Instanyl 50, 100 and 200 mcg nasal spray, solution in single-dose container

  • Name:

    Instanyl 50, 100 and 200 mcg nasal spray, solution in single-dose container

  • Company:
    info
  • Active Ingredients:

    fentanyl citrate

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 24/10/19

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 24/10/2019

Click on this link to Download PDF directly

Takeda Products Ireland Ltd

Takeda Products Ireland Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Actos tablets Active Ingredients pioglitazone hydrochloride
Medicine Name Adcetris 50 mg powder for concentrate for solution for infusion Active Ingredients Brentuximab vedotin
Medicine Name Alofisel 5 million cells/mL suspension for injection Active Ingredients Human Allogeneic Mesenchymal Adult Stem Cells
Medicine Name Alunbrig Active Ingredients Brigatinib
Medicine Name Blopress Plus Tablets Active Ingredients Candesartan Cilexetil, Hydrochlorothiazide
Medicine Name Blopress tablets Active Ingredients Candesartan Cilexetil
Medicine Name Calcichew 500mg Chewable Tablets Active Ingredients Calcium Carbonate
Medicine Name Calcichew-D3 Forte Chewable Tablets Active Ingredients Calcium Carbonate, Colecalciferol (Vitamin D3)
Medicine Name Calcichew-D3 Forte Double Strength 1000 mg/800 IU chewable tablets Active Ingredients Calcium Carbonate, Colecalciferol (Vitamin D3)
Medicine Name Competact 15 mg/850 mg film-coated Tablets Active Ingredients Metformin Hydrochloride, pioglitazone hydrochloride
Medicine Name Condyline Cutaneous Solution 5 mg/ml Active Ingredients Podophyllotoxin
Medicine Name Edarbi Tablets Active Ingredients Azilsartan medoxomil potassium
Medicine Name Entyvio 300 mg powder for concentrate for solution for infusion Active Ingredients Vedolizumab
Medicine Name Instanyl 50, 100 and 200 mcg nasal spray, solution in single-dose container Active Ingredients fentanyl citrate
Medicine Name Matrifen Transdermal patch Active Ingredients Fentanyl
Medicine Name Mepact 4mg powder for suspension for infusion Active Ingredients Mifamurtide
Medicine Name Midon 2.5 mg Tablets Active Ingredients Midodrine Hydrochloride
Medicine Name Midon 5 mg Tablets Active Ingredients Midodrine Hydrochloride
Medicine Name NINLARO 2.3 mg, 3 mg, 4 mg hard capsules Active Ingredients Ixazomib Citrate
Medicine Name Prostap 3 DCS Active Ingredients Leuprorelin Acetate
Medicine Name Prostap 6 DCS Active Ingredients Leuprorelin Acetate
Medicine Name Prostap SR DCS Active Ingredients Leuprorelin Acetate
Medicine Name Protium 20mg Active Ingredients Pantoprazole sodium sesquihydrate
Medicine Name Protium 40mg Active Ingredients Pantoprazole sodium sesquihydrate
Medicine Name Protium 40mg iv Active Ingredients Pantoprazole sodium sesquihydrate
1 - 0 of 26 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 24 October 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 24 October 2019 SmPC

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

The following changes have been made to the SmPC:

 

Section

Changes

4.8          Undesirable effects

 

 

Added

Respiratory, thoracic and mediastinal disorders

dyspnoea

10.          DATE OF REVISION OF THE TEXT

10 October 2019

 

Updated on 22 August 2019 Ed-HCP

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

Pharmacist's Guide to Dispensing provides Instanyl dispensing checklist and required actions before Instanyl Single Dose Nasal Spray is supplied

Updated on 22 August 2019 Ed-HCP

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

Physician's Guide to Prescribing provides Instanyl prescribing checklist and required actions before Instanyl Single Dose Nasal Spray is prescribed

Updated on 11 July 2019 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose

Updated on 11 July 2019 SmPC

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 4.7 - Effects on ability to drive and use machines
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The EMA have approved the Instanyl Renewal and during the procedure a number of changes were made to the SmPC and PIL.

Section

Update

4.2 - Posology and method of administration

 

Updated text in red:

 

Treatment should be initiated by and remain under the supervision of a physician experienced in the management of opioid therapy in cancer patients. Physicians should keep in mind the potential of abuse, misuse, addiction and overdose of fentanyl.

 

 

Elderly and Cachectic population

Limited data on pharmacokinetics, efficacy and safety are available for the use of Instanyl in patients above 65 years of age. Elderly patients may have a reduced clearance, a prolonged half‑life and higher sensitivity to fentanyl than younger patients. Limited data on pharmacokinetics are available for the use of fentanyl in cachectic (debilitated) patients. Cachectic patients may have reduced clearance of fentanyl. Caution should therefore be taken in treatment of elderly, cachectic or debilitated patients.

 

 

4.4 - Special warnings and precautions for use

 

Cardiac disease

Fentanyl use may be associated with bradycardia.

4.6 - Fertility, pregnancy and lactation

 

Pregnancy

There are no adequate data from the use of fentanyl in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Instanyl should not be used in pregnancy unless clearly necessary and if the benefits outweigh the risks.

 

Following long‑term treatment, fentanyl may cause withdrawal in the new‑born infant.

It is advised not to use fentanyl during labour and delivery (including caesarean section) because fentanyl passes through the placenta and may cause respiratory depression in the newborn (neonate). If Instanyl has been administered, an antidote for the child should be readily available.

