Vesitirim 10mg Film-coated Tablets

  • Name:

    Vesitirim 10mg Film-coated Tablets

  • Company:
    info
  • Active Ingredients:

    Solifenacin succinate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 27/03/19

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Summary of Product Characteristics last updated on medicines.ie: 12/5/2018
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Astellas Pharma Co. Ltd

Astellas Pharma Co

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Medicine Name Prograf Concentrate for Infusion Active Ingredients Tacrolimus
Medicine Name Vesitirim 1 mg/ml oral suspension Active Ingredients Solifenacin succinate
Medicine Name Vesitirim 10mg Film-coated Tablets Active Ingredients Solifenacin succinate
Medicine Name Vesitirim 5mg Film-Coated tablets Active Ingredients Solifenacin succinate
Medicine Name Vesomni 6 mg/0.4 mg modified release tablets Active Ingredients Solifenacin succinate, Tamsulosin Hydrochloride
Medicine Name Xtandi 40 mg soft capsules Active Ingredients enzalutamide
Medicine Name Zepholin SR 100mg Prolonged Release Capsules Active Ingredients Theophylline
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1 - 0 of 23 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 27 March 2019 PIL

Reasons for updating

  • Change to date of revision

Updated on 26 March 2019 PIL

Reasons for updating

  • Change to date of revision

Updated on 12 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 21 July 2015 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 21 July 2015 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

The section on reporting of side-effects has been amended to include the HPRA e-mail adress

Updated on 2 June 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 June 2015 SmPC

Reasons for updating

  • 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

HPRA contact details revised in section 4.8 regarding reporting of side-effects
Date of revision updated to May 2015

Updated on 2 June 2015 PIL

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 20 February 2014 SmPC

Reasons for updating

  • Change to improve clarity and readability

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

Free text change information supplied by the pharmaceutical company

correction to section 10. year was not included in previous upload

Updated on 3 January 2014 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 20 December 2013 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.3 - Preclinical safety data
  • 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

4.8     Undesirable effects

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the online reporting option (preferred method) accessible from the IMB homepage (www.imb.ie).  A downloadable report form is also accessible from the IMB website, which may be completed manually and submitted to the IMB via ‘freepost’ (see details below). Alternatively, the traditional post-paid ‘yellow card’ option may also be used.

 

FREEPOST

Pharmacovigilance Section

Irish Medicines Board

Kevin O’Malley House

Earlsfort Centre

Earlsfort Terrace

Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

 

5.3     Preclinical safety data

 

Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, fertility, embryofetal development, genotoxicity, and carcinogenic potential. In the pre- and postnatal development study in mice, solifenacin treatment of the mother during lactation caused dose-dependent lower postpartum survival rate, decreased pup weight and slower physical development at clinically relevant levels. Dose related increased mortality without preceding clinical signs occurred in juvenile mice treated from day 10 or 21 after birth with doses that achieved a pharmacological effect and both groups had higher mortality compared to adult mice. In juvenile mice treated from postnatal day 10, plasma exposure was higher than in adult mice; from postnatal day 21 onwards, the systemic exposure was comparable to adult mice. The clinical implications of the increased mortality in juvenile mice are not known.

 

10.     DATE OF REVISION OF THE TEXT

 

December August 2013

 

 

 

 

Updated on 19 September 2013 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 5.1 - Pharmacodynamic 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

4.4     Special warnings and precautions for use

 

 

Vesitirim should be used with caution in patients with:

-        clinically significant bladder outflow obstruction at risk of urinary retention.

-        gastrointestinal obstructive disorders.

-        risk of decreased gastrointestinal motility.

-        severe renal impairment (creatinine clearance ≤  30 ml/min; see Section 4.2 and 5.2), and doses should not exceed 5 mg for these patients.

-        moderate hepatic impairment (Child-Pugh score of 7 to 9; see Section 4.2 and 5.2), and doses should not exceed 5 mg for these patients.

