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Mimpara tablets

*
Pharmacy Only: Prescription

  • Company:

    Amgen Ireland Ltd

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Cinacalcet Hydrochloride

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

Updated on 03 February 2023

File name

en_mimpara_tablets_approved_spc_v65.pdf

Reasons for updating

  • Document format updated

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

Updated on 11 January 2022

File name

en_mimpara tablets_approved_PIL_v71 XI and IE.pdf

Reasons for updating

  • Change to MA holder contact details

Free text change information supplied by the pharmaceutical company

QRDv10.2

Updated on 27 February 2020

File name

en_mimpara_tablets_approved_spc_v65.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • 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)

Updated on 05 July 2019

File name

en_mimpara_spc_tablets_v62_.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

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

File name

PIL_9250_889.pdf

Updated on 07 September 2017

File name

PIL_9250_889.pdf

Reasons for updating

  • New PIL for new product

Updated on 07 September 2017

Reasons for updating

  • Correction of spelling/typing errors

Updated on 04 September 2017

Reasons for updating

  • New SPC for new product

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

Updated on 04 September 2017

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company



4.1 Therapeutic indications

Text in SmPC updated as follows (new text in yellow and bold):

 

Secondary hyperparathyroidism

 

Adults

Treatment of secondary hyperparathyroidism (HPT) in adult patients with end‑stage renal disease (ESRD) on maintenance dialysis therapy.

 

Paediatric population

Treatment of secondary hyperparathyroidism (HPT) in children aged 3 years and older with end‑stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy (see section 4.4).

 

Mimpara may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5.1).

 

Parathyroid carcinoma and primary hyperparathyroidism in adults

 

Reduction of hypercalcaemia in adult patients with:

·                parathyroid carcinoma.

·                primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.

 

 

 

4.2 Posology and method of administration

 

The sub-section secondary hyperparathyroidism has been updated with the following:

·         the table for managing hypocalcaemia has been moved to this section from section 4.4

·         new information added regarding use in paediatric population

 

The sub-section parathyroid carcinoma and primary hyperparathyroidism has been updated with the following:

·         The safety and efficacy of Mimpara in children for the treatment of parathyroid carcinoma and primary hyperparathyroidism have not been established. No data are available.

 

The sub-section Method of administration has been updated with the following:

·         Tablets should be taken whole and should not be chewed, crushed or divided.

·         Mimpara is also available as granules for paediatric use. Children who require doses lower than 30 mg, or who are unable to swallow tablets should receive Mimpara granules.

 

 

 

 

 

 

 

4.3 Contraindications

 

Hypocalcaemia has been added as a contraindication

4.4 Special warnings and precautions for use

 

The sub-section serum calcium has been updated with the following:

·         the table for managing hypocalcaemia has been moved to section 4.2

·         three sections under this sub-section have been created – adults, paediatrics and CKD patients not on dialysis

.

The sub-section seizures has been updated

 

Addition of a new sub-section

·         Co-administration with other medicinal products

 

 

 

 

 

4.5 Interaction with other medicinal products and other forms of interaction

 

This section has been updated with the following – Concurrent administration of other medicinal products known to reduce serum calcium and Mimpara

may result in an increased risk of hypocalcaemia (see section 4.4). Patients receiving Mimpara should not be given etelcalcetide (see section 4.4).

 

 

 

4.7 Effects on ability to drive and use machines

 

This section has been updated with the following – Dizziness and seizures, which may have major influence on the ability to drive and use machines, have been reported by patients taking Mimpara

4.8 Undesirable effects

 

The paediatric population sub-section has been updated

4.9 Overdose

 

The information on the paediatric population has been updated.

5.1 Pharmacodynamic properties

 

A new sub-section regarding the paediatric population has been added

5.2 Pharmacokinetic properties

 

The information on the paediatric population has been updated in sub-section Pharmacokinetic/pharmacodynamics relationship(s)

5.3 Preclinical safety data

Information regarding toxicity studies in juvenile dogs has been added.

