MEMANTINE HYDROCHLORIDE

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 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 per day (10 mg) equivalent to two pump actuations, per day for 7 days. 5 ml solution per day (15 mg) equivalent to three pump actuations, per day for 7 days.

From Week 4 on:

The patient should take 2 ml solution per day (20 mg) equivalent to four pump actuations, once a day. 5 ml solution (5 mg) for 7 days.

Week 2 (day 8 14):

The patient should take 1 ml solution (10 mg) for 7 days. 5 ml solution (15 mg) for 7 days.

From Week 4 on:

The patient should take 2 ml solution (20 mg) 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) 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 (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 dosage adjustment is needed. No data on the use of memantine in patients with severe hepatic impairment are available. Administration of this medicinal product is not recommended in patients with severe hepatic impairment.

Paediatric population:

No data available Method of administration This medicinal product should be taken orally once daily at the same time each day. The solution can be taken with or without food. The solution must not be poured, pumped or pipetted into the mouth directly from the bottle, pump or pipette, but should be dosed onto a spoon or into a glass of water using the pump or pipette.

6.

4. 1. 3. PHARMACEUTCAL FORM Oral Solution. The solution is clear to colourless to light yellowish 4. 1 Therapeutic indications Treatment of adult patients with moderate to severe Alzheimer’s disease. 4. 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 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 per day (10 mg) equivalent to two pump actuations, per day for 7 days. 5 ml solution per day (15 mg) equivalent to three pump actuations, per day for 7 days.

From Week 4 on:

The patient should take 2 ml solution per day (20 mg) equivalent to four pump actuations, once a day. 5 ml solution (5 mg) for 7 days.

Week 2 (day 8 14):

The patient should take 1 ml solution (10 mg) for 7 days. 5 ml solution (15 mg) for 7 days.

From Week 4 on:

The patient should take 2 ml solution (20 mg) 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) 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 (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 dosage adjustment is needed. No data on the use of memantine in patients with severe hepatic impairment are available. Administration of this medicinal product is not recommended in patients with severe hepatic impairment.

Paediatric population:

No data available Method of administration This medicinal product should be taken orally once daily at the same time each day. The solution can be taken with or without food. The solution must not be poured, pumped or pipetted into the mouth directly from the bottle, pump or pipette, but should be dosed onto a spoon or into a glass of water using the pump or pipette.

6. 1. 4 Special warnings and precautions for use 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.

5 ml which is equivalent to 72 mg/ml.

1.