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Suprax 200mg Film-Coated Tablets

  • Name:

    Suprax 200mg Film-Coated Tablets

  • Company:
    info
  • Active Ingredients:

    Cefixime trihydrate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 25/01/19

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Summary of Product Characteristics last updated on medicines.ie: 25/10/2019

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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 25 October 2019 SmPC

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
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

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

Updated on 25 January 2019 PIL

Reasons for updating

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

Updated on 24 January 2019 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

6.5       Nature and Contents of container

 

HDPE tablet container with a tamper evident polypropylene screw cap or child resistant closure.

 

Pack sizes:       10, 20, 50, 100, 200.

Blister Packs:  PVC/aluminium foil laminate blister packs.

 

Pack sizes:       1, 2, 7, 14.

 

Not all pack sizes may be marketed.

Updated on 14 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 14 March 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 14 March 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 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:-

Beta-lactams, including cefixime, predispose the patient to encephalopathy risk (which may include convulsions, confusion, impairment of consciousness, movement disorders), particularly in case of overdose or renal impairment.

 

Section 4.7 added:-

In the case of side effects such as encephalopathy (which may include convulsions, confusion, impairment of consciousness, movement disorders), the patient should not operate machines or drive a vehicle

Section 4.7 removed:-

·         Not relevant

Section 4.8 added:-

Nervous System disorders

·         Beta-lactams, including cefixime, predispose the patient to encephalopathy risk (which may include convulsions, confusion, impairment of consciousness, movement disorders), particularly in case of overdose or renal impairment.

Section 4.9 added:-

·         Signs And Symptoms

·         There is a risk of encephalopathy in cases of administration of beta-lactam antibiotics, including cefixime, particularly in case of overdose or renal impairment.

Updated on 14 March 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - driving and using machines
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 1 February 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

Frequency not known- Frequency not known: Cases of convulsions have been reported with cephalosporins including cefixime

Updated on 28 January 2016 PIL

Reasons for updating

  • Change to side-effects

Updated on 27 April 2015 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 4.9 - Overdose
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.3: wording updated to read better.
Section 4.4: new information on severe cutaneous adverse reactions, renal failure and drug-induced haemolytic anaemia included. 
'A false positive direct Coombs test may occur with cephalosporins.' has been moved to section 4.5.
Section 4.5: paragraph on interaction with anticoagulants of the coumarin type has been reworded.
Section 4.8: Side effects tabulated and haemolytic anaema added.
Section 4.9: changed to read 'No specific antidote exists.  General supportive measures are recommended.'
Section 5.1: Reworded.
Section 5.2: Absorption reworded.  New paragraphs 'Paediatric Population', 'Distribution' and 'Renal Impairment'.  Paragraph 'Excretion' reworded to 'Metabolism & Excretion' and updated accordingly.

 

Updated on 19 December 2012 SmPC

Reasons for updating

  • Improved electronic presentation

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

Free text change information supplied by the pharmaceutical company

Updated SPC for Irish Audit

Updated on 13 December 2012 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 21 September 2011 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Change to 6.3 - Shelf Life - reduction of shelf life from 2 yrs to 18 mnths

Updated on 10 July 2009 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 19 May 2009 SmPC

Reasons for updating

  • Change to improve clarity and readability

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

Free text change information supplied by the pharmaceutical company

Amendment of minor typing errors.

Updated on 18 May 2009 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 2 October 2008 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 15 September 2008 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

Update Section 4.8 of SPC.
 
 

Updated on 19 December 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 11 December 2006 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 7 - Marketing authorisation holder
  • 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

Update
Section 4.4: Added statement regarding safety in newborn infants
Section 4.8: Added undesirable effect; increase in bilirubin
Section 7:    Change name of MAH
Section 10:  Change date of revision

Updated on 7 June 2006 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)

Updated on 16 May 2005 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 25 April 2005 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 15 February 2005 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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 not be renewed (A)

Updated on 19 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 18 August 2003 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 24 June 2003 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 23 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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