Vesitirim 5mg Film-Coated tablets

Change of Address of the MAH Astellas Pharma Co., Ltd.

Change of address of MAH Holder Astellas Pharma Co., Ltd.

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

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

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

7     Marketing authorisation holder

Astellas Pharma Co. Ltd.

5 Waterside

Citywest Business Campus

Naas Road

Dublin 24

Ireland

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.

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

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 3.        PHARMACEUTICAL FORM

Correction of spelling typing errors:

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

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

Vesitirim 5mg Film-Coated Tablets SPC:

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