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Astellas Pharma Co. Ltd

5 Waterside, Citywest Business Campus, Naas Road, Dublin 24,
Telephone: +353 1 467 1555
Fax: +353 1 467 1550
Summary of Product Characteristics last updated on medicines.ie: 21/07/2015
SPC Vesitirim 5mg Film-Coated tablets

When a pharmaceutical company changes an SPC or PIL, 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 21/07/2015 and displayed until Current
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   02-Jun-2015
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 02/06/2015 and displayed until 21/07/2015
Reasons for adding or updating:
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   25-May-2015
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 20/12/2013 and displayed until 02/06/2015
Reasons for adding or 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
Date of revision of text on the SPC:   09-Dec-2013
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 (preferable 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

 

August December 2013

 

 

 

 

Updated on 19/09/2013 and displayed until 20/12/2013
Reasons for adding or 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
Date of revision of text on the SPC:   27-Aug-2013
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 Hhypokalaemia

 

Safety and efficacy have not yet been established in patients with a neurogenic cause for detrusor overactivity.

 

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

 

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

 

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*

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 Abnormal discomfort*

Hepatobiliary disorders

 

 

 

 

 

Liver disorder*

Liver function test abnormal*

Skin and subcutaneous tissue disorders

 

 

Dry skin

Pruritus*, Rash*,

Erythema multiformea* , Urticaria*

Angioedema*

Exfoliative dermatitis*

 

 

 

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 stabilizes stabilised over a period of 12 weeks.

 

10.     DATE OF REVISION OF THE TEXT

August 2013  Jan 2013

Updated on 11/03/2013 and displayed until 19/09/2013
Reasons for adding or 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 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   31-Jan-2013
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 25/07/2012 and displayed until 11/03/2013
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   25-Jun-2012
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 26/10/2011 and displayed until 25/07/2012
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   13-Sep-2011
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 20/11/2009 and displayed until 26/10/2011
Reasons for adding or 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
Date of revision of text on the SPC:   30-Oct-2009
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 03/10/2009 and displayed until 20/11/2009
Reasons for adding or 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
Date of revision of text on the SPC:   01-May-2009
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 08/01/2009 and displayed until 03/10/2009
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   09/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

 

 

Section 3.        PHARMACEUTICAL FORM

 

Correction of spelling typing errors:

 

Light-pink tablet was changed to read  light-yellow tablet.

Updated on 29/10/2008 and displayed until 08/01/2009
Reasons for adding or 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   09/2008
Legal Category:   prescription only

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 5.1      Pharmacodynamic properties

 

M3 changed to M3

 

Section 5.2      Pharmacokinetic properties

 

General Font Format changes

 

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 26/07/2006 and displayed until 29/10/2008
Reasons for adding or updating:
  • New individual SPC (was previously included in combined SPC)
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   11/2005
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Vesitirim 5mg Film-Coated Tablets:

 

New individual SPC (was previously included in a combined SPC)

 

Section 4.5: Change in the spelling of “ethinyl oestradiol” to “ethinylestradiol”

 

Section 6.3: Increase in shelf life to 3 years

 

Section 6.5: Addition of pack size of 20 tablets

 

Section 7: Marketing Authorisation Holder changed from Yamanouchi to Astellas Pharma Co. Ltd

 

Section 8: Marketing Authorisation Number changed to 1241/9/1

 

Section 10: Date of Revision of the Text changed to November 2005

Updated on 11/07/2006 and displayed until 26/07/2006
Reasons for adding or updating:
  • New individual SPC (was previously included in combined SPC)
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   11/2005
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Vesitirim 5mg Film-Coated Tablets SPC:

 
Changes:
 

New individual SPC (was previously included in a combined SPC)

 

Section 4.5: Change in the spelling of “ethinyl oestradiol” to “ethinylestradiol”

 

Section 6.3: Increase in shelf life to 3 years

 

Section 6.5: Addition of pack size of 20 tablets

 

Section 7: Marketing Authorisation Holder changed from Yamanouchi to Astellas Pharma Co. Ltd

 

Section 8: Marketing Authorisation Number changed to 1241/9/1

 

Section 10: Date of Revision of the Text changed to November 2005

Updated on 03/09/2004 and displayed until 11/07/2006
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
   Solifenacin succinate