Galsya SR 8 mg prolonged-release capsules, hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Galantamine

Available from:

KRKA, d.d., Novo mesto

ATC code:

N06DA; N06DA04

INN (International Name):

Galantamine

Dosage:

8 milligram(s)

Pharmaceutical form:

Prolonged-release capsule, hard

Prescription type:

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

Therapeutic area:

Anticholinesterases; galantamine

Authorization status:

Marketed

Authorization date:

2011-06-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GALSYA SR 8 MG PROLONGED-RELEASE CAPSULES, HARD
GALSYA SR 16 MG PROLONGED-RELEASE CAPSULES, HARD
GALSYA SR 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.
WHAT IS IN THIS LEAFLET
1.
What Galsya SR is and what it is used for
2.
What you need to know before you take Galsya SR
3.
How to take Galsya SR
4.
Possible side effects
5.
How to store Galsya SR
6.
Contents of the pack and other information
1.
WHAT GALSYA SR IS AND WHAT IT IS USED FOR
Galsya SR contains the active substance ‘galantamine’ that is 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. Galsya SR
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE GALSYA SR
DO NOT TAKE GALSYA SR
-
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 you

Summary of Product characteristics

Health Products Regulatory Authority
06 October 2022
CRN00CYYX
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Galsya SR 8 mg prolonged-release capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release capsule, hard contains 8 mg galantamine (as
hydrobromide).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release capsule, hard
White capsulessize 2 (capsule length: 17.6 - 18.4 mm) with G8
imprinted on the capsule’s cap. Content of capsule is one white
oval, prolonged-release tablet core.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Galsya SR 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