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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: 01/03/2012
SPC Ciproxin Suspension

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 01/03/2012 and displayed until Current
Reasons for adding or updating:
  • 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-Sep-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The key changes to the SmPC are:

·        Removal of the Trading Style from Section 7 of the SmPCs for Ciproxin Tablets, Infusion and Suspension, with a consequential removal of the 'Bayer Schering Pharma Logo' from the packaging.

·        To update the name of the finished product manufacturer (Batch Release site) from 'Bayer Schering Pharma AG' to ''Bayer Pharma AG' with a consequential change to the PILs.
Updated on 30/04/2010 and displayed until 01/03/2012
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Sections 2, 3 & 6 have been extensively updated to reflect changes in the registered Quality information - especially the shelf-life and storage conditions.
Section 10  Revision date is now April 2010
Updated on 12/11/2008 and displayed until 30/04/2010
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 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
  • Change to section 1 -Name of the Medicinal product
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   01-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 1: the wording of the product name has changed from "Ciproxin Oral Suspension 250mg/5ml" to "Ciproxin 50mg/mL granules and solvent for oral suspension".

Section 4.1: significant changes based on information available on resistance for each adult indication.

Section 4.2: updated in-line with section 4.1 and addition of guidance on dose adjustments in renally impaired elderly patients.

Section 4.4: additional warnings and precautions (several on suitability of treatment with Ciproxin plus those on cardiac disorders, hepatobiliary system, resistance, cytochrome P450 and methotrexate).

Section 4.5: additional interactions (xanthine derivatives, clozapine).

Section 4.8: conversion to MedDRA terminology.

Sections 5.1-5.3: addition of new pharmacodynamic (including updated resistance data)/pharmacokinetic and preclinical data.

Section 10 - Revision date is now October 2008
Updated on 09/06/2008 and displayed until 12/11/2008
Reasons for adding or updating:
  • 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:   02-May-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7 (MA Holder) has been updated with the 'Bayer Schering Pharma' trading sytle.
Section 10 (Date of Revision of the Text) has been updated with the date of approval of the above. 
Updated on 27/05/2008 and displayed until 09/06/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 5.2 - Pharmacokinetic Properties
  • 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
Date of revision of text on the SPC:   17-Apr-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Amendments to the SmPC, Sections 4.1, 4.2, 4.3, 4.4, 4.8, 5.2 and 5.3 following the EU work sharing project assessment of paediatric data. 
Updated on 08/01/2007 and displayed until 27/05/2008
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.3 (Contraindications) has been updated to add hypersensitivity to any of the excipients as a contraindication. 

 

Section 4.5 (Interaction with other medicinal products and other forms of interaction) has been updated to add duloxetine and sevelamer drug interactions.

 

Section 10 (Date of revision of the text) has been updated to ‘January 2006’. 

Updated on 13/12/2006 and displayed until 08/01/2007
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Updated on 03/05/2006 and displayed until 13/12/2006
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   01/09/2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.3 (Contraindications) New information on tizanidine:

“Concurrent administration of ciprofloxacin and tizanidine is contraindicated since an undesirable increase in serum tizanidine concentrations associated with clinically relevant tizanidine-induced side-effects (hypotension, somnolence) can occur.“

 

Section 4.5 (Interaction with other medicinal products and other forms of interaction) New information on tizanidine:

“Ciprofloxacin inhibits CYP1A2 and thus may cause increased serum concentration of concomitantly administered substances metabolised by this enzyme (e.g. theophylline, clozapine, tacrine, ropinirol, tizanidine). Therefore, patients taking these substances concomitantly with ciprofloxacin should be monitored closely for clinical signs of overdose, and determination of serum concentrations, especially of theophylline, may be necessary. “

and

“In a crossover study, 10 healthy subjects were given ciprofloxacin 500mg or placebo twice daily for three days, at the end of which a single dose of tizanidine 4mg was given.  There was an increase in tizanidine serum concentrations (Cmax increase: 7-fold, range: 4 to 21-fold; AUC increase: 10-fold, range: 6 to 24-fold) when given concomitantly with ciprofloxacin compared to placebo. Associated with the increased serum concentrations was a potentiated hypotensive and sedative effect. Tizanidine must not be administered together with ciprofloxacin (refer to Section 4.3). “

 

Section 10 (Date of revision of the text) New date:

“September 2005”.

 
Updated on 09/03/2006 and displayed until 03/05/2006
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 4.3 - Contra-indications
  • 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 4.9 - Overdose
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • 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 13/11/2003 and displayed until 09/03/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
Updated on 02/09/2003 and displayed until 13/11/2003
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Updated on 30/01/2002 and displayed until 02/09/2003
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 08/01/2002 and displayed until 30/01/2002
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 - Contra-indications
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 (date of (partial) revision of the text
Updated on 15/08/2001 and displayed until 08/01/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 28/03/2001 and displayed until 15/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 12/09/2000 and displayed until 28/03/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 12/09/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  ciprofloxacin