We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we'll assume that you are happy to receive all cookies on the medicines.ie website. Find out more

Takeda Products Ireland Ltd

First Floor, 3013 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 642 0021
Fax: +353 1 642 0020
Medical Information Direct Line: 1800 937970
Medical Information e-mail: DSO-UK@takeda.com
Medical Information Facsimile: +44 (0)1628 526 617
Summary of Product Characteristics last updated on medicines.ie: 20/03/2017
SPC Instanyl 50, 100 and 200 mcg nasal spray, solution in single-dose container

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 20/03/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • 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:   07-Mar-2017
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Change to section

Details of change

4.2 Posology and method of administration

Text in blue removed and text in red added:

 

Posology

Patients should be individually titrated to the dose that provides adequate analgesia with tolerable adverse drug reactions. Patients must be carefully monitored during the titration process.

Titration to a higher dose necessitates contact with the health care professional.

 

The dose of Instanyl for treatment of breakthrough pain was independent of the daily maintenance dose of opioid in the clinical studies (see section 5.1).

 

Maximum daily dose: Treatment of up to four breakthrough pain episodes, each with no more than two doses separated by at least 10 minutes.

 

Patients should wait at least 4 hours before treating another breakthrough pain episode with Instanyl during both titration and maintenance therapy. On exceptional occasions where a new episode occurs earlier, patients can use Instanyl to treat it but they must wait at least 2 hours before doing so. Dose adjustment of the background opioid therapy following pain reassessment should be considered if the patient frequently presents with breakthrough pain episodes that are less than 4 hours apart or with more than four breakthrough pain episodes per 24 hours.

...

 

Dose adjustment

Generally, the maintenance strength of Instanyl should be increased when a patient requires more than one dose per breakthrough pain episode for several consecutive episodes.

 

Dose adjustment of the background opioid therapy following pain reassessment should be considered may be required if the patient frequently consistently presents with breakthrough pain episodes that are less than 4 hours apart or with more than four breakthrough pain episodes per 24 hours.

 

If adverse reactions are intolerable or persistent, the strength should be reduced or treatment with Instanyl be replaced by other analgesics.

 

5.1 Pharmacological Properties

Text in blue removed and text in red added:

 

 

Clinical safety and efficacy

The efficacy and safety of Instanyl (50, 100 and 200 micrograms) have been assessed in two randomised, double-blind, cross-over, placebo-controlled pivotal studies in 279 opioid-tolerant adult cancer patients (age 32-86 years) with breakthrough pain (BTP). The patients had an average of 1 to 4 episodes per day while taking maintenance opioid therapy. Patients in the second pivotal study had earlier participated in the Instanyl pharmacokinetic study or in the first pivotal study.

 

The clinical studies demonstrated the efficacy and safety of Instanyl. No distinct correlation between the maintenance opioid dose and Instanyl doses have been established, however in the second pivotal study patients with low maintenance opioid dose tended to achieve effective pain relief with a correspondingly lower strength of Instanyl compared to patients taking higher levels of maintenance opioid dose. This was most distinct for patients ending on Instanyl 50 micrograms.

 

In the clinical studies in cancer patients, the most frequent strengths used were 100 and 200 micrograms; however, patients should be titrated to the optimal dose of Instanyl for treating BTP in cancer (see section 4.2).

 

 

10. Date of revision of the text

Updated text in red:

 

7th March 2017

 

Updated on 03/10/2016 and displayed until 20/03/2017
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   22-Sep-2016
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Change to section

Details of change

6.1 List of excipients

Text in blue removed and text in red added:

 

Sodium dihydrogen phosphate dihydrate

Disodium phosphate dihydrate

Purified water Water for injections

 

10. Date of revision of the text

Updated text in red:

 

22nd September 2016

Updated on 22/04/2016 and displayed until 03/10/2016
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors
  • Change to improve clarity and readability
Date of revision of text on the SPC:   01-Apr-2016
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

The date of revision has been updated to 01 April 2016.
Amends and improvements to text have been made to sections 2, 4,2, 4.4, 5.1, & 6.3.
Updated on 03/03/2016 and displayed until 22/04/2016
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   18-Feb-2016
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

CHANGE TO SECTION 6.3- reduction in shelf life from 42 months to 36 months for single dose 100mcg product only

Updated on 08/10/2015 and displayed until 03/03/2016
Reasons for adding or updating:
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   17-Sep-2015
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Change to section

Details of change

6.4 Special precautions for storage

Added:

Keep the blister in the outer carton. Keep stored upright.

