Memantine Sandoz 10mg Film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MEMANTINE HYDROCHLORIDE

Available from:

Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia

ATC code:

N06DX01

INN (International Name):

MEMANTINE HYDROCHLORIDE 10 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

MEMANTINE HYDROCHLORIDE 10 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Withdrawn

Authorization date:

2015-02-23

Patient Information leaflet

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1.3.1.3 PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
MEMANTINE SANDOZ 10 MG FILM-COATED TABLETS
MEMANTINE SANDOZ 20 MG FILM-COATED TABLETS
MEMANTINE SANDOZ 10 MG/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 possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Memantine Sandoz is and what it is used for
2. What you need to know before you take Memantine Sandoz
3. How to take Memantine Sandoz
4. Possible side effects
5. How to store Memantine Sandoz
6. Contents of the pack and other information
1. WHAT Memantine Sandoz IS AND WHAT IT IS USED FOR
_ _
HOW DOES MEMANTINE SANDOZ WORK
Memantine Sandoz 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 Sandoz
belongs to a group of
medicines called NMDA-receptor antagonists. Memantine Sandoz acts on
these NMDA-receptors
improving the transmission of nerve signals and the memory.
WHAT IS MEMANTINE SANDOZ USED FOR
[Nationally completed] name is used for the treatment of patients with
moderate to severe
Alzheimer’s disease.
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2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE Memantine Sandoz
_ _
DO NOT TAKE Memantine Sandoz

if you are allergic to memantine hydrochloride or any of the other
ingredients of this medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
Tal

Summary of Product characteristics

Page 1 of 14
1.3.1.1 SUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Memantine Sandoz 10 mg film-coated tablets
Memantine Sandoz 20 mg film-coated tablets
Memantine Sandoz 10 mg/ml oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg memantine hydrochloride which is equivalent
to 8.31 mg of memantine.
Excipient(s) with known effect: each tablet contains 132 mg lactose
monohydrate.
Each tablet contains 20 mg memantine hydrochloride which is equivalent
to 16.62 mg of
memantine.
Excipient(s) with known effect: each tablet contains 242 mg lactose
monohydrate.
Each ml of memantine oral solution contains 10 mg memantine
hydrochloride which is equivalent
to 8.31 mg of memantine.
Excipient(s) with known effect: each ml contains 89 mg sorbitol,
liquid (non
crystallising).
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Film-coated tablet 10 mg:
White film-coated tablet of oval shape (6.1 x 11.6 mm) with a breaking
line on both sides.
The tablet can be divided into equaldoses.
Film-coated tablet 20 mg:
Light red film-coated tablet of round shape (diameter 11.1 mm) with
two crossed breaking lines on
one side.
The tablet can be divided into equal quarters.
Oral solution.
Colourless and clear solution.
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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.
Posology
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
t