Memantine Clonmel 10 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MEMANTINE HYDROCHLORIDE

Available from:

Clonmel Healthcare Limited Waterford Road, Clonmel, Co. Tipperary E91 D768, Ireland

ATC code:

N06DX01

INN (International Name):

MEMANTINE HYDROCHLORIDE 10 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

MEMANTINE HYDROCHLORIDE 10 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2020-10-21

Patient Information leaflet

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

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1
.
NAME OF THE MEDICINAL PRODUCT
Memantine Clonmel 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of memantine hydrochloride
equivalent to 8.31 mg
memantine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
The 10 mg film-coated tablets are white, slim through the middle,
biconvex, 10 mm – 5.6 mm, film-
coated tablet with breaking lines on both sides and engraving ‘10’
on one side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of patients with moderate to severe Alzheimer’s disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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.
_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:
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Week 1 (day 1-7):
The patient should take half a 10 mg film-coated tablet (5 mg) per day
for 7 days.
Week 2 (day 8-14)