APO-MEMANTINE memantine hydrochloride 10mg tablet bottle pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

memantine hydrochloride, Quantity: 10 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

memantine hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: titanium dioxide; lactose monohydrate; macrogol 8000; magnesium stearate; croscarmellose sodium; hypromellose; hyprolose; microcrystalline cellulose

Administration route:

Oral

Units in package:

14, 1000, 50, 56, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of the symptoms of moderately severe to severe Alzheimer's disease

Product summary:

Visual Identification: White, peanut shaped, biconvex film coated tablet. Engraved "APO" bisect "APO" on one side, "MEM" bisect "10" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2010-01-29

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO- MEMANTINE (MEMANTINE HYDROCHLORIDE)
TABLETS
1
NAME OF THE MEDICINE
Memantine hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg or 20 mg memantine hydrochloride as the
active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
APO-MEMANTINE 10 MG TABLETS
White, peanut shaped, biconvex film coated tablet. Engraved “APO”
bisect “APO” on one side,
“MEM” bisect “10” on the other side.
APO-MEMANTINE 20 MG TABLETS
Pale red, oval, biconvex, film coated tablet. Engraved “MEM 20” on
one side, “APO” on the
other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of the symptoms of moderately severe to severe Alzheimer's
disease (see sections
5 PHARMACOLOGICAL PROPERTIES and 4.4 SPECIAL WARNINGS AND PRECAUTIONS
FOR USE).
2
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Memantine tablets are intended for oral administration.
DOSAGE
Memantine tablets should be administered once a day and should be
taken at the same time
every day with a little liquid, with or without food.
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 guideline. 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
The recommended maintenance dose is 20 mg per day. This is achieved by
upward titration
of 5 mg per week. The 10 mg tablet is required for titration as
follows:
Dose Titration
Week 1 (Day 1 - 7)
The patient should take 5 mg (½ x 10 mg tablet) per day.
Week