Xanax Tablets 250 micrograms

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ALPRAZOLAM

Available from:

Pfizer Hellas S.A.

ATC code:

N05BA12

INN (International Name):

ALPRAZOLAM

Pharmaceutical form:

TABLET

Composition:

ALPRAZOLAM 250 microgram(s)

Prescription type:

POM

Therapeutic area:

PSYCHOLEPTICS

Authorization status:

Authorised

Authorization date:

2005-10-26

Patient Information leaflet

Page 1 of 7
2015-0013890
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
XANAX
® 250 MICROGRAM AND 500 MICROGRAM 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 your pharmacist.

This medicine has been prescribed for you only. Do not pass it onto
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 is a tranquilliser containing the active ingredient alprazolam.
Alprazolam belongs
to one of a group of medicines called benzodiazepines. Benzodiazepines
affect chemical
activity in the brain to promote sleep and to reduce anxiety and
worry.

Xanax tablets are only used to treat severe anxiety and severe anxiety
associated with
depression. Xanax is not recommended for the treatment of depression.

Xanax tablets should only be used for short-term treatment of anxiety.
The overall
duration of treatment should not be more than 12 weeks including a
period where the
dose is gradually reduced (this is called dose ‘tapering’).
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

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Xanax 250 microgram Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Alprazolam 250 micrograms.
Excipient(s) with known effect:
Each tablet also contains 96 mg lactose monohydrate.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Tablet
White, oval, biconvex tablet scored on one side and marked "Upjohn 29"
on the other.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Xanax is indicated for the short-term treatment of moderate or severe
anxiety states and anxiety associated
with depression. It is only indicated when the disorder is severe,
disabling or subjecting the individual to
extreme distress.
Xanax should not be used to treat short-term mild anxiety, such as
anxiety or tension associated with the
stress of everyday life. As the efficacy of Xanax in depression and in
phobic or obsessional states has yet to
be established, specific treatment may have to be considered.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY _
Treatment should be as short as possible. It is recommended that the
patient be reassessed at the end of no
longer than 4 weeks’ treatment and the need for continued treatment
established, especially in case the patient
is symptom free. The overall duration of treatment should not be more
than 8-12 weeks, including a tapering
off process.
In certain cases extension beyond the maximum treatment period may be
necessary; if so, it should not take
place without re-evaluation of the patient’s status with special
expertise. As with all benzodiazepines,
physicians should be aware that long-term use might lead to dependence
in certain patients.
The optimum dosage of Xanax should be based upon the severity of the
symptoms and individual patient
response. The lowest dose which can control symptoms should be used.
Dosage should be reassessed at
intervals of no more than 4 weeks. The usual dosage is stated below;
in the few patients who require higher
doses, the dos