Galantamine 4mg/ml Oral Solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

GALANTAMINE HYDROBROMIDE

Available from:

Syri Pharma Limited Floor 0 1 WML, 1 Windmill Lane Dublin 2, D02 F206, Ireland

ATC code:

N06DA04

INN (International Name):

GALANTAMINE HYDROBROMIDE 4 mg/ml

Pharmaceutical form:

ORAL SOLUTION

Composition:

GALANTAMINE HYDROBROMIDE 4 mg/ml

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Authorised

Authorization date:

2016-09-27

Patient Information leaflet

PAGE 1 OF 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
GALANTAMINE 4MG/ML ORAL SOLUTION
(galantamine hydrobromide)
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.
The name of your medicine is Galantamine 4mg/ml Oral Solution but it
will be referred to as
Galantamine throughout this leaflet.
WHAT IS IN THIS LEAFLET
1.
WHAT GALANTAMINE IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE GALANTAMINE
3.
HOW TO TAKE GALANTAMINE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE GALANTAMINE
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT GALANTAMINE IS AND WHAT IT IS USED FOR
This medicine 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. Galantamine increases the amount
of acetylcholine in
the brain and treats the signs of the disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE GALANTAMINE
DO NOT TAKE GALANTAMINE IF:

you are allergic to galantamine or to any of the other ingredients of
this medicine
(listed in section 6)

you have severe liver or severe kidney disease.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Galantam

Summary of Product characteristics

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1
of
12
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Galantamine 4mg/ml Oral Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral solution contains 4mg galantamine (as hydrobromide).
_Excipients with known effect_
:
Each ml of oral solution contains 1.2mg methyl parahydroxybenzoate
(E218).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Oral solution
A clear, colourless solution with odour of lime
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Galantamine 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.
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12
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 sh