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: 12/09/19

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Summary of Product Characteristics last updated on medicines.ie: 12/9/2019

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Shire Pharmaceuticals Ireland Limited

Shire Pharmaceuticals Ireland Limited

Address: Shire Pharmaceuticals Ireland Limited, Block 2, Miesian Plaza, 50-58 Baggot St, Dublin 2, Ireland

Medical Information E-mail: medinfoEMEA@shire.com

Customer Care direct line: 01800837470

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 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 Tyvense 20mg, 40mg & 60mg Capsules, hard Active Ingredients Lisdexamfetamine dimesylate
Medicine Name Xagrid 0.5mg hard capsule Active Ingredients Anagrelide hydrochloride
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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 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

  • New SmPC for new product

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

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 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 PIL

Reasons for updating

  • New PIL for new product

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)