Reminyl 12mg tablets

Држава: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Galantamine hydrobromide

Доступно од:

Dowelhurst Ltd

АТЦ код:

N06DA04

INN (Међународно име):

Galantamine hydrobromide

Дозирање:

12mg

Фармацеутски облик:

Oral tablet

Пут администрације:

Oral

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 04110000

Информативни летак

Technical Info
Profile
1516v6
Reminyl PIL Ireland UK 4mg 8mg 12mg 56ct 161220074429502
2154
556414A07
N/A
7
160x800mm
16-05-17
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Black
GFW-045 00
FONTS USED:
Helvetica Neue LT Std-55 Roman
Helvetica Neue LT Std-75 Bold
NimbusSanLOT-Bold
NimbusSanLOT-Regular
NimbusSanLOTBla-Regular
SMALLEST POINT SIZED USED:
7.0 pt
AVERAGE TEXT SIZE (BODY TEXT):
9.0 pt
Package leaflet: Information for the user
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 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 (li

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Reminyl 12 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 12 mg tablet contains 12 mg galantamine (as hydrobromide).
Excipients with known effect:
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).
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.
_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 after appropriate assessment
including evaluation of
clinical benefit and tolerability.
In individual patients not showing