Active substance: ALPRAZOLAM

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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.
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’).

Stopping treatment
• 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 readjusts. 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) or
• yellowing of the skin and whites of the eyes (jaundice).
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.

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 (see Section 6 ‘Further information’
for more details).
• suffer from a disease called ‘myasthenia gravis’ where you suffer from
very weak and tired muscles.
• have severe chest problems or breathing difficulties (e.g. chronic
bronchitis or emphysema).
• have severe liver problems.
• have ‘sleep apnoea’ - this is a condition where your breathing becomes
irregular, even stopping for short periods, while you are asleep.
• 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.
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 may be stronger 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.

• 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 side effects: may affect more than 1 in 10 people
• Sleepiness and drowsiness
Common side effects: 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

• antihistamines for relief of allergies.
• medicines for treating fungal infections (e.g. ketoconazole).
• oral contraceptives (‘the pill’).
• certain antibiotics (e.g. erythromycin).
• cimetidine (for treating stomach ulcers).
• diltiazem (used for angina and high blood pressure).
• 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.
Xanax may be harmful to the developing baby so you should not take
Xanax if you are pregnant or planning to become pregnant. Tell your
doctor immediately if you think you may be pregnant.
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’s very important you do not drive or operate machinery until you
know how the tablets affect you.
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
an intolerance to some sugars contact your doctor before taking this
medicinal product

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.
This may be increased gradually up to a total of 3000 micrograms (3 mg)
a day in divided doses throughout the day.
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 don’t 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
is time for your next dose. Do not take a double dose to make up for
a missed dose.

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.

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.

Uncommon side effects: 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

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, docusate
sodium and sodium benzoate. The 500 microgram tablets also contain
the colour erythrosine sodium aluminium lake.

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
If you experience any of the above side effects or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
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’.
Do not store your tablets above 25°C and keep your blister strips securely
in the 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 to protect the environment.


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.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Pharmacia 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: 06/2012
Ref: XX 8_1


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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.