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An increase to the maintenance dose of 24 mg/day12 mg twice a dayshould be considered on an individual basis after appropriate assessment including evaluation of clinical benefit and tolerability.

Therapeutic doses of galantamine 24 mg/day had no effect on the kinetics of digoxinalthough pharmacodynamic interactions may occursee also pharmacodynamic interactions

The use of galantamine is contraindicated in patients with creatinine clearance less than 9 ml/minsee section 4.3

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Serious skin reactionsStevens-Johnson syndrome and acute generalized exanthematous pustulosishave been reported in patients receiving Reminylsee section 4.8It is recommended that patients be informed about the signs of serious skin reactionsand that use of Reminyl be discontinued at the first appearance of skin rash.

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The table below reflects data obtained with Reminyl in eight placebo-controlleddouble-blind clinical trialsN=6,502five open-label clinical trialsN=1,454and from postmarketing spontaneous reportsThe most commonly reported adverse reactions were nausea21and vomiting11They occurred mainly during titration periodslasted less than a week in most cases and the majority of patients had one episodePrescription of anti-emetics and ensuring adequate fluid intake may be useful in these instances.

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