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Zemplar 1 microgram and 2 microgram capsules, soft

*
Pharmacy Only: Prescription

  • Company:

    AbbVie Limited

  • Status:

    Updated

  • Legal Category:

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

  • Active Ingredient(s):

    Paricalcitol

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

  • Zemplar 1 microgram and 2 microgram capsules, soft Packshot Zemplar 1mcg Carton
  • Zemplar 1 microgram and 2 microgram capsules, soft Packshot Zemplar 2mcg Carton
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Updated on 11 November 2022

File name

PL_Zemplar 1mcg-2mcg Capsules_V098_Nov 2022.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 2 of the Package Leaflet (PL) was updated to implement the wording of the latest Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use', in relation to the ethanol contained in Zemplar capsules.

In addition the list of local representatives has also been updated in the PIL, in line with recent licence withdrawals and made some minor editorial changes in the PIL.

Updated on 11 November 2022

File name

SPC_Zemplar 1mcg-2mcg Capsules_V098_Nov 2022.pdf

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

Update was made to section 4.4 of the SmPC to implement the wording of the latest Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use' in relation to the ethanol contained in Zemplar capsules.

 In addition we made some minor editorial changes throughout the SPC.

Updated on 01 March 2021

File name

PL_ Zemplar 1mcg_2mcg Capsules_V97_January 21.pdf

Reasons for updating

  • Change to name of manufacturer

Updated on 10 December 2020

File name

PL_ Zemplar 1mcg_2mcg Capsules_V96_Sep 2020.pdf

Reasons for updating

  • Addition of manufacturer

Updated on 10 December 2020

File name

PL_ Zemplar 1mcg_2mcg Capsules_V96_Sep 2020.pdf

Reasons for updating

  • Addition of manufacturer

Updated on 17 December 2019

File name

SPC_ Zemplar 1mcg_2mcg Capsules_V94_Dec 2019.pdf

Reasons for updating

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

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

Updated on 17 December 2019

File name

PL_Zemplar 1mcg_2mcg Capsules_V94_Nov 2019.pdf

Reasons for updating

  • Change to date of revision

Updated on 02 December 2019

File name

SPC_ Zemplar 1mcg_2mcg Capsules_V94_Nov 2019.pdf

Reasons for updating

  • Change from individual to joint SPC

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

Updated on 02 December 2019

File name

PL_Zemplar 1mcg_2mcg Capsules_V94_Nov 2019.pdf

Reasons for updating

  • Individual PILs superseded by joint PIL

Updated on 29 April 2019

File name

Zemplar 2mcg Capsules_PL_V91_March 2019.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 27 March 2019

File name

Zemplar 2mcg Capsules_PL_V91_March 2019.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 18 July 2018

File name

SPC_1mcg, 2mcg Zemplar Capsules_IE_V88_logo removal_March 2018.pdf

Reasons for updating

  • File format updated to PDF

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

Updated on 23 March 2018

Reasons for updating

  • New SPC for new product

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

Updated on 23 March 2018

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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

$0SmPC for Zemplar 1mcg ang 2 mcg capsules updated toreflect approval of V88 -  Type IA grouped variation toremove the Abbot logo from the capsules and to delete obsolete specification.$0$0 $0$0The following is summary of changes:$0$0 $0$0Section 3Pharmaceutical form$0$0Removal of Abbot logo from capsules.$0$0 $0$0Section10. Date of revision of the text$0$0Updated to March 2018.$0

Updated on 22 March 2018

File name

PIL_12815_874.pdf

Reasons for updating

  • New PIL for new product

Updated on 22 March 2018

Reasons for updating

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

Updated on 21 March 2018

Reasons for updating

  • 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

Date of revision of text corrected to March 2018. No other changes to the text were made. 

Updated on 20 March 2018

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

$0SmPC for Zemplar 1mcg ang 2 mcg capsules updated toreflect approval of V82 Paediatric Label Update.$0$0The following is summary of changes:$0$0 $0$0Section 3Pharmaceutical form$0$0Removal of Abbot logo from capsules.$0$0 $0$0Section 4.1 Therapeutic indications$0$0Update to include paediatric subgroup into therapeutic indication. $0$0 $0$0Section 4.2Posology and method of administration$0$0Update to include information on paediatric dosing.$0$0 $0$0Section4.4 Special warnings and precautions for use$0$0Minor typo corrections.$0$0 $0$0Section 4.5 Interaction withother medicinal products and other forms of interaction$0$0Minor typo corrections.$0$0 $0$0Section4.8 Undesirable effects$0$0Update to safety profile to add paediatricinformation. Adverse reaction table updated. $0$0$0Section5.1 Pharmacodynamic properties$0$0Major update to the section – paediatric populationdata added $0$0$0$0Section5.2 Pharmacokinetic properties$0$0Paediatric population added under Special Populationheading. Minot typo corrections.$0$0 $0$0Section10. Date of revision of the text$0$0Updated to February 2018.$0

