REMINYL 12mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

GALANTAMINE

Available from:

Janssen-Cilag International NV Turnhoutsewes 30, B-2340 Beerse, Belgium

ATC code:

N06DA04

INN (International Name):

GALANTAMINE

Pharmaceutical form:

FILM-COATED TABLET

Composition:

GALANTAMINE

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Withdrawn

Authorization date:

2006-12-18

Patient Information leaflet

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
REMINYL 4 MG FILM-COATED TABLETS
REMINYL 8 MG FILM-COATED TABLETS
REMINYL 12 MG FILM-COATED TABLETS
galantamine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IF 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 Reminyl is and what it is used for
2.
What you need to know before you take Reminyl
3.
How to take Reminyl
4.
Possible side effects
5.
How to store Reminyl
6.
Contents of the pack and other information.
1.
WHAT REMINYL IS AND WHAT IT IS USED FOR
Reminyl contains the active substance ‘galantamine’, an
antidementia medicine. It is used in adults to
treat the symptoms of mild to moderately severe Alzheimer’s disease,
a type of dementia that alters
brain function.
Alzheimer’s disease causes increasing memory loss, confusion and
behavioural changes, which make
it increasingly difficult to carry out normal daily activities. These
effects are thought to be caused by a
lack of ‘acetylcholine’, a substance responsible for sending
messages between brain cells. Reminyl
increases the amount of acetylcholine in the brain and treats the
signs of the disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE REMINYL
DO NOT TAKE REMINYL

if you are allergic to galantamine or to any of the other ingredients
of this medicine (listed in
section 6).

if you have severe liver or severe kidney disease.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Reminyl. This medicine
is only used in Alzheimer’s
disease, and is not recommended for other types of memory loss or
confusi

Summary of Product characteristics

Page 1 of 12
1.
NAME
OF
THE
MEDICINAL
PRODUCT
REMINYL 4 mg film-coated tablets
REMINYL 8 mg film-coated tablets
REMINYL 12 mg film-coated tablets
2.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
Each 4 mg tablet contains 4 mg galantamine (as hydrobromide).
Each 8 mg tablet contains 8 mg galantamine (as hydrobromide).
Each 12 mg tablet contains 12 mg galantamine (as hydrobromide).
Excipients with known effect:
4 mg tablet: lactose monohydrate 38.59 mg
8 mg tablet: lactose monohydrate 77.18 mg
12 mg tablet: lactose monohydrate 115.77 mg and orange yellow S
aluminium lake (E110) 0.45 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Film-coated tablet (tablet).
4 mg tablet: Off-white, circular, biconvex tablets with the
inscription “JANSSEN” on one side and
“G4” on the other side;
8 mg tablet: Pink, circular, biconvex tablets with the inscription
“JANSSEN” on one side and “G8” on
the other side;
12 mg tablet: Orange-brown, circular, biconvex tablets with the
inscription “JANSSEN” on one side
and “G12” on the other side.
4.
CLINICAL
PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Reminyl is indicated for the symptomatic treatment of mild to
moderately severe dementia of the
Alzheimer type.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults/Elderly _
_Before start of treatment _
The diagnosis of probable Alzheimer type of dementia should be
adequately confirmed according to
current clinical guidelines (see section 4.4).
_Starting dose _
The recommended starting dose is 8 mg/day (4 mg twice a day) for 4
weeks.
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_Maintenance dose _
The tolerance and dosing of galantamine should be reassessed on a
regular basis, preferably within
3 months after start of treatment. Thereafter, the clinical benefit of
galantamine 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 therapeutic
benefit is favourable and the patient
tolerates treatment with gala