 

 

10. DATE OF REVISION OF THE TEXT

 

Changed to:

17th September 2015

Updated on 30/03/2015 and displayed until 08/10/2015
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   05-Mar-2015
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Change to section

Details of change

4.6. Fertility, pregnancy and lactation

Changed:

Breast-feeding

Fentanyl passes into breast milk and may cause sedation and respiratory depression in the breast-fed child. Fentanyl should not be used by breastfeeding women and breastfeeding should not be restarted until at least 48 hours 5 days after the last administration of fentanyl.

 

 

 

4.8. Undesirable Effects

 Added:

Fatigue, malaise peripheral oedema, withdrawal syndrome*

*opioid withdrawal symptoms such as nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating have been observed with transmucosal fentanyl

10. DATE OF REVISION OF THE TEXT

 

Changed to:

05th March 2015

Updated on 17/09/2014 and displayed until 30/03/2015
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:   15-Aug-2014
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



SECTION 7. MARKETING AUTHORISATION HOLDER- has the name change approval to the following:

 

Takeda Pharma A/S

Dybendal Alle 10

DK-2630 Taastrup

Denmark

 

SECTION 10. DATE OF REVISION OF THE TEXT

15th August 2014

Updated on 12/05/2014 and displayed until 17/09/2014
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
  • Change to improve clarity and readability
Date of revision of text on the SPC:   23-Apr-2014
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



The minor wording changes in the updated Instanyl (fentanyl citrate) SmPC, contain general formatting and re wording with no impact on the actual context.

 

The updated Instanyl SmPC contains additional/amended information in the following section(s):

 

Change to section

Details of change

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Changed:

‘‘For a full list of excipients’’

 

to

 

‘’For the full list of excipients’’

 

4.2. Posology and method of administration

Formatting:

Font italic; No underlined headings.

 

Paediatric population section moved after Renal impairment section.

 

4.3. Contraindications

Added:

‘’ Hypersensitivity to the active substance or to any of the excipients listed in section 6.1’’

 

4.4.  Special warnings and precautions for use

 

Changed/exclusion:

Respiratory depression

As with all potent opioids cClinical significant respiratory depression may occur with fentanyl

 

to

 

Respiratory depression

‘’Clinical significant respiratory depression may occur with fentanyl’’

 

The exclusion of:

‘’Treatment with other nasally administered medicinal products

When initiating treatment with Instanyl, alternative administration forms should be considered for concurrent treatment of concomitant diseases that can be treated via nasal administration’’.

 

4.8. Undesirable effects

Formatting:

Underlined headings.

 

5.1. Pharmacodynamic properties

Changed:

‘’Pharmacodynamic effects’’

to

‘’Clinical safety and efficacy’’

5.2     Pharmacokinetic properties

Formatting:

Font Not italic; Underlined headings

10. DATE OF REVISION OF THE TEXT

 

Changed to:

23rd April 2014

 

Updated on 17/04/2014 and displayed until 12/05/2014
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • 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 10 - Date of revision of the text
Date of revision of text on the SPC:   28-Feb-2014
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Change to section

Details of change

4.3. Contradictions

Added:

‘‘Patients without maintenance opioid therapy as there is an increased risk of respiratory depression’’

 

‘’Treatment of acute pain other than breakthrough pain’’

4.4. Special warnings and precautions for use

Changed/Added:

Fentanyl may produce bradycardia. Fentanyl should therefore be administered used with caution to in patients with previous or pre-existing bradyarrhythmias

 

Added:

Serotonin Syndrome

Caution is advised when Instanyl is coadministered with drugs that affect the serotoninergic neurotransmitter systems.

