Xanax

Nchi: Nyuzilandi

Lugha: Kiingereza

Chanzo: Medsafe (Medicines Safety Authority)

Nunua Sasa

Taarifa za kipeperushi Taarifa za kipeperushi (PIL)
18-01-2021
Tabia za bidhaa Tabia za bidhaa (SPC)
04-01-2021

Viambatanisho vya kazi:

Alprazolam 0.25mg (Exclusive of 1.5% excess.);  ;  

Inapatikana kutoka:

Upjohn New Zealand ULC

INN (Jina la Kimataifa):

Alprazolam 0.25 mg (Exclusive of 1.5% excess.)

Kipimo:

0.25 mg

Dawa fomu:

Tablet

Tungo:

Active: Alprazolam 0.25mg (Exclusive of 1.5% excess.)     Excipient: Colloidal silicon dioxide [Docusate sodium (85% ) with sodium benzoate [15%] Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose

Vitengo katika mfuko:

Blister pack, 50 tablets

Darasa:

Class C5 Controlled Drug

Dawa ya aina:

Class C5 Controlled Drug

Viwandani na:

Valdepharm

Matibabu dalili:

1. Anxiety states (anxiety neuroses). Symptoms which occur in such patients include anxiety, tension, fear, insomnia, apprehension, restlessness, concentration difficulties, irritability and/or autonomic hyperactivity resulting in a variety of somatic complaints. 2. Mixed anxiety-depression. Symptoms of both anxiety and depression occur concurrently in such patients. 3. Neurotic or reactive depression. Such patients primarily exhibit a depressed mood or a pervasive loss of interest or pleasure. Other characteristics include anxiety, appetite disturbances, changes in weight, cognitive disturbances, decreased energy, feeling of worthlessness or guilt, insomnia, somatic complaints, or thoughts of death or suicide. 4. Anxiety states, mixed anxiety-depression, or neurotic 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.

Bidhaa muhtasari:

Package - Contents - Shelf Life: Blister pack, - 50 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, - 100 tablets - 36 months from date of manufacture stored at or below 25°C

Idhini ya tarehe:

1984-08-29

Taarifa za kipeperushi

                                XANAX
®
1
XANAX
®
TABLETS
_Alprazolam_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Xanax.
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 Xanax against
the benefits this medicine is expected
to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT XANAX IS USED
FOR
Xanax is used to treat anxiety.
Anxiety or tension associated with
the normal stress of everyday life
usually does not require treatment
with medicines.
Xanax is also used to treat panic
attacks.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
Your doctor may have prescribed
Xanax for another purpose.
Xanax belongs to a group of
medicines called benzodiazepines.
They are thought to work by their
action on brain chemicals.
IF YOU TAKE XANAX FOR TOO LONG, IT
MAY BECOME HABIT-FORMING.
BENZODIAZEPINES MAY LEAD TO
PHYSICAL OR PSYCHOLOGICAL
DEPENDENCE. IF YOU HAVE ANY
CONCERNS, YOU SHOULD DISCUSS THIS
WITH YOUR DOCTOR.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE XANAX
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE XANAX IF YOU HAVE AN
ALLERGY TO:

any medicine containing
alprazolam

any of the ingredients listed at the
end of this leaflet

any other medicine in the
benzodiazepine group.
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 XANAX IF YOU HAVE OR
HAVE HAD ANY OF THE FOLLOWING
MEDICAL CONDITIONS:

myasthenia gravis which causes
severe muscle weakness

severe and chronic lung disease.
DO NOT TAKE THIS MEDICINE IF YOU
ARE PREGNANT.
It may affect your
                                
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Tabia za bidhaa

                                Version:pfdxanat10119
Supersedes: pfdxanat11018
Page 1 of 12
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
XANAX
®
0.25 mg, 0.5 mg and 1.0 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.25 mg tablet contains 0.25 mg alprazolam
Each 0.5 mg tablet contains 0.5 mg alprazolam
Each 1.0 mg tablet contains 1.0 mg alprazolam
Excipients with known effects:

Lactose monohydrate

Sodium benzoate
For the full list of excipients, see section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
XANAX 0.25mg tablets are white, scored, ovoid shaped tablets coded
"Upjohn 29". Length
9.1 mm, Width 5.5 mm, Thickness 3.5 mm.
XANAX 0.5mg tablets are pink coloured, scored, ovoid shaped tablets
coded "Upjohn 55".
Length 9.1 mm, Width 5.5 mm, Thickness 3.5 mm.
XANAX 1.0mg tablets are lavender coloured, scored, ovoid shaped
tablets coded "Upjohn 90".
Length 9.1 mm, Width 5.5 mm, Thickness 3.5 mm.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
XANAX (alprazolam) is indicated for the treatment of:
1.
ANXIETY STATES (ANXIETY NEUROSES).
Symptoms which occur in such patients include anxiety, tension, fear,
insomnia,
apprehension, restlessness, concentration difficulties, irritability
and/or autonomic
hyperactivity resulting in a variety of somatic complaints.
2.
MIXED ANXIETY-DEPRESSION.
Symptoms of both anxiety and depression occur concurrently in such
patients.
Version:pfdxanat10119
Supersedes: pfdxanat11018
Page 2 of 12
3.
NEUROTIC OR REACTIVE DEPRESSION.
Such patients primarily exhibit a depressed mood or a pervasive loss
of interest or
pleasure. Other characteristics include anxiety, appetite
disturbances, changes in weight,
cognitive disturbances, decreased energy, feeling of worthlessness or
guilt, insomnia,
somatic complaints, or thoughts of death or suicide.
4.
ANXIETY STATES, MIXED ANXIETY-DEPRESSION, OR NEUROTIC 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.

                                
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