Prostap 6 DCS

  • Name:

    Prostap 6 DCS

  • Company:
    info
  • Active Ingredients:

    Leuprorelin Acetate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/07/20

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Summary of Product Characteristics last updated on medicines.ie: 6/7/2020

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Takeda Products Ireland Ltd

Takeda Products Ireland Ltd

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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
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1 - 0 of 27 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 6 July 2020 PIL

Reasons for updating

  • 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 4 - possible side effects
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

The PIL has been aligned with the Company Core Data Sheet (CCDS).

Updated on 6 July 2020 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.2 - Incompatibilities
  • 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

Following an alignment with the Company Core Data Sheet, the following changes have been made to the SmPC:

Section

Change

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Update/Removal of text:

Powder: Each single-dose syringe contains contains 30 mg leuprorelin acetate

Solvent: Solvent contains approximately 0.4 mg (<1mmol) sodium (as carmellose sodium). 

3 PHARMACEUTICAL FORM

Update:

Solvent: A colourless, odourless, slightly viscous, aqueous sterile solvent.

4.2 Posology and method of administration

Update:

Prostate Cancer:  The usual recommended dose is 30 mg presented as a six month depot injection and administered as a single subcutaneous injection at intervals of six months.

 

Response to PROSTAP 6 therapy should be monitored by clinical parameters and by measuring prostate-specific antigen (PSA) and testosterone serum levels…Transient increases in PSA levels sometimes occur early in the treatment period but usually return to normal or near normal values by the 4th week of treatment.

4.3 Contraindications

Minor updates:

Hypersensitivity to the leuprorelin, any of the excipients (listed in section 6.1) or to other synthetic gonadotrophin releasing hormone (Gn-RH) analogues or Gn-RH derivatives.

4.4 Special warnings and precautions for use

Added:

PROSTAP 6 injectable suspension must be prepared at the time of use and, after reconstitution, used immediately.

 

Updated:

...Patients should be informed and monitored accordingly and treated as appropriate if symptoms occur.

 

In order to reduce the risk of flare, an anti-androgen may be administered beginning 3 days prior to leuprorelin therapy and continuing for the first two to three weeks of treatment. This has been reported to prevent the sequelae of an initial rise in serum testosterone.  If an anti-androgen is used over a prolonged period, due attention should be paid to the contra-indications and precautions associated with its extended use.

Patients at risk of or with ureteric obstruction or spinal cord compression due to metastasis should be considered carefully and closely supervised in the first few weeks of treatment as bone pain, weakness of the lower extremities and paraesthesia (as neurologic symptoms) may occur.

Bone mineral loss:

Long-term androgen deprivation either by bilateral orchiectomy or administration of GnRH analogues is associated with increased risk of bone mineral loss which, in patients with additional risk factors, may lead to osteoporosis and an increased risk of bone fracture (see section 4.8).

 

The resulting hypogonadism, commonly observed under long term therapy with GnRH analogues or orchiectomy, may lead to the onset of osteoporosis with the increased risk of bone fracture. However, the development of osteoporosis due to hypogonadism is secondary to an increase in cortisol levels, and is more pronounced after orchiectomy than after administration of GnRH analogues. In patients at risk, the additional administration of a bisphosphonate may represent a prophylactic measure against such bone demineralization.

 

Epidemiological data have shown that during androgen deprivation therapy is associated with metabolic changes in the metabolic condition (e.g. reduction in glucose tolerance or aggravation of pre-existing diabetes) as well as an increased risk for cardiovascular diseases may occur. However, prospective data did not confirm the link between treatment with GnRH analogues and an increase in cardiovascular mortality. Patients at high risk for metabolic or cardiovascular diseases should be appropriately monitored. Diabetic patients may require more frequent monitoring of blood glucose during treatment with PROSTAP 6.

 

If an anti-androgen is used over a prolonged period, due attention should be paid to the contra-indications and precautions associated with its extended use.

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 risks and benefits benefit risk ratio including the potential for Torsade de pointes prior to initiating treatment with PROSTAP 6.

 

PROSTAP 6 contains sodium.  This medicine contains less than 1 mmol sodium (23 mg) per injection, that is to say it is essentially ‘sodium free’.