 

The development of a potentially life-threatening serotonin syndrome may occur with the concomitant use of serotonergic drugs such as Selective Serotonin Re-uptake Inhibitors (SSRIs) and Serotonin Norepinephrine Re-uptake Inhibitors (SNRIs), and with drugs which impair metabolism of serotonin (including Monoamine Oxidase Inhibitors [MAOIs]). This may occur within the recommended dose.

 

Serotonin syndrome may include mental-status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular abnormalities (e.g., hyperreflexia, incoordination, rigidity), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea).

 

If serotonin syndrome is suspected, treatment with Instanyl should be discontinued’’

 

 

 

4.5. Interaction with other medicinal products and other forms of interaction

Added:

‘’Coadministration of fentanyl with a serotoninergic agent, such as a Selective Serotonin Re uptake Inhibitor (SSRI) or a Serotonin Norepinephrine Re uptake Inhibitor (SNRI) or a Monoamine Oxidase Inhibitor (MAOI), may increase the risk of serotonin syndrome, a potentially life threatening condition’’

 

Changed:

‘’Monoamine Oxidase MAO’’ to ‘’ a Monoamine Oxidase Inhibitor MAOI’’

 

4.6  Fertility, pregnancy and lactation

 

Changed:

Breastfeeding

Fentanyl is excreted into human milk and may cause sedation and respiratory depression in the breast-fed infant. Fentanyl should only be used by breastfeeding women if the benefits outweigh the potential risks for both mother and child” to

 

‘’Breast-feeding

Fentanyl passes into breast milk and may cause sedation and respiratory depression in the breast-fed child. Fentanyl should not be used by breastfeeding women and breastfeeding should not be restarted until at least 48 hours after the last administration of fentanyl’’

 

4.8. Undesirable effects

 

 

 

 

 

 

 

 

 
Tabular list of adverse reactions














4.8. Undesirable effects- how to report a side  

 

 

 

Added:

‘’Tabular list of adverse reactions’’

 

‘’The following adverse reactions have been reported with Instanyl and/or other fentanyl-containing compounds during clinical studies and post marketing experience’’

 

 

 

 

‘’Injury, poisoning and procedural complications’’

Not known: Fall

 

General disorders and administration site conditions:

Not known: ‘’Fatigue, malaise peripheral oedema’’

 

Gastrointestinal disorders

Not known: ‘’ Diarrhoea’’

 

Nervous system disorders:

Not known: ‘’ Convulsion’’

 

 

 

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 to Pharmacovigilance Section, Irish Medicines Board, Kevin O'Malley House, Earlsfort Centre, Earlsfort Terrace, IRL – Dublin 2. Tel: +353 1 6764971, Fax: +353 1 6767836, Website: www.imb.ie. e-mail:imbpharmacovigilance@imb.ie. 

 

 

 

 

 

 

10. DATE OF REVISION OF THE TEXT

 

Changed to:

28th February 2014

 

Updated on 16/09/2013 and displayed until 17/04/2014
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   01-Sep-2013
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



MAH name change approved to:

Takeda Pharma A/S
Langebjerg 1
DK-4000 Roskilde
Denmark
Tel.: +45 4677 1111

 

Updated on 11/07/2013 and displayed until 16/09/2013
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   21-Mar-2013
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Section 4.8 Undesirable effects: Nasal septum perforation has been added as a recognised side effect within the side effects table. Frequency- not known

Date of revision of text has been amended to 21st March 2013

Updated on 13/09/2012 and displayed until 11/07/2013
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   09-Aug-2012
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

As this is a joint SmPC, all strengths in the range are included. The recent changed to increase the shelf-life only applies to the two higher strengths (100 and 200 mcg) and not to the 50 mcg strength. Section 10 has therefore been revised as follows:

100 and 200 mcg - 9th August 2012
50 mcg – 9th August 2011

Updated on 28/08/2012 and displayed until 13/09/2012
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   09-Aug-2012
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

In section 6.3, the shelf-life has been changed

50 mcg/dose : 23 months - unchanged

100 mcg/dose: 42 months

200 mcg/dose: 42 months

Updated on 12/10/2011 and displayed until 28/08/2012
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

None provided

Document Links

 
  View all medicines
from this company
View Document
Bookmark and Share

Active Ingredients

 
   fentanyl citrate