MEMANTINE GLENMARK

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 PT/H/0938/001/IB/001 March 2015 considered when evidence of a therapeutic effect is no longer present or if the patient does not tolerate treatment.

Memantine oral solution should be taken once daily at the same time each day. The solution can be taken with or without food. The solution must not be poured or pumped into the mouth directly from the bottle or the pump, but should be dosed onto a spoon or into a glass of water using the pump.

6.

Adults:

Dose titration The maximum daily dose is 20 mg per day. 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.

Paedriatic population:

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.

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).

Infections and infestations Uncommon Fungal infections Immune system disorders Common Drug hypersensitivity Psychiatric disorders Common Uncommon Uncommon Not known Somnolence Confusion Hallucinations1 Psychotic reactions2 Common Dizziness Common Balance disorders Uncommon Gait abnormal Nervous system disorders Very rare Seizures Cardiac disorders Uncommon Cardiac failure Common Hypertension Vascular disorders Uncommon Venous PT/H/0938/001/IB/001 March 2015 thrombosis/thromboembolism Respiratory, thoracic and mediastinal disorders Common Dyspnoea Common Constipation Uncommon VomitingGastrointestinal disorders Not known Pancreatitis2 Common Elevated liver function test Hepatobiliary disorders Not known Hepatits Common HeadacheGeneral disorders and administration site conditions Uncommon Fatigue 1Hallucinations have mainly been observed in patients with severe Alzheimer’s disease.

2Isolated 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 memantine.

4. 1. 3 PHARMACEUTICAL FORM Oral solution. The solution is clear, nearly colorless to yellowish. 1 Therapeutic indications Treatment of 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.

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 PT/H/0938/001/IB/001 March 2015 considered when evidence of a therapeutic effect is no longer present or if the patient does not tolerate treatment. Memantine oral solution should be taken once daily at the same time each day.

The solution can be taken with or without food. The solution must not be poured or pumped into the mouth directly from the bottle or the pump, but should be dosed onto a spoon or into a glass of water using the pump. 6.

Adults:

Dose titration The maximum daily dose is 20 mg per day. 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.

1.