Flagyl 200mg Tablets * Pharmacy Only: Prescription
Company:
SANOFIStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 16 August 2022
File name
62fb5b80c8112.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
62fb5b4a44d75.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 medical prescription which may not be renewed (A)
Updated on 12 July 2021
File name
Flagyl Tablets 200mg 400.mg PIL Adobe Acrobat Pro_1626106381.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 200mg 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 medical prescription which may not be renewed (A)
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 medical prescription which may not be renewed (A)
Updated on 22 December 2016
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
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 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
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 medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 30 April 2013
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 6.4: 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
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 medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 21 December 2011
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 14 December 2011
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
CSDS Update & Article 45
Updated on 15 February 2010
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
Updated on 23 September 2009
Reasons for updating
- Change due to user-testing of patient information
Updated on 11 September 2009
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
Updated on 13 May 2008
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 May 2008
Reasons for updating
- New PIL for medicines.ie
Updated on 08 August 2007
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
Updated on 02 May 2007
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 November 2006
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
Updated on 10 May 2005
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 December 2003
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 05 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)