Flagyl 200mg Tablets

  • Name:

    Flagyl 200mg Tablets

  • Company:
    info
  • Active Ingredients:

    Metronidazole

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/07/20

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Summary of Product Characteristics last updated on medicines.ie: 20/7/2018

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SANOFI

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 6 July 2020 PIL

Reasons for updating

  • XPIL Removed

Updated on 20 July 2018 PIL

Reasons for updating

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

Updated on 20 July 2018

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

Free text change information supplied by the pharmaceutical company

 

4.4 Special warnings and special precautions for use

 

Wording replaced in paragraph with:-

 

  • (SJS),
  • (TEN) or acute generalised exanthematous pustulosis (AGEP)
  • AGEP
  • must be immediately

4.8 Undesirable effects

 

Skin and subcutaneous tissue disorders

 

Wording added into paragragh

 

  • acute generalised exanthematous pustulosis

Updated on 22 December 2016

Reasons for updating

  • New SmPC for new product

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

Updated on 22 December 2016 SPC

Reasons for updating

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

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

Updated on 20 December 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 20 December 2016 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 19 August 2016 SPC

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             Undesirable effects

Frequency, type and severity of adverse reactions in children are the same as in adults.

 

 

            Gastrointestinal disorders

-     epigastric pain, nausea, vomiting, malaise, diarrhoea.

-     oral mucositis, taste disorders, dry mouth, anorexia.

-     reversible cases of pancreatitis.

-     tongue discolouration/furry tongue.

 

Immune system disorders

-           angioedema,  anaphylactic shock.

           

           Nervous system disorders

-     peripheral sensory neuropathy, paraesthesia

-          headache, convulsions, dizziness.

-          reports of encephalopathy (e.g. confusion) and subacute cerebellar syndrome (e.g. ataxia, dysathria, gait impairment, nystagmus and tremor) which may resolve with discontinuation of the drug.

-          aseptic meningitis

 

Psychiatric disorders

-          psychotic disorders including confusion, hallucinations

-          depressed mood

 

Eye disorders

-     transient vision disorders such as diplopia, myopia, blurred vision, decreased visual acuity, changes in color vision.

-     Optic neuropathy/neuritis.

 

Ear and labyrinth disorders

-          hearing impaired/hearing loss (including sensorineural)

-          tinnitus

 

Blood and lymphatic system disorders

-     cases of agranulocytosis, neutropenia and thrombocytopenia have been reported.

 

Hepatobiliary disorders

-      increase in liver enzymes (AST, ALT, alkaline phosphatase), cholestatic or mixed hepatitis and hepatocellular liver injury, sometimes with jaundice, have been reported.

-      cases of liver failure requiring liver transplant have been reported in patients treated with metronidazole mostly when used in combination with other antibiotic drugs.

 

Skin and subcutaneous tissue disorders

-      rash, pruritus, flushing, urticaria

-      pustalar eruptions

-      fixed drug eruption

-      Stevens-Johnson syndrome, toxic epidermal necrolysis.

 

General disorders and administration site conditions

-  fever

 

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

Updated on 18 August 2016 PIL

Reasons for updating

  • Change to side-effects

Updated on 4 April 2014 PIL

Reasons for updating

  • Change to side-effects

Updated on 19 March 2014 SPC

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

Type II.C.1.4 variation to update the SPC for the product range following the revision of the Core Safety Data Sheet for metronidazole. The update concerns the addition of adverse events to section 4.8 of the SPC.

Updated on 30 April 2013 SPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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

Section 6.3: shelf life reduced from 5 years to 3 years.
Section 6.4: storage changed from ‘Do not store above 25°C. Store in the original container.’ to ‘Store below 30ºC in the original packaging (protect from light).’
Section 7: 'Sanofi' added as a trading style.

Updated on 25 April 2013 PIL

Reasons for updating

  • Change to storage instructions
  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 5 March 2013 SPC

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 updated re Hepatic disorders

Updated on 21 December 2011 PIL

Reasons for updating

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

Updated on 14 December 2011 SPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

C.I.3.b To update sections 4.1, 4.2, 4.4, 4.7, 4.8 & 5.3 of the SPC
CSDS Update & Article 45

Updated on 15 February 2010 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

Administrative amendment.

Updated on 23 September 2009 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 11 September 2009 SPC

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

Addition of depressed mood and possible jaundice.

Updated on 13 May 2008 SPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 6 May 2008 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 8 August 2007 SPC

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

Update Sections
4.4 - Addition of recommendation of regular blood tests.
4.8 - Addition of malaise and parasthesia.
10 - Date of revision.

Updated on 2 May 2007 SPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 23 November 2006 SPC

Reasons for updating

  • 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 7 - Change MAH to sanofi-aventis Ireland Ltd.

Updated on 10 May 2005 SPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 3 December 2003 SPC

Reasons for updating

  • 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)

Updated on 5 June 2003 SPC

Reasons for updating

  • New SPC for medicines.ie

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