Memantine Clonmel 10mg Film-coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MEMANTINE HYDROCHLORIDE

Available from:

Clonmel Healthcare Ltd

ATC code:

N06DX; N06DX01

INN (International Name):

MEMANTINE HYDROCHLORIDE

Dosage:

10 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:

Marketed

Authorization date:

2013-09-20

Patient Information leaflet

Page 1 of 5
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

Health Products Regulatory Authority
11 October 2021
CRN00C8V0
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Memantine Clonmel 10mg Film-coated Tablet
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, 10mm – 5.6mm, film-coated tablet with breaking
lines on both sides and engraving ‘1 0’ on one side.
The 10 mg 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:
Week 1 (day 1-7):
The patient should take half a 10 mg film-coated tablet (5