-        concomitant use of a potent CYP3A4 inhibitor, e.g. ketoconazole (see 4.2 and 4.5).

-        hiatus hernia/gastro-oesophageal oesophagal reflux and/or who are concurrently taking medicinal products (such as bisphosphonates) that can cause or exacerbate oesophagitis.

-        autonomic neuropathy.

QT prolongation and Torsade de Pointes have been observed in patients with risk factors, such as pre-existing long QT syndrome and hypokalaemia hypokalaemis.

 

4.8     Undesirable effects

 

Tabulated list of adverse reactions

 

MedDRA system organ class

Very common ≥1/10

Common

≥1/100, <1/10

Uncommon

≥1/1000, <1/100

Rare

≥ 1/10000, <1/1000

Very rare

<1/10,000

Not known (cannot be estimated from the available Ddata)

Infections and infestations

 

 

Urinary tract infection

Cystitis

 

 

 

Immune system disorders

 

 

 

 

 

Anaphylactic reaction*

Metabolism and nutrition disorders

 

 

 

 

 

Decreased appetite*

Hyperkalaemia*

Psychiatric disorders

 

 

 

 

Hallucinations*, Confusional state*

Delerium Delirium*

Nervous system disorders

 

 

Somnolence

Dysgeusia

Dizziness*, Headache*

 

 

Eye disorders

 

Blurred vision

Dry eyes

 

 

Glaucoma*

Cardiac disorders

 

 

 

 

 

Torsade de Pointes*

Electrocardiogram QT prolonged*

Atrial fibrillation*

Palpitations*

Tachycardia*

Respiratory, thoracic and mediastinal disorders

 

 

Nasal dryness

 

 

Dysphonia*

Gastrointestinal disorders

Dry mouth

Constipation
Nausea
Dyspepsia
Abdominal pain

Gastro-oesophageal reflux diseases

Dry throat

Colonic obstruction

Faecal impaction, Vomiting*

 

Ileus*

Abdominal discomfort*

Hepatobiliary disorders

 

 

 

 

 

Liver disorder*

Liver function test abnormal*

Skin and subcutaneous tissue disorders

 

 

Dry skin

Rash*, ,

Pruritus

Erythema multiforma*, Urticaria*, Angioedema*

Exfoliative dermatitis*

Musculoskeletal and connective tissue disorders

 

 

 

 

 

Muscular weakness*

Renal and urinary disorders

 

 

Difficulty in micturition

Urinary retention

 

Renal impairment*

General disorders and administration site conditions

 

 

Fatigue Peripheral oedema

 

 

 

 

5.       PHARMACOLOGICAL PROPERTIES

 

5.1     Pharmacodynamic properties

 

Pharmacodynamic effects

Treatment with Vesitirim in doses of 5 mg and 10 mg daily was studied in several double blind, randomised, controlled clinical trials in men and women with overactive bladder.

As shown in the table below, both the 5 mg and 10 mg doses of Vesitirim produced statistically significant improvements in the primary and secondary endpoints compared with placebo. Efficacy was observed within one week of starting treatment and stabilises stabilised over a period of 12 weeks.

 

10.     DATE OF REVISION OF THE TEXT

 

August 2013  Jan 2013

Updated on 18 September 2013 PIL

Reasons for updating

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

Updated on 4 July 2013 SmPC

Reasons for updating

  • Change to improve clarity and readability

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

Free text change information supplied by the pharmaceutical company

Correction of spacing errors

Updated on 14 June 2013 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 12 March 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects

Updated on 11 March 2013 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

In section 2.0 (QUALITATIVE AND QUANTITATIVE COMPOSITION); text has been re-worded with minimal effect.

In section 4.2 (
Posology and method of administration); title "Children and adolescents" has been replaced by "Paediatric population". In main text; the "effectiveness" has been replaced by "efficacy of Vesitirim". "Special populations" heading has been deleted.

