Xanax 250microgram tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Alprazolam

Available from:

Viatris UK Healthcare Ltd

ATC code:

N05BA12

INN (International Name):

Alprazolam

Dosage:

250microgram

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

Schedule 4 (CD Benz)

Prescription type:

Invalid to prescribe in NHS primary care

Product summary:

BNF: 04010200; GTIN: 5013457027228

Patient Information leaflet

Page 1 of 7
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 breathing difficulties (e.g.
chronic b

Summary of Product characteristics

OBJECT 1
XANAX TABLETS 250 MICROGRAMS
Summary of Product Characteristics Updated 09-May-2018 | Pfizer
Limited
1. Name of the medicinal product
Xanax 250 microgram Tablets
2. Qualitative and quantitative composition
Each tablet contains 250 micrograms alprazolam.
Excipient(s) with known effect:
Lactose, 91.1 mg per tablet.
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
_Anxiety_
250 micrograms (0.25 mg) to 500 micrograms (0.5 mg) three times daily,
increasing if required to a total
of 3 mg daily.
_The elderly or in the presence of debilitating disease_
250 micrograms (0.25 mg) two to three times daily to be gradually
increased if needed and tolerated.
If side-effects occur, the dose should be lowered. It is advisable to
review treatment regularly and to
discontinue use as soon as possible. Should longer term treatment be
necessary, then intermittent
treatment may be considered to minimize the risk of dependence.
_Paediatric population _
The safety and efficacy of alprazolam in children and adolescents
below the age of 18 years have not
been established. No data are available.
Method of administration
For oral use.
Treatment should be as short as possible. It is recommended that the
patient be reassessed at the end of no
longer than 4 weeks of treatment and the need for continued treatment
estab