 

4.7 - Effects on ability to drive and use machines

 

No studies of the effects on the ability to drive and use machines have been performed. However, opioid analgesics are known to impair the mental and/or physical ability required for driving or operating machinery. Patients undergoing treatment with Instanyl should be advised not to drive or operate machinery. Instanyl can cause somnolence, dizziness, visual disturbances or other adverse reactions which may affect their ability to drive or operate machinery.

 

4.8 - Undesirable effects

 

Deleted text:

 

The clinical trials of Instanyl were designed to evaluate safety and efficacy in treating breakthrough pain. All patients were also taking concomitant opioids, such as sustained -release morphine or transdermal fentanyl, for their persistent pain. Thus, it is not possible to definitively separate the effects of Instanyl alone. The adverse reactions considered to be at least possibly related to treatment in the clinical trials of Instanyl are included in the table below.

 

4.9 - Overdose

 

 

The signs and symptoms of fentanyl overdose are expected to be an extension of its pharmacological actions e.g. lethargy, coma and severe respiratory depression. Other signs may be hypothermia, decreased muscle tonus, bradycardia and hypotension. Signs of toxicity are deep sedation, ataxia, miosis, convulsions and respiratory depression, which is the main symptom.

 

5.1 - Pharmacodynamic properties

 

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 receiving low maintenance opioid dose tended to achieve effective pain relief with a lower strength of Instanyl compared to patients taking higher levels of maintenance opioid dose. This observation was most distinct for patients receiving Instanyl 50 micrograms.

 

5.2 - Pharmacokinetic properties

The plasma protein binding of fentanyl is approximately 80%. The absolute bioavailability of Instanyl is approximately 89%.

 

10 – Date of Revision of the text

01 July 2019

Updated on 22 March 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 22 March 2019 SmPC

Reasons for 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 4.8 – 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section

Changes

4.3          Contraindications

Added:

Patients being treated with medicinal products containing sodium oxybate.

 

4.4          Special warnings and precautions for use

Respiratory depression

Clinically significant respiratory depression may occur with fentanyl, and patients must be observed for these effects. Patients with pain who receive chronic opioid therapy develop tolerance to respiratory depression and hence the risk of respiratory depression in these patients is may be reduced. The use of concomitant central nervous system depressants may increase the risk of respiratory depression (see section 4.5).

 

Chronic pulmonary disease

In patients with chronic obstructive pulmonary diseases, fentanyl may have more severe adverse reactions. In these patients, opioids may decrease respiratory drive and increase airway resistance.

4.5          Interaction with other medicinal products and other forms of interaction

Added

Concomitant use of medicinal products containing sodium oxybate and fentanyl is contraindicated (see section 4.3).

 

The concomitant use of other central nervous system depressants, (including other opioids, sedatives or, hypnotics, general anaesthetics, phenothiazines, tranquillisers, skeletal muscle relaxants, sedating antihistamines, and alcohol) and skeletal muscle relaxants, may produce additive depressant effects: hypoventilation, hypotension, profound sedation, coma or death may occur. Therefore, the use of any of these medicinal products concomitantly with Instanyl requires special patient care and observation.

 

 

4.8          Undesirable effects

Added/ updated:

 

Nervous system disorders: Convulsions, loss of consciousness

 

Pregnancy, puerperium and perinatal conditions: Neonatal withdrawal syndrome

 

Injury, poisoning and procedural complications: Fatigue, malaise peripheral oedema, withdrawal syndrome*, neonatal withdrawal syndrome

 

10. Date of Revision of the text

5 March 2019

 

Updated on 29 May 2018 SmPC

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 4.8 – Undesirable effects - how to report a side effect
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

  • In section 4.2, the following wording has been added: In absence of adequate pain control, the possibility of hyperalgesia, tolerance and progression of underlying disease should be considered (see section 4.4).
  • In section 4.4, information on hyperalgesia has been added
  • In 4.8, drug dependence (addiction, drug abuse (frequency not known) and neonatal withdrawal symdrome (frequency not known) have been added
  • In section 5.1, the following information has been added: Opioids may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Some changes that can be seen include an increase in serum prolactin, and decreases in plasma cortisol and testosterone. Clinical signs and symptoms may be manifest from these hormonal changes.

Updated on 20 March 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 20 March 2017 SmPC

Reasons for 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

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 17 March 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 17 March 2017 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 3 October 2016 SmPC

Reasons for updating

  • 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 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 30 September 2016 PIL

Reasons for updating

  • Change of active ingredient
  • Change to date of revision

Updated on 22 April 2016 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors
  • Change to improve clarity and readability

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 3 March 2016 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

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 8 October 2015 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

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 8 October 2015 PIL

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 8 May 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation

Updated on 30 March 2015 SmPC

Reasons for 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

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 30 March 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 2 March 2015 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 17 September 2014 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 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 17 September 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 12 May 2014 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to improve clarity and readability

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 12 May 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability

Updated on 17 April 2014 SmPC

Reasons for 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

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 17 April 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 13 December 2013 PIL

Reasons for updating

  • Change of manufacturer

Updated on 17 September 2013 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 16 September 2013 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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 July 2013 SmPC

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 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 9 July 2013 PIL

Reasons for updating

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

Updated on 13 September 2012 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

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 August 2012 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

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 23 August 2012 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 12 October 2011 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 11 October 2011 PIL

Reasons for updating

  • New PIL for new product