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MEMANTINE HYDROCHLORIDE NICHE 10MG FILM-COATED TABLETS

Active substance(s): MEMANTINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Memantine Hydrochloride Niche
10 mg and 20 mg 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 or pharmacist. This
includes any possible side effects not listed in this leaflet. See section 4.
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-Daspartate (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 accordingly.
The use of medicinal products
called amantadine (for the
treatment of Parkinson’s disease),
ketamine (a substance generally
used as an anaesthetic),
dextromethorphan (generally used
to treat cough) and other NMDAantagonists at the same time
should be avoided.
Children and adolescents
Memantine Hydrochloride Niche is
not recommended for children and
adolescents under the age of 18
years.

Other medicines and Memantine
Hydrochloride Niche
Please tell your doctor or
pharmacist if you are taking or have
recently taken any other medicines.
In particular, Memantine
Hydrochloride Niche may change
the effects of the following
medicines and their dose may need
to be adjusted by your doctor:
■ amantadine, ketamine,
dextromethorphan
■ dantrolene, baclofen
■ cimetidine, ranitidine,
procainamide, quinidine, quinine,
nicotine
■ hydrochlorothiazide (or any
combination with
hydrochlorothiazide)
■ anticholinergics (substances
generally used to treat movement
disorders or intestinal cramps)
■ anticonvulsants (substances used
to prevent and relieve seizures)
■ barbiturates (substances
generally used to induce sleep)
■ dopaminergic agonists (substances
such as L-dopa, bromocriptine)
■ neuroleptics (substances used in
the treatment of mental disorders)
■ oral anticoagulants
If you go into hospital, let your
doctor know that you are taking
Memantine Hydrochloride Niche.
Memantine Hydrochloride Niche
with food and drink
You should inform your doctor if
you have recently changed or intend
to change your diet substantially
(e.g. from normal diet to strict
vegetarian diet) or if you are suffering
from states of renal tubulary
acidosis (RTA, an excess of acidforming substances in the blood
due to renal dysfunction (poor
kidney function)) or severe
infections of the urinary tract
(structure that carries urine), as
your doctor may need to adjust the
dose of your medicine.
Pregnancy and breast-feeding
Pregnancy
Ask your doctor or pharmacist for
advice before taking any medicine.
Tell your doctor if you are pregnant
or planning to become pregnant.
The use of Memantine
Hydrochloride Niche in pregnant
women is not recommended.
Breast-feeding
Women taking Memantine
Hydrochloride Niche should not
breast-feed.
Driving and using machines
Your doctor will tell you whether
your illness allows you to drive and
to use machines safely.
Also, Memantine Hydrochloride
Niche may change your reactivity,
making driving or operating
machinery inappropriate.

3.How to take Memantine
Hydrochloride Niche
Always take this medicine exactly as
your doctor has told you. You
should check with your doctor or
pharmacist if you are not sure.
The recommended treatment dose
of 20 mg per day is achieved by a
gradual increase of the Memantine
Hydrochloride Niche dose during
the first 3 weeks of treatment. In
order to reduce the risk of side
effects this dose is achieved
gradually by the following daily
treatment scheme:

week 1
week 2
week 3

half a 10 mg tablet
one 10 mg tablet
one and a half 10 mg
tablets
week 4 and two 10 mg tablets once a
beyond
day or one 20 mg tablet
once a day

The usual starting dose is half a 10
mg tablet once a day (1x 5 mg) for
the first week. This is increased to
one 10 mg tablet once a day (1x 10
mg) in the second week and to one
and a half 10 mg tablets (1 x 15 mg)
once a day in the third week. From
the fourth week on, the usual dose
is two 10 mg tablets once a day (1x
20 mg) or one 20 mg tablet once a
day (1 x 20 mg).
Dosage in patients with
impaired kidney function
If you have impaired kidney
function, your doctor will decide
upon a dose that suits your
condition. In this case, monitoring
of your kidney function should be
performed by your doctor at
specified intervals.
Administration
Memantine Hydrochloride Niche
should be administered orally once
a day. To benefit from your
medicine you should take it
regularly every day at the same
time of the day. The tablets should
be swallowed with some water. The
tablets can be taken with or without
food.
Duration of treatment
Continue to take Memantine
Hydrochloride Niche as long as it is
of benefit to you. Your doctor
should assess your treatment on a
regular basis.
If you take more Memantine
Hydrochloride Niche than you
should
■ In general, taking too much
Memantine Hydrochloride Niche
should not result in any harm to
you. You may experience increased
symptoms as described in section
4. “Possible side effects”.
■ If you take a large overdose of
Memantine Hydrochloride Niche,
contact your doctor or get
medical advice, as you may need
medical attention.
If you forget to take Memantine
Hydrochloride Niche
■ If you find you have forgotten to
take your dose of Memantine
Hydrochloride Niche, wait and take
your next dose at the usual time.
■ Do not take a double dose to
make up for a forgotten dose.
If you have any further questions on
the use of this medicine, ask your
doctor or pharmacist.

