Mezavant XL
*Company:
Takeda Products Ireland LtdStatus:
No Recent UpdateLegal 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.
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4 Possible Side Effects |
Added:
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),… |
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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. |
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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). |
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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.
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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. |
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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. 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. |
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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. |
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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. |
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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. |
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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. |
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6.6 Special precautions for disposal |
Updated: Any unused medicinal product or waste material should be disposed of in accordance with local requirements. |
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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. |
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4.8 Undesirable effects |
Addition of adverse drug reaction under renal and urinary disorders: Nephrolithiasis* |
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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 4.5 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 (
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
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:
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 4.5: 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