Raxone 150 mg film-coated tablets *

  • Company:

    Chiesi Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to restricted prescription (C)
  • Active Ingredient(s):

    This medicinal product is subject to additional monitoring.

    *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 22 September 2020

File name

Raxone EU CP0068-3_1600766985.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 22 September 2020

File name

Raxone EU CS0107-2_1600766749.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 – Undesirable effects - how to report a side effect
  • 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 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Renewal application for Raxone 150 mg film-coated tablets.

There are only minor updates to the SmPC and the following sections have been impacted: 4.4, 4.5, 4.6, 4.8 (ADR reporting only), 5.1, 5.2 & 6.1.

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each film-coated tablet contains 150 mg idebenone.

 

Excipients with known effect:

 

Each film-coated tablet contains 46 mg of lactose (as monohydrate) and 0.23 mg of sunset yellow FCF (E110).

 

4.4          Special warnings and precautions for use

Lactose

 

Raxone contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapptotal lactase deficiency or glucose-galactose malabsorption should not take Raxone.

 

4.5         Interaction with other medicinal products and other forms of interaction

 

Idebenone may inhibit P-glycoprotein (Pp-gp) with possible exposure increases of, e.g., dabigatran etexilate, digoxin or aliskiren. These medicines should be administered with caution in patients receiving idebenone.  Idebenone is not a substrate for pP-gp in vitro.

4.6     Fertility, pregnancy and lactation

Breast-feeding

 

Available pharmacodynamic/toxicological data in animals have shown excretion of idebenone in milk (for details see 5.3). A risk to the suckling child cannot be excluded. Studies in rats have shown that idebenone is excreted into maternal milkTherefore, aA decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Raxone therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the motherwoman.

 

4.8     Undesirable effects

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 via:

United Kingdom: Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

Ireland: HPRA Pharmacovigilance, Website: www.hpra.ie United Kingdom: Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax:

+353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

 

6.1     List of excipients

 

Core tTablet core

 

Lactose monohydrate

Microcrystalline cCellulose, microcrystalline

Croscarmellose sodium

Povidone (K25)

Magnesium stearate

Colloidal sSilica, colloidal anhydrous

 

Film-Ccoating

 

Macrogol (3350)

Poly(vinyl alcohol)

Talc

Titanium dioxide

Sunset yellow FCF (E110)

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Date of first authorisation: 8 September 2015

Date of latest renewal: 6 August 2020

 

 

10.     DATE OF REVISION OF THE TEXT

 

August 2020

Updated on 05 February 2020

File name

Raxone EU CP0068-2_revison date update_text version only_1580916404.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 05 February 2020

File name

Raxone EU CP0068-2_1580814615.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect

Free text change information supplied by the pharmaceutical company

There was an error in the previous versions submitted they were missing local information under Section 4 which refers to reporting side effects using the "the national reporting system listed in Appendix V" these have now been completed with  information specific to Ireland 

Updated on 05 February 2020

File name

Raxone EU CP0068-2_1580814615.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect

Free text change information supplied by the pharmaceutical company

Section 4 refers to reporting side effects using the "the national reporting system listed in Appendix V" which have now been updated to include information specific to Ireland

Updated on 04 February 2020

File name

Raxone EU CP0068-2_1580814615.pdf

Reasons for updating

  • New PIL for new product

Updated on 03 February 2020

File name

Raxone EU CS0107-1_1580742424.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to restricted prescription (C)