Reminyl XL 24 mg prolonged-release capsules, hard

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Galantamine

Доступна с:

Originalis B.V.

код АТС:

N06DA; N06DA04

ИНН (Международная Имя):

Galantamine

дозировка:

24 milligram(s)

Фармацевтическая форма:

Prolonged-release capsule, hard

Тип рецепта:

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

Терапевтические области:

Anticholinesterases; galantamine

Дата Авторизация:

2018-12-07

тонкая брошюра

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 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.
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
Talk to your doctor or pharmacist before taking Reminyl XL. This
medicine is only used in Alzheimer’s
disease, and is not recommended for other types of memory loss or
confusion.
SERIOUS SIDE EFFECTS
Reminyl XL can cause serious skin reactions, heart problems and fits
(seizures). You must be aware of
these side effects while you are taking Reminyl XL. See ‘Look out
for serious side effects’ in section 4.
BEFORE YOU TAKE REMINYL XL, your doctor needs to know if you have, or
have had, any of the following:
•
liver or kidney problems
•
a heart condition (such as chest discomfort that is often brought on
by physical activity, a heart
attack, heart failure, slow or uneven heart beat, prolonged QTc
interval)
•
changes in ‘electro

Характеристики продукта

Health Products Regulatory Authority
01 March 2023
CRN00DG15
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 hard prolonged-release capsule contains 24 mg of galantamine (as
hydrobromide).
Excipients with known effect: sucrose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard prolonged-release capsule
_Product imported from 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
Diethyl phthalate
Ethylcellulose
Hypromellose
Macrogol 400
Maize starch
Sucrose
Gelatin
Titanium dioxide (E171)
iron oxide yellow (E172).
Shellac
Iron oxide red (E172)
Propylene glycol (E1520)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister and outer package of the product as marketed
in the country of origin.
Health Products Regulatory Authority
01 March 2023
CRN00DG15
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30ºC.
6.5 NATURE AND CONTENTS OF CONTAINER
Blisters of 28 hard prolonged-release capsules
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Originalis B.V.
Joop Geesinkweg 901
1114 AB Amsterdam-Duivendrecht
Netherlands
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA2306/009/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 7
th
December 2018
10 DATE OF REVISION OF THE TEXT
March 2023