MEMANTINE ACCORD

Posology Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's dementia. Therapy should only be started if a caregiver is available who will regularly monitor the intake of the medicinal product by the patient.

Diagnosis should be made according to current guidelines. The tolerance and dosing of memantine should be reassessed on a regular basis, preferably within three months after start of treatment. Thereafter, the clinical benefit of memantine and the patient's tolerance of treatment should be reassessed on a regular basis according to current clinical guidelines.

Maintenance treatment can be continued for as long as a therapeutic benefit is favourable and the patient tolerates treatment with memantine. Discontinuation of memantine should be considered when evidence of a therapeutic effect is no longer present or if the patient does not tolerate treatment.

Adults Dose titration The recommended starting dose is 5 mg per day which is stepwise increased over the first 4 weeks of treatment reaching the recommended maintenance dose as follows: Week 1 (day 1-7): The patient should take one 5 mg film-coated tablet per day (white) for 7 days.

Week 2 (day 8-14):

The patient should take one 10 mg film-coated tablet per day (white, scored) for 7 days.

Week 3 (day 15-21):

The patient should take one 15 mg film-coated tablet per day (orange to grey-orange) for 7 days.

Week 4 (day 22-28):

The patient should take one 20 mg film-coated tablet per day (pale red to grey-red, scored) for 7 days. Maintenance dose The recommended maintenance dose is 20 mg per day. Elderly On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day (20 mg tablets once a day) as described above.

Renal impairment In patients with mildly impaired renal function (creatinine clearance 50-80 ml/min) no dose adjustment is required. In patients with moderate renal impairment (creatinine clearance 30-49 ml/min) daily dose should be 10 mg per day.

If tolerated well after at least 7 days of treatment, the dose could be increased up to 20 mg/day according to standard titration scheme. In patients with severe renal impairment (creatinine clearance 5-29 ml/min) daily dose should be 10 mg per day.

Summary of the safety profile In clinical trials in mild to severe dementia, involving 1,784 patients treated with memantine and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions with memantine did not differ from those with placebo; the adverse reactions were usually mild to moderate in severity.

8 %). The following adverse reactions listed in the table below have been accumulated in clinical studies with memantine and since its introduction in the market. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Tabulated list of adverse reactions Adverse reactions are ranked according to system organ class, using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).

System Organ Class Frequency Adverse Reaction Infections and infestations Uncommon Fungal infections Immune systeme disorders Common Drug hypersensitivity Common Somnolence Uncommon Confusion Uncommon Hallucinations1 Psychiatric disorders Not known Psychotic reactions2 Common Dizziness Common Balance disorders Nervous system disorders Uncommon Gait abnormal Very rare Seizures Cardiac disorders Uncommon Cardiac failure Common HypertensionVascular disorders Uncommon Venous thrombosis/thromboembolism Respiratory, thoracic and mediastinal disorders Common Dyspnoea Common Constipation Uncommon Vomiting Gastrointestinal disorders Not known Pancreatitis2 Common Elevated liver function testHepatobiliary disorders Not known Hepatitis Common HeadacheGeneral disorders and administration site conditions Uncommon Fatigue 1 Hallucinations have mainly been observed in patients with severe Alzheimer's disease.

2 Isolated cases reported in post-marketing experience. Description of selected adverse reactions Alzheimer's disease has been associated with depression, suicidal ideation and suicide. In post-marketing experience these events have been reported in patients treated with memantine.

Caution is recommended in patients with epilepsy, former history of convulsions or patients with predisposing factors for epilepsy. Concomitant use of N-methyl-D-aspartate (NMDA)-antagonists such as amantadine, ketamine or dextromethorphan should be avoided.

5). 2 'Elimination') may necessitate careful monitoring of the patient. g. from a carnivore to a vegetarian diet, or a massive ingestion of alkalising gastric buffers. Also, urine pH may be elevated by states of renal tubulary acidosis (RTA) or severe infections of the urinary tract with Proteus bacteria.

In most clinical trials, patients with recent myocardial infarction, uncompensated congestive heart failure (NYHA III-IV), or uncontrolled hypertension were excluded. As a consequence, only limited data are available and patients with these conditions should be closely supervised.

Excipients Memantine Accord contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactosemalabsorption should not take this medicinal product.

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