Product Monograph ZANTAC - GlaxoSmithKline

Use in the ElderlySince malignancy is more common in the elderly, particular consideration must be givento this before therapy with ZANTAC ® is instituted. Elderly patients receiving nonsteroidalanti-inflammatory drugs concomitantly with ZANTAC ® should be closelysupervised.As with all medication in the elderly, when prescribing ZANTAC ® , consideration shouldbe given to the patient's concurrent drug therapy. Sporadic cases of drug interactionhave been reported in elderly patients involving both hypoglycaemic drugs andtheophylline. The significance of these reports cannot be determined at present, ascontrolled clinical trials with theophylline and ZANTAC ® have not shown interaction.Elderly patients may be at increased risk for confusional states and depression.ADVERSE REACTIONSTablets and InjectionThe following adverse reactions have been reported as events in clinical trials or in theroutine management of patients treated with ZANTAC ® (ranitidine hydrochloride). Acause and effect relationship to ZANTAC ® is not always established.Central Nervous SystemHeadache, sometimes severe; malaise; dizziness; somnolence; insomnia; vertigo; andreversible blurred vision suggestive of a change in accommodation. Isolated cases ofreversible mental confusion, agitation, depression, hallucinations have been reported,predominantly in severely ill elderly patients. In addition, reversible involuntarymovement disorders have been reported rarely.February 18, 2014Page 10 of 41