Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
Malignancy
The possibility of malignancy should be excluded before commencement of therapy in patients with gastric ulcer and in patients of middle age and over with new or recently changed dyspeptic symptoms) as treatment with ranitidine may mask symptoms of gastric carcinoma.

Renal Disease
Ranitidine is excreted via the kidney and so plasma levels of the drug are increased in patients with renal impairment. The dose should be adjusted as detailed in section 4.2 Patients with renal impairment.
Regular supervision of patients who are taking non-steroidal anti- inflammatory drugs concomitantly with ranitidine is recommended, especially in the elderly. Current evidence shows that ranitidine protects against NSAID associated ulceration in the duodenum and not in the stomach.
Rare clinical reports suggest that ranitidine may precipitate acute porphyric attacks. Ranitidine should therefore be avoided in patients with a history of acute porphyria.
In patients such as the elderly, persons with chronic lung disease, diabetes or the immunocompromised, there may be an increased risk of developing community acquired pneumonia. A large epidemiological study showed an increased risk of developing community acquired pneumonia in current users of ranitidine alone versus those who had stopped treatment, with an observed adjusted relative risk increase of 1.82 (95% CI 1.26-2.64). Post- marketing data indicate reversible mental confusion, depression, and hallucinations have been reported most frequently in severely ill and elderly patients (see section 4.8).

• ZARIDEX contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• ZARIDEX contains the excipient sunset yellow FCF (E110), which may cause allergic reactions.

Effects on Driving

4.7 Effects on ability to drive and use machines
None reported.