OXAZEPAM TABLETS 10MG
Active substance: OXAZEPAM
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OXAZEPAM 10 mg, 15 mg & 30 mg TABLETS
(oxazepam)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side eects gets serious, or if you notice any side eects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Oxazepam is and what it is used for. 2. Before you take Oxazepam. 3. How to take Oxazepam. 4. Possible side eects. 5. How to store Oxazepam. 6. Further information. 1. WHAT OXAZEPAM IS AND WHAT IT IS USED FOR Oxazepam belongs to a group of medicines called benzodiazepines. It is not clear exactly how this medicine works but it is thought that Oxazepam increases the actions of a naturally occurring substance called GABA, in the brain. Oxazepam is used for the shortterm (2-4 weeks) treatment of anxiety, which is severe, disabling, distressing and which may be associated with sleeplessness or with other illnesses.
stopping treatment. This may be accompanied by other reactions (see Section 3 of this leaflet under 'If you stop taking Oxazepam'). Amnesia - Oxazepam can cause memory loss. To reduce the risk you should ensure you are able to have 7-8 hours of uninterrupted sleep. Psychiatric and 'paradoxical' reactions Oxazepam can cause restlessness, agitation, irritability, aggressiveness, delusions (false beliefs), rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other behavioural disturbances. If you experience any of these symptoms Oxazepam treatment should be stopped. Taking other medicines - Tell you doctor if you are taking any of the following medicines: antidepressants, antipsychotics, sedatives (to calm you down), hypnotics (to help you sleep) or strong pain killers e.g. morphine, codeine. These medicines act in the same way as oxazepam and could make you very sleepy anaesthetics or sedative antihistamines. medicines for epilepsy e.g. barbiturates or phenytoin. These can make the side eects of oxazepam worse. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking Oxazepam with food and drink - Do not drink alcohol while you are taking Oxazepam. Alcohol may increase the sedative eects of Oxazepam and make you very sleepy.
If you are taking Oxazepam to help you sleep, the usual dose is 15-25 mg, but some patients may need up to 50 mg. The dose should be taken one hour before bedtime. If you suer from liver or kidney problems, you may be prescribed a lower dose. Children - Benzodiazepines should not be given to children without careful assessment of the need to do so; the duration of treatment must be kept to a minimum. Elderly - The recommended dose for severe anxiety is 10-20 mg three or four times daily. If you have liver or kidney problems or breathing difficulties you may be given a lower dose. If you take more Oxazepam than you should - If you take more Oxazepam than you should contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you. If you forget to take Oxazepam - If you forget to take a dose of Oxazepam take it as soon as you remember, unless it is almost time for your next dose, in which case miss out the forgotten dose completely and carry on as normal. Do not take a double dose to make up for a forgotten dose. If you stop taking Oxazepam - Do not stop taking your medicine without telling your doctor. Treatment should be gradually withdrawn as the symptoms that Oxazepam was used to treat will return with more intensity than before (rebound insomnia). Other such withdrawal symptoms could include anxiety, restlessness and mood changes, these will however disappear with time. If you have become physically dependent on Oxazepam, sudden withdrawal of treatment could lead to symptoms such as depression, anxiety, headaches, nervousness, sleeplessness, irritability, sweating or diarrhoea and occasionally confusion, convulsions or unusual behaviour. Other symptoms, such as persistent ringing in the ears, involuntary movements, tingling or numbness, convulsions, abdominal and muscle cramps and vomiting, may also occur. In more severe cases, it has also been reported hypersensitivity to light, noise and physical contact, hallucinations and epileptic seizures. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Oxazepam can cause side eects, although not everybody gets them. The following side effects happen predominantly at the start of the treatment and usually disappear with repeated administration: drowsiness during the day numbed emotions reduced alertness confusion headache dizziness feeling weak and tired double vision lack of muscle coordination (ataxia) muscle weakness. Other side effects that occur occasionally are: stomach upsets skin rashes or itching lack of sexual drive oedema (swollen hands and feet) blood problems
