REMINYL 4 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

GALANTAMINE HYDROBROMIDE

Available from:

Shire Pharmaceuticals Limited

ATC code:

N06DA04

INN (International Name):

GALANTAMINE HYDROBROMIDE

Dosage:

4 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Anticholinesterases

Authorization status:

Authorised

Authorization date:

2000-09-15

Patient Information leaflet

FONTS USED:
Helvetica Neue LT Std-55 Roman
Helvetica Neue LT Std-75 Bold
NimbusSanLOT-Bold
NimbusSanLOT-Regular
NimbusSanLOTBla-Regular
SMALLEST POINT SIZED USED:
6.5 pt
AVERAGE TEXT SIZE (BODY TEXT):
9.0 pt
Technical Info
Profile
1515v6
Reminyl PIL Ireland UK 8mg 16mg 24mg 28ct 161220074429502
77
556411A05
N/A
5
160x536mm
21-04-17
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Black
GFW-045 00
Package leaflet: Information for the user
8mg prolonged-release capsules, hard
galantamine
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 Reminyl XL is and what it is
used for
2. What you need to know before you take
Reminyl XL
3. How to take Reminyl XL
4. Possible side effects
5. How to store Reminyl XL
6. Contents of the pack and other
information
1. What Reminyl XL is and what it is used for
Reminyl XL 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.
The capsules are made in a ‘prolonged-release’
form. This means that they release the medicine
slowly.
2.

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
REMINYL 4 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 4 mg tablet contains 4 mg galantamine (as hydrobromide).
Excipients with known effect:
Lactose monohydrate 38.59 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.
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.
_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 galantamine.
Discontinuation of
galantamine should be considered when evidence of a therapeutic effect
is no longer present or if the patient does not
tolerate treatment.
The initial maintenance dose is 16 mg/day (8 mg twice a day) and
patients should be maintained on 16 mg/day for at
least 4 weeks.
An increase to the maintenance dose of 24 mg/day (12 mg twice a day)
should be considered on an individual basis
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