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Spiriva

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Pharmacy Only: Prescription

Updated on 31 March 2023

File name

PIL 54412-21 04.01.2023 PIP007960-021 cropped.pdf

Reasons for updating

  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 6 - what the product looks like and pack contents
  • Improved presentation of PIL

Updated on 30 March 2023

File name

S8-E-SPC-26 - medicines.ie.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

  • Section 4.1: ‘Tiotropium’ has been replaced with ‘Spiriva’
  • Section 4.2: ‘Tiotropium Bromide’ has been replaced with ‘Spiriva’; Method of administration sub-section updated to include statement on how HandiHaler is designed; Instructions for use also updated
  • Section 4.6: Removal of a hyphen from ‘breast-feeding’ subheading
  • Section 5.1: Format changes
  • Section 7: Updated to remove “-D” from Marketing Authorisation Holder address
  • Section 10: The date of revision for the UK and IE SmPCs has been updated to March 2023


Editorial updates have been made throughout the SmPC to change ‘SPIRIVA’ to ‘Spiriva’.

Updated on 02 March 2023

File name

S8-E-SPC-24 - Approved.pdf

Reasons for updating

  • Document format updated

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

Updated on 23 December 2020

File name

PIL text med.ie.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 14 January 2019

File name

Cropped Leaflet - 54412-18 22.11.2018 PIP007960-018-AMT 90121.pdf

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 14 January 2019

File name

S8-E-SPC-24 - Approved.pdf

Reasons for updating

  • 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 6.5: To add polycarbonate (“PC”, tradename Lexan HP2EU) as alternative plastic material for one of the components (capsule chamber) of the inhalation device.
  • Section 10: Date of revision has been updated to January 2019

Updated on 09 May 2018

Reasons for updating

  • New SPC for new product

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

Updated on 23 May 2017

File name

PIL_13886_752.pdf

Reasons for updating

  • New PIL for new product

Updated on 23 May 2017

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • 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 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 18 May 2017

Reasons for updating

  • New SPC for new product

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

Updated on 18 May 2017

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.3 - 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • 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 9 - Date of first authorisation/renewal of the 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

The main changes are re-wording existing contraindications (section 4.3) and including additional information in Quantitative and Qualitative Composition (section 2), Pharmaceutical form (section 3), Special Warnings and Precautions (4.4) and List of excipients (6.1).  The other section changes are minor re-wording of existing texts or editorial.

Updated on 05 January 2015

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 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

The main aim was to add the results of the Tiospir study

SPC sections affected by the variation are 4.4, 4.5, 4.6, 4.8, 5.1 and 5.2 and 10

Updated on 18 December 2014

Reasons for updating

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

Updated on 22 November 2013

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

Section 4.8 has been updated to include ‘anaphylactic reaction’ with frequency ‘unknown’ in the list of side effects.

Section 10 Date of revision has been revised to 10/2013.

Updated on 07 November 2013

Reasons for updating

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

Updated on 26 June 2013

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic 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 main changes are to include COPD and cystic fibrosis paediatric waivers in section 5.1 and paediatric use on section 4.2 to comply with the paediatric regulation. Other additional minor revisions have been made to sections 2, 4.2, 4.6, 5.1 and 6.6. The date of revision of the text (section 10) has also been amended.

Updated on 24 June 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration
  • Change of special precautions for disposal

Updated on 08 April 2013

Reasons for updating

  • Change in co-marketing arrangement

Updated on 04 July 2012

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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

The main change is to Section 5.1 - Pharmacodynamic Properties which has been updated with clinical information from the POET-COPD trial

Minor revisions have been made to the following sections:
Section 4.2 - Posology and Method of Administration
Section 4.4 - Special Warnings and Special Precautions for Use
Section 4.6 - Fertility, Pregnancy and Lactation
Section 4.8 - Undesirable Effects
Section 5.2 - Pharmacokinetic Properties
Section 5.3 - Preclinical Safety Data
Section 6.5 - Nature and Contents of Container
Section 10 - Date of Revision of the Text

Updated on 14 June 2012

Reasons for updating

  • Change to side-effects
  • Change to further information section
  • Change to date of revision

Updated on 15 March 2011

Reasons for updating

  • Change in co-marketing arrangement

Updated on 26 May 2010

Reasons for updating

  • 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

Section 5.1:

 

The following section has been deleted:

While the SGRQ subdomains "activity" and "impact on daily life" were not improved significantly, the improvement on total score resulted from a marked improvement in the SGRQ subdomain disease related "symptoms".

 

The following section has been added:

The improvements of the subdomains of the SGRQ-score were 8.19 units for “symptoms”, 3.91 units for “activity” and 3.61 units for “impact on daily life”. The improvements of all these separate subdomians were statistically significant.

 

Section 10:

Date has been revised to May 2010.

