Rifinah 300/150mg film-coated tablets

  • Name:

    Rifinah 300/150mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Isoniazid, Rifampicin

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 31/03/20

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Summary of Product Characteristics last updated on medicines.ie: 31/3/2020

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SANOFI

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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 31 March 2020 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 not be renewed (A)

Updated on 31 March 2020 PIL

Reasons for updating

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

Updated on 5 February 2020 SmPC

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

For variation:

 

This VAN relates to the approval of CCDS 5 & 6 and SmPC alignment DDI Morphine- PRAC recommendation, details for which are outlined below:  

 

TII C.1.4. variation - CCDS V5 -impacts section 4.3 & 4.5  

 

The nature of the update concerns the revision of the following sections of the SPCs:

 

  • Section 4.3 Contra-indications & 4.5 Interactions with other Medicaments and other forms of Interaction -updated with the information on rifampicin interactions with hepatitis C therapy

 

  • Section 4.5 Interactions with other Medicaments and other forms of Interaction - is reorganized and updated to reflect a review which assessed rifampicin regarding its potential as a perpetrator of drug interactions, primarily via induction of drug metabolizing enzymes and transporters  

 

 

TII C.1.4. variation - CCDS V6 - section 4.4,4.5 & 4.8.

 

The nature of the update concerns the revision of the SPCs to include reference to the adverse biological effect of rifampicin and cefazolin when administered concurrently, which may lead to severe coagulation disorders including those with fatal outcome.

 

As a direct result the following sections of the SPCs have been updated as outlined below:

 

  • Section 4.4 Special Warnings and Special Precautions for Use

Updated to include reference to vitamin K dependent coagulopathy and severe bleeding.

  • Section 4.5 Interactions with other Medicaments and other forms of Interaction Updated to include reference to concomitant use of rifampicin and other antibiotics causing vitamin K dependent coagulopathy such as cefazolin should be avoided as it may lead to severe coagulation disorders, which may result in fatal outcome.
  • Section 4.8 Undesirable effects

Updated to include references to AEs Vitamin K dependent coagulation disorders, bleeding.  

 

DDI Morphine- alignment with PRAC recommendation: (submitted as part of CCDS 5)

 

Update to section 4.5 of the SmPCs to reference the analgesic effect of morphine.  The proposed update is aligned with CMD guidance for Rifampicin containing products which states the following:

 

For medicinal products containing rifampicin, whose product information does not already have information on the topic, the following text should be included in section 4.5 of the SPC:

 

“Plasma concentrations of morphine may be reduced by rifampicin. The analgesic effect of morphine should be monitored and doses of morphine adjusted during and after treatment with rifampicin.”

 

 

In addition to the above the Malta reporting details have been added to the PIL to support shared supply

Updated on 12 September 2018 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 23 August 2018 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 4.8 – Undesirable effects - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

Approval of a type II C.1.4 variation for the above mentioned product to update the SPC in accordance with CCDS V4.  The nature of the update concerns the revision of the following sections of the SPC:

 

  • Section 4.4 Special Warnings and Precautions for Use to include reference to severe bullous reactions

 

  • Section 4.8 Undesirable Effects to include adverse event acute generalized exanthematous pustulosis (AGEP)

Updated on 4 April 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 4 April 2018 SmPC

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 6.3 Shelf Life reduced from 4 years to 3 years.

Updated on 6 March 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 6 March 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 6 March 2018 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4

Added:-discolouration (yellow, orange, red, brown) of the teeth,

Removed:-reddish

Section 4.8

Gastrointestinal disorders

Added  Unknown:-tooth discolouration(which may be permanent)

Added Endocrine disorders - Gynecomastia

Updated on 6 March 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 12 April 2017 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Type II.C.1.4 Alignment of SmPC/Labelling with CCDSv2

Updated on 10 April 2017 PIL

Reasons for updating

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

Updated on 18 April 2016 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

4.8

Updated on 21 December 2015 PIL

Reasons for updating

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

Updated on 18 December 2015 PIL

Reasons for updating

  • Change to side-effects

Updated on 8 December 2015 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

 

            The following CIOMS frequency rating is used, when applicable:

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 available data).


 

Gastrointestinal disorders

frequency not known: Pancreatitis ,

nausea, vomiting, epigastric distress.

 

Hepatobiliary disorders

Severe and sometimes fatal hepatitis

Uncommon: hepatitis

 

Skin and subcutaneous tissue disorders

Rash, acne, Stevens-Johnson syndrome, exfoliative dermatitis, pemphigus.

Rare: toxic epiderman necrolysis, eosinophilia systemic symptoms

Updated on 16 May 2014 SmPC

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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 27 June 2013 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 10 December 2012 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 11 May 2011 PIL

Reasons for updating

  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about driving or using machinery

Updated on 20 January 2011 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 16 May 2008 PIL

Reasons for updating

  • Improved electronic presentation
  • Change due to harmonisation of patient information leaflet

Updated on 19 December 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 10 November 2006 PIL

Reasons for updating

  • Change of licence holder

Updated on 10 May 2005 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 2 February 2005 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 18 November 2004 PIL

Reasons for updating

  • Change of active ingredient
  • Improved electronic presentation

Updated on 19 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie