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Active substance: ALPRAZOLAM

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4211247 07

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18.09.2014 D03

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Package leaflet: Information for the patient

250 microgram and 500 microgram Tablets
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’).
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,

is time for your next dose. Do not take a double dose to make up for
a missed dose.
Length of treatment
• Xanax tablets are only used for short-term treatment (not more than
12 weeks). You will not normally be given a prescription for more than
4 weeks and you will be regularly reviewed by your doctor during this
time. A decreased effect of the drug may develop if used for more
than a few weeks.
If you stop taking Xanax
Always see your doctor before you stop taking Xanax tablets as the dose
needs to be reduced gradually. If you stop taking the tablets or reduce
the dose suddenly you can get ‘rebound’ effects which might cause
you to become temporarily more anxious or restless or to have difficulty
sleeping. These symptoms will go away as your body re-adjusts. If you
are worried, your doctor can tell you more about this.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.
4. Possible side effects
Like all medicines this medicine can cause side effects although not
everyone gets them, and if you do get them they may differ in intensity
for different people.
Reasons for stopping Xanax treatment immediately
If you get any of these symptoms see your doctor straight away as
treatment will need to be discontinued. Your doctor will then advise
how treatment will be stopped.
• Very occasionally treatment with Xanax can cause serious behavioural or
psychiatric effects - for example agitation, restlessness, aggressiveness,
irritability, violent anger, false beliefs, nightmares and hallucinations or
other inappropriate behaviour.
• Sudden wheeziness, difficulty in swallowing or breathing, swelling of
eyelids, face or lips, rash or itching (especially affecting the whole body).
Reasons for seeing your doctor straight away
Tell your doctor straight away if you get the following symptoms as your
dose or treatment might need to be changed:
• Memory loss (amnesia)
• Yellowing of the skin and whites of the eyes (jaundice).

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Pfizer Italia S.r.l.

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.
• If you are pregnant, think you might be pregnant now, are planning to
become pregnant or if you are breast-feeding (see also the sections
on ‘Pregnancy’ and ‘Breast-feeding’ for more information).
Warnings and precautions
Talk to your doctor or pharmacist before taking Xanax if you:
• have ever felt so depressed that you have thought about taking your
own life.
• have ever suffered any mental illness that required hospital treatment.
• have problems with your lungs, kidneys or liver.
• have abused drugs or alcohol in the past or find it difficult to stop taking
medicines, drinking or taking drugs. Your doctor may want to give you
special help when you need to stop taking these tablets.
• have been prescribed medicines for severe anxiety before, because
your body can quickly become used to this type of medicine so that
it no longer helps you.
Children and adolescents
Alprazolam is not recommended for children and adolescents under the
age of 18 years.
Other medicines and Xanax
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines, especially medicines listed below, as
the effect of Xanax or the other medicine may change when taken at
the same time:
• any other medicines to treat anxiety or depression or to help you sleep
(e.g. nefazodone, fluvoxamine, fluoxetine).
• some strong pain killers (e.g. morphine, codeine or propoxyphene).
• antipsychotic medicines used to treat mental illnesses like schizophrenia.
• medicines to treat epilepsy.
• antihistamines for relief of allergies.
• medicines for treating fungal infections (e.g. ketoconazole).

Dependence and withdrawal symptoms
• It is possible to become dependent on medicines like Xanax while you
are taking them which increases the likelihood of getting withdrawal
symptoms when you stop treatment.
• Withdrawal symptoms are more common if you:
- stop treatment suddenly
- have been taking high doses
- have been taking this medicine for long time
- have a history of alcohol or drug abuse.
This can cause effects such as headaches, muscle pain, extreme anxiety,
tension, restlessness, confusion, mood changes, difficulty sleeping and
In severe cases of withdrawal you can also get the following symptoms:
nausea (feeling sick), vomiting, sweating, stomach cramps, muscle cramps,
a feeling of unreality or detachment, being unusually sensitive to sound,
light or physical contact, numbness and tingling of the feet and hands,
hallucinations (seeing or hearing things which are not there while you
are awake), tremor or epileptic fits.
Other side effects that may occur are:
Very common: may affect more than 1 in 10 people
• Sleepiness and drowsiness
Common: may affect up to 1 in 10 people
• Loss of appetite
• Confusion and disorientation
• Depression
• Changes in your sex drive (men and women)
• Jerky, uncoordinated movements
• Problems with balance, and unsteadiness (similar to feeling drunk)
especially during the day
• Inability to remember bits of information
• Slurred speech
• Loss of alertness or concentration
• Inability to stay awake, feeling sluggish
• Dizziness, light-headedness
• Headaches
• Double or blurred vision
• Constipation, dry mouth, feeling sick
• Tiredness
• Irritability









