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Rosemont Pharmaceuticals Limited
Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE
Telephone: +44 (0)113 244 1400
Fax: +44 (0)113 246 0738
WWW: http://www.rosemontpharma.com
Customer Care direct line: +44 (0)800 919 312
Out of Hours Telephone: +44 (0)7836 557 879
Out of Hours contact: pharmacovigilance@rosemontpharma.com

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: 23/05/2012
SPC Nalidixic Acid 300mg/5ml Oral 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 23/05/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   14-May-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 6.3 (Shelf life) This has been reduced from 36 months to 24 months.
In section 10 (Date of revision of the text) The date has been updated to 14-May-2012.
Updated on 24/03/2010 and displayed until 23/05/2012
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 4.1 - Therapeutic indications
  • 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 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   26-Jan-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


In section 1 (name of the medicinal product): Changed from Uriben to Nalidixic Acid.
In section 4.1 (therapeutic indications): Product name changed from Uriben to Nalidixic acid oral suspension.
In section 4.4 (special warnings and precautions for use): A precaution for use in hepatic impairment, moderate renal impairment or cerebral arteriosclerosis (risk of seizures) has been added. Text to monitor full blood count, renal function and hepatic impairment in long term therapy has been included. There has been an addition of a precaution to discontinue treatment if symptoms of neuropathy or arthropathy occur. A warning to include tendon damage or rupture has been added. Advise to discontinue treatment if patients experience tendon pain, inflammation or tendon rupture has been added.
In section 4.5 (Interaction with other medicinal products and other forms of interaction): This section has been updated to include other antibacterials, oestrogens, oral typhoid vaccination strontium ranelate, sucralfate and products containing divalent or trivalent cations.
In section 4.6 (Pregnancy and lactation): The product name has been updated fro Uriben to Nalidixic Acid Oral Suspension.
In section 4.8 (Undesirable effects): Updated to include metabolic acidosis, allergic reactions and named photosensitivity reactions. The skin reactions, Stevens Johnson syndrome, erythema mutiforme, eosinophilia, angioedema and anaphylaxis have been added. Tendon damage or rupture, vertigo, drowsiness, excitement and toxic psychoses have also been added. An increased risk of convulsions has been added in patients with a post history of convulsions or cerebral arteriosclerosis. Reports of peripheral neuropathy, sixth cranial nerve palsy and intracranial hypertension have also been added.
In section 5.2 (Pharmacokinetic properties): A typo of 'prsence' has been corrected to 'presence'.
In section 10 (Date of revision of text): the date has been updated from21.1.09 to 26th January 2010.
Updated on 26/05/2009 and displayed until 24/03/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   21-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4: Change in strawberry flavour leading to the removal of carmoisine E122 and ingredients of animal origin
Section 6.1: Change in excipients reflecting change in strawberry flavour
Updated on 16/04/2008 and displayed until 26/05/2009
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
Date of revision of text on the SPC:   02/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section1: Name re-arrangement
Updated on 21/09/2005 and displayed until 16/04/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 10 (date of (partial) revision of the text
Updated on 26/09/2002 and displayed until 21/09/2005
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  nalidixic acid