenance of remission.

Children and adolescents (weighing more than 50 kg and age 10 years or older)

For the induction and maintenance of clinical and endoscopic remission in patients with mild to moderate, active ulcerative colitis.

4.2 Posology and method of administration

Update:

Children and adolescents (weighing more than 50 kg and age 10 years or older)

For induction of remission (initial 8 weeks): 2.4 g to 4.8 g (two to four tablets) should be taken once daily.

For maintenance of remission: 2.4 g (two tablets) should be taken once daily.

Mesalazine 1200 mg tablets should not be used by paediatric patients weighing 50 kg or less and should not be used in paediatric patients below the age of 10 years due to a lack of data on safety and efficacy in these patients.

4.8 Undesirable effects

Addition:

The safety profile in the paediatric population is consistent with the safety profile in adult studies and in post marketing experience.

5.1 Pharmacodynamic properties

Addition:

A Phase 3, multicentre, randomized, double‑blind, parallel‑group study was conducted in 107 paediatric patients aged 5 to 17 years (inclusive) with mild to moderate ulcerative colitis to evaluate the safety and efficacy of Mezavant in both double‑blind acute (Double‑Blind Acute, DBA) and double‑blind maintenance (Double‑Blind Maintenance, DBM) phases. Subjects received a low or a high weight‑based dose of mesalazine in four weight groups: 18 kg to £23 kg (n=3), >23 kg to £35 kg (n=9), >35 kg to £50 kg (n=29), and >50 kg to £90 kg (n=66). The low dose ranged from 900 mg/day to 2,400 mg/day and the high dose ranged from 1,800 mg/day to 4,800 mg/day. Clinical effects of 1200‑mg mesalazine tablets were evaluated in 66 subjects >50 kg to £90 kg in the age range 10 to 17 years.

Primary endpoint of the double‑blind treatment phases was defined in terms of clinical response. Clinical response was defined as a partial Ulcerative Colitis Disease Activity Index (UC‑DAI) score of £1 with a score of 0 for rectal bleeding and £1 for stool frequency and physician’s global assessment = 0.

After 8 weeks of treatment in the DBA phase, 37.0% of subjects achieved a clinical response in the low‑dose arm compared to 65.4% of subjects in the high‑dose arm. The response rates at week 8 in these dose arms were 50.0% and 56.3% respectively in subjects weighing >50 kg to £90 kg who received 1200‑mg mesalazine tablets. In the DBM phase, after 26 weeks of treatment, 54.8% of subjects maintained a clinical response in the low‑dose arm compared to 53.3% in the high‑dose arm. The response rate at week 26 was 50% in both dose arms in subjects weighing >50 kg to £90 kg who received 1200‑mg mesalazine tablets. The study was not powered to assess differences between the low dose and high dose.

5.2 Pharmacokinetic properties

Addition

In a Phase 1, multicentre, open label study (SPD476 112) in paediatric subjects (aged 5 to 17 years) diagnosed with UC, dosing of mesalazine was stratified by weight. Subjects were randomized to 1 of 3 possible treatments: 30, 60, or, 100 mg/kg/day. Subjects received a total dose between 900 and 4,800 mg of mesalazine per day for 7 days.

Pharmacokinetic steady state was attained by Day 5 for all doses. On Day 7, systemic 5 ASA exposure, as measured by mean AUCss and Cmax,ss, increased in a dose proportional manner between 30 and 60 mg/kg/day of mesalazine. Between 60 and 100 mg/kg/day, systemic exposure of mesalazine increased in a sub proportional manner. The mean percentage of mesalazine absorbed (based on urinary recovery) was similar at 30 and 60mg/kg/day doses, being 29.4% and 27.0%, respectively. These results are similar to the percentage of mesalazine dose absorbed in adults from a previous study (SPD476 105), with values ranging from 17-22% for adult males and 24-32% for adult females.

The percentage of mesalazine absorbed was lower at 100 mg/kg/day 5 ASA (22.1%). There was no discernible difference of 5 ASA (and N Ac 5 ASA) systemic exposure between children (aged 5 through 12 years) and adolescents (aged 13 through 17 years) with this weight based (i.e., mg/kg) dosing paradigm.

In adults, the mean renal clearances (CLR) were 1.8 L/h and 2.9 L/h for single doses of 2.4 g and 4.8 g, respectively, and slightly higher on Day 14 of multiple dosing: 5.5 L/h and 6.4 L/h for 2.4 g/day and 4.8 g/day. Mean renal clearances for the metabolite were higher, at approximately 12 15 L/h following single and multiple doses of mesalazine 2.4 g/day and 4.8 g/day.

In paediatric patients, the mean renal clearance of 5 ASA at steady state ranged from approximately 5.0 6.5 L/h (83 108 mL/min), which is similar to that observed with adult volunteers. There was a trend for CLR to decrease with increasing dose, and individual CLR estimates were highly variable. The mean CLR of N Ac 5 ASA ranged from 10.0 16.2 L/h (166 270 mL/min), with a trend to decrease with increasing dose.

6.6 Special precautions for disposal

Updated:

Any unused medicinal product or waste material should be disposed of in accordance with local requirements. No special requirements.

