Reminyl XL 24 mg prolonged-release capsules, hard

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Galantamine

Commercializzato da:

PCO Manufacturing Ltd.

Codice ATC:

N06DA; N06DA04

INN (Nome Internazionale):

Galantamine

Dosaggio:

24 milligram(s)

Forma farmaceutica:

Prolonged-release capsule, hard

Tipo di ricetta:

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

Area terapeutica:

Anticholinesterases; galantamine

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2013-05-31

Foglio illustrativo

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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 PRECAUT

Scheda tecnica

Health Products Regulatory Authority
16 May 2022
CRN00CY1N
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Reminyl XL 24 mg prolonged-release capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 24 mg capsule, contains 24 mg galantamine (as hydrobromide).
Excipients with known effect: sucrose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release capsule, hard
_Product imported from Italy and Greece:_
Caramel opaque, size 1 hard capsules with the inscription “G24”,
containing white to off-white pellets.
4 CLINICAL PARTICULARS
As per PA23211/003/004
5 PHARMACOLOGICAL PROPERTIES
As per PA23211/003/004
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Prolonged-release pellets_
Diethyl phthalate
Ethylcellulose
Hypromellose
Macrogol 400
Maize starch
Sucrose
_Capsules_
Gelatin
Titanium dioxide (E171)
Red ferric oxide (E172)
Yellow ferric oxide (E172)
_Imprinting ink_
Iron oxide black (E172)
Shellac
Propylene glycol
6.2 INCOMPATIBILITIES
Not applicable.
Health Products Regulatory Authority
16 May 2022
CRN00CY1N
Page 2 of 2
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer packaging of the product on the
market in the country of origin
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30ºC.
6.5 NATURE AND CONTENTS OF CONTAINER
Carton containing 4 blister strips (7 capsules per strip)
Pack size: 28 capsules
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/166/003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 31st May 2013
10 DATE OF REVISION OF THE TEXT
May 2022