Updated on 25 March 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 16 July 2009

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company



Section 4.8 - Updated frequencies of adverse events following a pooled analysis of 26 placebo-controlled clinical trials (including the UPLIFT trial).

Section 5.1 - Updated to include information from the UPLIFT trial. The following paragraph has been added:

 

In a 4-year, randomised, double-blind, placebo-controlled clinical trial of 5,993 randomised patients (3,006 receiving placebo and 2,987 receiving Spiriva), the improvement in FEV1 resulting from Spiriva, compared with placebo, remained constant throughout 4 years. A higher proportion of patients completed ≥ 45 months of treatment in the Spiriva group compared with the placebo group (63.8% vs. 55.4%, p<0.001). The annualized rate of decline of FEV1 compared to placebo was similar between Spiriva and placebo. During treatment, there was a 16% reduction in the risk of death. The incidence rate of death was 4.79 per 100 patient years in the placebo group vs. 4.10 per 100 patient years in the tiotropium group (hazard ratio (tiotropium/placebo) = 0.84, 95% CI = 0.73, 0.97). Treatment with tiotropium reduced the risk of respiratory failure (as recorded through adverse event reporting) by 19% (2.09 vs. 1.68 cases per 100 patient years, relative risk (tiotropium/placebo) = 0.81, 95% CI = 0.65, 0.999).

 

 

 

 

 

Updated on 11 November 2008

Reasons for updating

  • New PIL for medicines.ie

Updated on 02 May 2008

Reasons for updating

  • 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

Electrophysiology: In a dedicated QT study involving 53 healthy volunteers, SPIRIVA 18 mcg and 54 mcg (i.e. three times the therapeutic dose) over 12 days did not significantly prolong QT intervals of the ECG.

 

·         In a 9-month, randomized, double-blind, placebo-controlled clinical trial of 492 patients, SPIRIVA improved health-related quality of life as determined by the St. George’s Respiratory Questionnaire (SGRQ) total score. The proportion of patients treated with SPIRIVA which achieved a meaningful improvement in the SGRQ total score (i.e. > 4 units) was 10.9% higher compared with placebo (59,1% in the SPIRIVA groups vs. 48.2% in the placebo group (p=0.029). The mean difference between the groups was 4.19 units (p=0.001; confidence interval: 1.69 – 6.68). While the SGRQ subdomains "activity" and "impact on daily life" were not improved significantly, the improvement on total score resulted from a marked improvement in the SGRQ subdomain disease related "symptoms

Updated on 03 March 2008

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 Spiriva HandiHaler has been modified with new improved handling features. To make it easier for patients to take Spiriva the HandiHaler the dust cap and mouthpiece have been redesigned.  The opening function of the HandiHaler has been improved so patients can now open the dust cap by pressing the green button on the side of the HandiHaler. In addition, the mouthpiece has now been redesigned and features a lip at the base of the mouthpiece to enable easier grip when lifting the mouthpiece.

Updated on 15 May 2007

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • 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 information for the "what's new" section of the site is as follows:

Section 4.2 (Posology and method of administration): Instruction on how to use the HandiHaler device and administer Spiriva capsules has moved from section 6.6 to section 4.2).

Section 4.7 (Effects on ability to drive and use machines) has been updated and now states " No studies on the effects on the ability to drive and use machines have been performed. The occurrence of dizziness, blurred vision, or headache may influence the ability to drive and use machinery". It was previous advised that there was no evidence for a potential influence on the ability to drive and use machines.

Section 4.8 (Undesirable effects) has been updated to include information on the incidence of adverse drug reactions from 5,437 patients on Spiriva in 19 pooled placebo controlled clinical studies. Taste disorders, dyphonia, dental caries, dysphagia, intestinal obstruction and urinary tract infection have been added to the list of undesirable effects.

Updated on 23 June 2006

Reasons for updating

  • 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

Section 5.1
 
The following information has been added:
 

"In a randomized, double-blind, placebo controlled trial of 1,829 patients with moderate to very severe COPD, tiotropium bromide statistically significantly reduced the proportion of patients who experienced exacerbations of COPD (32.2% to 27.8%) and statistically significantly reduced the number of exacerbations by 19% (1.05 to 0.85 events per patient year of exposure). In addition, 7.0% of patients in the tiotropium bromide group and 9.5% of patients in the placebo group were hospitalized due to a COPD exacerbation (p=0.056).  The number of hospitalizations due to COPD was reduced by 30% (0.25 to 0.18 events per patient year of exposure)".

Updated on 13 April 2006

Reasons for updating

  • 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)

Updated on 07 March 2006

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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)

Updated on 11 March 2005

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 10 - Date of revision of the text

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

Updated on 20 October 2004

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

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

Updated on 22 June 2004

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life

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

Updated on 19 June 2003

Reasons for updating

  • New SPC for medicines.ie

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