Xanax Tablet 0.25 mg

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Δραστική ουσία:

ALPRAZOLAM

Διαθέσιμο από:

VIATRIS SDN. BHD.

INN (Διεθνής Όνομα):

ALPRAZOLAM

Μονάδες σε πακέτο:

30Tablet Tablets; 10Tablet Tablets; 100Tablet Tablets

Κατασκευάζεται από:

SANICO N.V.

Φύλλο οδηγιών χρήσης

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
XANAX
®
TABLETS
Alprazolam (0.25 mg, 0.5 mg, 1 mg)
1
WHAT IS IN THIS LEAFLET
1. What XANAX is used for
2. How XANAX works
3. Before you use XANAX
4. How to use XANAX
5. While you are using it
6. Side Effects
7. Storage and Disposal of XANAX
8. Product Description
9. Manufacturer and Product Registration
Holder
10. Date of Revision
11. Serial Number
WHAT XANAX IS USED FOR
XANAX tablets are used to treat

severe anxiety

severe anxiety associated with
depression

depression where individuals show
loss of interest or depression
associated with other diseases

panic related disorders

neurotic or reactive depression
XANAX tablets should only be used for
short-term treatment of anxiety. The
overall duration of treatment should not
be more than 12 weeks including a
period where the dose is gradually
reduced (this is called dose ‘tapering’).
HOW XANAX WORKS
XANAX is a tranquilliser containing the
active ingredient alprazolam. Alprazolam
belongs to one of a group of medicines
called benzodiazepines. Benzodiazepines
affect chemical activity in the brain and
impacts central nervous system function
like reduction in anxiety and worry.
BEFORE YOU USE XANAX
-
_When you must not use it_
Do not take XANAX if you:
- Are allergic to alprazolam or other
similar benzodiazepine medicines, or
to any of the other ingredients (see
Section 10 ‘Product Description’ for
more details)
_Pregnancy and lactation_
XANAX may be harmful to the
developing baby so you should not
take XANAX if you are pregnant or
planning to become pregnant.
Tell your doctor immediately if you
think you may be pregnant.
Do not breastfeed while taking
XANAX, as the drug may pass into
breast milk.
Ask your doctor or pharmacist for
advice before taking any medicine.
-
_Before you start to use it_
Talk to your doctor or pharmacist
before taking XANAX if you:
- Are pregnant, think you might be
pregnant now, are planning to
become pregnant or if you are
breastfeeding (see also Section
Before you us

Αρχείο Π.Χ.Π.

1
1. NAME OF THE MEDICINAL PRODUCT
XANAX
®
(ALPRAZOLAM TABLETS)
2. QUALITATIVE & QUANTITATIVE COMPOSITION
Each
immediate-release
(IR)
tablet
contains
0.25 mg,
0.5 mg
or
1 mg
of
alprazolam.
3. PHARMACEUTICAL FORM
Immediate-release tablets.
XANAX
®
0.25 mg Tablets – White, elliptical full oval scored tablets.
XANAX
®
0.5 mg Tablets – Pink-coloured, elliptical full oval scored tablets.
XANAX
®
1 mg Tablets – Lavender-coloured, elliptical full oval scored
tablets.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION
Alprazolam is indicated for the treatment of:
● ANXIETY STATES (ANXIETY NEUROSES)
Symptoms which occur in such patients include anxiety, tension,
agitation,
insomnia, apprehension, irritability and/or autonomic hyperactivity
resulting in a
variety of somatic complaints.
● MIXED ANXIETY-DEPRESSION
Symptoms of both anxiety and depression occur simultaneously in such
patients.
● NEUROTIC OR REACTIVE DEPRESSION
Such patients primarily exhibit a depressed mood or a pervasive loss
of interest
or pleasure. Symptoms of anxiety, psychomotor agitation and insomnia
are
usually present. Other characteristics include appetite disturbances,
changes
in weight, somatic complaints, cognitive disturbances, decreased
energy,
feeling of worthlessness or guilt, or thoughts of death or suicide.
● ANXIETY STATES, MIXED ANXIETY-DEPRESSION, OR DEPRESSION ASSOCIATED
WITH
OTHER DISEASES
Such as the chronic phase of alcohol withdrawal and functional or
organic
disease, particularly certain gastrointestinal, cardiovascular or
dermatological
disorders.
● PANIC RELATED DISORDERS
Alprazolam is indicated in the treatment of panic disorder with or
without some
phobic avoidance. Alprazolam is also indicated for the blocking or
attenuation
of panic attacks and phobias in patients who have agoraphobia with
panic
2
attacks. The effectiveness of alprazolam in the treatment of anxiety,
anxiety
associated with depression and neurotic (reactive) depression for
long-term use
exceeding six months has not been established by system