10 Date of revision of the text

8th July 2020

 

Updated on 01 May 2020

File name

ie-pl-mezavantxl-TII-025-clean-jan2020.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 01 May 2020

File name

ie-spc-mezavantxl-TII-025-clean-apr2020.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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)

Free text change information supplied by the pharmaceutical company

Summary of changes:

Section

Change

4.4          Special warnings and precautions for use

Addition of text:

Cases of nephrolithiasis 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.

4.8 Undesirable effects

Addition of adverse drug reaction under renal and urinary disorders:

Nephrolithiasis*

10 Date of revision of the text

21st April 2020

Updated on 17 April 2020

File name

Mezavant-pl-1200mg-clean-Nov-19-TII-023.pdf

Reasons for updating

  • Previous version of PIL reinstated

Free text change information supplied by the pharmaceutical company

An incorrect version of the PIL was uploaded. The correct version has been reinstated. 

Updated on 17 April 2020

File name

Mezavant-spc-1200mg-clean-16Dec2019-TII-023.pdf

Reasons for updating

  • Previous version of SPC reinstated

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

Free text change information supplied by the pharmaceutical company

An incorrect version of the SmPC was uploaded. The previous version was reinstated. 

Updated on 08 April 2020

File name

uk-spc-mezavantxl-TII-025-clean.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)

Updated on 08 April 2020

File name

uk-pl-mezavantxl-TII-025-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 12 September 2019

File name

ie-spc-mezavantxl1200mg April 19.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

Section 4.4 Photosensitivity texts removed Section 4.8 Photosensitivity texts added; ADR Oligospermia (reversible) with frequency of not known added

Updated on 12 September 2019

File name

ie-mt-uk-pl-mezavantxl1200mg April 19.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 27 September 2017

Reasons for updating

  • New SPC for new product

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

Updated on 27 September 2017

File name

PIL_12952_845.pdf

Reasons for updating

  • New PIL for new product

Updated on 27 September 2017

Reasons for updating

  • 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)

Free text change information supplied by the pharmaceutical company

  • Addition of 2 adrs to section 4.8 ( Lupus-like syndrome, Intracranial pressure increased).
  • Change of adr contact from the IMB to the HPRA.
  • Subsequent change to date of revision of the text.

Updated on 27 September 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 19 April 2017

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 24 March 2016

Reasons for updating

  • Correction of spelling/typing errors

Updated on 02 September 2014

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

Section 4.4 Special warnings and precautions for use: addition of renal failure and interactional with laboratory tests.
Section 4.5 Interaction with other medicnial products and other forms of interactions: no interactions of Mezavant with amoxicillin, metronidazole and sulfamethoxazole.
Section 4.6 Fertility added to head of section.
Section 4.8 Undesirable effects: QRD update, ADRs update, System organ class updates, addition of reporting of suspected adverse reactions.
Section 5.1 Change of wording from Mode of action to Mechanism of action.
Section 5.2 Pharmacokinetic properties: addition of "approximately" in the sentence, Increased age resulted in increased systemic exposure (up to approximaley 2 fold, based on AUC0-t, AUC0-∞ and Cmax) to mesalazine and its metabolite N-acetyl-5-amniosalicylic acid but not affect the precentage of mesalazine absorbed.
change of heading from special patient populations to Hepatic Impairment.
Section 6.6 change of heading to, Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product.
Section 10, Change of revision date to February 2014

Updated on 22 August 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Addition of information on reporting a side effect.

Updated on 16 February 2012

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 9 - Date of renewal of authorisation
  • 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


Section 4.8: Update to the incidence category in line with the latest QRD. i.e Common (³1% and <10%) (³1/100 to <1/10)

Section 5.1: The Mezavant XL tablet contains a core of mesalazine (5-aminosalicylic acid)  1.2g formulated in a multi-matrix system. This system is coated with methacrylic acid copolymers, Type A and Type B methacrylic acid – methyl methacrylate copolymer (1:1) and methacrylic acid – methyl methacrylate copolymer (1:2), which are designed to  delay release of mesalazine until exposure to approximately  pH 7.

Section 6.1:

List of excipients

Tablet core:

Carmellose sodium

Carnauba Wax

Stearic Acid

Silica, Colloidal Hydrated

Sodium Starch Glycolate (Type A)

Talc

Magnesium Stearate

Film-coating:

Talc

Methacrylic Acid – Methyl Methacrylate Copolymer (1:1) Type A, Type B Methacrylic Acid – Methyl Methacrylate Copolymer (1:2)

Triethylcitrate

Titanium Dioxide (E171)

Red Ferric Oxide (E172)

Macrogol 6000

Section 6.4:

Store in the original package in order to protect from moisture

Section 9:

Date of last renewal: 13/12/2011 

 

Section 10:

3 February 2012

Updated on 15 February 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to further information section

Updated on 12 October 2010

Reasons for updating

  • 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 4.8 - 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 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

Section 4.4: Re-worded for clarification
Section 4.5: Updated and reworded for clarity
Section 4.8: Significant updates to this section have occured with the addition, removal and reclassification of the adverse drug reactions
Section 4.9: No case of overdose statement has been deleted
Section 5.1: Significant chnages to this section have occured
Section 5.2: Significant chnages to this section have occured
Section 10: Date of Revision of Text has been updated to October 2010.

Updated on 08 October 2010

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 01 April 2008

Reasons for updating

  • New SPC for new product

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

Updated on 01 April 2008

Reasons for updating

  • New PIL for new product