Memantine Hydrochloride Niche 20mg Film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MEMANTINE HYDROCHLORIDE

Available from:

Niche Generics Limited

ATC code:

N06DX; N06DX01

INN (International Name):

MEMANTINE HYDROCHLORIDE

Dosage:

20 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

Other anti-dementia drugs; memantine

Authorization status:

Not marketed

Authorization date:

2014-07-18

Patient Information leaflet

WHAT IS IN THIS LEAFLET
1. What Memantine Hydrochloride
Niche is and what it is used for
2. What you need to know before
you take Memantine
Hydrochloride Niche
3. How to take Memantine
Hydrochloride Niche
4. Possible side effects
5. How to store Memantine
Hydrochloride Niche
6. Contents of the pack and other
information
1.WHAT MEMANTINE
HYDROCHLORIDE NICHE IS
AND WHAT IT IS USED FOR
Memantine Hydrochloride Niche
contains the active substance
memantine hydrochloride.
Memantine Hydrochloride Niche
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 hydrochloride
belongs to a group of medicines
called NMDA-receptor antagonists.
Memantine hydrochloride acts on
these NMDA-receptors improving
the transmission of nerve signals
and the memory.
Memantine hydrochloride is used
for the treatment of patients with
moderate to severe Alzheimer’s
disease.
2.WHAT YOU NEED TO KNOW
BEFORE YOU TAKE
MEMANTINE HYDROCHLORIDE
NICHE
DO NOT TAKE MEMANTINE
HYDROCHLORIDE NICHE:
■
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 or pharmacist
before taking Memantine
Hydrochloride Niche if you:
■
have a history of epileptic seizures
■
have recently experienced a
myocardial infarction (heart
attack), or if you are suffering
from congestive heart failure or
from an uncontrolled hypertension
(high blood pressure).
In these situations the treatment
should be carefully supervised, and
the clinical benefit of Memantine
Hydrochloride Niche reassessed by
your doctor on a regular basis.
If you suffer from renal impairment
(kidney problems), your doctor
should closely monitor your kidney
function and if necessary adapt the
Memantine Hydrochloride Niche
doses according

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Memantine Hydrochloride Niche 20mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg of memantine hydrochloride
equivalent to 16.62 mg memantine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
Off white oval shaped film-coated tablets debossed with “U” on one
side and plain on the other side.
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.
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 hydrochloride should be reassessed on a regular basis,
preferably within three months after start of
treatment.
Thereafter, the clinical benefit of memantine hydrochloride 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 hydrochloride.
Discontinuation of memantine hydrochloride should be considered when
evidence of a therapeutic effect is no longer
present or if the patient does not tolerate treatment.
Memantine hydrochloride 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