XANAX X.R. 0.5 MG
Country: Israel
Language: English
Source: Ministry of Health
Patient Information leaflet
(PIL)
22-02-2022
Summary of Product characteristics
(SPC)
05-06-2023
Public Assessment Report
(PAR)
18-08-2016
Active ingredient:
ALPRAZOLAM
Available from:
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
ATC code:
N05BA12
Pharmaceutical form:
TABLETS SUSTAINED RELEASE
Composition:
ALPRAZOLAM 0.5 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
PFIZER ITALIA S.R.L, ITALY
Therapeutic group:
ALPRAZOLAM
Therapeutic area:
ALPRAZOLAM
Therapeutic indications:
For the treatment of anxiety and anxiety associated with depression.Treatment of panic disorder with or without phobic avoidance
Authorization date:
2013-04-30
Patient Information leaflet
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
XANAX
® XR 0.5 MG
XANAX
® XR 1 MG
XANAX
® XR 2 MG
SUSTAINED-RELEASE TABLETS
ACTIVE INGREDIENT AND ITS QUANTITY:
Each sustained-release tablet contains:
ALPRAZOLAM 0.5 MG, 1 MG, 2 MG
For
a
list
of
inactive
ingredients
and
allergens,
see
section 2 under ‘Important information about some of this
medicine’s ingredients’ and section 6 ‘Further information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS
MEDICINE. This leaflet contains concise information about
this medicine. If you have any further questions, consult
your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass
it on to others. It may harm them, even if it seems to you
that their medical condition is similar to yours.
XANAX
® XR IS A PSYCHOTROPIC MEDICATION CONTAINING
ALPRAZOLAM, THAT CAN BE ABUSED OR LEAD TO DEPENDENCE.
INFORM YOUR DOCTOR IF YOU CURRENTLY ABUSE OR HAVE
PREVIOUSLY ABUSED OR DEVELOPED A DEPENDENCE ON
ALCOHOL,
PRESCRIPTION
MEDICINES
OR
DRUGS.
GIVING
AWAY OR SELLING THE MEDICINE MAY HARM OTHERS AND
IS AGAINST THE LAW. KEEP THE MEDICINE IN A SAFE PLACE
AND AWAY FROM CHILDREN.
WHAT IS IMPORTANT TO KNOW ABOUT XANAX
® XR?
THIS
MEDICINE
BELONGS
TO
THE
BENZODIAZEPINE
GROUP, which has special characteristics that require
extra caution when using it.
TAKING THIS MEDICINE WITH MEDICINES OF THE OPIOID
GROUP, ALCOHOL, OR OTHER CENTRAL NERVOUS SYSTEM
DEPRESSANTS
(INCLUDING
STREET
DRUGS)
CAN
CAUSE
SEVERE DROWSINESS, BREATHING PROBLEMS (RESPIRATORY
DEPRESSION), COMA AND DEATH. Get emergency help
right away if any of the following happens:
shallow or slowed breathing
breathing stops (may lead to the heart stopping)
excessive sleepiness (sedation)
Do not drive or operate dangerous machines until you
know how this medicine affects you.
RISK OF ABUSE, MISUSE AND ADDICTION. There is a risk of
abuse, misuse and addiction with use of benzodiazepines,
including Xanax
®
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Summary of Product characteristics
Xanax XR LPD CC 300323
FULL PRESCRIBING INFORMATION
1. DOSAGE FORMS AND STRENGTHS
XANAX
®
XR 0.5 mg
XANAX
®
XR 1 mg
XANAX
®
XR 2 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient is Alprazolam.
For the full list of excipients, see section 11, DESCRIPTION.
Excipient with known effect
Each tablet XANAX
®
XR 0.5 mg, 1 mg & 2 mg contains 221.7 mg lactose
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 _[_SEE _WARNINGS,
DRUG _
_INTERACTIONS]_. 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 (5.1), DRUG INTERACTIONS (7.1)]_.
•
.
THE USE OF BENZODIAZEPINES, INCLUDING XANAX XR, 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
XANAX
XR AND THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK FOR ABUSE,
MISUSE, AND
ADDICTION _[SEE WARNINGS AND PRECAUTIONS (5.2)]._
•
THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING XANAX XR, 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 XANAX XR 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 XANAX XR OR REDUCE THE DOSAGE _[SEE DOSAGE AND _
_ADMINISTRATION (3.2), WARNINGS AND PRECAUTIONS (5.3)]._
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