Xanax® Tablets

Alprazolam

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Xanax. It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Xanax against the benefits this medicine is expected to have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with your medicine. You may need to read it again.

What Xanax is used for

Xanax is used to treat anxiety. Anxiety or tension associated with the normal stress of everyday life usually does not require treatment with medicines.

Xanax is also used to treat panic attacks.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed Xanax for another purpose.

Xanax belongs to a group of medicines called benzodiazepines. They are thought to work by their action on brain chemicals.

If you take Xanax for too long, it may become habit-forming. Benzodiazepines may lead to physical or psychological dependence. If you have any concerns, you should discuss this with your doctor.

This medicine is available only with a doctor's prescription.

Before you take Xanax

When you must not take it

Do not take Xanax if you have an allergy to:

• any medicine containing alprazolam
• any of the ingredients listed at the end of this leaflet
• any other medicine in the benzodiazepine group

Some of the symptoms of an allergic reaction may include:

• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives on the skin.

Do not take Xanax if you have or have had any of the following medical conditions:

• myasthenia gravis which causes severe muscle weakness
• severe and chronic lung disease.

Do not take this medicine if you are pregnant. It may affect your developing baby if you take it during pregnancy

Do not breastfeed if you are taking this medicine. The active ingredient in Xanax passes into breast milk, and there is a possibility that your baby may be affected, e.g. your baby may become drowsy or experience feeding difficulties.

Do not give this medicine to a child unless advised by the child's doctor. The safety and effectiveness of Xanax in children have not been established.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

• depression, psychosis or schizophrenia
• fits or convulsions
• liver, kidney or lung disease
• glaucoma (high pressure in the eye)
• low blood pressure.

Tell your doctor if you are pregnant or planning to become pregnant or are breastfeeding. Your doctor can discuss with you the risks and benefits involved.

Tell your doctor if you have a history of alcohol or drug abuse, or find it difficult to stop taking medicines, drugs or drinking alcohol. Your doctor may want to give you extra support when you need to stop taking Xanax.

If you have not told your doctor about any of the above, tell him/her before you start taking Xanax.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including:

• all prescription medicines
• all medicines, vitamins, herbal supplements or natural therapies you buy without a prescription from a pharmacy, supermarket, naturopath or health food shop.

Some medicines may be affected by Xanax or may affect how well Xanax works. You may need different amounts of your medicines, or you may need to take different medicines. Your doctor will advise you.

Tell your doctor or pharmacist if you are taking any of the following:

• sleeping tablets
• sedatives (medicines used to produce calmness) or tranquilisers
• medicines for depression
• medicines for allergies, such as hay fever, e.g. antihistamines or cold tablets
• pain relievers, especially strong pain relievers e.g. containing codeine or opioids (codeine-like medicines)
• medicines to relax muscles
• medicines to control fits or seizures
• medicines used to treat certain mental and emotional conditions
• cimetidine (a medicine used to treat reflux and ulcers)
• disulfiram (a medicine used to treat alcoholism)
• antibiotics, such as erythromycin
• medicines used to treat fungal infections, such as ketoconazole and itraconazole
• oral contraceptives (birth control pill)
• medicines used to treat HIV infection
• medicines used to treat high blood pressure
• lithium (a medicine used to treat mood swings and some types of depression).

Your doctor or pharmacist has more information on medicines to be careful of while taking Xanax.

How to take Xanax

How much to take

Follow all directions given to you by your doctor or pharmacist carefully. The dose of Xanax may be different for each person. Your doctor will decide the right dose for you.

If you do not understand the instructions on the label, ask your doctor or pharmacist for help.

How to take it

Swallow the tablets with a full glass of water.

When to take it

Take your tablets at about the same time each day. Your doctor will tell you how many times a day you should take your medicine, but taking it at the same time each day will have the best effect. It will also help you remember to take it.

Take Xanax immediately after food.

Side effects such as sleepiness or drowsiness may be reduced if you take it immediately after meals.

How long to take it

Do not take Xanax for longer than your doctor prescribes it. Usually Xanax should be used for short periods only (for example, 2-4 weeks).

Continuous long term use is not recommended unless advised by your doctor. The use of benzodiazepines may lead to dependence on the medicine.

Continue taking Xanax for as long as your doctor recommends and always see your doctor before you stop taking it. Your dose will need to be reduced gradually to prevent unwanted side effects.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for the dose that you missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Xanax.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Tell the doctor, nurse or pharmacist about any alcohol or other medicines which you have taken.

Symptoms of an overdose may include:

• drowsiness
• confusion
• tiredness
• dizziness
• difficulty breathing
• feeling week
• unconsciousness.

While you are taking Xanax

Things you must do

Take Xanax exactly as your doctor has prescribed.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Xanax.

Tell all doctors, dentists and pharmacists who are treating you that you are taking Xanax.

If you are going to have an operation, tell your doctor or anaesthetist that you are taking Xanax. It may affect other medicines used during surgery.

If you become pregnant while you are taking this medicine, tell your doctor.

If you are about to have any blood tests, tell your doctor that you are taking this medicine.

Tell your doctor if, for any reason, you have not taken Xanax exactly as prescribed. Otherwise your doctor may think that it was not effective and change your treatment unnecessarily.

Tell your doctor if you feel that Xanax is not helping your condition, or appears to have stopped helping your condition.