have been reported in patients
treated with memantine
hydrochloride .
Reporting of side effects
If you get any side effects, talk to
your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet.
You can also report side effects
directly via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can
help provide more information on
the safety of this medicine.

5.How to store Memantine
Hydrochloride Niche
Keep this medicine out of the sight
and reach of children.
Do not use Memantine
Hydrochloride Niche after the
expiry date which is stated on the
carton and the blister after EXP.
The expiry date refers to the last
day of that month.
Store below 25°C for the 10 mg
tablet and store below 30°C for the
20 mg tablet.
Do not throw away any medicines
via wastewater or household waste.
Ask your pharmacist how to throw
away medicines you no longer use.
These measures will help to protect
the environment.

6.Contents of the pack
and other information

What Memantine Hydrochloride
Niche contains
The active substance is memantine
hydrochloride. The 10 mg filmcoated tablet contains 10 mg
memantine hydrochloride
equivalent to 8.31 mg memantine.
The 20 mg film-coated tablet
contains 20 mg memantine
hydrochloride equivalent to 16.62
mg memantine.
The other ingredients are
microcrystalline cellulose,
crospovidone, povidone K 29/32,
colloidal anhydrous silica, purified
talc and magnesium stearate, all in
the tablet core; and hypromellose,
macrogol 4000 and titanium dioxide
(E171), all in the tablet coating.
What Memantine Hydrochloride
Niche looks like and contents of
the pack
The 10 mg film-coated tablets are
presented as off white capsule
shaped biconvex, film-coated
tablets debossed with “M” and “10”
on either side of the breakline on
one side and breakline on the other
side.
The 20 mg film-coated tablets are
presented as off white oval shaped
film-coated tablets with “U”
4.Possible side effects
Like all medicines, this medicine can debossed on one side and plain on
the other side.
cause side effects, although not
Memantine Hydrochloride Niche 10
everybody gets them.
mg and 20 mg film-coated tablets
In general, the observed side
are supplied in cartons containing
effects are mild to moderate.
14, 28, 42, 56, 70, 84, 98 or 112
Common: may affect up to 1 in 10
film-coated tablets in blisters of
people
PVC/PE/PVdC and aluminium foil.
■ Headache, sleepiness,
Not all pack sizes may be marketed.
constipation, elevated liver
function tests, dizziness, balance Marketing Authorisation Holder
and Manufacturer
disorders, shortness of breath,
high blood pressure and drug
Marketing Authorisation Holder:
hypersensitivity
Niche Generics Limited, 1 The Cam
Uncommon: may affect up to 1 in
Centre, Wilbury Way, Hitchin,
100 people
Hertfordshire SG4 0TW, United
■ Tiredness, fungal infections,
Kingdom.
confusion, hallucinations,
Manufacturer:
vomiting, abnormal gait, heart
Niche Generics Limited,
failure and venous blood clotting Unit 5, 151 Baldoyle Industrial
(thrombosis/thromboembolism)
Estate, Baldoyle, Dublin 13, Ireland.
Very Rare: may affect up to 1 in
This medicinal product is
10,000 people:
authorised in the Member
■ Seizures
States of the EEA under the
Not known (frequency cannot
following names:
be estimated from the available Ireland: Memantine Hydrochloride
data):
Niche 10 & 20 mg Film-coated Tablets
■ Inflammation of the pancreas,
United Kingdom: Memantine
inflammation of the liver
Hydrochloride Niche 10 & 20 mg
(hepatitis) and psychotic
Film-coated Tablets
reactions
Germany: Memantinhydrochlorid
Alzheimer’s disease has been
Unichem 10 & 20 mg Filmtabletten
associated with depression, suicidal
thoughts and suicide. These events This leaflet was last revised in:
04/2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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