TEMAZEPAM 10MG TABLETS
Active substance: TEMAZEPAM
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PACKAGE LEAFLET: INFORMATION FOR THE USER
TEMAZEPAM 10 mg AND 20 mg TABLETS
(Temazepam)
Read all of this leaflet carefully before you start taking this medicine. Keep this leaet. You may need to read it again. If you have 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 leaet, please tell your doctor or pharmacist.
any medicine to treat severe mental conditions Disulram used in the treatment of alcohol dependence strong pain killers e.g. Morphine antihistamines that cause drowsiness, used to treat allergies any medicine to treat Parkinson's disease medicine to treat convulsions or ts (epilepsy) any other medicine that can make you feel drowsy or less alert as Temazepam may increase this eect. If you are going to have an operation or need an anaesthetic, tell the doctor or dentist that you are taking Temazepam. If you take Temazepam before a minor operation or procedure it is important that you have someone to accompany you home. Taking Temazepam with food and drink - Do not drink alcohol while you are taking Temazepam as it will change the way this medicine works. Pregnancy and breast-feeding - Do not take Temazepam if you are pregnant, might become pregnant or are breast-feeding. If your doctor has decided that you should receive this medicine during late pregnancy or during labour, your baby might have a low body temperature, oppiness, and breathing and feeding diculties. If this medicine is taken regularly in late pregnancy, your baby may develop withdrawal symptoms. Driving and using machines - Temazepam may make you sleepy or aect your concentration. This may aect your ability to drive or operate machinery. Important information about some of the ingredients of Temazepam - This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor before taking this medicine. 3. HOW TO TAKE TEMAZEPAM Always take Temazepam exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Your doctor will usually give you Temazepam for a maximum of 4 weeks, this will include a period of time when your dose is reduced. Reducing your dose slowly will help to reduce the risk of side eects from withdrawal of the product. If you take Temazepam for sleeping diculties it is important that you are able to have 7-8 hours of uninterrupted sleep after taking your tablet. If you are late getting to bed or your sleep is interrupted you may suer from unwanted side eects such as memory loss or feeling drowsy. You may also behave strangely or dierently to how you would normally behave. At high doses taken for a long period of time, it is possible that you may become dependent on your medicine. If this happens to you, you must speak to you doctor. Adults: Insomnia - The usual dose is 10 mg or 20 mg half an hour before going to bed. In certain cases your doctor may increase the dose to 30 mg or 40 mg.
LT1486AC
Pre-medication - The usual dose is 20-40 mg, half to one hour before your procedure. Elderly: Elderly patients usually require smaller doses of 10 mg at night, but in certain cases the dose may be increased to 20 mg at night. As this medicine is a muscle relaxant, elderly patients who have taken Temazepam and get up during the night are at risk of falling and fracturing their hip. Pre-medication - The usual dose is 10-20 mg, half to one hour before your procedure. Children - Temazepam is not recommended for use in children or adolescents younger than 18 years of age. People with breathing difficulties or liver problems - If you have a long-term problem with your breathing or problems with your liver you are likely to be given a lower dose. If you take more Temazepam than you should Contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you. Symptoms of overdose include drowsiness and confusion. In more serious cases of overdose, symptoms include uncontrollable movements, oppiness, shallow breathing, unconsciousness, dizziness, light-headedness or fainting on standing up. If you forget to take Temazepam - If you are still likely to have uninterrupted sleep of 7-8 hours, then take it as soon as you remember. Otherwise, if you miss a dose do not take a double dose to make up for a forgotten dose. Take your normal dose the following night. If you stop taking Temazepam - You should only stop taking this medicine when your doctor tells you. Do not suddenly stop. If this happens you may suer from side eects such as feeling nervous, depressed, irritable, suer from sleep problems, sweating, diarrhoea, confusion, psychosis, ts or shaking. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Temazepam can cause side eects, although not everybody gets them. In some patients, particularly young people and the elderly, Temazepam can cause unusual reactions. If any of the following happen, tell your doctor or pharmacist. You may need to stop taking Temazepam or lower your dose: restlessness agitation irritability aggressiveness delusions rage nightmares hallucinations (feeling, hearing or seeing things which are not there).