Visit your doctor regularly. Your doctor needs to check your progress and see whether you need to keep taking Xanax.

Always discuss with your doctor any problems or difficulties during or after taking Xanax. If you are being treated for anxiety, be sure to tell your doctor how you feel, especially if your anxiety attacks are getting worse or more frequent.

This will help your doctor to determine the best treatment for you.

Do not run out of your medicine. It is important that you take your medicine regularly.

Things you must not do

Do not take Xanax to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not drive or operate machinery until you know how Xanax affects you. Xanax may cause drowsiness or dizziness in some people and therefore may affect alertness.
Make sure you know how you react to Xanax before you drive a car, operate machinery, or do anything else that could be dangerous if you are drowsy, dizzy or not alert.
Even if you take Xanax at night, you may still be drowsy or dizzy the next day.

Do not take your medicine for a longer time than your doctor has prescribed. Xanax should be taken for short periods only (for example 2 to 4 weeks), unless advised otherwise by your doctor.

Do not increase your dose of Xanax, without first checking with your doctor. If your symptoms have returned even though you are taking the same dose, you should speak to your doctor, who will determine whether a dose adjustment is required.

Do not stop taking Xanax or lower the dose, without first checking with your doctor, especially if you suffer from epilepsy. Stopping this medicine suddenly may cause some unwanted effects. You and your doctor will slowly reduce your dose of Xanax before you can stop taking it completely.
Stopping this medicine suddenly may make your epilepsy worse.

Things to be careful of

Be careful when drinking alcohol while you are taking this medicine.

If you drink alcohol, symptoms such as sleepiness, dizziness or lightheadedness may be worse.

Your doctor may suggest that you avoid alcohol or reduce the amount of alcohol you drink while you are taking Xanax.

Be careful if you are elderly, unwell or taking other medicines.

You may be more likely to experience side effects such as drowsiness, confusion, dizziness and unsteadiness, which may increase the risk of a fall.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Xanax.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some side effects.

It can be difficult to tell whether side effects are the result of taking Xanax, effects of your condition or side effects of other medicines you may be taking. For this reason it is important to tell your doctor of any change in your condition.

If you are over 65 years, you may have an increased chance of getting side effects.

Do not be alarmed by the list of side effects.

You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if...

Tell your doctor or pharmacist if you notice any of the following and they worry you:

• drowsiness, tiredness
• dizziness, lightheadedness
• clumsiness, unsteadiness
• slurred speech
• loss of appetite
• gastrointestinal problems
  - nausea (feeling sick)
  - constipation
  - dry mouth
• change in sex drive
• headache
• blurred vision.

The above list includes the more common side effects of your medicine. They are usually mild and do not last very long.

Tell your doctor as soon as possible if...

Tell your doctor as soon as possible if you notice any of the following:

• loss of alertness or concentration, memory loss
• nervousness or feeling anxious
• shakiness or tremor, muscle weakness
• swelling of hands, ankles or feet
• yellowing of the skin and whites of the eyes.

The above list includes serious side effects that may require medical attention. Serious side effects are not common.

Go to hospital if...

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital, if you notice any of the following:

• aggressive behaviour, hostility, agitation, violent anger, hallucinations
• sudden onset of wheezing, difficulty swallowing, swelling of the face, lips or tongue, rash or itching of the skin.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.

Other side effects not listed above may also occur in some people.

After taking Xanax

Storage

Keep your tablets in their blister pack or bottle until it is time to take them. If you take the tablets out of the blister pack or bottle they may not keep well.

Keep your tablets in a cool dry place, protected from light, where the temperature stays below 30°C (for the bottle) and below 25°C (for the blister pack).

Do not store Xanax, or any other medicines, in a bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

Xanax tablets are available in 4 strengths:

• Xanax 250 microgram tablets are white, scored, oval-shaped tablets marked "Upjohn 29". They are available blister packs of 50 tablets.
• Xanax 500 microgram tablets are pink, scored, oval-shaped tablets marked "Upjohn 55". They are available in blister packs of 50 tablets.
• Xanax 1 mg tablets are lilac, scored, oval-shaped tablets marked "Upjohn 90". They are available in blister packs of 50 tablets.
• Xanax 2 mg tablets are white, tri-scored, capsule-shaped tablets marked with "U" and "94" on one side. They are available in bottles of 50 tablets.

Ingredients

Xanax tablets contain alprazolam as the active ingredient.

It also contains:

• lactose
• microcrystalline cellulose
• colloidal silica anhydrous
• maize starch
• docusate sodium with sodium benzoate
• magnesium stearate
• erythrosine CI 45430 (500 microgram and 1 mg tablet only)
• indigo carmine CI 73015 (1 mg tablet only).

Supplier

Xanax is supplied in Australia by:
Pfizer Australia Pty Ltd
ABN 50 008 422 348
38-42 Wharf Road
West Ryde NSW 2114
Australia
Toll Free number: 1800 675 229

Australian registration numbers

• 250 microgram tablet: AUST R 62558
• 500 microgram tablet: AUST R 12352
• 1 mg tablet: AUST R 12353
• 2 mg tablet: AUST R 53931

Date of preparation

This leaflet was prepared in July 2011.

® = Registered Trademark
© Pfizer Australia Pty Ltd

Published by MIMS/myDr November 2011

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