XANAGIS 1 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ALPRAZOLAM

Available from:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

ATC code:

N05BA12

Pharmaceutical form:

TABLETS

Composition:

ALPRAZOLAM 1 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

Therapeutic group:

ALPRAZOLAM

Therapeutic area:

ALPRAZOLAM

Therapeutic indications:

Treatment of anxiety accompanied by depression. Treatment of panic states with or without accompanying phobia.

Authorization date:

2014-04-30

Patient Information leaflet

PATIENT PACKAGE INSERT ACCORDING TO
PHARMACISTS’ REGULATIONS )PREPARATIONS(-1986
This medicine can be sold with a physician’s prescription
only
XANAGIS 0.25 MG
TABLETS
XANAGIS 0.5 MG
TABLETS
XANAGIS 1 MG
TABLETS
Each tablet contains:
Alprazolam 0.25 mg
Alprazolam 0.5 mg
Alprazolam 1 mg
Inactive
ingredients
and
allergens:
See
in
section
6
"
ADDITIONAL
INFORMATION”
and
in
section
2
"
IMPORTANT
INFORMATION
ABOUT
SOME
OF
THE
INGREDIENTS
OF
THIS
MEDICINE
"
.
READ
THIS
ENTIRE
LEAFLET
CAREFULLY
BEFORE
USING
THIS
MEDICINE. This leaflet contains concise information about
the medicine. If you have any further questions, refer to the
doctor or pharmacist.
This medicine has been prescribed for the treatment of your
illness. Do not pass it on to others. It might harm them, even
if you think that their medical condition is similar.
WHAT IS THE MOST IMPORTANT INFORMATION I NEED TO KNOW
ABOUT THE MEDICINE?
TAKING THIS MEDICINE WITH MEDICINES FROM THE OPIOID
FAMILY,
OTHER
CENTRAL
NERVOUS
SYSTEM
DEPRESSANTS
)INCLUDING DRUGS( OR ALCOHOL MAY CAUSE A SENSE OF
DEEP
DROWSINESS,
BREATHING
DIFFICULTY
)RESPIRATORY
DEPRESSION(, COMA AND DEATH.
Introduction to the benzodiazepines patient leaflet
This medicine belongs to the benzodiazepines group, which
has special characteristics necessitating great caution with
its use.
• Close medical monitoring is very important when taking this
medicine.
• When you take this medicine, be sure to refer to the doctor after
2-4 weeks, as the treatment is meant for short periods only.
• Prolonged use of the medicine may cause the medicine’s
effect to decrease.
• Prolonged use may cause severe dependence, which will
make it difficult for the patient to stop taking the medicine.
• Uncontrolled discontinuation of treatment may be accompanied by
withdrawal symptoms, such as: tension, nervousness, confusion,
tremor, insomnia, abdominal pain, vomiting, nausea, sweating,
spasms, muscle cramps and pain.
• Sometimes,
prolonged
use
of
the
medicine
may
cause
changes in behavior patterns and obsessi

Summary of Product characteristics

NAME OF THE MEDICINAL PRODUCT
Xanagis 0.25 mg
Xanagis 0.5 mg
Xanagis 1 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
tablet of Xanagis 0.25 mg contains 0.25 mg of alprazolam.
Each tablet of Xanagis 0.5 mg contains 0.5 mg of alprazolam.
Each tablet of Xanagis 1 mg contains 1 mg of alprazolam
PHARMACEUTICAL FORM
Tablets
INDICATIONS AND USAGE
•
Treatment
of anxiety
accompanied by depression
.
•
Treatment
of panic
states
with or without
accompanying phobia
.
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE,
AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS
•
Concomitant use of benzodiazepines and opioids may result in profound
sedation, respiratory
depression, coma, and death.
•
Reserve concomitant prescribing of these drugs for patients for whom
alternative treatment options are
inadequate. Limit dosages and durations to the minimum required.
•
Follow patients for signs and symptoms of respiratory depression and
sedation (see WARNINGS
AND PRECAUTIONS).
•
The use of benzodiazepines, including
XANAGIS
, exposes users to risks of abuse, misuse, and
addiction, which can lead to overdose or death. Abuse and misuse of
benzodiazepines commonly
involve concomitant use of other medications, alcohol, and/or illicit
substances, which is associated
with an increased frequency of serious adverse outcomes. Before
prescribing
XANAGIS
and
throughout treatment, assess each patient’s risk for abuse, misuse,
and addiction (see WARNINGS
AND PRECAUTIONS).
•
The continued use of benzodiazepines, including
XANAGIS
, may lead to clinically significant
physical dependence. The risks of dependence and withdrawal increase
with longer treatment duration
and higher daily dose. Abrupt discontinuation or rapid dosage
reduction of
XANAGIS
after continued
use may precipitate acute withdrawal reactions, which can be
life-threatening. To reduce the risk of
withdrawal reactions, use a gradual taper to discontinue
XANAGIS
or reduce the dosage (see
DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS).
DESCRIPTIO