Rilutek 50mg Film Coated Tablet

  • Name:

    Rilutek 50mg Film Coated Tablet

  • Company:
    info
  • Active Ingredients:

    Riluzole

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/10/19

files-icon(Click to Download)

XPIL

Summary of Product Characteristics last updated on medicines.ie: 16/10/2019

Click on this link to Download PDF directly

SANOFI

SANOFI

Company Products

Medicine NameActive Ingredients
Medicine Name Adenocor Active Ingredients Adenosine
Medicine Name Amaryl 1mg Tablets Active Ingredients Glimepiride
Medicine Name Amaryl 3mg Tablets Active Ingredients Glimepiride
Medicine Name Anthisan Cream Active Ingredients Mepyramine Maleate
Medicine Name Apidra 100 units/ml solution for injection in a cartridge Active Ingredients Insulin Glulisine
Medicine Name Apidra 100 Units/ml solution for injection in a vial Active Ingredients Insulin Glulisine
Medicine Name Apidra SoloStar 100 units/ml solution for injection in a pre-filled pen Active Ingredients Insulin Glulisine
Medicine Name Aprovel 150mg film-coated tablets Active Ingredients Irbesartan
Medicine Name Aprovel 300mg film-coated tablets Active Ingredients Irbesartan
Medicine Name Aprovel 75mg film-coated tablets Active Ingredients Irbesartan
Medicine Name Arava 10 mg film-coated tablets Active Ingredients Leflunomide
Medicine Name Arava 20 mg film-coated tablets Active Ingredients Leflunomide
Medicine Name Bisolvon Oral Solution Active Ingredients Bromhexine hydrochloride
Medicine Name Brolene 0.1%w/v Eye Drops Solution Active Ingredients Propamidine Isethionate
Medicine Name Brolene 0.15% w/w Eye Ointment Active Ingredients Dibromopropamidine Isethionate
Medicine Name Buscopan 10 mg Coated Tablets Active Ingredients hyoscine butylbromide
Medicine Name Buscopan Ampoules Active Ingredients hyoscine butylbromide
Medicine Name Buscopan Rx 10mg Coated Tablets Active Ingredients hyoscine butylbromide
Medicine Name Calcium Resonium Active Ingredients Calcium polystyrene sulfonate
Medicine Name Cerubidin 20mg Powder for Solution for Injection Active Ingredients daunorubicin hydrochloride
Medicine Name Cidomycin Paediatric 20mg/2ml Solution For Injection Active Ingredients Gentamicin sulfate
Medicine Name Claforan Powder for Solution for Injection 1g Active Ingredients Cefotaxime sodium
Medicine Name Claforan Powder for Solution for Injection 500mg Active Ingredients Cefotaxime sodium
Medicine Name Clexane 10,000 IU (100mg)/1ml Solution for Injection Active Ingredients Enoxaparin sodium
Medicine Name Clexane 2,000 IU (20 mg) /0.2 mL Solution for Injection Active Ingredients Enoxaparin sodium
1 - 0 of 176 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 16 October 2019 SmPC

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 not be renewed (A)

Updated on 8 October 2019 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 18 June 2019 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

For variation:

MAH transfer to:

Sanofi Mature IP

54 Rue de la Boétie

75008 Paris

France

Updated on 18 June 2019 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

MAH transfer to:

Sanofi Mature IP

54 Rue de la Boétie

75008 Paris

France

Updated on 11 December 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 11 December 2017 SmPC

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.8 addition of

 

 

 

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie

 

 

Updated on 19 February 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 February 2015 PIL

Reasons for updating

  • Change to further information section

Updated on 6 January 2014 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • 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 6.5 - Nature and contents of container
  • Change to section 2 - Qualitative and quantitative composition

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

Free text change information supplied by the pharmaceutical company

Type IB to add Croatia and QRD v59

Updated on 15 January 2013 PIL

Reasons for updating

  • Change of distributor details

Updated on 23 February 2011 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 14 July 2009 SmPC

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update Sections 4.4
Cases of interstitial lung disease have been reported in patients treated with riluzole, some of them were severe (see section 4.8). If respiratory symptoms develop such as dry cough and/or dyspnea, chest radiography should be performed, and in case of findings suggestive of interstitial lung disease (e.g. bilateral diffuse lung opacities), riluzole should be discontinued immediately. In the majority of the reported cases, symptoms resolved after drug discontinuation and symptomatic treatment."

Section 4.8 addition of: "Respiratory, thoracic and mediastinal disorders, Uncommon: interstitial lung disease (see section 4.4)"



 

Updated on 8 July 2009 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 24 June 2009 PIL

Reasons for updating

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

Updated on 27 June 2008 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 2 May 2008 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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 4.8 Adverse reactions
Section 5.2 Pharmacokinetics
Section 10: Date of revision

Updated on 19 December 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 19 October 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 28 August 2006 SmPC

Reasons for updating

  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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

Section 4.2: Information on use in children updated.

Section 4.3: breast-feeding replaces the word lactating

Section 4.4: Information on use in children deleted

Section 4.6: breast-feeding replaces the word lactating

Section 4.7: The sentence 'No studies on the effects on the ability to drive and use machines have been performed'.

Section 4.8: All section 4.8 has been updated and previous text deleted. The frequency of the occurrence of adverse events are now documented.

Updated on 21 March 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 18 May 2005 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 17 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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