4.5 Interaction with other medicinal products and other forms of interaction

Update:

No interaction studies have been performed

4.8 Undesirable effects

The following table lists adverse reactions with leuprorelin based on experience from clinical trials as well as from post-marketing experience. Adverse reactions are grouped by MedDRA System Organ Classes and frequency classification. Frequencies are defined as follows: very common (> 1/10), common (> 1/100 to < 1/10), uncommon (>1/1,000 to <1/100), rare (> 1/10,000 to < 1/1.000), very rare (< 1/10,000), not known (cannot be estimated from the available data)).

In cases where a "tumour flare" occurs after PROSTAP 6 therapy, an exacerbation may occur in any symptoms or signs due to disease. Adverse events, which may occur particularly at the beginning of treatment include urinary tract obstruction (as urinary symptoms). In patients with spinal cord compression, bone pain, weakness of lower extremities and paresthesia (as neurologic symptoms) may also occur (see section 4.4). These symptoms subside on continuation of therapy.

 

6.2 Incompatibilities

Added:

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

 

6.6 Special precautions for disposal and other handling

Added:

Prepare the injectable suspension at the time of use and, after reconstituting, use immediately.

 

10 Date of revision of the text

28th May 2020

Updated on 29 May 2020 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

The MAH (Takeda Products Ireland Limited) address has been changed to:

6th Floor, South Bank House, Barrow Street, Dublin 4, Ireland.

This is the legally registered office.

Also, the local representative/’trading as’ address has been added to the PIL:

5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland. 

The date of revision of the SmPC is February 2020.

Updated on 29 May 2020 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 11, the MAH (Takeda Products Ireland Limited) address has been changed to:

6th Floor, South Bank House, Barrow Street, Dublin 4, Ireland.

This is the legally registered office.

In section 10, the date of revision of the SmPC is 12th May 2020.

Updated on 22 August 2019 SmPC

Reasons for updating

  • File format updated to PDF

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

Updated on 12 July 2019 PIL

Reasons for updating

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

Updated on 28 June 2018 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

The updated Prostap DCS SmPCs contain additional information in the following section(s):

  • In section 4.8 (undesirable effects), interstitial lung disease has been added as a side effect with unknown frequency.
  • The date of revision is 09/06/2018.

Updated on 24 May 2018 SmPC

Reasons for updating

  • 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 HPRA has renewed the licence for Prostap DCS.

Updated on 2 November 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 November 2016 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 7 March 2016 SmPC

Reasons for updating

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

Change to section

Details of change

4.4 Special warnings and precautions for use

Text in red added:

Postmarketing reports of seizures have been observed in patients treated with leuprorelin acetate and these events have been reported in both children and adults, and in those with or without a history of epilepsy, seizure disorders or risk disorders for seizures.

 

4.8 Undesirable effects

Text in red added

Nervous system disorders:

Common:  headache (occasionally severe)

Rare: dizziness

Very rare: pituitary apoplexy has been reported after administration of both short-and long acting GnRH agonists

Not known: paralysis, seizure

 

 

Nervous system disorders:          

Common: headache

Not known: seizure

 

10. Date of revision of the text

Updated text in red:

 

23 February 2016

Updated on 7 March 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 3 March 2016 PIL

Reasons for updating

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

Updated on 3 July 2015 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

4.2       Posology and method of administration

 

In patients treated with GnRH analogues for prostate cancer, treatment is usually continued upon development of castrate-resistant prostate cancer. Reference should be made to relevant guidelines.

 

5.1       Pharmacodynamic properties

Leuprorelin acetate is inactive when given orally.

In patients with metastatic castration resistant prostate cancer, clinical studies have shown benefit from the addition of secondary agents to treatment with LHRH agonists such as leuprorelin. Androgen deprivation therapy (ADT) is generally continued in conjunction with secondary therapies after progression on the initial ADT regimen.

10      DATE OF REVISION OF THE TEXT

                23 June 2015

Updated on 17 November 2014 PIL

Reasons for updating

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

Updated on 17 November 2014 SmPC

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 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

Change to section

Details of change

4.4 Special warnings and precautions for use

Addition of text:

 

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 PROSTAP 6.

