Memantine Teva 20mg Film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MEMANTINE HYDROCHLORIDE

Available from:

Teva Pharma B.V. Swensweg 5, 2031 GA Haarlem, Netherlands

ATC code:

N06DX01

INN (International Name):

MEMANTINE HYDROCHLORIDE 20 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

MEMANTINE HYDROCHLORIDE 20 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Withdrawn

Authorization date:

2014-02-18

Patient Information leaflet

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
MEMANTINE TEVA 10 MG FILM-COATED TABLETS
MEMANTINE TEVA 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.
WHAT IS IN THIS LEAFLET:
1.
What
Memantine Teva is and what it is used for
2.
What you need to know before you take Memantine Teva
3.
How to take Memantine Teva
4.
Possible side effects
5.
How to store Memantine Teva
6.
Contents of the pack and other information
1.
WHAT MEMANTINE TEVA IS AND WHAT IT IS USED FOR
HOW DOES MEMANTINE TEVA WORK
Memantine Teva 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 Teva belongs
to a group of medicines
called NMDA-receptor antagonists. Memantine Teva acts on these
NMDA-receptors improving the
transmission of nerve signals and the memory.
WHAT IS MEMANTINE TEVA USED FOR
Memantine Teva is used for the treatment of patients with moderate to
severe Alzheimer’s disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINE TEVA
DO NOT TAKE MEMANTINE TEVA
-
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 Teva:
-
if you have a history of epileptic seizures
-
if you

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Memantine Teva 20 mg Film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 20 mg film-coated tablet contains 20 mg memantine hydrochloride
equivalent to 16.62 mg
memantine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
The 20 mg film-coated tablets are light pink to pink, oval shaped film
coated tablets, approximately
12.1 mm x 6.5 mm, debossed with "M" on one side of the tablet and with
"20" 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
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.
Posology
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.
For up-titration other tablet strengths are available.
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Week 1 (day 1-7):
The patient should take 5 mg per day for 7 days.
Week 2 (day 8-14)