Galantamine Oral Solution 4mg/ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

GALANTAMINE HYDROBROMIDE

Available from:

Rosemont Pharmaceuticals Limited Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds LS11 9XE, United Kingdom

ATC code:

N06DA04

INN (International Name):

GALANTAMINE HYDROBROMIDE 4 mg

Pharmaceutical form:

ORAL SOLUTION

Composition:

GALANTAMINE HYDROBROMIDE 4 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Withdrawn

Authorization date:

2016-03-24

Patient Information leaflet

GALANTAMINE 4MG/ML ORAL SOLUTION
MODULE 1.3.1
SPC, LABEL, LEAFLET
VERSION: APRIL 2016
PAGE 1
PATIENT INFORMATION LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 Galantamine Oral Solution is and what it is used for
2.
What you need to know before you take Galantamine Oral Solution
3.
How to take Galantamine Oral Solution
4.
Possible side effects
5.
How to store Galantamine Oral Solution
6.
Contents of the pack and other information
WHAT YOUR MEDICINE IS
The full name of your medicine is Galantamine 4mg/ml Oral Solution. In
this leaflet
the shorter name Galantamine is used. Galantamine belongs to a group
of medicines
known as ‘anti-dementia’ medicines.
WHAT YOUR MEDICINE IS USED FOR
Galantamine is used in adults to treat the symptoms of mild to
moderately severe
Alzheimer’s disease. This is a type of dementia that alters the way
the brain works.
Alzheimer’s disease causes memory loss, confusion and changes in
behaviour, which
make it increasingly difficult to carry out normal daily tasks.
HOW YOUR MEDICINE WORKS
The effects of Alzheimer’s disease on the brain are thought to be
caused by a lack of
‘acetylcholine’. This is a substance which sends messages between
brain cells.
Galantamine increases the amount of ‘acetylcholine’ in the brain
and helps more
messages be sent.
GALANTAMINE 4MG/ML ORAL SOLUTION
1. WHAT GALANTAMINE ORAL SOLUTION IS AND WHAT IT IS USED FOR
GALANTAMINE 4MG/ML ORAL SOLUTION
MODULE 1.3.1
SPC, LABEL, LE

Summary of Product characteristics

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:
Methyl parahydroxybenzoate (as sodium salt)
0.2mg/ml
Propyl parahydroxybenzoate (as sodium salt)
1.8mg/ml
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Oral Solution
A clear colourless solution.
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 four
weeks.
_ _
_Maintenance dose_
The tolerance and dosing of galantamine should be reassessed on a
regular basis,
preferably within three 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 an increased response or not
tolerating 24 mg/day,
a dose reduction to 16 mg/day