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GlaxoSmithKline Consumer Healthcare
980 Great West Road, Brentford, Middlesex, TW8 9GS
Telephone: +44 (0)20 8047 5000
Medical Information Direct Line: +44 (0)20 8047 2500
Medical Information e-mail: customer.relations@gsk.com
Customer Care direct line: +44 (0)20 8047 2700
Medical Information Fax: +44 (0)20 8047 6860

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: 02/08/2011
SPC Zantac 75 Relief

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 02/08/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   18-Jul-2011
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 5.2 revised to include further information, particularly distribution, elimination and use in special patient populations.
Updated on 28/06/2011 and displayed until 02/08/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   16-Jun-2011
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - addition of creatinine clearance figures
Updated on 04/01/2011 and displayed until 28/06/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   09-Sep-2010
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - Addition of information regarding community acquired pneumonia.
Updated on 20/11/2009 and displayed until 04/01/2011
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   02-Nov-2009
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.5 (Interaction with other medicinal products and other forms of interaction) now states the following:

Ranitidine has the potential to affect the absorption, metabolism or renal excretion of other drugs. The altered pharmacokinetics may necessitate dosage adjustment of the affected drug or discontinuation of treatment.

 

            Interactions occur by several mechanisms including:

 

1) Inhibition of cytochrome P450-linked mixed function oxygenase system:

 

Ranitidine at usual therapeutic doses does not potentiate the actions of drugs which are inactivated by this enzyme such as diazepam, lidocaine, phenytoin, propranolol and theophylline.

 

There have been reports of altered prothrombin time with coumarin anticoagulants (e.g. warfarin). Due to the narrow therapeutic index, close monitoring of increased or decreased prothrombin time is recommended during concurrent treatment with ranitidine.

 

           2) Alteration of gastric pH:

 

The bioavailability of certain drugs may be affected. This can result in either an increase in absorption or a decrease in absorption.

Updated on 15/10/2009 and displayed until 20/11/2009
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   08-Oct-2009
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The changes to section 4.1 are as a result of the changes to 4.4.

In section 4.4, the following paragraph has been added:

"Ranitidine is excreted via the kidney and so plasma levels of the drug are increased in patients with severe renal impairment. Zantac 75 Relief is not suitable for these patients."

The text in red has been added to the following paragraph in section 4.4.

People taking non-steroidal anti-inflammatory drugs, especially those with a history of peptic ulcer and the elderly, should not self-medicate with Zantac 75 Relief but seek their doctor’s advice before use.

In section 4.4, the following paragraph has been added:

"The product is not indicated in the following people without seeking their doctor's advice:

 

Patients with renal and/or hepatic impairment. 

 

Patients under regular medical supervision for other reasons.

Patients suffering from any other illness or taking medications either physician prescribed or self prescribed.

Patients of middle age or older with new or recently changed symptoms of indigestion.

 

Patients with unintended weight loss in association with symptoms of indigestion."


In section 4.8 ( undesirable effects) the following paragraph has been added:

"Eye Disorders

 

Very Rare: Reversible blurred vision.

There have been reports of blurred vision, which is suggestive of a change of accommodation."


In the following section of section 4.8, the words "in men" have been removed. 


Reproductive System and Breast Disorders

Very Rare:        Reversible impotence. Breast symptoms and conditions (such as gynaecomastia and galactorrhea in men).
Updated on 22/10/2007 and displayed until 15/10/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   08/2007
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7 - Marketing authorisation holder changed from GlaxoWellcome to Beecham Group Plc, with subsequent change to marketing authorisation number in Section 8
 
Sections 9 and 10  updated
Updated on 08/06/2005 and displayed until 22/10/2007
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 12/05/2005 and displayed until 08/06/2005
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change from BAN to rINN
  • Improved Electronic Presentation
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 (date of (partial) revision of the text
Updated on 22/03/2004 and displayed until 12/05/2005
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  ranitidine hydrochloride