jaundice (yellowing of the skin and whites of the eyes) feeling unusually tired. The following side effects have also been reported: feeling over excited, nervous or irritable experiencing rage having nightmares and hallucinations (feeling or seeing things that are not there) exhibiting inappropriate behaviour feeling restless, agitated, aggressive suering from delusions (false beliefs) and psychoses. These eects may be severe and are more likely in the elderly. When these reactions occur, you should tell your doctor immediately as your doctor will need to stop your treatment. Psychological dependence may occur meaning you think you cannot ever sleep without taking Oxazepam. Use (even at therapeutic doses) may lead to physical dependence, which may result in you suering withdrawal eects and a recurrence of your problems if you suddenly stop Oxazepam treatment. If any side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE OXAZEPAM Keep your tablets out of the reach and sight of children. Do not use Oxazepam after the expiry date, which is stated on the carton after 'EXP'. The expiry date refers to the last day of that month. Store below 25C. Store your medicine in a cool dry place, away from light. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Oxazepam contains: The active substance is oxazepam. Each Oxazepam 10 mg tablet contains 10 mg of Oxazepam. Each Oxazepam 15 mg tablet contains 15 mg Oxazepam. Each Oxazepam 30 mg tablet contains 30 mg of Oxazepam. The other ingredients are lactose monohydrate, maize starch and magnesium stearate. The 10 mg tablet contains isopropyl alcohol, povidone and sodium starch glycollate. The 15 mg and 30 mg tablets also contain Quinoline Yellow and Erythrosine. What Oxazepam looks like and contents of the pack - The Oxazepam 10 mg tablet is white and marked 'OM' breakline - '10' on one side and 'G' on the other. The Oxazepam 15 mg tablet is pale yellow and marked 'OM' breakline - '15' on one side and 'G' on the other. The Oxazepam 30 mg tablet is orange and marked 'OM' - breakline '30' on one side and 'G' on the other. Oxazepam is available in blisters containing 28 tablets and bottles containing 100, 250, 500 and 1,000 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer: Generics [UK] Limited t/a Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
2. BEFORE YOU TAKE OXAZEPAM Do not take Oxazepam: if you are allergic (hypersensitive) to oxazepam or any of the other ingredients in your tablets if you have severe breathlessness or breathing difficulties if you suer from Myasthenia Gravis (a condition which causes muscles to weaken and tire easily) if you are being treated for mental illness if you suer from sleep apnoea (a condition where you stop breathing when asleep) if you have severe problems with your liver if you are pregnant, might become pregnant or are breast-feeding. Take special care with Oxazepam - You should tell your doctor before taking this medicine if: you have problems with your liver, kidneys or lungs someone close to you has recently died you have a history of alcoholism or drug abuse. The risk of dependence to Oxazepam increases in these patients and with the dose and length of treatment you have a personality disorder. Other considerations when taking Oxazepam are: Tolerance - if after a few weeks you notice that the tablets are not working as well as they did when you first started taking them, you should see your doctor, as an adjustment of your dose may be required. Dependence - when taking this type of medicine there is a risk of dependence, which increases with dose and length of treatment. There is a greater risk in patients with a history of alcohol or drug abuse. Withdrawal - treatment should be gradually withdrawn. Some patients find that their symptoms of diculty sleeping and anxiety reoccur when
Pregnancy and breast-feeding - You should not take Oxazepam if you are pregnant, planning to become pregnant or if you are breast-feeding. If you take Oxazepam late in your pregnancy or during labour your baby might have a low body temperature, floppiness, breathing and feeding diculties. If you take this medicine regularly during late pregnancy, your baby may develop withdrawal symptoms (please see the next section). Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines - Oxazepam may make you feel sleepy or aect your concentration. Do not drive or use any tools or machines if you are aected in this way and do not drink alcohol, as this will make these eects worse. Important information about some of the ingredients of Oxazepam Oxazepam contain lactose (a type of sugar). If you have been told that you have intolerance to some sugars contact your doctor before taking this medicine. 3. HOW TO TAKE OXAZEPAM Always take Oxazepam exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The number of tablets you take will depend on what you are taking the tablets for. You should not take Oxazepam for anxiety for longer than 8 to 12 weeks, including the time required for gradual reduction of your dosage. For insomnia associated with anxiety, the maximum duration of treatment is 4 weeks, including time required for gradual reduction of your dosage. Oxazepam should be gradually withdrawn as adverse eects have been observed on abrupt withdrawal. Swallow the tablets whole. Adults - If you are taking the tablets for severe anxiety the usual dose is 15-30 mg three (or four) times daily.