 

4.5       Interaction with other medicinal products and other forms of interaction

Addition of text:

 

Since androgen deprivation treatment may prolong the QT interval, the concomitant use of PROSTAP 6 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).

 

4.8       Undesirable effects

 

Addition of text:

 

Cardiac disorders:

Not known, palpitations, QT prolongation (see sections 4.4 and 4.5)

 

10        DATE OF REVISION OF THE TEXT

 

 

31/10/2014

 

Updated on 2 October 2014 SmPC

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company



SECTION 7. MARKETING AUTHORISATION HOLDER


Change of address of Marketing Authorisation Holder to: 
 

Takeda UK Limited

Building 3, Glory Park,

Glory Park Avenue,

Wooburn Green,

BUCKS,

HP10 0DF

 

SECTION 10. DATE OF REVISION OF THE TEXT

 

26/09/2014

Updated on 2 October 2014 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 4 June 2014 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 following highlighted text has been added 

Change to Section 2 an additional word "the" has been added: "For the full list of excipients, see section 6.1"

 

Change to Section 4.2 Additional highlighted text has been added: the word "posology" and the words "Method of"


4.2       Posology and method of administration

Posology

and 

Method of Administration
Change to section 4.3       Contraindications Addition of text “”listed in section 6.1)”

Hypersensitivity to the active substance, any of the excipients (listed in section 6.1) or to synthetic gonadotrophin releasing homone (Gn-RH) or Gn-RH derivatives.


Change to Section 4.4
additional paragraphs have been added to 4.4 Special warnings and precautions for use

 

Epidemiological data have shown that during androgen deprivation therapy changes in the metabolic condition (e.g. reduction in glucose tolerance or aggravation of pre-existing diabetes) as well as an increased risk for cardiovascular diseases may occur. However, prospective data did not confirm the link between treatment with GnRH analogues and an increase in cardiovascular mortality. Patients at high risk for metabolic or cardiovascular diseases should be appropriately monitored.

 
Change to section 4.6 There is an insertion of an additional word, "Fertility": 4.6       Fertility, pregnancy and lactation

Change to section 4.8
insertion of an additional paragraph at the end of section 4.8

 

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 1 676 2517, Website: www.imb.ie. e-mail:imbpharmacovigilance@imb.ie. 

Change to section 6.6
insertion of the additional words as highlighted: 6.6       Special precautions for disposal and handling

 

Change to section 10 – date of revision of text is : 26/05/2014

Updated on 4 June 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 7 May 2013 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

change to the Smpc to reflect the addition of the safety device to the dual chamber syringe.

6.5       Nature and contents of container

One dual chamber pre-filled syringe containing 11.25 mg leuprorelin acetate in the front chamber and 1 ml of aqueous sterile solvent in the rear chamber.

 

1 x 23 gauge syringe needle fitted with safety device

1 x syringe plunger

6.6       Special precautions for disposal

Always ensure the safety device to prevent needle-stick injury is deployed after injection.  For single use only. Discard any unused content. Any unused product or waste material should be disposed of in accordance with local requirements.

Updated on 4 March 2013 SmPC

Reasons for updating

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

Change to section 4.4 to which the following text has been added;

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

section 10: date of revision of text has been updated to 08/02/2013

Updated on 21 February 2013 PIL

Reasons for updating

  • Change of manufacturer
  • Change to warnings or special precautions for use

Updated on 19 June 2012 SmPC

Reasons for updating

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

The IMB has approved new versions of the Prostap DCS SmPCs. The updates are as follows:

 

1.      warning around injection site reactions in section 4.4 (Special warnings and precautions) : In the rare event of an abscess occurring at the injection site, testosterone level should be monitored as there may be inadequate absorption of leuprorelin from the depot formulation.”

 

2.      Section 4.8- Undesirable effects have been updated to include the following adverse events:

Uncommon: as with other medicinal products of this class, anaemia has been reported

Rare: reactions at the injection site, e.g., induration, erythema, pain, abscesses, swelling, nodules, ulcers and necrosis have been reported rarely

Updated on 19 June 2012 PIL

Reasons for updating

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

Updated on 29 November 2011 PIL

Reasons for updating

  • New PIL for new product

Updated on 29 November 2011 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Free text change information supplied by the pharmaceutical company

None provided