Memantine Clonmel 10 mg/ml oral solution

Země: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktivní složka:

MEMANTINE HYDROCHLORIDE

Dostupné s:

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

ATC kód:

N06DX01

INN (Mezinárodní Name):

MEMANTINE HYDROCHLORIDE 10 mg/ml

Léková forma:

ORAL SOLUTION

Složení:

MEMANTINE HYDROCHLORIDE 10 mg/ml

Druh předpisu:

POM

Terapeutické oblasti:

PSYCHOANALEPTICS

Přehled produktů:

Licence number in the source country: NOT APPLICAPABLE

Stav Autorizace:

Authorised

Datum autorizace:

2020-04-15

Informace pro uživatele

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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

Charakteristika produktu

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Memantine Clonmel 10 mg/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 10 mg of memantine hydrochloride.
Excipients with known effect:
Each millilitre of solution contains 100 mg sorbitol (E420) and 0.5 mg
of potassium, see section
4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTCAL 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.
2
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 directly from the
bottle pump or pipette, but
sho