GALANTYL galantamine (as hydrobromide) 16 mg modified release capsule blister pack

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

galantamine hydrobromide, Quantity: 20.512 mg

متاح من:

Alphapharm Pty Ltd

INN (الاسم الدولي):

Galantamine hydrobromide

الشكل الصيدلاني:

Capsule, modified release

تركيب:

Excipient Ingredients: povidone; magnesium stearate; hydrogenated vegetable oil; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide; titanium dioxide; allura red AC; potable water; Gelatin; sodium lauryl sulfate; colloidal anhydrous silica; polyvinyl acetate

طريقة التعاطي:

Oral

الوحدات في الحزمة:

28 capsules, 30 capsules

نوع الوصفة الطبية :

(S4) Prescription Only Medicine

الخصائص العلاجية:

GALANTYL is indicated for the treatment of mild to moderately severe dementia of the Alzheimer type.

ملخص المنتج:

Visual Identification: Size 2, hard gelatin capsule with a white body and pale pink cap printed in black ink "MYLAN" over "GT 16" on both the body and the cap.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

الوضع إذن:

Licence status A

تاريخ الترخيص:

2010-04-23

نشرة المعلومات

GALANTYL™
_galantamine (as hydrobromide)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about GALANTYL
modified release capsules.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking GALANTYL
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING GALANTYL, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT GALANTYL IS
USED FOR
GALANTYL is used to treat mild to
moderately severe dementia of the
Alzheimer's type.
The symptoms of Alzheimer's
disease include confusion, memory
loss or other changes in behaviour.
As the disease progresses, patients
find it more and more difficult to
carry out their normal daily activities.
The symptoms of Alzheimer's
disease are thought to be due to a
lack of acetylcholine, a substance
which transmits messages between
brain cells. GALANTYL increases
the amount of this substance to help
improve or stabilise the symptoms
and therefore slow the progress of
Alzheimer's disease.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
It is available only with a doctor's
prescription.
BEFORE YOU TAKE
GALANTYL
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE GALANTYL IF YOU
HAVE:
•
an allergy to any medicine
containing galantamine
•
an allergy to any of the
ingredients listed at the end of
this leaflet
•
severe liver and/or kidney
disease.
Some of the symptoms of an allergic
reaction may include
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
If it has expired or

خصائص المنتج

AUSTRALIAN PRODUCT INFORMATION
GALANTYL
_(Galantamine) modified release capsules _
1
NAME OF THE MEDICINE
Galantamine (as hydrobromide)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 8 mg; 16 mg; or 24 mg of galantamine (as
hydrobromide) as the active ingredient.
Excipients with known effect: traces of sulfites
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
GALANTYL 8 mg modified release capsules are size 2, hard gelatin
capsules with a white body and pink cap
printed in black ink "MYLAN" over "GT 8" on both the body and the cap.
GALANTYL 16 mg modified release capsules are size 2, hard gelatin
capsule with a white body and pale pink
cap printed in black ink "MYLAN" over "GT 16" on both the body and the
cap.
GALANTYL 24 mg modified release capsules are Size 1, hard gelatin
capsule with a white body and pink
cap printed in black ink "MYLAN" over "GT 24" on both the body and the
cap.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
GALANTYL is indicated for the treatment of mild to moderately severe
dementia of the Alzheimer type.
4.2
DOSE AND METHOD OF ADMINISTRATION
GALANTYL modified release capsules should be administered once daily
in the morning, preferably with
food. Ensure adequate fluid intake during treatment. The dose of
GALANTYL should be gradually increased
to the maintenance dose to minimise side effects.
STARTING DOSE
The recommended starting dose is 8 mg a day for four weeks.
MAINTENANCE DOSE
•
The initial maintenance dose is 16 mg a day and patients should be
maintained on this dose for
at least 4 weeks.
•
An increase to the maximum recommended maintenance dose of 24 mg a day
should be
considered after appropriate assessment including evaluation of
clinical benefit and tolerability.
•
There is no rebound effect after abrupt discontinuation of treatment,
for example, prior to
surgery.
RE-INITIATION OF THERAPY
If treatment is interrupted for longer than several days, treatment
should be re-initiated with the lowest daily
dose and gr