Updated on 19 March 2018

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • 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

Updated on 07 December 2017

Reasons for updating

  • Change to Section 1 - what the product is
  • 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 6 - manufacturer
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 11 March 2016

Reasons for updating

  • 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

Ø  Update the IE MAH address:

 

Present:

Proposed:

 

AbbVie Limited

Block B

Liffey Valley Office Campus

Quarryvale

Co. Dublin

 

 

 

AbbVie Limited

Citywest Business Campus

Dublin 24

Ireland

Updated on 10 March 2016

Reasons for updating

  • Change to MA holder contact details

Updated on 17 November 2015

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Update section 4.8 of the Summary of Product characteristics (SmPC) and PL for Zemplar 1mcg and 2mcg Capsules to include a single tabulated list of all Adverse reactions (ADR) with their respective frequency category.

Updated on 17 November 2015

Reasons for updating

  • Change to side-effects

Updated on 23 September 2015

Reasons for updating

  • Change to MA holder contact details

Updated on 18 June 2015

Reasons for updating

  • Addition of manufacturer

Updated on 27 November 2014

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

To update Section 4.2 of the SPC to include dosing on renal transplant patients.

Updated on 26 November 2014

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 11 September 2014

Reasons for updating

  • Correction of spelling/typing errors

Updated on 29 July 2014

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

To update the section 4.8 of the SPC and section 4 of the PIL in accordance with the update to CCDS03570713 adverse reactions.

Updated on 23 July 2014

Reasons for updating

  • Change to side-effects
  • Addition of information on reporting a side effect.

Updated on 17 July 2013

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

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

Free text change information supplied by the pharmaceutical company

-          Section 4.4:

The following text was added:

Phosphate or vitamin D-related medicinal products should not be taken concomitantly with

paricalcitol due to an increased risk of hypercalcaemia and Ca x P product elevation (see Section

4.5).

In pre-dialysis patients, paricalcitol, like other vitamin D receptor activators, may increase

serum creatinine (and therefore decrease the estimated GFR [eGFR]) without changing true

glomerular filtration rate (GFR).

                 -          Section 6.1:

The composition of the Black ink was updated to replace Polyethylene glycol 400 with Macrogal 400.

-          Section 6.5:

This section was updated with e following text

High-density polyethylene (HDPE) bottles closed with children resistant polypropylene caps.  Each bottle contains 30 capsules.

PVC/fluoropolymer/aluminium blister strips containing 7 capsules. Each carton contains 1 or 4 blisters strips. Packaged in outer cartons containing either 7 or 28 capsules.

 

-          Section 7:

 

This section was update to AbbVie name and Address:

 

AbbVie Limited

Block B

Liffey Valley Office Campus

Quarryvale

Co. Dublin

 

 

-          Section 8:

 

PA number updated to AbbVie new PA, PA 1824/5/1

Updated on 12 July 2013

Reasons for updating

  • Change of licence holder
  • Change to further information section

Updated on 08 August 2011

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

SPC section 4.8 - to reformat the Zemplar Solution for Injection ADR's in the Zemplar Capsules SPC
SPC section 5.1 - to inlcude 'Unlike calcitriol, paracalcitol is a selective Vitamin D receptor (VDR) activator' in line with WHO reclassification of paricalcitol from 'Vitamin D analogs' (ATC Code: A11CC) to 'Anti-parathyroid agents' (ATC Code: HO5BX).

Updated on 25 February 2011

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

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

Free text change information supplied by the pharmaceutical company


Section 4.4 has been updated to add a warning regarding chronic hypercalcaemia and it's possible association with generalised vascular calcification and other soft tissue calcification.

               Section 4.5 has been updated to add information on interactions with drugs that impair intestinal absorption of fat-soluble  
               vitamins, such as cholestyramine.

Updated on 23 February 2011

Reasons for updating

  • Change to drug interactions

Updated on 29 July 2010

Reasons for updating

  • Change to joint SPC covering all presentations

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

Free text change information supplied by the pharmaceutical company

Removal of 4mcg presentation from joint SPC as presentation not marketed

Updated on 28 July 2010

Reasons for updating

  • Change to MA holder contact details

Updated on 13 January 2010

Reasons for updating

  • 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

Section 5.1 updated to change the pharmacotherapeutic group from 'Vitamin D and analogues A11CC' to 'Anti-parathyroid agents H05BX02'.

Updated on 21 July 2008

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 13 February 2008

Reasons for updating

  • New PIL for new product

Updated on 11 February 2008

Reasons for updating

  • New SPC for new product

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

AbbVie Limited

AbbVie Limited