In section 4.3 Contraindications:
Reference to section 6.1 newly included i.e. "excipients listed in 6.1".

In section 4.4 Special warnings & precautions for use:
Sentence added "
QT prolongation and Torsade de Pointes have been observed in patients with risk factors, such as pre-existing long QT syndrome and Hypokalaemia."
Further new text added to 4.4 is "Anaphylactic reaction has been reported in some patients treated with solifenacin succinate. In patients who develop anaphylactic reactions, solifenacin succinate shold be discontinued and appropriate therapy and/or measures should be taken."

In section 4.6 Fertility, pregnancy and lactation:
heading "Lactation" has been replaced by "Breast-feeding"

In section 4.8 Undesirable Effects, new heading included after main heading "Summary of the safety profile".
Second new heading added "Tabulated list of adverse reactions".
Also multiple updates made to tabulated list of adverse reactions:
New additions:
"Immune system disorders" - "Anaphylactic reaction*"
"Metabolism and nutrition disorders - "Decreased appetite*", "Hyperkalaemia"
Psychiatric disorders - "Delerium*"
Eye disorders - "Glaucoma*"
"Cardiac disorders - Torsades de Pointes*, Electrocardiogram QT prolonged*"
Resp, thoracic & mediastinal dosorders - "Dysphonia*"
Gastrointestinal disorders -"Ileus*, Abnormal discomfort"
Hepatobiliary disorders -Liver disorder*, Liver function test abnormal*"

 Skin and subcutaneous tissue disorders - "Exfoliative dermatitis*"
"Musculoskeletal and connective tissue disorders - Muscular Weakness*"
Renal and Urinary disorders -"Renal Impairment*"

In section 5.2 Pharmacokinetics,
the heading " General Characteristics" has been deleted.
the heading "Metabolism" has been replaced by
"Biotransformation"
the heading "Excretion" has been replaced by "
Elimination"
the heading "Dose Proportionality" has been replaced by
"Linearity/non-linearity"
the heading "Characteristics in patients" has been replaced by "Other special populations"
the heading "Age" has been replaced by "Elderly"

In section 6.1 List of excipients, "Film coating" replaces "Film Coating"

In section 10, the date of revision of the text has been updated to
"January 2013"

Updated on 17 August 2012 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 25 July 2012 SmPC

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

7     Marketing authorisation holder

Astellas Pharma Co. Ltd.

5 Waterside

Citywest Business Campus

Naas Road

Dublin 24

Ireland

Updated on 14 March 2012 PIL

Reasons for updating

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

Updated on 26 October 2011 SmPC

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

Angioedema with airway obstruction has been reported in some patients on solifenacin succinate. If angioedema occurs, solifenacin succinate should be discontinued and appropriate therapy and/or measures should be taken.

Updated on 21 July 2010 PIL

Reasons for updating

  • Change of manufacturer

Updated on 20 November 2009 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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 6.5     Nature and contents of container

Included:

Or 200 tablets

 

Section 9. Date of First Authorisation/Renewal of authorisation.

 

Included: Date of last renewal: 22 May 2009

 

Section 10.     DATE OF REVISION OF THE TEXT

Updated from May 2009 to Oct 2009

Updated on 3 October 2009 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • 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     Undesirable effects-

The following Very rare  side effects included: Confusional state* Erythema multiforme*

 

Following paragraph included:

QT prolongation and Torsade de Pointes have been reported in association with solifenacin use in worldwide post marketing experience. Because these spontaneously reported events are from the worldwide post marketing experience, the frequency of events and the role of solifenacin in their causation cannot be reliably determined.

 

Section 6.3     Shelf life

 

Following paragraph included:

After first opening of the bottles, the tablets can be stored for 6 months. Keep the bottle tightly closed.

Section 6.5     Nature and contents of container

Included:

or in HDPE bottles with PP cap

100 tablets (not all pack sizes may be marketed).

