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Flagyl 400mg Tablets

*
Pharmacy Only: Prescription

  • Company:

    SANOFI

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to restricted prescription (C)

  • Active Ingredient(s):

    Metronidazole

    *Additional information is available within the SPC or upon request to the company

Updated on 17 July 2023

File name

1.3.2.1 Mock-up - Package Leaflet (PIL) Flagyl Tablets (Riells).pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 25 April 2023

File name

1.3.1.1 (SmPC) - Flagyl 400mg.pdf

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 restricted prescription (C)

Updated on 29 March 2023

File name

1.3.2.1 Mock-up - Package Leaflet (PIL)- Flagyl Tablets (FAMAR) (3).pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 16 March 2023

File name

1.3.1.3 Package Leaflet (PIL text) Flagyl Tablets.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 16 March 2023

File name

1.3.2 Mock-up PIL-IE-MT-XI (1).pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 13 January 2023

File name

1.3.2 Mock-up PIL-IE-MT-XI.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 25 November 2022

File name

1.3.2.1 Mock-up - Package Leaflet (PIL)- Flagyl Tablets (FAMAR).pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 19 October 2022

File name

1.3.1.3 Package Leaflet (PIL text) Flagyl Tablets.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 19 October 2022

File name

1.3.1.1 Summary of Product Characteristics (SmPC) Flagyl 400mg.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - 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 restricted prescription (C)

Updated on 16 August 2022

File name

1.3.1.3 Package Leaflet (PIL text)- Flagyl Tablets 200mg 400mg.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 16 August 2022

File name

1.3.1 Flagyl 400mg tablet SmPC Vertigo.pdf

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 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to restricted prescription (C)

Updated on 12 July 2021

File name

Flagyl Tablets 200mg 400.mg PIL Adobe Acrobat Pro.pdf

Reasons for updating

  • XPIL Removed

Updated on 06 July 2020

File name

Flagyl Tablets 200mg 400.mg PIL Adobe Acrobat Pro.pdf

Reasons for updating

  • XPIL Removed

Updated on 20 July 2018

File name

Flagyl Tablets 200mg 400.mg PIL Adobe Acrobat Pro.pdf

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

File name

Flagyl 400mg tablets SPC.PDF

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 restricted prescription (C)

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 SPC for new product

Legal category:Product subject to restricted prescription (C)

Updated on 22 December 2016

Reasons for updating

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

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Update section 4.4

Updated on 20 December 2016

File name

PIL_13110_409.pdf

Reasons for updating

  • New PIL for new product

Updated on 20 December 2016

Reasons for updating

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

Updated on 19 August 2016

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to restricted prescription (C)

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

Reasons for updating

  • Change to side-effects

Updated on 04 April 2014

Reasons for updating

  • Change to side-effects

Updated on 19 March 2014

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to restricted prescription (C)

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 26 April 2013

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 6.3: Shelf life reduced
Section 6.4: Changed to Store below 30º C in the original packaging (protect from light).
Section 7: Addition of 'Sanofi' as a trading style

Updated on 25 April 2013

Reasons for updating

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

Updated on 05 March 2013

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 restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 4.8 updated re Hepatic disorders

Updated on 27 November 2012

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 21 December 2011

Reasons for updating

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

Updated on 23 September 2009

Reasons for updating

  • Change due to user-testing of patient information

Updated on 06 May 2008

Reasons for updating

  • New PIL for medicines.ie