Gonapeptyl Depot 3.75 mg powder and solvent for suspension for injection *

  • Company:

    Ferring Ireland Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

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 06 December 2019

File name

Gonapeptyl SPC_in line with licence dated 05 Dec 2019_1575634754.pdf

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

Update to Section 6.6 to include new Instructions for Use to include new adapter.

This product is being discontinued in Ireland and therefore this change will not be implemented for the Irish packs.

Updated on 10 May 2018

Reasons for updating

  • New SPC for new product

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

Updated on 19 June 2015

Reasons for updating

  • New SPC for new product

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

Updated on 19 June 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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

Section 4.4:
New text added:

"Androgen deprivation therapy may prolong the QT interval.

In patients with a history of or risk factors for QT prolongation and in patients receiving concomitant medicinal products that might prolong the QT interval (see section 4.5) physicians should assess the benefit risk ratio including the potential for Torsade de pointes prior to initiating GONAPEPTYL."

Section 4.5:
New text added:
"Since androgen deprivation treatment may prolong the QT interval, the concomitant use of GONAPEPTYL with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics, etc. should be carefully evaluated (see section 4.4)."

Section 4.8:
'Not known' AE added: "QT prolongation (see section 4.4 and 4.5)"

- Reporting of side effects information added

Updated on 19 June 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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Free text change information supplied by the pharmaceutical company

Section 4.4:
New text added:

"Androgen deprivation therapy may prolong the QT interval.

In patients with a history of or risk factors for QT prolongation and in patients receiving concomitant medicinal products that might prolong the QT interval (see section 4.5) physicians should assess the benefit risk ratio including the potential for Torsade de pointes prior to initiating GONAPEPTYL."

Section 4.5:
New text added:
"Since androgen deprivation treatment may prolong the QT interval, the concomitant use of GONAPEPTYL with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics, etc. should be carefully evaluated (see section 4.4)."

Section 4.8:
'Not known' AE added: "QT prolongation (see section 4.4 and 4.5)"

- Reporting of side effects information added

Updated on 30 January 2013

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Section 4.4: 

There is an increased risk of incident depression (which may be severe) in patients undergoing treatment with GnRH agonists, such as triptorelin.  Patients should be informed accordingly and treated as appropriate if symptoms occur.

 

Mood changes, including depression have been reported. Patients with known depression should be monitored closely during therapy.

 

Section 4.8:

General tolerance in men:
- Common: "Depressed mood, sleep disorder" updated to "Mood changes, depressed mood, depression, sleep disorder"

General tolerance in women:
- Introductory paragraph: "mood altered" updated to "mood changes"
- Very common: "mood altered" updated to "mood changes"
- Common: "Depressed mood" updated to "Depressed mood, depression" 

General tolerance in children:
- Common: new text, "Mood changes, depression"

Updated on 30 January 2013

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

Section 4.4: 

There is an increased risk of incident depression (which may be severe) in patients undergoing treatment with GnRH agonists, such as triptorelin.  Patients should be informed accordingly and treated as appropriate if symptoms occur.

 

Mood changes, including depression have been reported. Patients with known depression should be monitored closely during therapy.

 

Section 4.8:

General tolerance in men:
- Common: "Depressed mood, sleep disorder" updated to "Mood changes, depressed mood, depression, sleep disorder"

General tolerance in women:
- Introductory paragraph: "mood altered" updated to "mood changes"
- Very common: "mood altered" updated to "mood changes"
- Common: "Depressed mood" updated to "Depressed mood, depression" 

General tolerance in children:
- Common: new text, "Mood changes, depression"

Updated on 27 October 2010

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

Free text change information supplied by the pharmaceutical company

Section 4.2: New statement "The treatment of children with triptorelin should be under the overall supervision of the paediatric endocrinologist or of a paediatrician or endocrinologist with expertise in the treatment of central precocious puberty."

Section 4.4: Full section update.

 

Section 4.5: New statement,No formal drug-drug interaction studies have been performed. The possibility of interactions with commonly used medicinal products, including histamine liberating products, cannot be excluded.

Statement deleted “Estrogen containing medicinal products should not be used during treatment with GONAPEPTYL Depot.”

 

Section 4.6: New statement:Prior to treatment, potentially fertile women should be examined carefully to exclude pregnancy.”

 

Section 4.7: New statement: “However, the ability to drive and use machines may be impaired should the patient experience dizziness, somnolence and visual disturbances being possible undesirable effects of treatment, or resulting from the underlying disease”

 

Section 4.8: full section update

Updated on 27 October 2010

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

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

Free text change information supplied by the pharmaceutical company

Section 4.2: New statement "The treatment of children with triptorelin should be under the overall supervision of the paediatric endocrinologist or of a paediatrician or endocrinologist with expertise in the treatment of central precocious puberty."

Section 4.4: Full section update.

 

Section 4.5: New statement,No formal drug-drug interaction studies have been performed. The possibility of interactions with commonly used medicinal products, including histamine liberating products, cannot be excluded.

Statement deleted “Estrogen containing medicinal products should not be used during treatment with GONAPEPTYL Depot.”

 

Section 4.6: New statement:Prior to treatment, potentially fertile women should be examined carefully to exclude pregnancy.”

 

Section 4.7: New statement: “However, the ability to drive and use machines may be impaired should the patient experience dizziness, somnolence and visual disturbances being possible undesirable effects of treatment, or resulting from the underlying disease”

 

Section 4.8: full section update

Updated on 04 June 2009

Reasons for updating

  • Change to section 6.1 - List of excipients

Free text change information supplied by the pharmaceutical company

Section 6.1:  Excipient updated to 'propyleneglycol dicaprylocaprate'

Updated on 04 June 2009

Reasons for updating

  • Change to section 6.1 - List of excipients

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

Free text change information supplied by the pharmaceutical company

Section 6.1:  Excipient updated to 'propyleneglycol dicaprylocaprate'

Updated on 29 August 2007

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

  error in date of revision of text section 10-updated to June 2007

Updated on 29 August 2007

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

  error in date of revision of text section 10-updated to June 2007

Updated on 29 May 2007

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

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

Free text change information supplied by the pharmaceutical company

SPC updated following Renewal

Updated on 29 May 2007

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

Free text change information supplied by the pharmaceutical company

SPC updated following Renewal

Updated on 18 April 2007

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

Free text change information supplied by the pharmaceutical company

Date of authorisation was missing-SPC updated

Updated on 18 April 2007

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

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

Free text change information supplied by the pharmaceutical company

Date of authorisation was missing-SPC updated

Updated on 27 June 2005

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)

Updated on 27 June 2005

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Updated on 21 August 2003

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 21 August 2003

Reasons for updating

  • Correction of spelling/typing errors

Updated on 26 June 2003

Reasons for updating

  • New SPC for medicines.ie

Updated on 26 June 2003

Reasons for updating

  • New SPC for medicines.ie

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