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Bayer plc
Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
Telephone: +44 (0)1635 563 000
Fax: +44 (0)1635 563 393
WWW: http://www.bayer.co.uk

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 04/01/2012
SPC Avelox 400 mg film-coated tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 04/01/2012 and displayed until Current
Reasons for adding or 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 4.9 - Overdose
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   11-Nov-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


The key changes are:-

  • Section 4.4 (Special warnings and precautions for use) of the SmPC with a warning in regard of the clinical efficacy of moxifloxacin in special types of complicated skin and skin structure infections (cSSSI).
  • Sections 4.5 (Interactions with other medicinal products and other forms of interaction) and 4.9 (Overdose) of the SmPC have been adapted to the final agreed wording for QT-Interval-Prolongation as agreed by the Pharmacovigilance Working Party (PhVWP) and CMD(h). 
  • Section 4.4 (Special warnings and precautions for use), Section 4.5 (Interactions with other medicinal products and other forms of interaction) , Section 4.6 (Pregnancy and Lactation)  of the SmPC have been adapted to the Core Safety Profile (CSP). 
  • Section 7 (Marketing Authorisation Holder) - removal of the Trading style 'Bayer plc, Bayer Schering Pharma'. 
Updated on 03/12/2010 and displayed until 04/01/2012
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   25-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


The MHRA has approved the following changes to section 4.1 (Therapeutic indications) of the Avelox tablets SmPC:

the PID indication has been restricted

tablets can be used to complete a course of therapy in CAP and cSSSI patients who have shown improvement during initial moxifloxacin IV therapy:

Updated on 25/10/2010 and displayed until 03/12/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


They key changes are:

Additions to section 4.4- in case of seizures, discontinuation of moxifloxacin and appropriate measures taken

- to use moxifloxacin with caution in patients with a history of psychiatric disease and a recommendation to discontinue treatment if a patient develops psychiatric reactions whilst receiving moxifloxacin

- that tendon inflammation and rupture can occur up to several months after discontinuing quinolone therapy

- moxifloxacin may interfere with some biological tests causing false negative results

Additions to section 4.8

- muscle weakness added as a rare side effect

Additions to section 4.9

- ECG monitoring should be undertaken in the case of an overdose

 
Updated on 02/08/2010 and displayed until 25/10/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   12-Feb-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


The key changes are as follows:

  • SPC section 4.4: cases of sensory or sensorimotor polyneuropathy have been reported. As such a warning has been added that patients experiencing symptoms of neuropathy should be advised to contact their doctor before continuing treatment
  • SPC section 4.8: addition of rare/very rare moxifloxacin side effects - "agranulocytosis", examples of self-endangering behaviour ("suicidal thoughts/attempts") added to Psychiatric Disorder side effects and "hearing impairment including deafness". "Transient loss of vision" has also been added (moved from the more general "fluoroquinolone" section (see comment below)
  • SPC section 4.8: very rare fluoroquinolone side effects - addition of "peripheral neuropathy" (in line with section 4.4 change) and "haemolytic anaemia"; removal of "haemolysis" and "transient loss of vision"
  •  SPC section 6.4: "in order to protect from moisture" added as an explanation for storage instruction
Updated on 21/01/2010 and displayed until 02/08/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   19-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

  • The MHRA has approved the addition of the following statement to SmPC section 4.4 "Special warnings and precautions for use":

"Moxifloxacin is not recommended for the treatment of MRSA infections. In case of a suspected or confirmed infection due to MRSA, treatment with an appropriate antibacterial agent should be started (see section 5.1)."
  • The MHRA's date of approval is backdated in line with that of the RMS for this variation (19 Oct 2009).
Updated on 23/01/2009 and displayed until 21/01/2010
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • 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 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.1 ( Therapeutic indications) - text concerning pelvic inflammatory disease has been added.
Section 4.2 ( Posology and method of administration) - duration of administration - mild to moderate pelvic inflamatory disease of 14 days has been added.
Section 4.3 ( Contraindications) - Children and growing adolescents has been replaced by patients under 18 years of age.
Section 4.4 (Special warnings and precautions for use) - information concerning pelvic inflammatory disease has been inserted.
Section 4.7 ( Effects on ability to drive and use machines) - warning re loss of consciousness has been added.
Section 4.8 ( Undesirable effects) - under cardiac disorders row - rare effects loss of conciousness has been added.  Under Hepatobiliary disorders - mention of fatal cases has been included under very rare column.  Musculoskeletal disorders, exacerbation of symptoms has been inserted under very rare events. At base to table rhabdomyolysis has been added.
Section 5.1 ( Pharmacodynamic properties) - extensive update to table regarding specis has been carried out.
Section 5.2 ( Pharmcokinetic properties ) - a table has been inserted regarding peak concentration
Section 7 ( MAH) - this has been amended from Bayer plc, T/A Pharaceutical Division to Bayer Schering Pharma.
Section 10 (Revision date) - now December 2008 
  
Updated on 01/11/2007 and displayed until 23/01/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

The SmPC has been updated to reflect changes based on the Company Core Data Sheets:

 

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

The addition of:

‘Excipient: The film-coated tablet contains lactose monohydrate (see section 4.4).’

 

4.4     Special warnings and precautions for use

The addition of:

‘fulminant hepatitis’

‘(incl. pseudomembranous colitis)’

 

4.8        Undesirable effects

The addition of:

‘fulminant hepatitis potentially leading to life-threatening liver failure (see section 4.4)’

‘(incl. pseudomembranous colitis)’

‘bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially life-threatening)’

‘Feeling unwell (predominantly asthenia or fatigue)’

Plus, some cross-referencing to Section 4.4. 

 

5.1     Pharmacodynamic properties

The addition of:

‘Staphylococcus spp. and fastidious organisms (M100-S17, 2007)’

 

10.     DATE OF REVISION OF THE TEXT

The date has been amended to 02/2007. 

 
Updated on 15/11/2006 and displayed until 01/11/2007
Reasons for adding or 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 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   07/2006
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

Section 4.4 (Special warnings and precautions for use:

Bullet point 2, paragraph 3 has been re-worded.

Bullet point 9, has been reworded.

Bullet point 10, has been reworded

 

Section 4.5 (Interaction with other medicinal products and other forms of interactions):

Paragraph 7 has been amended to read: “Clinical studies have shown that there are no interactions following …..”. 

 

Section 4.7 (Effects on ability to drive and use machines):

The wording has been amended slightly: “….. (e.g. dizziness, see section 4.8). 

 

Section 4.8 (Undesirable effects):

The table has been extensively revised to reflect MedDRA terminology.

 

Section 5.1 (Pharmacodynamic properties):

The wording has been updated in line with the Company Core Data Sheet.

 

Section 10 (Date of revision of the text):

This has been updated to ’26.07.2006’. 

 
Updated on 04/08/2005 and displayed until 15/11/2006
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 (date of (partial) revision of the text
Updated on 19/08/2004 and displayed until 04/08/2005
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 16/12/2003 and displayed until 19/08/2004
Reasons for adding or 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 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.3 - Preclinical Safety Data
Updated on 15/12/2003 and displayed until 16/12/2003
Reasons for adding or 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 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
Updated on 02/10/2003 and displayed until 15/12/2003
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
Updated on 21/03/2003 and displayed until 02/10/2003
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  moxifloxacin hydrochloride