Memantine 20mg tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Memantine hydrochloride

זמין מ:

Zentiva

קוד ATC:

N06DX01

INN (שם בינלאומי):

Memantine hydrochloride

כמות:

20mg

טופס פרצבטיות:

Tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: ; GTIN: 5000283657101

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MEMANTINE HYDROCHLORIDE 10 MG FILM-COATED TABLETS
MEMANTINE HYDROCHLORIDE 20 MG FILM-COATED TABLETS
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 hydrochloride is and what it is used for
2. What you need to know before you take memantine hydrochloride
3. How to take memantine hydrochloride
4. Possible side effects
5. How to store memantine hydrochloride
6. Contents of the pack and other information 1. WHAT MEMANTINE HYDROCHLORIDE IS AND WHAT IT IS
USED FOR
The name of your medicine is Memantine
Hydrochloride Film-Coated Tablets (referred to as
memantine hydrchloride throughout this leaflet).
Memantine hydrochloride is used for the treatment of
patients with moderate to severe Alzheimer’s disease.
Memantine hydrochloride 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 hydrochloride belongs to a group of
medicines called (NMDA)-receptor antagonists.
Memantine hydrochloride acts on these
(NMDA)-receptors improving the transmission of
nerve signals and the memory. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
MEMANTINE HYDROCHLORIDE
DO NOT TAKE MEMANTINE HYDROCHLORIDE
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if you are allergic to memantine hydrochloride or
any of the other ingredients of this medicine (listed
in sect

מאפייני מוצר

OBJECT 1
MEMANTINE HYDROCHLORIDE 20 MG FILM-COATED
TABLETS
Summary of Product Characteristics Updated 08-May-2014 | Zentiva
1. Name of the medicinal product
Memantine hydrochloride Zentiva 20 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 20 mg of memantine hydrochloride
(equivalent to 16.62 mg memantine).
Excipients with known effect:
Memantine hydrochloride 20 mg film-coated tablets: Each film-coated
tablet contains 266.00 mg of
lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Memantine hydrochloride 20 mg film-coated tablets: 20mg breakable
film-coated tablets.
White to off-white, capsule shaped film coated tablets with length
approx.13.30±0.2 mm and width
approx. 7.2±0.2 mm, having “SNAP TAB“ score line on one side and
break line on the other side.
The 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
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.
Memantine hydrochloride 20 mg f