EBIXA

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 once daily. 5 ml solution (5 mg) equivalent to one pump actuation per day for 7 days. Week 2 (day 8-14) The patient should take 1 ml solution (10 mg) equivalent to two pump actuations per day for 7 days.

5 ml solution (15 mg) equivalent to three pump actuations per day for 7 days. From Week 4 on The patient should take 2 ml solution (20 mg) equivalent to four pump actuations once a 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 (2 ml solution, equivalent to four pump actuations) 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 (1 ml solution, equivalent to two pump actuations). 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 (1 ml solution, equivalent to two pump actuations) per day. Hepatic impairment In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B), no dose adjustment is needed.

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

8%). Tabulated list of adverse reactions The following Adverse Reactions listed in the Table below have been accumulated in clinical studies with Ebixa 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 Psychiatric disorders Common Somnolence Uncommon Confusion Uncommon Hallucinations1 Not known Psychotic reactions2 Nervous system disorders Common Dizziness Common Balance disorders 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 Common Elevated liver function testHepatobiliary disorders 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 reactions have been reported in patients treated with Ebixa.

4. 1. 3 PHARMACEUTICAL FORM Oral solution. The solution is clear and colourless to light yellowish. 1 Therapeutic indications Treatment of adult patients with moderate to severe Alzheimer’s disease. 2 Posology and method of administration 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 once daily. 5 ml solution (5 mg) equivalent to one pump actuation per day for 7 days.

Week 2 (day 8-14) The patient should take 1 ml solution (10 mg) equivalent to two pump actuations per day for 7 days. 5 ml solution (15 mg) equivalent to three pump actuations per day for 7 days. From Week 4 on The patient should take 2 ml solution (20 mg) equivalent to four pump actuations once a 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 (2 ml solution, equivalent to four pump actuations) as described above.

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