REMINYL PROLONGED RELEASE CAPSULE 8 MG

Země: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktivní složka:

GALANTAMINE HBR. 10.25 MG EQV GALANTAMINE BASE

Dostupné s:

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

ATC kód:

N06DA04

Dávkování:

8 MG

Léková forma:

CAPSULE, COATED, EXTENDED RELEASE

Složení:

GALANTAMINE HBR. 10.25 MG EQV GALANTAMINE BASE 8 MG

Podání:

ORAL

Druh předpisu:

Prescription Only

Výrobce:

JANSSEN PHARMACEUTICA NV

Stav Autorizace:

ACTIVE

Datum autorizace:

2004-08-10

Informace pro uživatele

PRODUCT NAME 
REMINYL
®
 (galantamine hydrobromide)
DOSAGE FORMS AND STRENGTHS

ORAL SOLUTION 
Clear,  colourless  solution  containing  galantamine  hydrobromide,  equivalent  to  4 mg/ml 
galantamine base. 
PROLONGED-RELEASE CAPSULES FOR ORAL USE 
_8 MG CAPSULES _
White  opaque,  size  4  hard  gelatin  capsules  with  the  inscription  “GAL  8”,  containing 
white  to  off-white  pellets.  Each  capsule  contains  galantamine  hydrobromide,  equivalent 
to 8 mg galantamine base. 
_16 MG CAPSULES _
Pink  opaque,  size  2  hard  gelatin  capsules  with  the  inscription  “GAL  16”,  containing 
white  to  off-white  pellets.  Each  capsule  contains  galantamine  hydrobromide,  equivalent 
to 16 mg galantamine base. 
_24 MG CAPSULES _
Caramel opaque, size 1 hard gelatin capsules with the inscription “GAL 24”, containing 
white  to  off-white  pellets.  Each  capsule  contains  galantamine  hydrobromide,  equivalent 
to 24 mg galantamine base. 
For excipients, see _List of Excipients_. 
CLINICAL INFORMATION 
INDICATIONS 
REMINYL
®
 is indicated for the treatment of mild to moderately severe dementia of the
Alzheimer type. 
DOSAGE AND ADMINISTRATION 
DOSAGE 
– ADULTS  
Ensure adequate fluid intake during treatment. 
_STARTING DOSE _
The recommended starting dose  of REMINYL
®
  oral  solution  is  4 mg twice a day for 4
weeks. 

The recommended starting dose of REMINYL
®
 prolonged-release capsules is 8 mg once 
daily for 4 weeks.  

The  dose  of  REMINYL
®
  should  be  gradually  increased  to  the  maintenance  dose  to 
minimize side effects. 

_MAINTENANCE DOSE _
The  initial  maintenance  dose  is  16  mg/day  (8  mg  twice  a  day)  and  patients  should  be 
maintained on 16 mg/day fo

Charakteristika produktu

PRODUCT NAME
REMINYL
®
(galantamine hydrobromide)
DOSAGE FORMS AND STRENGTHS
PROLONGED-RELEASE CAPSULES FOR ORAL USE
_ _
_8 MG CAPSULES _
White opaque, size 4 hard gelatin capsules with the inscription “GAL
8”, containing
white to off-white pellets. Each capsule contains galantamine
hydrobromide, equivalent
to 8 mg galantamine base.
_16 MG CAPSULES _
Pink opaque, size 2 hard gelatin capsules with the inscription “GAL
16”, containing
white to off-white pellets. Each capsule contains galantamine
hydrobromide, equivalent
to 16 mg galantamine base.
_24 MG CAPSULES _
Caramel opaque, size 1 hard gelatin capsules with the inscription
“GAL 24”, containing
white to off-white pellets. Each capsule contains galantamine
hydrobromide, equivalent
to 24 mg galantamine base.
For excipients, see
_List of Excipients_
.
CLINICAL INFORMATION
INDICATIONS
REMINYL
®
is indicated for the treatment of mild to moderately severe dementia
of the
Alzheimer type.
DOSAGE AND ADMINISTRATION
DOSAGE – ADULTS
Ensure adequate fluid intake during treatment.
_ _
_STARTING DOSE _
The recommended starting dose of REMINYL
®
prolonged-release capsules is 8 mg once
daily for 4 weeks.
The dose of REMINYL
®
should be gradually increased to the maintenance dose to
minimize side effects.
_MAINTENANCE DOSE _
The initial maintenance dose is 16 mg/day (16 mg once a day with
capsules) and patients
should be maintained on 16 mg/day for at least 4 weeks. An increase to
the maximum
recommended maintenance dose of 24 mg/day (24 mg once a day with
capsules) should
be considered after appropriate assessment including evaluation of
clinical benefit and
tolerability.
TREATMENT WITHDRAWAL
There is no rebound effect after abrupt discontinuation of treatment
(e.g. in preparation
for surgery).
_ _
RE-INITIATION OF THERAPY
If the treatment is interrupted for longer than several days,
treatment should be re-
initiated with the lowest daily dose and gradually increased to the
maximum tolerated
dose to achieve the desired clinical effect. The incidence and
seve