Other side eects are: drowsiness, tiredness or less alert during the next day, reduced alertness, sleep disturbances numbed emotions, depression reduced alertness, confusion, memory loss, accompanied by odd behavior headaches, dizziness, double vision low blood pressure, which will make you feel dizzy or faint when you stand up muscle weakness or lack of co-ordination lack of sex drive stomach pain or diarrhoea skin rashes, yellowing of the skin or whites of the eyes caused by blood disorders or liver problems (jaundice). 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 TEMAZEPAM Keep out of the reach and sight of children. Do not use Temazepam after the expiry date, which is stated on the bottle, container, blister or carton after 'EXP'. The expiry date refers to the last day of that month. Store below 25C. Keep your medicine in the original package. Plastic Containers and Amber Glass Bottles: Store in the original container. Replace the cap immediately after use. Blisters: Store in the original package. 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 Temazepam contains - each tablet contains 10 mg or 20 mg of temazepam as the active substance. The other ingredients are lactose monohydrate, maize starch, gelatin, talc and magnesium stearate. What Temazepam looks like and contents of the pack - Your medicine comes as a white or pale yellow round tablet in either two strengths of 10 mg or 20 mg. The tablets are marked 'T/10' for the 10 mg and 'T/20' for the 20 mg on one side and 'G' on the other. Temazepam is available in amber glass bottles, plastic containers or blisters of 7, 10, 14, 28, 30, 56, 60, 84, 90, 100, 250 and 500 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder: Generics [UK] Ltd. t/a Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom. Manufacturer: McDermott Laboratories T/A Gerard Laboratories, Baldoyle Industrial Estate, Dublin 13, Ireland.
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In this leaflet: 1. What Temazepam is and what it is used for. 2. Before you take Temazepam. 3. How to take Temazepam. 4. Possible side eects. 5. How to store Temazepam. 6. Further information. 1. WHAT TEMAZEPAM IS AND WHAT IT IS USED FOR Temazepam belongs to a group of medicines called benzodiazepines or hypnotics. Benzodiazepines are used to make you feel less anxious, they can also be used to make you feel sleepy, relax your muscles and stop or prevent ts. Temazepam can be used for the following: diculty sleeping (insomnia), when your lack of sleep is causing you a lot of distress given before minor surgery and other similar procedures (pre-medication) to make you feel more relaxed (or less anxious). 2. BEFORE YOU TAKE TEMAZEPAM Do not take Temazepam if you: are allergic (hypersensitive) to temazepam or any other benzodiazepine or any of the other ingredients in this medicine suer from long term fatigue and muscle weakness (myasthenia gravis) suer from irregular breathing whilst asleep (sleep apnoea syndrome) have severe lung or liver problems are under 18 years old. Take special care with Temazepam - You should tell your doctor before taking this medicine if you: have a history of alcohol or drug abuse have liver or kidney problems are suering from depression or anxiety associated with depression have a personality disorder such as schizophrenia. Taking other medicines - Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, or the following: any other medicine to treat nervousness or feeling anxious
12212
21221
This leaet was last approved in:15/02/2011
LT1486AC ITEM CODE
TEMAZEPAM 10 mg AND 20 mg TABLETS
(Temazepam)
Read all of this leaflet carefully before you start taking this medicine. Keep this leaet. You may need to read it again. If you have 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 leaet, please tell your doctor or pharmacist.
any medicine to treat severe mental conditions Disulram used in the treatment of alcohol dependence strong pain killers e.g. Morphine antihistamines that cause drowsiness, used to treat allergies any medicine to treat Parkinson's disease medicine to treat convulsions or ts (epilepsy) any other medicine that can make you feel drowsy or less alert as Temazepam may increase this eect. If you are going to have an operation or need an anaesthetic, tell the doctor or dentist that you are taking Temazepam. If you take Temazepam before a minor operation or procedure it is important that you have someone to accompany you home. Taking Temazepam with food and drink - Do not drink alcohol while you are taking Temazepam as it will change the way this medicine works. Pregnancy and breast-feeding - Do not take Temazepam if you are pregnant, might become pregnant or are breast-feeding. If your doctor has decided that you should receive this medicine during late pregnancy or during labour, your baby might have a low body temperature, oppiness, and breathing and feeding diculties. If this medicine is taken regularly in late pregnancy, your baby may develop withdrawal symptoms. Driving and using machines - Temazepam may make you sleepy or aect your concentration. This may aect your ability to drive or operate machinery. Important information about some of the ingredients of Temazepam - This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor before taking this medicine. 3. HOW TO TAKE TEMAZEPAM Always take Temazepam exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Your doctor will usually give you Temazepam for a maximum of 4 weeks, this will include a period of time when your dose is reduced. Reducing your dose slowly will help to reduce the risk of side eects from withdrawal of the product. If you take Temazepam for sleeping diculties it is important that you are able to have 7-8 hours of uninterrupted sleep after taking your tablet. If you are late getting to bed or your sleep is interrupted you may suer from unwanted side eects such as memory loss or feeling drowsy. You may also behave strangely or dierently to how you would normally behave. At high doses taken for a long period of time, it is possible that you may become dependent on your medicine. If this happens to you, you must speak to you doctor. Adults: Insomnia - The usual dose is 10 mg or 20 mg half an hour before going to bed. In certain cases your doctor may increase the dose to 30 mg or 40 mg.
