KALMA 2 alprazolam 2mg tablet bottle

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

alprazolam, Quantity: 2 mg

Disponible des:

Alphapharm Pty Ltd

formulario farmacéutico:

Tablet, uncoated

Composición:

Excipient Ingredients: docusate sodium; sodium starch glycollate; povidone; maize starch; sodium benzoate; lactose monohydrate; magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica

Vía de administración:

Oral

Unidades en paquete:

50 tablets

tipo de receta:

(S8) Controlled Drug

indicaciones terapéuticas:

Anxiety. Short-term symptomatic treatment of anxiety including treatment of anxious patients with some symptoms of depression. Panic disorder. The treatment of panic disorder with or without some phobic avoidance, and for blocking or attenuation of panic attacks and phobias in patients who have agoraphobia with panic attacks. The diagnostic criteria for panic disorder in DSM-III-R are as follows: The panic attacks (discrete periods of intense fear or discomfort), at least initially, are unexpected. Later in the course of this disturbance, certain situations (eg. driving a car or being in a crowded place) may become associated with having a panic attack. These panic attacks are not triggered by situations in which the person is the focus of others' attention (as in social phobia). The diagnosis requires four such attacks within a four week period, or one or more attacks followed by at least a month of persistent fear of having another attack. The panic attacks must be characterised by at least four of the following symptoms: dyspnoea or smothering sensations; dizziness, unsteady feelings or faintness; palpitations or tachycardia; trembling or shaking; sweating; choking; nausea or abdominal distress; depersonalisation or derealisation; paraesthesiae; flushes (hot flashes) or chills; chest pain or discomfort; fear of dying; fear of going crazy or of doing something uncontrolled. NOTE: Attacks involving four or more symptoms are panic attacks; attacks involving fewer than four are limited symptom attacks. At least some of the panic attack symptoms must develop suddenly and increase in intensity within ten minutes of the beginning of the first symptom noticed in the attack. The panic attack must not be attributable to some known organic factor, eg. amphetamine or caffeine, intoxication, hyper-thyroidism. The efficacy of alprazolam in conditions where the above criteria are not met has not been established. The risk versus benefits of alprazolam use in milder disorders, which do not meet the above criteria, has not been evaluated. Although current evidence supports the long-term clinical effectiveness of alprazolam in panic disorder, the continuing use of alprazolam needs to be weighed against the difficulties that can occur with dependence and discontinuation. The results of a long-term study in patients taking alprazolam (ie. beyond three months) suggest that many patients continue to benefit from alprazolam therapy and that alprazolam efficacy is maintained for up to eight months. The physician should periodically reassess the usefulness of the drug for each patient. A comparative study of alprazolam and placebo in the treatment of panic attacks in patients with panic disorder involved 543 patients over an eight week period. Alprazolam was significantly more effective than placebo in reducing the total number of panic attacks (p<0.0001); at week 4, 46.8% of alprazolam patients had achieved zero total panic attacks when compared to 27.1% of placebo patients. Panic disorders are often severe, chronic illnesses that cause a high level of work and social disability, increased substance abuse and potentially increased morbidity and mortality. Psychological and social factors are important in the pathogenesis of panic attacks, either acting alone or in combination with biological factors. Prolonged pharmacological therapy may be used as an adjunct to psychosocial therapy in the treatment of patients with panic disorders.

Resumen del producto:

Visual Identification: 9.5 mm x 9.0 mm white oval bevel edged quadrisect tablet marked "A" in the upper left quadrant "L" in the upper right quadrant "G" in the lower left quadrant, "2" in the lower right quadrant on one side, plain quadrisect on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Estat d'Autorització:

Licence status A

Data d'autorització:

1998-05-18

Informació per a l'usuari

KALMA
_contains the active ingredient alprazolam_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Kalma.
It does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Kalma against the
benefits this medicine is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
Kalma. It contains the active
ingredient alprazolam.
It is used to treat:
•
anxiety.
•
panic attacks.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY KALMA HAS
BEEN PRESCRIBED FOR YOU.
Your doctor, however, may have
prescribed Kalma for another reason.
Kalma is available only with a
doctor's prescription.
_HOW IT WORKS_
Kalma belongs to a group of
medicines called benzodiazepines.
These medicines are thought to work
by their action on brain chemicals.
In general, benzodiazepines such as
alprazolam are taken for short
periods only (for example 2 to 4
weeks). Continuous long term use is
not recommended unless advised by
your doctor. The use of
benzodiazepines may lead to
dependence on the medicine.
IF YOU TAKE KALMA 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.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF:
•
YOU ARE ALLERGIC TO ALPRAZOLAM,
BENZODIAZEPINES OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Some of the symptoms of an
allergic reaction may include skin
rash, itching or hives, swelling of
the face, lips or tongue which
may cause difficulty in
swallowing or breathing,
wheezing or shortness of breath.
•
YOU HAVE HAD ANY OF THE
FOLLOWING:
•
SEVERE AND CHRONIC LUNG
DISE

Fitxa tècnica

AUSTRALIAN PRODUCT INFORMATION
KALMA
_alprazolam _
1 NAME OF THE MEDICINE
Active ingredient: Alprazolam
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Kalma
tablets
contain
alprazolam,
an
anti-anxiety,
benzodiazepine
derivative
chemically
and
pharmacologically related to other drugs of this class.
Each Kalma 0.25 tablet contains 0.25 mg of alprazolam; each Kalma 0.5
tablet contains 0.5 mg of alprazolam;
each Kalma 1 tablet contains 1 mg of alprazolam; each Kalma 2 tablet
contains 2 mg of alprazolam.
Kalma also contains sugars (as lactose), benzoates and sulfites.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
_KALMA 0.25:_
alprazolam 0.25 mg tablet: white, oval, marked AL

0.25 on one side, G on reverse.
_KALMA 0.5:_
alprazolam 0.5 mg tablet: pale pink, oval, marked AL

0.5 on one side, G on reverse.
_KALMA 1:_
alprazolam 1 mg tablet: pale blue, oval, marked AL

1.0 on one side, G on reverse.
_KALMA 2:_
alprazolam 2 mg tablet: approximately 9.5 mm x 9.0 mm, white, oval,
bevel edged, quadrisect tablet
marked "A" in the upper left quadrant, "L" in the upper right
quadrant, "G" in the lower left quadrant and "2"
in the lower right quadrant on one side, and plain quadrisect on the
other side..
_ _
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ANXIETY
Short-term symptomatic treatment of anxiety including treatment of
anxious patients with some symptoms of
depression.
PANIC DISORDER
The treatment of panic disorder with or without some phobic avoidance,
and for blocking or attenuation of
panic attacks and phobias in patients who have agoraphobia with panic
attacks.
The diagnostic criteria for panic disorder in DSM-III-R are as
follows:
The panic attacks (discrete periods of intense fear or discomfort), at
least initially, are unexpected. Later in the
course of this disturbance, certain situations (e.g. driving a car or
being in a crowded place) may become
associated with having a panic attack. These panic attacks are not
triggered by situations in which the person
is