REMINYL 4mg/ml oral solution

Land: Malta

Språk: engelska

Källa: Medicines Authority

Aktiva substanser:

GALANTAMINE

Tillgänglig från:

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

ATC-kod:

N06DA04

INN (International namn):

GALANTAMINE

Läkemedelsform:

ORAL SOLUTION

Sammansättning:

GALANTAMINE

Receptbelagda typ:

POM

Terapiområde:

PSYCHOANALEPTICS

Bemyndigande status:

Authorised

Tillstånd datum:

2006-12-29

Bipacksedel

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
REMINYL 4 MG/ML ORAL SOLUTION
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
confusion.
SERIOUS SIDE EFFECTS
Reminyl can cause serious skin reacti

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME
OF
THE
MEDICINAL
PRODUCT
REMINYL 4 mg/mL oral solution
2.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
1 mL oral solution contains 4 mg galantamine (as hydrobromide).
Excipients with known effect
methyl parahydroxybenzoate and propyl parahydroxybenzoate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Oral solution.
Clear and colourless oral solution.
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.
3
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 an increased response or not
tolerating 24 mg/day, a dose reduction
to 16 mg/day should be considered.
_Treatment withdrawa