Axura

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.

Axura 10 mg film-coated tablets 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 half a 10 mg film-coated tablet (5 mg) per day for 7 days.

Week 2 (day 8-14):

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

Week 3 (day 15-21):

The patient should take one and a half 10 mg film-coated tablet (15 mg) per day for 7 days.

From Week 4 on:

The patient should take two 10 mg film-coated tablets (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 (two 10 mg tablets once a day) as described above.

Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets 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 to off-white, oval shaped) for 7 days.

Week 2 (day 8-14): 4 The patient should take one 10 mg film-coated tablet per day (pale yellow to yellow, oval shaped) for 7 days.

Week 3 (day 15-21):

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

Week 4 (day 22-28):

Summary of the safety profile In clinical trials in mild to severe dementia, involving 1,784 patients treated with Axura and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions with Axura 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 Axura 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 7 SYSTEM ORGAN CLASS FREQUENCY ADVERSE REACTION Immune systeme disorders Common Drug hypersensitivity Psychiatric disorders Common Somnolence Uncommon Confusion Uncommon Hallucinations1 Not known Psychotic reactions2 Nervous system disorders Common Dizziness Common Balance disorder Uncommon Gait abnormal Very rare Seizures Cardiac disorders Uncommon Cardiac failure Vascular disorders Common Hypertension Uncommon Venous thrombosis/thromboembolism Respiratory, thoracic and mediastinal disorders Common Dyspnoea Gastrointestinal disorders Common Constipation Uncommon Vomiting Not known Pancreatitis2 Hepatobiliary disorders Common Elevated liver function test Not known Hepatitis General disorders and administration site conditions Common Headache 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 events have been reported in patients treated with Axura.

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 medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.

1.