 

Section 10.     DATE OF REVISION OF THE TEXT

Updated from Sept 2008 to May 2009

Updated on 24 September 2009 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 29 October 2008 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • 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 1 Name of Medicinal Product

Vesitirim TM changed to Vesitirim

 

 

Section 2.        QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Addition of :

 

For excipients, see Section 6.1. has been changed to For a full list of excipients, see Section 6.1.

 

Addition of: Excipients: Lactose monohydrate (107.5mg)

 

 

Section 3.        PHARMACEUTICAL FORM

 

Yamanouchi logo changed to read  logo

 

Section 4.8      Undesirable effects

 

Table updated from:

 

The table below reflects the data obtained with Vesitirim in clinical trials.

 

MedDRA system organ class

Common

 >1/100, <1/10

Uncommon

 >1/1000, <1/100

Rare                    

 > 1/10000, <1/1000

Gastrointestinal disorders

Constipation
Nausea
Dyspepsia
Abdominal pain

Gastroesophageal reflux diseases

Dry throat

Colonic obstruction

Faecal impaction

Infections and infestations

 

Urinary tract infection

Cystitis

 

Nervous system disorders

 

Somnolence

Dysgeusia

 

Eye disorders

Blurred vision

Dry eyes

 

General disorders and administration site conditions

 

Fatigue

Oedema lower limb

 

Respiratory, thoracic and mediastinal disorders

 

Nasal dryness

 

Skin and subcutaneous tissue disorders

 

Dry skin

 

Renal and urinary disorders

 

Difficulty in micturition

Urinary retention

 

Allergic reactions were not observed during the clinical development. However, the occurrence of allergic reactions can never be excluded.

 

 

To

 

 

MedDRA system organ class

Very common ≥1/10

Common

>1/100, <1/10

Uncommon

>1/1000, <1/100

Rare

> 1/10000, <1/1000

Very rare

<1/10,000, not known (cannot be estimated from the available data)

Infections and infestations

 

 

Urinary tract infection

Cystitis

 

 

Psychiatric disorders

 

 

 

 

Hallucinations*

Nervous system disorders

 

 

Somnolence

Dysgeusia

 

Dizziness*, Headache*

Eye disorders

 

Blurred vision

Dry eyes

 

 

Respiratory, thoracic and mediastinal disorders

 

 

Nasal dryness

 

 

Gastrointestinal disorders

Dry mouth

Constipation
Nausea
Dyspepsia
Abdominal pain

Gastro-oesophageal reflux diseases

Dry throat

Colonic obstruction

Faecal impaction

Vomiting*

Skin and subcutaneous tissue disorders

 

 

Dry skin

 

Pruritus*, Rash*, Urticaria*

Renal and urinary disorders

 

 

Difficulty in micturition

Urinary retention

 

General disorders and administration site conditions

 

 

Fatigue Peripheral oedema

 

 

* observed post-marketing

 

 

Section 4.9      Overdose

 

Omitted:

The highest dose of solifenacin succinate given to human volunteers was 100 mg as a single dose. At this dose, the most frequent adverse events were headache (mild), dry mouth (moderate), dizziness (moderate), drowsiness (mild) and blurred vision (moderate).

 

No cases of acute overdose have been reported. In the event of overdose with solifenacin succinate, the patient should be treated with activated charcoal. Gastric lavage may be performed, but vomiting should not be induced.

 

 

 

 

Added:

Treatment

In the event of overdose with solifenacin succinate the patient should be treated with activated charcoal. Gastric lavage is useful if performed within 1 hour, but vomiting should not be induced.

 

 

Section  9.      DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Changed from 13 August 2004

 To

Date of first authorisation: 13 August 2004

 

 

Section 10.      DATE OF REVISION OF THE TEXT

 

Changed from November 2005 to September 2008

Updated on 18 September 2008 PIL

Reasons for updating

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

Updated on 6 July 2006 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 26 June 2006 PIL

Reasons for updating

  • New PIL for medicines.ie