Gatalin XL 16mg capsules

Држава: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Galantamine hydrobromide

Доступно од:

Aspire Pharma Ltd

АТЦ код:

N06DA04

INN (Међународно име):

Galantamine hydrobromide

Дозирање:

16mg

Фармацеутски облик:

Modified-release capsule

Пут администрације:

Oral

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 04110000; GTIN: 5060209730615

Информативни летак

Package leaflet: Information for the user
GATALIN XL 8MG PROLONGED-RELEASE CAPSULES, HARD
GATALIN XL 16MG PROLONGED-RELEASE CAPSULES, HARD
GATALIN XL 24MG PROLONGED-RELEASE CAPSULES, HARD
galantamine
WHAT IS IN THIS LEAFLET:
1. What Gatalin XL is and what it is used for
2. What you need to know before you take
Gatalin XL
3. How to take Gatalin XL
4. Possible side effects
5. How to store Gatalin XL
6. Contents of the pack and other information
1. WHAT GATALIN XL IS AND WHAT
IT IS USED FOR
Gatalin 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. Galantamine increases the amount of
acetylcholine in the brain and treats the signs of
the disease.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE GATALIN XL
DO NOT TAKE GATALIN 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
Gatalin 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
Galantamine can cause serious skin reactions,
heart problems and fits (seizures). You must be
aware of these side effects while you are taking
Gatalin XL. See ‘Look out for serious side
effects’ in section 4.
BEFORE YOU TAKE GATALIN 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,

Карактеристике производа

OBJECT 1
GATALIN XL 16MG PROLONGED RELEASE CAPSULES,
HARD
Summary of Product Characteristics Updated 16-Dec-2016 | Aspire Pharma
Ltd
1. Name of the medicinal product
Gatalin XL 16 mg prolonged release capsules, hard
2. Qualitative and quantitative composition
Each 16 mg capsule contains 16 mg galantamine (as hydrobromide).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged release capsule, hard
16mg: Opaque, flesh size 2 hard gelatine capsules containing two round
biconvex tablets
4. Clinical particulars
4.1 Therapeutic indications
Gatalin 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
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 or not
tolerating 24 mg/day, a dose reduction
to 16 mg/day should