Active Ingredient and Strength	MEMANTINE HYDROCHLORIDE - 10 MG
Dosage Form	TABLET, FILM COATED
Manufacturer and Country	DR REDDY’S LABORATORIES LIMITED - INDIA
Registration Number	SIN16928P
Licence Holder	ZYFAS PHARMA PTE LTD
Forensic Classification	PRESCRIPTION ONLY MEDICINES
Anatomical Therapeutic Chemical (ATC) code	N06DX01

4.1 Therapeutic indications

Treatment of 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. 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.

Memantine should be administered once a day and should be taken at the same time every day. The film-coated tablets can be taken with or without food.

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 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 tablets once a day) as described above.

Children and adolescents: Memantine is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.

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 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 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. No data on the use of memantine in patients with severe hepatic impairment are available. Administration of Memantine is not recommended in patients with severe hepatic impairment.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.