Memantine 20mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Memantine hydrochloride

Available from:

Dr Reddy's Laboratories (UK

ATC code:

N06DX01

INN (International Name):

Memantine hydrochloride

Dosage:

20mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF:

Patient Information leaflet

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
Memantine hydrochloride contains the active substance
memantine hydrochloride. It 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
DO NOT TAKE MEMANTINE HYDROCHLORIDE
•
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 or pharmacist before taking
Memantine hydrochloride
•
if you have a history of epileptic seizures
•
if you have recently experienced a myocardial
infarction (heart attack), or if you are suffering from
congestive heart failure or from an uncontrolled
hypertension (high blood pressure).
In these situations the treatment should be carefully
supervised, and the clinical benefit of Memantine
hydrochloride reassessed by your doctor on a regular
basis.
If you suffer from renal impairment (kidney problems),
your doctor should closely monitor your kidney function
and if necessary adapt the memantine hydrochloride
doses accordingly.
The use of medicinal products called amantadine
(for the treatment of Parkinson’s disease), ket

Summary of Product characteristics

OBJECT 1
MEMANTINE DR. REDDYS 20 MG FILM-COATED
TABLETS
Summary of Product Characteristics Updated 12-Jun-2017 | Dr. Reddy's
Laboratories (UK) Ltd
1. Name of the medicinal product
Memantine Dr. Reddy's 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 tablet.
Pale red to grey red, oval shaped film-coated tablet with breaking
line and engravings “2 0” on one side
and “R R” on the other side. The tablet can be divided into equal
doses.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of adult 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 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.
_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 ta