2406/0
Pharmacode
Pharmacode
Pharmacode
Pharmacode
This leaflet was last approved in: December 2010
10002841
2406/0
(oxazepam)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side eects gets serious, or if you notice any side eects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Oxazepam is and what it is used for. 2. Before you take Oxazepam. 3. How to take Oxazepam. 4. Possible side eects. 5. How to store Oxazepam. 6. Further information. 1. WHAT OXAZEPAM IS AND WHAT IT IS USED FOR Oxazepam belongs to a group of medicines called benzodiazepines. It is not clear exactly how this medicine works but it is thought that Oxazepam increases the actions of a naturally occurring substance called GABA, in the brain. Oxazepam is used for the shortterm (2-4 weeks) treatment of anxiety, which is severe, disabling, distressing and which may be associated with sleeplessness or with other illnesses.
stopping treatment. This may be accompanied by other reactions (see Section 3 of this leaflet under 'If you stop taking Oxazepam'). Amnesia - Oxazepam can cause memory loss. To reduce the risk you should ensure you are able to have 7-8 hours of uninterrupted sleep. Psychiatric and 'paradoxical' reactions Oxazepam can cause restlessness, agitation, irritability, aggressiveness, delusions (false beliefs), rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other behavioural disturbances. If you experience any of these symptoms Oxazepam treatment should be stopped. Taking other medicines - Tell you doctor if you are taking any of the following medicines: antidepressants, antipsychotics, sedatives (to calm you down), hypnotics (to help you sleep) or strong pain killers e.g. morphine, codeine. These medicines act in the same way as oxazepam and could make you very sleepy anaesthetics or sedative antihistamines. medicines for epilepsy e.g. barbiturates or phenytoin. These can make the side eects of oxazepam worse. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking Oxazepam with food and drink - Do not drink alcohol while you are taking Oxazepam. Alcohol may increase the sedative eects of Oxazepam and make you very sleepy.
If you are taking Oxazepam to help you sleep, the usual dose is 15-25 mg, but some patients may need up to 50 mg. The dose should be taken one hour before bedtime. If you suer from liver or kidney problems, you may be prescribed a lower dose. Children - Benzodiazepines should not be given to children without careful assessment of the need to do so; the duration of treatment must be kept to a minimum. Elderly - The recommended dose for severe anxiety is 10-20 mg three or four times daily. If you have liver or kidney problems or breathing difficulties you may be given a lower dose. If you take more Oxazepam than you should - If you take more Oxazepam than you should contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you. If you forget to take Oxazepam - If you forget to take a dose of Oxazepam take it as soon as you remember, unless it is almost time for your next dose, in which case miss out the forgotten dose completely and carry on as normal. Do not take a double dose to make up for a forgotten dose. If you stop taking Oxazepam - Do not stop taking your medicine without telling your doctor. Treatment should be gradually withdrawn as the symptoms that Oxazepam was used to treat will return with more intensity than before (rebound insomnia). Other such withdrawal symptoms could include anxiety, restlessness and mood changes, these will however disappear with time. If you have become physically dependent on Oxazepam, sudden withdrawal of treatment could lead to symptoms such as depression, anxiety, headaches, nervousness, sleeplessness, irritability, sweating or diarrhoea and occasionally confusion, convulsions or unusual behaviour. Other symptoms, such as persistent ringing in the ears, involuntary movements, tingling or numbness, convulsions, abdominal and muscle cramps and vomiting, may also occur. In more severe cases, it has also been reported hypersensitivity to light, noise and physical contact, hallucinations and epileptic seizures. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Oxazepam can cause side eects, although not everybody gets them. The following side effects happen predominantly at the start of the treatment and usually disappear with repeated administration: drowsiness during the day numbed emotions reduced alertness confusion headache dizziness feeling weak and tired double vision lack of muscle coordination (ataxia) muscle weakness. Other side effects that occur occasionally are: stomach upsets skin rashes or itching lack of sexual drive oedema (swollen hands and feet) blood problems
