Lynparza 50 mg hard capsules

  • Name:

    Lynparza 50 mg hard capsules

  • Company:
    info
  • Active Ingredients:

    Olaparib

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 30/10/19

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Summary of Product Characteristics last updated on medicines.ie: 3/10/2019

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AstraZeneca Pharmaceuticals (Ireland) DAC

AstraZeneca Pharmaceuticals (Ireland) DAC

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1 - 0 of 52 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 30 October 2019 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Removal of Black Inverted Triangle

Updated on 3 October 2019 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Removal of Black Inverted Triangle

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

Free text change information supplied by the pharmaceutical company

Renewal - Removal of black triangle (additional monitoring requirement), addition of renewal date, update to HPRA adverse event reporting details, change to date of revision of the text

Updated on 3 October 2019 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Removal of Black Inverted Triangle

Free text change information supplied by the pharmaceutical company

Renewal - removal of requirement for additional monitoring, update to HPRA adverse event reporting details and change to date of revision

Updated on 8 August 2019 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Addition of Black Inverted Triangle

Updated on 8 August 2019 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Addition of Black Inverted Triangle

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

Updated on 31 July 2019 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Removal of Black Inverted Triangle

Updated on 31 July 2019 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Removal of Black Inverted Triangle

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

Updated on 25 June 2019 PIL

Reasons for updating

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

Updated on 25 June 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 4.8 - Undesirable effects
  • 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)

Updated on 28 May 2019 SmPC

Reasons for updating

  • 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 not be renewed (A)

Updated on 23 April 2019 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 23 April 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 4.8 - Undesirable effects
  • 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)

Updated on 31 July 2018 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 31 July 2018 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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

Section 6.3          Update of shelf-life to 2 years.

Section 6.4          Update to cold-chain storage conditions.

Section 10           Update to the date of revision

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 4.5 - 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 - 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
  • Change to section 5.3 - Preclinical safety data
  • 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 13 May 2018 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 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 3 - dose and frequency
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 9 August 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 9 August 2017 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-     Addition of rash, hypersensitivity and dermatitis

Section 10 -     Revision date updated

Updated on 1 August 2017 PIL

Reasons for updating

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

Updated on 1 August 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 22 June 2017 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

In section 6.3, the shelf-life has been changed from 2 years to 18 months.

Updated on 3 January 2017 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

Section

Change

SmPC 4.2 Posology and method of administration

Revised hepatic impairment text

FROM:

The effect of hepatic impairment on exposure to Lynparza has not been studied. Therefore, Lynparza is not recommended for use in patients with hepatic impairment (serum bilirubin greater than 1.5 times upper limit of normal), as safety and efficacy have not been established.

 

TO:

Lynparza can be administered to patients with mild hepatic impairment (Child-Pugh classification A) with no dose adjustment (see section 5.2). Lynparza is not recommended for use in patients with moderate or severe hepatic impairment, as safety and efficacy have not been studied in these patients.

SmPC 4.4 Special warnings and precautions for use, Interactions

Revised to add ‘moderate’ CYP3A inducers to existing strong CYP3A inducer text to read:

Olaparib co‑administration with strong or moderate CYP3A inducers is not recommended (see section 4.5). In the event that a patient already receiving olaparib requires treatment with a strong or moderate CYP3A inducer, the prescriber should be aware that the efficacy of olaparib may be substantially reduced (see section 4.5)

SmPC 4.5 Interaction with other medicinal products and other forms of interaction, Effect of other drugs on olaparib

Minor change to end of first paragraph:

Therefore, known strong inducers of this isozyme (e.g. phenytoin, rifampicin, rifapentine, carbamazepine, nevirapine, phenobarbital, and St John’s Wort) are not recommended with olaparib, as it is possible that the efficacy of olaparib could be substantially reduced (see section 4.4). The magnitude of the effect of moderate to strong inducers (e.g. efavirenz, rifabutin) on olaparib exposure is not established, therefore the co-administration of olaparib with these drugs is also not recommended (see section 4.4).

 

SmPC 5.2 Pharmacokinetic Properties, Hepatic impairment

Revised hepatic impairment text

FROM:

The effect of hepatic impairment on exposure to olaparib has not been studied. Olaparib is not recommended for use in patients with hepatic impairment (serum bilirubin > 1.5 time upper limit of normal).

 

TO:

In patients with mild hepatic impairment (Child-Pugh classification A), AUC increased by 15% and Cmax by 13% compared with patients with normal hepatic function. No Lynparza dose adjustment is required for patients with mild hepatic impairment (see section 4.2). There are no data in patients with moderate or severe hepatic impairment.

 

 

 

Updated on 1 December 2016 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 1 December 2016 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 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

Change

SmPC 4.2

Revision of text from the effect of renal impairment on exposure to Lynparza has not been studied to:

·         no dose adjustment required for patients with mild renal impairment

·         dose adjustment (300mg twice daily) required for patients with moderate renal impairment

SmPC 5.1

Editorial change

SmPC 5.2

Revision of renal impairment text to reflect study D0816C00006 results

 

SmPC 5.3

Revision of text from:

Ex vivo studies using human bone marrow cells also confirmed that olaparib is cytotoxic to human bone marrow cells.

To:

Studies using human bone marrow cells also showed that direct exposure to olaparib can result in toxicity to bone marrow cells in ex vivo assays.

 

 


and change to revision date

Updated on 20 April 2016 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • 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 9 - Date of renewal of authorisation
  • 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 4.2

Addition of dose adjustment for co-administration with strong or moderate CYP3A inhibitors

Section 4.4

Addition of warning for co-administration with moderate CYP3A inhibitors

Addition of dose reduction wording when co-administered with a strong or moderate CYP3A inhibitor

Addition of reduced olaparib efficacy wording when co-administered with strong CYP3A inducer

Section 4.5

Extensive revision based on new in vivo and in vitro studies including the following changes:

·         Addition of examples of strong & moderate CYP3A inhibitors, strong & moderate CYP3A inducers including grapefruit juice (Please note that during late stage linguistic review the EMA instructed AZ to remove ciprofloxacin as an example of a moderate CYP3A inhibitor)

·         Addition of possible increase in exposure to olaparib with P-gp inhibitors

·         Addition of olaparib as a mild CYP3A inhibitor in vivo so caution required when used with sensitive CYP3A substrates or those with narrow therapeutic margin and for the latter appropriate clinical monitoring is recommended

·         Amendment of CYP3A4 most likely to be induced to clinically relevant extent to CYP2B6

·         Addition of olaparib as P-gp inhibitor and as such clinically relevant drug interactions with P-gp substrates cannot be excluded so appropriate clinical monitoring is recommended

·         Addition of olaparib as an inhibitor of OATP1B1, OCT1, OCT2, OAT3, MATE1 and MATE2K

 

 

 

 

 

Section 4.6

Addition of reduced efficacy of hormonal contraceptives if co-administered with olaparib

Section 5.1

Addition of ATC code L01XX46

Section 5.2

Section 5.3

Addition of % binding to HSA and AAG

Minor editorial/formatting changes.

Section 9

Section 10

Addition of Date of first authorisation

Change to revision date.

Updated on 19 April 2016 PIL

Reasons for updating

  • Change to drug interactions
  • Change to date of revision
  • Addition of information on reporting a side effect.
  • Correction of spelling/typing errors

Updated on 4 January 2016 SmPC

Reasons for updating

  • New SPC for medicines.ie

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 4 January 2016 PIL

Reasons for updating

  • New PIL for medicines.ie