Memantine Clonmel 10mg/ml Oral Solution

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Memantine hydrochloride

Dostupné z:

Clonmel Healthcare Ltd

ATC kód:

N06DX; N06DX01

INN (Medzinárodný Name):

Memantine hydrochloride

Dávkovanie:

10 milligram(s)/millilitre

Forma lieku:

Oral solution

Typ predpisu:

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

Terapeutické oblasti:

Other anti-dementia drugs; memantine

Stav Autorizácia:

Marketed

Dátum Autorizácia:

2013-08-23

Príbalový leták

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
MEMANTINE CLONMEL 10MG/ML ORAL SOLUTION
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 side effects not
listed in this leaflet.
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
Memantine Clonmel contains the active substance memantine
hydrochloride.
WHAT IS MEMANTINE CLONMEL USED FOR
Memantine Clonmel is used to treat patients with moderate to severe
Alzheimer’s disease in adults.
HOW MEMANTINE CLONMEL WORKS
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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINE CLONMEL
DO NOT TAKE MEMANTINE CLONMEL
if you are allergic (hypersensitive) to memantine hydrochloride or
any of the other ingredients of this medicine. (See section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Memantine Clonmel

if y

Súhrn charakteristických

Health Products Regulatory Authority
11 June 2021
CRN009YQ1
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Memantine Clonmel 10mg/ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Pump: Each actuation of the pump (one downward pump) delivers 0.5 ml
of solution containing 5 mg of memantine
hydrochloride equivalent to 4.16 mg of memantine.
Dosing Pipette: 0.5 ml contains 5 mg of memantine hydrochloride
equivalent to 4.16 mg of memantine.
Each millilitre of solution contains 10mg of memantine hydrochloride.
Excipients with known effect:
Each millilitre of solution contains 100 mg sorbitol, liquid
(non-crystallising) (E420).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
The solution is clear to colourless to light yellowish
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.
This medicinal product should be taken once daily at the same time
each day. The solution must not be poured, pumped or
pipetted into the mouth