LT1486AC
Pre-medication - The usual dose is 20-40 mg, half to one hour before your procedure. Elderly: Elderly patients usually require smaller doses of 10 mg at night, but in certain cases the dose may be increased to 20 mg at night. As this medicine is a muscle relaxant, elderly patients who have taken Temazepam and get up during the night are at risk of falling and fracturing their hip. Pre-medication - The usual dose is 10-20 mg, half to one hour before your procedure. Children - Temazepam is not recommended for use in children or adolescents younger than 18 years of age. People with breathing difficulties or liver problems - If you have a long-term problem with your breathing or problems with your liver you are likely to be given a lower dose. If you take more Temazepam than you should Contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you. Symptoms of overdose include drowsiness and confusion. In more serious cases of overdose, symptoms include uncontrollable movements, oppiness, shallow breathing, unconsciousness, dizziness, light-headedness or fainting on standing up. If you forget to take Temazepam - If you are still likely to have uninterrupted sleep of 7-8 hours, then take it as soon as you remember. Otherwise, if you miss a dose do not take a double dose to make up for a forgotten dose. Take your normal dose the following night. If you stop taking Temazepam - You should only stop taking this medicine when your doctor tells you. Do not suddenly stop. If this happens you may suer from side eects such as feeling nervous, depressed, irritable, suer from sleep problems, sweating, diarrhoea, confusion, psychosis, ts or shaking. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Temazepam can cause side eects, although not everybody gets them. In some patients, particularly young people and the elderly, Temazepam can cause unusual reactions. If any of the following happen, tell your doctor or pharmacist. You may need to stop taking Temazepam or lower your dose: restlessness agitation irritability aggressiveness delusions rage nightmares hallucinations (feeling, hearing or seeing things which are not there).
Other side eects are: drowsiness, tiredness or less alert during the next day, reduced alertness, sleep disturbances numbed emotions, depression reduced alertness, confusion, memory loss, accompanied by odd behavior headaches, dizziness, double vision low blood pressure, which will make you feel dizzy or faint when you stand up muscle weakness or lack of co-ordination lack of sex drive stomach pain or diarrhoea skin rashes, yellowing of the skin or whites of the eyes caused by blood disorders or liver problems (jaundice). 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 TEMAZEPAM Keep out of the reach and sight of children. Do not use Temazepam after the expiry date, which is stated on the bottle, container, blister or carton after 'EXP'. The expiry date refers to the last day of that month. Store below 25C. Keep your medicine in the original package. Plastic Containers and Amber Glass Bottles: Store in the original container. Replace the cap immediately after use. Blisters: Store in the original package. 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 Temazepam contains - each tablet contains 10 mg or 20 mg of temazepam as the active substance. The other ingredients are lactose monohydrate, maize starch, gelatin, talc and magnesium stearate. What Temazepam looks like and contents of the pack - Your medicine comes as a white or pale yellow round tablet in either two strengths of 10 mg or 20 mg. The tablets are marked 'T/10' for the 10 mg and 'T/20' for the 20 mg on one side and 'G' on the other. Temazepam is available in amber glass bottles, plastic containers or blisters of 7, 10, 14, 28, 30, 56, 60, 84, 90, 100, 250 and 500 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder: Generics [UK] Ltd. t/a Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom. Manufacturer: McDermott Laboratories T/A Gerard Laboratories, Baldoyle Industrial Estate, Dublin 13, Ireland.
12212
In this leaflet: 1. What Temazepam is and what it is used for. 2. Before you take Temazepam. 3. How to take Temazepam. 4. Possible side eects. 5. How to store Temazepam. 6. Further information. 1. WHAT TEMAZEPAM IS AND WHAT IT IS USED FOR Temazepam belongs to a group of medicines called benzodiazepines or hypnotics. Benzodiazepines are used to make you feel less anxious, they can also be used to make you feel sleepy, relax your muscles and stop or prevent ts. Temazepam can be used for the following: diculty sleeping (insomnia), when your lack of sleep is causing you a lot of distress given before minor surgery and other similar procedures (pre-medication) to make you feel more relaxed (or less anxious). 2. BEFORE YOU TAKE TEMAZEPAM Do not take Temazepam if you: are allergic (hypersensitive) to temazepam or any other benzodiazepine or any of the other ingredients in this medicine suer from long term fatigue and muscle weakness (myasthenia gravis) suer from irregular breathing whilst asleep (sleep apnoea syndrome) have severe lung or liver problems are under 18 years old. Take special care with Temazepam - You should tell your doctor before taking this medicine if you: have a history of alcohol or drug abuse have liver or kidney problems are suering from depression or anxiety associated with depression have a personality disorder such as schizophrenia. Taking other medicines - Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, or the following: any other medicine to treat nervousness or feeling anxious
12212
21221
This leaet was last approved in:15/02/2011
LT1486AC ITEM CODE
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.
