Xanax Tablets 500 micrograms

• 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.

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

• 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 bronchitis or emphysema).
• 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 have severe liver problems.
• 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).

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. There have been reports of death when Xanax is abused with alcohol, prescription medicines or street drugs.
• 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.

Benzodiazepines and related products should be used with caution in elderly, due to the risk of sedation and / or musculoskeletal weakness that can promote falls, often with serious consequences in this population.

Do not give this medicine to children and adolescents below the age of 18 years because safety and efficacy have not been established.

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. opioids such as - 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).
• 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.

Concomitant use of Xanax and opioids (strong pain killers, medicines for substitution therapy and some cough medicines) increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However if your doctor does prescribe Xanax together with opioids the dosage and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all opioid medicines you are taking, and follow your doctor’s dosage recommendation closely. It could be helpful to inform friends or relatives to be aware of sign and symptoms stated above. Contact your doctor when experiencing such symptoms.

It is important not to drink any alcohol while you are taking Xanax, as alcohol increases the effects of the medicine. Please refer to section 3.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

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:
  • The medicine has been prescribed to treat a medical or dental problem and
  • You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
  • 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.

Lactose - If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Sodium Benzoate – this medicine contains 0.11mg Sodium Benzoate in each tablet.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

For oral use.

The risk of dependency and abuse may increase with the dose and duration of treatment. The doctor will therefore prescribe the lowest effective dose and treatment duration possible, and frequently reassess the need for continued treatment (see section 2 - Warnings and precautions).

The maximum duration of treatment should not be more than 2-4 weeks. Long-term treatment is not recommended.

Your doctor will prescribe the lowest possible effective dose and duration, and will reassess the need for your continued treatment frequently. A decreased effect of the drug may develop if used for more than a few weeks.

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 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.

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.

Your doctor will therefore reduce the dose gradually when the treatment is ended. Dose reduction is done according to individual needs, since gradual discontinuation depends on several factors (e.g. treatment duration and your daily dose). Ask your doctor about how to reduce your dose gradually.

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).

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).

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 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.

Xanax Tablets should only be used by those they are prescribed for. Do not give your medicine to anyone else. Overuse and abuse can lead to overdose and/or death.

Very common: may affect more than 1 in 10 people

• Depression
• Sleepiness and drowsiness
• Jerky, uncoordinated movements
• Inability to remember bits of information
• Slurred speech
• Dizziness, light-headedness
• Headaches
• Constipation
• Dry mouth
• Tiredness
• Irritability

Common: may affect up to 1 in 10 people

• Loss of appetite
• Confusion and disorientation
• Increased sex drive (men and women) and erectile dysfunction
• Nervousness or feeling anxious or agitated
• Insomnia (inability to sleep or disturbed sleep)
• Problems with balance, and unsteadiness (similar to feeling drunk) especially during the day
• Loss of alertness or concentration
• Inability to stay awake, feeling sluggish
• Shakiness or trembling
• Double or blurred vision
• Feeling sick
• Skin reactions
• Change in your weight

Uncommon: may affect up to 1 in 100 people

• Feeling elated or over-excited, which causes unusual behaviour
• Hallucination (seeing or hearing things that do not exist)
• Feeling agitated or angry
• Incontinence
• Cramping pain in the lower back and thighs, which may indicate menstrual disorder
• Muscle spasms or weakness
• Drug addiction
• Drug withdrawal symptoms

Not known: frequency cannot be estimated from available data

• In women, irregular periods or production of too much prolactin (the hormone that stimulates milk production)
• Feeling hostile or aggressive
• 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)
• 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
• Difficulty urinating or bladder control problems
• Increased pressure in the eyes, which can also affect your vision
• Drug abuse

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

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 (section 2 Xanax contains lactose), microcrystalline cellulose, colloidal anhydrous silica, maize starch, magnesium stearate and docusate sodium with sodium benzoate (E 211). The 500 microgram tablets also contain the colour erythrosine sodium aluminium lake.

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 marketed.

Marketing Authorisation Holder:

United Kingdom

Manufacturer: