Gazylan XL 8mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Galantamine hydrobromide

Available from:

Teva UK Ltd

ATC code:

N06DA04

INN (International Name):

Galantamine hydrobromide

Dosage:

8mg

Pharmaceutical form:

Modified-release capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04110000; GTIN: 5017007063223

Patient Information leaflet

GAZYLAN XL 8 MG, 16 MG, 24 MG
PROLONGED-RELEASE CAPSULES,
HARD
GALANTAMINE
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.
1. What Gazylan XL is and what it is used for
2. What you need to know before you take
Gazylan XL
3. How to take Gazylan XL
4. Possible side effects
5. How to store Gazylan XL
6. Contents of the pack and other information
WHAT GAZYLAN XL IS AND WHAT IT IS
USED FOR
Gazylan XL 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. Gazylan XL increases the amount of
acetylcholine in the brain and treats the signs of
the disease.
The capsules are made in a ‘prolonged-release’
form. This means that they release the medicine
slowly.
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE GAZYLAN XL
DO NOT TAKE GAZYLAN 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
Gazylan XL.
This medicine is only used in Alzheimer’s
disease, and is not recommended for other types
of

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gazylan XL 8 mg prolonged-release capsules, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 8 mg prolonged-release capsule contains 8 mg galantamine (as
hydrobromide).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Prolonged release capsule, hard
Opaque white size 2 hard gelatine capsules containing one round
biconvex
prolonged-release tablet of 8 mg
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gazylan XL 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 for 4 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 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 patients not showing an increased response or not
tolerating 24
mg/day, a dose reduction to 16 mg/day should be considered.
_Treatment withdrawal _
There is no rebound effect after a