Xanax 1 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Alprazolam

Available from:

Upjohn EESV

ATC code:

N05BA; N05BA12

INN (International Name):

Alprazolam

Dosage:

1 milligram(s)

Pharmaceutical form:

Tablet

Therapeutic area:

Benzodiazepine derivatives; alprazolam

Authorization status:

Marketed

Authorization date:

1982-11-01

Patient Information leaflet

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
XANAX ® 250 MICROGRAM TABLETS
XANAX
® 500 MICROGRAM TABLETS
XANAX
® 1 MG TABLETS
alprazolam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Xanax is and what it is used for
2.
What you need to know before you take Xanax
3.
How to take Xanax
4.
Possible side effects
5.
How to store Xanax
6.
Contents of the pack and other information
1.
WHAT XANAX IS AND WHAT IT IS USED FOR
Xanax contains the active ingredient alprazolam. It belongs to a group
of medicines called
benzodiazepines (anxiety-relieving medicines).
Xanax is used in adults for treatment of anxiety symptoms which are
severe, disabling or causing
the patient great distress. This medicine is for short-term use only.
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE XANAX
DO NOT TAKE XANAX:
•
If you are allergic to alprazolam or other similar benzodiazepine
medicines, or to any of
the other ingredients of this medicine (listed in section 6).
•
If you suffer from a disease called ‘myasthenia gravis’ where you
suffer from very weak
and tired muscles.
•
If you have severe chest problems or breathing difficulties (e.g.
chronic bronchitis or
emphysema).
•
If you have severe liver problems.
•
If you have ‘sleep apnoea’ - this is a condition where your
breathing becomes irregular,
even stopping for short periods, while you are asleep.
Page 2 of 8
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before

Summary of Product characteristics

Health Products Regulatory Authority
20 April 2023
CRN00DF1X
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xanax 1 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg alprazolam
Excipient(s) with known effect:
Each tablet contains 96 mg lactose monohydrate.
Each tablet contains 0.11 mg sodium benzoate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Lavender, oval, biconvex tablets scored on one side and marked
‘Upjohn 90’ on the other.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Anxiety_
Xanax is indicated for short-term symptomatic treatment of anxiety in
adults. Xanax is only indicated when the disorder is
severe, disabling or subjecting the individual to extreme distress.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Duration of treatment_
Xanax should be used in the lowest possible effective dose, for the
shortest possible time and for a maximum of 2-4 weeks.
The need for continued treatment should be reassessed frequently.
Long-term treatment is not recommended. The risk of
dependence may increase with dose and duration of treatment (see
section 4.4).
It is usual to commence with a dose of 500 micrograms to 1 mg daily in
divided doses, with increments (no greater than 1 mg
every 3-4 days), to the level of optimal control usually 3 to 4 mg
daily.
The dose must be gradually reduced to avoid withdrawal symptoms.
_Elderly_
In the elderly or debilitated patient a regimen of 250 micrograms
twice daily should be used initially with gradual increments if
required and tolerance is assured.
_Paediatric population_
Safety and efficacy of alprazolam have not been established in
children and adolescents below the age of 18 years; therefore
use of alprazolam is not recommended.
_Method of administration_
For oral use.
Treatment should be started with the lower recommended dose. The
maximum dose should not