MemantinAST oral solution

Pajjiż: Armenja

Lingwa: Ingliż

Sors: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredjent attiv:

memantine (memantine hydrochloride)

Disponibbli minn:

ONE PHARMA INDUSTRIAL PHARMACEUTICAL COMPANY SOCIETE ANONYME

Kodiċi ATC:

N06DX01

INN (Isem Internazzjonali):

memantine (memantine hydrochloride)

Dożaġġ:

5mg/0.5ml

Għamla farmaċewtika:

oral solution

Unitajiet fil-pakkett:

glass vial 50ml with plastic cap and dosing pump

Tip ta 'preskrizzjoni:

Prescription

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2022-03-23

Fuljett ta 'informazzjoni

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MEMANTINAST
® 5 MG/PUMP ACTUATION ORAL SOLUTION
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. 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 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 failure or from an

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
MemantinAST 5mg/pump actuation oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
pump
actuation
delivers
0.5ml
of
solution
which
contains
5
mg
of
memantine
hydrochloride equivalent to 4.16 mg memantine.
_ _
Excipients with known effect
_: _
Each millilitre of solution contains 100 mg sorbitol and 0.47 mg
potassium, see section 4.4.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
The solution is clear, nearly colorless to yellowish.
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 0.5 ml solution (5 mg) equivalent to one pump
actuation per day for 7
days.
Week 2 (day 8-14):
The patient should take 1