GALANTAX XL 24 Milligram Prolonged Release Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

GALANTAMINE HYDROBROMIDE

Available from:

Clonmel Healthcare Ltd

INN (International Name):

GALANTAMINE HYDROBROMIDE

Dosage:

24 Milligram

Pharmaceutical form:

Prolonged Release Capsules

Prescription type:

Product subject to prescription which may not be renewed (A)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

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.
GALANTAX XL 8MG 
PROLONGED-RELEASE CAPSULES, HARD
GALANTAX XL 16MG 
PROLONGED-RELEASE CAPSULES, HARD
GALANTAX XL 24MG 
PROLONGED-RELEASE CAPSULES, HARD
Galantamine
PACKAGE LEAFLET: INFORMATION FOR THE USER
WHAT IS IN THIS LEAFLET:
1. What Galantax XL is and what it is used for
2. What you need to know before you take Galantax XL
3. How to take Galantax XL
4. Possible side effects
5. How to store Galantax XL
6. Contents of the pack and other information
1.  WHAT GALANTAX XL IS AND WHAT IT IS USED FOR 
Galantax XL is an antidementia medicine used to treat the symp-
toms of mild to moderately severe dementia of the Alzheimer type,
a disease that alters brain function.
The symptoms of Alzheimer’s disease include increasing memory
loss, confusion and behavioural changes. As a result, it becomes
more and more difficult to carry out normal daily activities.
These symptoms are believed to be due to a lack of acetylcholine,
a substance responsible for sending messages between brain
cells. Galantax XL increases the amount of acetylcholine in the
brain and so could improve the symptoms of the disease.
2.  
WHAT YOU NEED TO KNOW BEFORE YOU TAKE 
    GALANTAX XL
DO NOT TAKE GALANTAX XL
• If you are allergic to galantamine or any of the other
ingredients
of this medicine (listed in section 6).
• If you have severe liver and/or severe kidney disease
WARNINGS AND PRECAUTIONS 
Talk to your doctor or pharmacist before taking Galantax XL.
Galantax XL shoul

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Galantax XL 24mg Prolonged-release Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 24 mg capsule contains 24 mg galantamine (as hydrobromide).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release capsule, hard
Opaque orange size 2 hard gelatine capsules containing three round biconvex tablets
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Galantax XL is indicated for the symptomatic treatment of mild to moderately severe dementia of the Alzheimer type.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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 for 4 weeks.
_Maintenance dose_
The tolerance and dosing of Galantax XL should be reassessed on a regular basis, preferably within three months
after start of treatment. Thereafter, the clinical benefit of Galantax XL 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 Galantax XL.
Discontinuation of Galantax XL 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 and patients should be maintained on 16 mg/day for at least 4 weeks.
An increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate
assessment including evaluation of clinical benefit and tolerability.
In individual p