jaundice (yellowing of the skin and whites of the eyes) feeling unusually tired. The following side effects have also been reported: feeling over excited, nervous or irritable experiencing rage having nightmares and hallucinations (feeling or seeing things that are not there) exhibiting inappropriate behaviour feeling restless, agitated, aggressive suering from delusions (false beliefs) and psychoses. These eects may be severe and are more likely in the elderly. When these reactions occur, you should tell your doctor immediately as your doctor will need to stop your treatment. Psychological dependence may occur meaning you think you cannot ever sleep without taking Oxazepam. Use (even at therapeutic doses) may lead to physical dependence, which may result in you suering withdrawal eects and a recurrence of your problems if you suddenly stop Oxazepam treatment. If any side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE OXAZEPAM Keep your tablets out of the reach and sight of children. Do not use Oxazepam after the expiry date, which is stated on the carton after 'EXP'. The expiry date refers to the last day of that month. Store below 25C. Store your medicine in a cool dry place, away from light. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Oxazepam contains: The active substance is oxazepam. Each Oxazepam 10 mg tablet contains 10 mg of Oxazepam. Each Oxazepam 15 mg tablet contains 15 mg Oxazepam. Each Oxazepam 30 mg tablet contains 30 mg of Oxazepam. The other ingredients are lactose monohydrate, maize starch and magnesium stearate. The 10 mg tablet contains isopropyl alcohol, povidone and sodium starch glycollate. The 15 mg and 30 mg tablets also contain Quinoline Yellow and Erythrosine. What Oxazepam looks like and contents of the pack - The Oxazepam 10 mg tablet is white and marked 'OM' breakline - '10' on one side and 'G' on the other. The Oxazepam 15 mg tablet is pale yellow and marked 'OM' breakline - '15' on one side and 'G' on the other. The Oxazepam 30 mg tablet is orange and marked 'OM' - breakline '30' on one side and 'G' on the other. Oxazepam is available in blisters containing 28 tablets and bottles containing 100, 250, 500 and 1,000 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer: Generics [UK] Limited t/a Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
2. BEFORE YOU TAKE OXAZEPAM Do not take Oxazepam: if you are allergic (hypersensitive) to oxazepam or any of the other ingredients in your tablets if you have severe breathlessness or breathing difficulties if you suer from Myasthenia Gravis (a condition which causes muscles to weaken and tire easily) if you are being treated for mental illness if you suer from sleep apnoea (a condition where you stop breathing when asleep) if you have severe problems with your liver if you are pregnant, might become pregnant or are breast-feeding. Take special care with Oxazepam - You should tell your doctor before taking this medicine if: you have problems with your liver, kidneys or lungs someone close to you has recently died you have a history of alcoholism or drug abuse. The risk of dependence to Oxazepam increases in these patients and with the dose and length of treatment you have a personality disorder. Other considerations when taking Oxazepam are: Tolerance - if after a few weeks you notice that the tablets are not working as well as they did when you first started taking them, you should see your doctor, as an adjustment of your dose may be required. Dependence - when taking this type of medicine there is a risk of dependence, which increases with dose and length of treatment. There is a greater risk in patients with a history of alcohol or drug abuse. Withdrawal - treatment should be gradually withdrawn. Some patients find that their symptoms of diculty sleeping and anxiety reoccur when
Pregnancy and breast-feeding - You should not take Oxazepam if you are pregnant, planning to become pregnant or if you are breast-feeding. If you take Oxazepam late in your pregnancy or during labour your baby might have a low body temperature, floppiness, breathing and feeding diculties. If you take this medicine regularly during late pregnancy, your baby may develop withdrawal symptoms (please see the next section). Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines - Oxazepam may make you feel sleepy or aect your concentration. Do not drive or use any tools or machines if you are aected in this way and do not drink alcohol, as this will make these eects worse. Important information about some of the ingredients of Oxazepam Oxazepam contain lactose (a type of sugar). If you have been told that you have intolerance to some sugars contact your doctor before taking this medicine. 3. HOW TO TAKE OXAZEPAM Always take Oxazepam exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The number of tablets you take will depend on what you are taking the tablets for. You should not take Oxazepam for anxiety for longer than 8 to 12 weeks, including the time required for gradual reduction of your dosage. For insomnia associated with anxiety, the maximum duration of treatment is 4 weeks, including time required for gradual reduction of your dosage. Oxazepam should be gradually withdrawn as adverse eects have been observed on abrupt withdrawal. Swallow the tablets whole. Adults - If you are taking the tablets for severe anxiety the usual dose is 15-30 mg three (or four) times daily.
2406/0
Pharmacode
Pharmacode
Pharmacode
Pharmacode
This leaflet was last approved in: December 2010
10002841
2406/0
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.
