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Beacon Pharmaceuticals
85 High Street, Tunbridge Wells, TN1 1YG
Telephone: +44 (0)1892 600 930
Fax: +44 (0)1892 600 937
WWW: http://www.beaconpharma.co.uk
Medical Information e-mail: info@beaconpharma.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: 01/11/2010
SPC Ranitidine 50mg/2ml Solution for Injection and Infusion

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 01/11/2010 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 4.8 - Undesirable Effects
  • 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):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - Extra paragraph relating to the elderly

Section 4.5 - additional sub sections 2) and 3) added

Section 4.8 - revisions to wording
Updated on 23/09/2010 and displayed until 01/11/2010
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 4.8 - Undesirable Effects
  • 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):   NO

Free-text change information supplied by the pharmaceutical company
all revisons due to safety update.

Section 4.4 - additional information added
Section 4.5 - additional information added
Section 4.8 - additonal information/headings added
Section 10 - date of revison changes to 01 September 2010
Updated on 21/12/2009 and displayed until 23/09/2010
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 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • 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:   27-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 4.1 added - Children 6 months - 18 years

In section 4.2 heading amended to read - Adults (including elderly) and adolescents (12 years and older)

In section 4.2 heading amended to read - Children/infants (6 months to 11 years) and additional information included in section

In section 4.8 added at the end a statement relating to safety of ranitidine in children 0 - 16 years.

In section 5.1 added at the end a statement concerning clinical data.

In section 5.2 added information on Special Patient Polulations and Neonates (under 1 month)

In section 10 - revision date added
Updated on 16/10/2009 and displayed until 21/12/2009
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  ranitidine hydrochloride