Reminyl XL 8mg Prolonged-release Capsules

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

GALANTAMINE HYDROBROMIDE

Предлага се от:

LTT Pharma Limited

АТС код:

N06DA; N06DA04

INN (Международно Name):

GALANTAMINE HYDROBROMIDE

дозиране:

8 milligram(s)

Лекарствена форма:

Prolonged-release capsule

Вид предписание :

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

Терапевтична област:

Anticholinesterases; galantamine

Статус Оторизация:

Authorised

Дата Оторизация:

2014-05-30

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Reminyl XL 8mg Prolonged-release Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 8 mg capsule contains 8 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
_Product imported from Spain_
White opaque, size 4 hard capsules with the inscription “G8”
containing white to off-white pellets.
4 CLINICAL PARTICULARS
As per PA0535/006/005
5 PHARMACOLOGICAL PROPERTIES
As per PA0535/006/005
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)
_Imprinting ink_
Iron oxide black (E172)
Shellac
Propylene glycol (E1520)
6.2 INCOMPATIBILITIES
Not applicable.
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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 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
28 prolonged-release capsules, hard (PVC-PE-PVDC/Aluminium blister)
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DE