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Xanax Tablets 250 micrograms & 500 micrograms

Xanax Tablets 250 micrograms and 500 micrograms

alprazolam

In this leaflet:

  • 1. What Xanax is and what it is used for
  • 2. Before you take Xanax
  • 3. How to take Xanax
  • 4. Possible side effects
  • 5. Storing Xanax
  • 6. Further information

Read all of this leaflet carefully before you start using this medicine.

It contains important information on the safe and effective use of your medicine. Keep this leaflet, you may need to read it again. If you have further questions, please ask your doctor or your pharmacist.

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’).

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).

Take special care with Xanax

Tell your doctor if you have any of these following conditions. If you :

  • have ever felt so depressed that you have thought about taking your own life.
  • have ever suffered any mental illness that requires hospital treatment.
  • are under 18 years old.
  • 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.

Taking other medicines

Tell your doctor or pharmacist if you are taking any of the following medicines, 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.
  • some strong pain killers (e.g. morphine or codeine).
  • 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).
  • 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 and drink

It is important not to drink any alcohol while you are taking Xanax, as alcohol increases the effects of the medicine.

Pregnancy

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.

Breast-feeding

Do not breast-feed while taking Xanax, as the drug may pass into breast milk.

Driving and using machinery

Xanax can make you feel sleepy or woozy and make you lose concentration and so it’s very important you do not drive or operate machinery until you know how the tablets affect you.

Important information about some of the ingredients of Xanax

Xanax contains an ingredient known as lactose 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

How to take Xanax

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. If you are not sure, check with your doctor or pharmacist.

Do not take your tablets with an alcoholic drink.

Adults

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 (3mg) 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.

Children

Xanax is not recommended for the treatment of children and teenagers.

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, 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.

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.

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 re-adjusts. If you are worried, your doctor can tell you more about this.

Possible side effects

Like all medicines Xanax 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

  • 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).
  • 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.

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.
  • Withdrawal symptoms are more common if you:
    • stop treatment suddenly
    • have been taking high doses
    • have been taking 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 irritability. 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:

Tell your doctor or pharmacist if you experience any of these side effects.

  • Loss of alertness or concentration
  • Tiredness
  • Insomnia (inability to sleep or disturbed sleep)
  • Sleepiness and unsteadiness (similar to feeling drunk) especially during the day
  • Light-headedness
  • Nervousness or feeling anxious
  • Confusion
  • Double or blurred vision
  • Increased pressure in the eyes, which can also affect your vision
  • Shakiness or trembling
  • Slurred speech
  • Stomach upsets
  • Loss of appetite or change in your weight
  • Muscle spasms or muscle weakness
  • Jerky, uncoordinated movements
  • Headaches
  • Difficulty urinating or bladder control problems
  • Dizziness
  • Skin reactions
  • Problems with liver function (this shows up in blood tests)
  • In women, irregular periods or production of too much prolactin (the hormone that stimulates milk production)
  • Changes in your sex drive (men and women)

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.

Storing Xanax

Xanax tablets should not be used after the expiry date printed on the carton and blister strip. Do not store your tablets above 25°C and keep your blister strips securely in the outer carton. As with all medicines, keep the tablets out of the sight and reach of children.

Further information

What Xanax looks like and contents of the pack

Xanax 250 microgram tablets are white oval tablets scored on one side and marked ‘Upjohn 29’ on the other. Xanax 500 microgram tablets are pink oval tablets scored on one side and marked ‘Upjohn 55’ on the other. They are available in blister packs of 60 tablets.

What Xanax contains

The active ingredient is alprazolam. In addition to the active ingredient, the tablets also contain 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.

Marketing Authorisation Holder:

Pharmacia Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom

Manufacturer:

Pharmacia Italia S.p.A.
Via del Commercio
63046, Localit? Marino del Tronto
Ascoli Pisceno (AP)
Italy

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

Leaflet last updated: June 2008.

Ref: XX 5_4





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