 

10 Date of revision of the text

This has been updated to August 2017

Updated on 04 September 2017

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 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - driving and using machines
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 19 December 2016

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 4.5 Interaction with other medicinal products and other forms of interaction has been updated to include the following information:

Dextromethorphan: Multiple doses of 50 mg cinacalcet increased the AUC of 30 mg dextromethorphan (metabolised primarily by CYP2D6) by 11-fold in CYP2D6 extensive metabolisers.

Section 10. DATE OF REVISION OF THE TEXT has been updated to:

December 2016

Updated on 19 December 2016

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 06 May 2016

Reasons for updating

  • Change to storage instructions
  • Deletion of a pack size

Updated on 24 August 2015

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision

Updated on 21 August 2014

Reasons for updating

  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8 – Addition of back pain as common adverse event

Section 5.1 – Addition of text around data from a recently completed Phase III study

Section 10 – Date of revision of the text has been updated to July 2014

Updated on 21 August 2014

Reasons for updating

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

Updated on 24 October 2013

Reasons for updating

  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4

Addition of text regarding life-threatening and fatal events reported in adults and paediatrics population and addition of text regarding management of hypocalcaemia.

  

Section 4.8

Updated table of Adverse Reactions

Addition of text around Paediatric Population

Addition of text around reporting of suspected Adverse Reactions

 

Section 5.1

Addition of text around new data (EVOLVE study)

  

Section 10

Updated to 19 September 2013

Updated on 24 October 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 17 July 2013

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 6.3 - Shelf life
Shelf life change from 4 years to 5 years

Section 10 - Date of revision of the text

Updated to 5 July 2013

Updated on 06 February 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 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 4.4 Special warnings and precautions for use

Addition of text regarding manifestations of hypocalcaemia and cases of QT prolongation

 

Section 4.8 Undesirable effects

Addition of text around QT prolongation in the post-marketing setting

 

Section 10 Date of revision of the text

Updated to 15 January 2013

Updated on 06 February 2013

Reasons for updating

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

Updated on 27 February 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 24 February 2012

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

In Section 4.4 - Text in Seizures has been added
In Section 4.6 - Fertility text has been added:  No effects on fertility in animal studies
In Section 5.2 - Absorption, Distribution, Elimination text and PK/PD relationship text has been updated
In Section 6.6 - Disposal text - Unused medicinal product to be disposed of appropriately
In Section 10 - Date of renewal

Updated on 08 October 2009

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

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

Free text change information supplied by the pharmaceutical company

Section 2 Qualitative and Quantitative Composition/4.4 Special warnings and precautions for use includes new information on quantity of lactose in each tablet strength and galactose intolerance warning (section 4.4)

 Section 4.2 Posology and method of administration makes it clear that cinacalcet is not indicated in children and cross-refers to section 5.2 Pharmacokinetics for paediatric PK data

Section 4.4 Special warnings and precautions for use – interactions sections have been deleted since they are already included in Section 4.5 Interactions with other medicines and other forms of interaction

Updated on 06 October 2009

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about overdose
  • Change to information about driving or using machinery

Updated on 11 May 2009

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

In section 5.2, pharmacokinetic data on a paediatric population has been included from a study of 12 paediatric patients given a single dose of cinacalcet.

Updated on 14 July 2008

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

Section 4.1 - addition of primary HPT indication
Section 4.5 - interaction with midazolam included
Section 5.1 - pd data around pHPT

Updated on 09 July 2008

Reasons for updating

  • Changes to therapeutic indications

Updated on 06 November 2007

Reasons for updating

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

Updated on 01 November 2007

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Addition of text following post market surveillance to section 4.4
Diarrhoea added to section 4.8

Updated on 17 August 2006

Reasons for updating

  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

Addition of text from in vitro studies added to section 5.3

Updated on 27 April 2006

Reasons for updating

  • Improved electronic presentation
  • Change to date of revision

Updated on 26 April 2006

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.3 - Shelf life

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

Updated on 21 March 2006

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life

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

Updated on 21 March 2006

Reasons for updating

  • Change to side-effects

Updated on 18 November 2004

Reasons for updating

  • New SPC for new product

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

Updated on 18 November 2004

Reasons for updating

  • New PIL for new product