Memantine Grindeks 10 mg film-coated tablets

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Memantine Hydrochloride

Commercializzato da:

AS Grindeks

Codice ATC:

N06DX01

INN (Nome Internazionale):

Memantine Hydrochloride

Dosaggio:

10 milligram(s)

Forma farmaceutica:

Film-coated tablet

Area terapeutica:

memantine

Data dell'autorizzazione:

2021-03-05

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
MEMANTINE GRINDEKS 10 MG 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 Grindeks is and what it is used for
2.
What you need to know before you take Memantine Grindeks
3.
How to take Memantine Grindeks
4.
Possible side effects
5.
How to store Memantine Grindeks
6.
Contents of the pack and other information
1.
WHAT MEMANTINE GRINDEKS IS AND WHAT IT IS USED FOR
Memantine Grindeks contains the active substance memantine
hydrochloride (further memantine).
Memantine is an anti-dementia medicine. It helps to ease the symptoms
of dementia in Alzheimer’s
disease.
HOW DOES MEMANTINE GRINDEKS WORK
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 belongs to a group
of medicines called
‘NMDA-receptor antagonists’. It acts on these NMDA-receptors
improving the transmission of nerve
signals and the memory.
WHAT IS MEMANTINE GRINDEKS USED FOR
Memantine Grindeks is used for the treatment of patients with moderate
and severe Alzheimer’s
disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINE GRINDEKS
DO NOT TAKE MEMANTINE GRINDEKS
•
if you are allergic to memantine or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Memantine

Scheda tecnica

Health Products Regulatory Authority
22 April 2021
CRN00C82F
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Memantine Grindeks 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film‑coated tablet contains 10 mg memantine hydrochloride
equivalent to 8.3 mg memantine.
Excipient with known effect:
One film‑coated tablet contains 166.44 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film‑coated tablet (tablet).
White to off‑white biconvex film‑coated oblong tablets with
rounded ends, concave in the middle and breakline on both
sides. Tablet size: length approximately 12.7 mm, height 3.7 mm.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Moderate and 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.
Posology
_Adults_
_Dose titration_
The maximum daily dose is 20 mg. 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:
TABLE