• oral contraceptives (‘the pill’).
• certain antibiotics (e.g. erythromycin).
• cimetidine (for treating stomach ulcers).
• diltiazem (used for angina and high blood pressure).
• digoxin (used to treat various heart conditions).
• ritonavir or other similar medicines used for treating HIV.
If you are going to have an operation where you will be given a general
anaesthetic, tell your doctor or anaesthetist that you are taking Xanax.
Taking Xanax with food, drink and alcohol
It is important not to drink any alcohol while you are taking Xanax, as
alcohol increases the effects of the medicine.
If you are pregnant, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine,
because Xanax may be harmful to the developing baby.
Do not breast-feed while taking Xanax, as the drug may pass into breast milk.
Driving and using machines
Xanax can make you feel sleepy or woozy and make you lose concentration
so it is very important you do not operate machinery until you know how
the tablets affect you.
Xanax can affect your ability to drive as it may make you sleepy or dizzy.
• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
o The medicine has been prescribed to treat a medical or dental problem
o You have taken it according to the instructions given by the prescriber
or in the information provided with the medicine and
o It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe
for you to drive while taking this medicine.
Xanax contains lactose monohydrate
Xanax contains an ingredient known as lactose monohydrate which is
a type of sugar. If you have been told by your doctor that you have

Uncommon: may affect up to 1 in 100 people
• Nervousness or feeling anxious or agitated
• Insomnia (inability to sleep or disturbed sleep)
• Shakiness or trembling
• In women, irregular periods or production of too much prolactin (the
hormone that stimulates milk production)
• Muscle spasms or weakness
• Change in your weight
• Feeling elated or over-excited, which causes unusual behaviour
• Hallucination (seeing or hearing things that do not exist)
• Feeling hostile and angry
• Abnormal thoughts
• Twisting or jerking movements
• Being hyperactive
• Stomach upsets
• Problems with liver function (this shows up in blood tests), inflammation
of the liver (hepatitis)
• Skin reactions
• Difficulty urinating or bladder control problems
• Increased pressure in the eyes, which can also affect your vision
Not known: frequency cannot be estimated from available data
• Imbalance to part of nervous system. Symptoms may include: fast heart
beat and unstable blood pressure (feeling dizzy, light-headed or faint)
• Serious allergic reaction which causes swelling of the face or throat
• Swelling of the ankles, feet or fingers
• Skin reaction caused by sensitivity to sunlight
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Xanax
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
carton and blister strip after ‘Use before’. The expiry date refers to the
last day of that month.
Do not store your tablets above 25°C. Keep the blister or bottle in the

an intolerance to some sugars contact your doctor before taking this
medicinal product
3. How to take Xanax
Always take this medicine exactly as your doctor has told you. Check
with your doctor or pharmacist if you are not sure. Your doctor will tell
you how many tablets to take and when to take them. This information
is also on the label of the carton the tablets come in.
Do not take your tablets with an alcoholic drink.
You will usually start by taking one 250 microgram or one 500 microgram
tablet three times a day. This gives a total dose of 750 micrograms to
1500 micrograms each day.
If clinically required your doctor may increase your medicine in small
increments.Where the dose does need to be increased, it is usual to
increase the night time dose first, before the daytime doses to make
sure you are more alert during the day. If you start to get side effects the
doctor may lower your dose.
The elderly
If you are an older patient or you have for example kidney or liver problems
and you need a lower dose you will normally start on a dose of 250
micrograms two or three times a day. This dose may be slowly increased
if needed and if you do not get any side effects.
Use in children and adolescents
Alprazolam is not recommended for children and adolescents under the
age of 18 years.
If you take more Xanax than you should
It is important that you do not take more tablets than you are told to. If you
do accidentally take too many tablets you may experience drowsiness,
confusion, feeling cold, slurred speech, drop in blood pressure and difficulty
breathing. If you do accidentally take too many tablets, seek medical
attention straight away.
If you forget to take Xanax
If you forget to take a dose, take it as soon as you remember unless it

outer carton.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.
6. Contents of the pack and other information
What Xanax contains
The active ingredient is alprazolam.
Each Xanax 250 microgram tablet contains 250 micrograms of the active
ingredient alprazolam.
Each Xanax 500 microgram tablet contains 500 micrograms of the active
ingredient alprazolam.
The other ingredients are: lactose monohydrate, microcrystalline cellulose,
colloidal anhydrous silica, maize starch, magnesium stearate and docusate
sodium with sodium benzoate. The 500 microgram tablets also contain
the colour erythrosine sodium aluminium lake.
What Xanax looks like and contents of the pack
Xanax 250 microgram tablets are white, oval, biconvex tablets scored
on one side and marked ‘Upjohn 29’ on the other. Xanax 500 microgram
tablets are pink, oval, biconvex tablets scored on one side and marked
‘Upjohn 55’ on the other. They are available in blister packs of 60 tablets
or bottles containing 100 or 1000 tablets. Not all pack sizes may be
Marketing Authorisation Holder:
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United
Pfizer Italia S.r.l., Località Marino del Tronto, 63100 - Ascoli Piceno (AP),
Company Contact Address:
For further information on your medicine contact Medical Information at
the following address:
Pfizer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS.
Telephone 01304 616161.
This leaflet was last revised in: 09/2014
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.