Memantine hydrochloride Pinewood 20 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MEMANTINE HYDROCHLORIDE

Available from:

Pinewood Laboratories Ltd

ATC code:

N06DX; N06DX01

INN (International Name):

MEMANTINE HYDROCHLORIDE

Dosage:

20 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Other anti-dementia drugs; memantine

Authorization status:

Marketed

Authorization date:

2014-07-18

Patient Information leaflet

PA 0281/166/001-002
November 2019
PACKAGE LEAFLET: INFORMATION FOR THE USER
MEMANTINE HYDROCHLORIDE PINEWOOD 10 MG FILM-COATED TABLETS
MEMANTINE HYDROCHLORIDE PINEWOOD 20 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 hydrochloride Pinewood is and what it is used for
2.
What you need to know before you take Memantine hydrochloride Pinewood
3.
How to take Memantine hydrochloride Pinewood
4.
Possible side effects
5.
How to store Memantine hydrochloride Pinewood
6.
Contents of the pack and other information
1.
WHAT MEMANTINE HYDROCHLORIDE PINEWOOD IS AND WHAT IT IS USED FOR
Memantine hydrochloride Pinewood contains the active substance
memantine hydrochloride.
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.
Memantine hydrochloride is used for the treatment of patients with
moderate to severe
Alzheimer’s disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINE HYDROCHLORIDE PINEWOOD
DO NOT TAKE MEMANTINE HYDROCHLORIDE PINEWOOD:
-
if you are allergic to memant

Summary of Product characteristics

Health Products Regulatory Authority
03 June 2021
CRN00C8SH
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Memantine hydrochloride Pinewood 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.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
Off white oval shaped film-coated tablets debossed with “U” on one
side and plain on the other side.
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 hydrochloride
should be reassessed on a regular basis, preferably within three
months after start of treatment. Thereafter, the clinical benefit
of memantine hydrochloride 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 hydrochloride.
Discontinuation of memantine hydrochloride should be considered
when evidence of a therapeutic effect is no longer present or if the
patient does not tolerate treatment.
_Adults:_
_ _
Dose titration
The maximum daily dose is 20 mg per day. 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:
Week 1 (day 1-7):
The patient should take half a 10 mg film-coated tablet (5 mg) per day
for 7 days.
Week 2 (day 8-14):
The pati