NEMDATINE

Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer’s dementia. Posology 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 maximum daily dose is 20 mg per day. In order to reduce the risk of undesirable effects, the maintenance dose is achieved by upward titration of 5 mg per week over the first 3 weeks as follows.

Week 1 (day 1-7):

The patient should take one 5 mg film-coated tablet (5 mg) or half a 10 mg film-coated tablet (5 mg) per day for 7 days.

Week 2 (day 8-14):

The patient should take two 5 mg film-coated tablets (10 mg) or one 10 mg film-coated tablet (10 mg) per day for 7 days.

Week 3 (day 15-21):

The patient should take three 5 mg film-coated tablets (15 mg) or one 15 mg film-coated tablet (15 mg) per day for 7 days.

From Week 4 on:

The patient should take four 5 mg film-coated tablets (20 mg), two 10 mg film-coated tablets (20 mg) or one 20 mg film-coated tablet (20 mg) per day. 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 (four 5 mg film-coated tablets (20 mg), two 10 mg film-coated tablets (20 mg) or one 20 mg film-coated tablet (20 mg) once a day) as described above.

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.

3 % vs. 2 % vs. 6 % vs. 4 % vs. 1 % vs. 8 %). Tabulated list of adverse reactions The following Adverse Reactions listed in the table below have been accumulated in clinical studies with memantine and since its introduction in the market.

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).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. SYSTEM ORGAN CLASS FREQUENCY ADVERSE REACTION Infections and infestations Uncommon Fungal infections Immune system disorders Common Drug hypersensitivity Common Somnolence Uncommon Confusion Uncommon Hallucinations1 Psychiatric disorders Not known Psychotic reactions2 Common Dizziness Common Balance disorders Uncommon Gait abnormal Nervous system disorders Very rare Seizures Cardiac disorders Uncommon Cardiac failure Vascular disorders Common Hypertension 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. Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. In post-marketing experience these reactions 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.

This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

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