This medicinal product should be taken once daily at the same time each day. The solution must not be poured, pumped or pipetted into the mouth directly from the bottlepump or pipette, but should be dosed onto a spoon or into a glass of water using the pump or pipette.

For detailed instructions on the preparation and handling of the product see section 6.6.

The solution can be taken with or without food.

Adults:

Dose titration

The maximum daily dose is 20 mg daily. 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:

(a)Pump pack of 5 mg/pump:

Week 1 (day 1 7):
The patient should take 0.5 ml solution (5 mg) equivalent to one downward 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 downward pumps actuations, per day for 7 days.
Week 3 (day 15 21):
The patient should take 1.5 ml solution per day (15 mg) equivalent to three downward pumps actuations, per day for 7 days.
From Week 4 on:
The patient should take 2 ml solution per day (20 mg) equivalent to four downward pumps actuations, once a 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 downward pumps actuations) as described above.

Children and adolescents under the age of 18 years: This medicinal product is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Paediatric population:
No data available
Renal impairment:
In patients with mildly impaired renal function (creatinine clearance 50 – 80 ml/min) no dosage 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 downward pumps 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 downward pumps 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.

For detailed instructions on the preparation and handling of the product see section 6.6.

Section 4.6 Fertility, pregnancy and lactation
Fertility
No adverse reactions of memantine were noted on male and female fertility.

Section 4.7 Effects on ability to drive and use machines
Furthermore, this medicinal product has minor or moderate influence on the ability to drive or use machines, such that outpatients should be warned to take special care.

Section 4.8 Undesirable effects 
Tabulated list of adverse reactions
The following Adverse Drug Reactions listed in the Table below have been accumulated in clinical studies with this memantine hydrochloride 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). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 


Nervous system disorders
uncommon common Balance disorders
Uncommon Gait abnormal
Very Rare Seizures