XANAX TABLETS 250 MICROGRAMS
Active substance: ALPRAZOLAM
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaet carefully before you start taking this medicine because it contains important information for you. Keep this leaet. 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 leaet. What is in this leaet: 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, 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 difculties (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 nd it difcult 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, uvoxamine, uoxetine). 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). 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. 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 if you think you may be pregnant. Breast-feeding 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 its 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 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.
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 (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 rst, 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 dont 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 difculty 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. 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.
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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 difculty 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, difculty 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.
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, difculty 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 ts. 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
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), inammation of the liver (hepatitis) Skin reactions Difculty 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 ngers If you experience any of the above side effects or if you notice any side effects not listed in this leaet, 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 25C 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.
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. 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 Kingdom. Manufacturer: Pzer Italia S.r.l., Localit Marino del Tronto, 63100 - Ascoli Piceno (AP), Italy. Company contact address: For further information on your medicine contact Medical Information at the following address: Pzer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS. Telephone 01304 616161. This leaet was last revised in: 06/2012 Ref: XX 8_1
4211247.04.9
Read all of this leaet carefully before you start taking this medicine because it contains important information for you. Keep this leaet. 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 leaet. What is in this leaet: 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, 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 difculties (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 nd it difcult 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, uvoxamine, uoxetine). 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). 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. 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 if you think you may be pregnant. Breast-feeding 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 its 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 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.
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 (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 rst, 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 dont 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 difculty 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. 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.
4211247.04.9
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 difculty 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, difculty 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.
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, difculty 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 ts. 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
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), inammation of the liver (hepatitis) Skin reactions Difculty 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 ngers If you experience any of the above side effects or if you notice any side effects not listed in this leaet, 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 25C 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.
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. 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 Kingdom. Manufacturer: Pzer Italia S.r.l., Localit Marino del Tronto, 63100 - Ascoli Piceno (AP), Italy. Company contact address: For further information on your medicine contact Medical Information at the following address: Pzer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS. Telephone 01304 616161. This leaet 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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
