REMINYL XL 8 mg prolonged-release capsules, hard

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

GALANTAMINE HYDROBROMIDE

Dostupné s:

Shire Pharmaceuticals Ireland Limited

ATC kód:

N06DA; N06DA04

INN (Mezinárodní Name):

GALANTAMINE HYDROBROMIDE

Dávkování:

8 milligram(s)

Léková forma:

Capsule, hard

Druh předpisu:

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

Terapeutické oblasti:

Anticholinesterases; galantamine

Stav Autorizace:

Marketed

Datum autorizace:

2004-11-19

Informace pro uživatele

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
REMINYL XL 8 MG PROLONGED-RELEASE CAPSULES, HARD
REMINYL XL 16 MG PROLONGED-RELEASE CAPSULES, HARD
REMINYL XL 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 Reminyl XL is and what it is used for
2.
What you need to know before you take Reminyl XL
3.
How to take Reminyl XL
4.
Possible side effects
5.
How to store Reminyl XL
6.
Contents of the pack and other information
1.
WHAT REMINYL XL IS AND WHAT IT IS USED FOR
Reminyl 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. Reminyl
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 REMINYL XL
DO NOT TAKE REMINYL XL

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
T

Charakteristika produktu

Health Products Regulatory Authority
19 March 2021
CRN00C5M5
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
REMINYL XL 8 mg prolonged-release capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 8 mg capsule contains 8 mg galantamine (as hydrobromide).
Excipients with known effect
8 mg capsules: sucrose 59 mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Prolonged-release capsule, hard
White opaque, size 4 hard capsules with the inscription “G8”,
containing white to off-white pellets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Reminyl 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 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 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.
Health Products Regulatory Authority
19 March 2021
CRN00C5M5
Page 2 of 11
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