GlaxoSmithKline Consumer Healthcare

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.

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

In section 4.4, the text in red has been added.

Patients who are taking non-steroidal anti-inflammatory drugs especially in those with a history of peptic ulcer and the elderly should be referred to their doctor before taking Zantac 75. 

In section 4.4, the following text has been added:

"The product is not indicated in the following patients without seeking their doctor's or pharmacist’s advice:

               1. Patients with renal and/or hepatic impairment. 

               2. Patients under regular medical supervision for other reasons.
    

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

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

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

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

            Eye Disorders

Very Rare:        Reversible blurred vision.

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

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

Reproductive System and Breast Disorders

Very Rare:        Reversible impotence. Breast symptoms and breast conditions (such as gynaecomastia and galactorrhea in men ).