Memantine STADA 10 mg/ml drank

Země: Nizozemsko

Jazyk: nizozemština

Zdroj: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktivní složka:

MEMANTINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; MEMANTINE

Dostupné s:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

ATC kód:

N06DX01

INN (Mezinárodní Name):

MEMANTINEHYDROCHLORIDE COMPOSITION in accordance with ; MEMANTINE

Léková forma:

Drank

Složení:

KALIUMSORBAAT (E 202) ; SORBITOL, VLOEIBAAR, NIET-KRISTALLISEERBAAR (E 420) ; WATER, GEZUIVERD,

Podání:

Oraal gebruik

Terapeutické oblasti:

Memantine

Přehled produktů:

Hulpstoffen: KALIUMSORBAAT (E 202); SORBITOL, VLOEIBAAR, NIET-KRISTALLISEERBAAR (E 420); WATER, GEZUIVERD;

Datum autorizace:

2013-11-12

Informace pro uživatele

PACKAGE LEAFLET: INFORMATION FOR THE USER
MEMANTINE STADA 10 MG/ML DRANK
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 STADA 10 mg/ml drank is and what it is used for
2. What you need to know before you take Memantine STADA 10 mg/ml
drank
3. How to take Memantine STADA 10 mg/ml drank
4. Possible side effects
5. How to store Memantine STADA 10 mg/ml drank
6. Contents of the pack and other information
Memantine STADA 10 mg/ml drank contains the active substance memantine
hydrochloride.
WHAT IS MEMANTINE STADA 10 MG/ML DRANK USED FOR
Memantine STADA 10 mg/ml drank is used to treat patients with moderate
to severe
Alzheimer’s disease in adults.
HOW MEMANTINE STADA 10 MG/ML DRANK WORKS
Memantine STADA 10 mg/ml drank 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
STADA 10 mg/ml
drank belongs to a group of medicines called NMDA-receptor
antagonists. Memantine
STADA 10 mg/ml drank acts on these NMDA-receptors improving the
transmission of nerve
signals and the memory.
•
DO NOT TAKE MEMANTINE STADA 10 MG/ML DRANK 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

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Memantine STADA 10 mg/ml drank
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, liquid
(non-crystallising) (E420).
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.
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 bottlepump or
pipette, but should be dosed onto a spoon or i