Memantine Hydrochloride 10mg/ml Oral Solution

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

MEMANTINE HYDROCHLORIDE

זמין מ:

McDermott Laboratories Ltd., T/A Gerard Laboratories

קוד ATC:

N06DX; N06DX01

INN (שם בינלאומי):

MEMANTINE HYDROCHLORIDE

כמות:

10 milligram(s)/millilitre

טופס פרצבטיות:

Oral solution

סוג מרשם:

Product subject to prescription which may not be renewed (A)

איזור תרפויטי:

Other anti-dementia drugs; memantine

מצב אישור:

Not marketed

תאריך אישור:

2013-11-08

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18 May 2015
1/2
10:51
Memantine Hydrochloride 10mg/ml 50/100ml
Leaflet
606325
577176L00
606325
PA 577/176/1
Chanelle Medical
N/A
N/A
N/A
253972
2
Ireland
N/A
N/A
1
Black
Myriad Pro
156 x 487 mm
9 pt
9 pt
PACKAGE LEAFLET: INFORMATION FOR THE USER
MEMANTINE
HYDROCHLORIDE
10MG/ML 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
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
or pharmacist. This includes any possible side
effects not listed in this leaflet. See Section 4.
WHAT IS IN THIS LEAFLET:
1. What Memantine is and what it is used for
2. What you need to know before you
take Memantine
3. How to take Memantine
4. Possible side effects
5. How to store Memantine
6. Contents of the pack and other information
1.
WHAT MEMANTINE IS AND WHAT IT IS
USED FOR
Memantine 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.
Memantine belongs to a group of medicines called
NMDA-receptor antagonists. Memantine acts on
these NMDA-receptors improving the transmissio

מאפייני מוצר

Health Products Regulatory Authority
12 October 2018
CRN008P4C
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Memantine Hydrochloride 10mg/ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Pump: Each pump actuation delivers 0.5 ml of solution which contains 5
mg of
memantine hydrochloride which is equivalent to 4.16 mg of memantine.
Dosing Pipette: 0.5 ml contains 5 mg of memantine hydrochloride
equivalent to 4.16
mg of memantine.
Each millilitre of solution contains 10mg of memantine hydrochloride.
Excipients with known effect:
Each millilitre of solution contains 100 mg sorbitol (E420) and 0.5mg
of potassium,
see section 4.4.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Solution.
The solution is clear to colourless to light yellowish
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of adult 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.
Health Products Regulatory Authority
12 October 2018
CRN008P4C
Page 2 of 15
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 do