Mezavant XL

  • Name:

    Mezavant XL

  • Company:
    info
  • Active Ingredients:

    Mesalazine

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/07/20

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Summary of Product Characteristics last updated on medicines.ie: 20/7/2020

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Shire Pharmaceuticals Ireland Limited

Shire Pharmaceuticals Ireland Limited

Company Products

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Medicine Name Buccolam 2.5mg, 5mg, 7.5mg and 10mg oromucosal solution Active Ingredients Midazolam Hydrochloride
Medicine Name Cinryze 500 IU powder and solvent for solution for injection Active Ingredients C1 inhibitor (human)
Medicine Name Equasym XL 10, 20 & 30mg Modified Release Capsules Active Ingredients Methylphenidate Hydrochloride
Medicine Name Firazyr 30 mg solution for injection in pre-filled syringe Active Ingredients Icatibant Acetate
Medicine Name Foznol 250mg, 500mg, 750mg & 1000mg Chewable Tablets Active Ingredients Lanthanum Carbonate Hydrate
Medicine Name Intuniv 1mg, 2mg, 3mg, 4mg prolonged-release tablets Active Ingredients Guanfacine hydrochloride
Medicine Name Mezavant XL Active Ingredients Mesalazine
Medicine Name Natpar 25, 50, 75, 100 micrograms/dose powder and solvent for solution for injection in pre filled pen Active Ingredients Parathyroid Hormone
Medicine Name Reminyl Oral Solution Active Ingredients Galantamine Hydrobromide
Medicine Name Reminyl XL 8mg, 16mg and 24 mg prolonged release capsules Active Ingredients Galantamine Hydrobromide
Medicine Name Resolor 1 mg film-coated tablets Active Ingredients Prucalopride Succinate
Medicine Name Resolor 2 mg film-coated tablets Active Ingredients Prucalopride Succinate
Medicine Name Tyvense 20mg, 30mg, 40mg, 50mg. 60mg & 70mg Capsules, hard Active Ingredients Lisdexamfetamine dimesylate
Medicine Name Xagrid 0.5mg hard capsule Active Ingredients Anagrelide hydrochloride
1 - 0 of 14 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 20 July 2020 PIL

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 SmPC

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 1 May 2020 PIL

Reasons for updating

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

Updated on 1 May 2020 SmPC

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 PIL

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 SmPC

Reasons for updating

  • Previous version of SmPC 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 8 April 2020 SmPC

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 8 April 2020 PIL

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 SmPC

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 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 27 September 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 27 September 2017 SmPC

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 PIL

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 27 September 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 19 April 2017 PIL

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 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 2 September 2014 SmPC

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 PIL

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 SmPC

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 PIL

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 SmPC

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 8 October 2010 PIL

Reasons for updating

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

Updated on 1 April 2008 SmPC

Reasons for updating

  • New SPC for new product

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

Updated on 1 April 2008 PIL

Reasons for updating

  • New PIL for new product