MemantinAST tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

memantine (memantine hydrochloride)

Available from:

ONE PHARMA INDUSTRIAL PHARMACEUTICAL COMPANY SOCIETE ANONYME

ATC code:

N06DX01

INN (International Name):

memantine (memantine hydrochloride)

Dosage:

10mg

Pharmaceutical form:

tablets film-coated

Units in package:

(28/4x7/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-03-23

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MEMANTINAST
®
10MG FILM-COATED TABLETS
Memantine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor. This includes any
possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What MemantinAST is and what it is used for
2.
What you need to know before you take MemantinAST
3.
How to take MemantinAST
4.
Possible side effects
5.
How to store MemantinAST
6.
Contents of the pack and other information
1. WHAT MEMANTINAST IS AND WHAT IT IS USED FOR
MemantinAST contains the active substance memantine hydrochloride. It
belongs to a group of medicines
known as anti-dementia medicines.
Memory loss in Alzheimer's disease is due to a disturbance of message
signals in the brain. The brain contains
so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in
transmitting nerve signals important in
learning and memory.
MemantinAST belongs to a group of medicines called NMDA-receptor
antagonists. MemantinAST acts on
these NMDA-receptors improving the transmission of nerve signals and
the memory.
MemantinAST is used for the treatment of patients with moderate to
severe Alzheimer’s disease.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINAST
DO NOT TAKE MEMANTINAST
if you are allergic (hypersensitive) to memantine hydrochloride or any
of the other ingredients of this medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking MemantinAST:
•
if you have a history of epileptic seizures;
•
if you have recently experienced a myocardial infarction (heart
attack), or if you are suffering from
congestive heart fail

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
MemantinAST 10mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of memantine hydrochloride
equivalent to 8.31 mg
memantine.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Yellow, oblong, biconvex tablets with score.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
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.
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 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 (10 mg) per day
for 7 days.
_Week 3 (day 15-21): _
The patient should take one and a half 10 mg film-coated tab