Patient leaflet - Temazepam 10 mg tablets
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 fits. Temazepam can be used for the following:
- difficulty sleeping (insomnia), when your lack of sleep is causing you a lot of distress • to be given before minor surgery and other similar procedures (pre-medication) to make you feel more relaxed (or less anxious).
This medicine has been prescribed to you and should not be given to anyone else. Benzodiazepines can cause dependence, tolerance and addiction, and you may get withdrawal symptoms if you stop taking it or reduce the dose suddenly. Your prescriber should have explained how long you will be taking it for and, when it is appropriate to stop, how to do this safely. When your treatment is stopped, it is usually done gradually over a period which is specific to you and may occur over a period of weeks to months.
2. What you need to know before you take Temazepam
Do not take Temazepam:
- if you are allergic to temazepam, or any other benzodiazepine medicine (such as diazepam or nitrazepam), or any of the other ingredients in this medicine (listed in section 6)
- if you suffer from long term fatigue and muscle weakness (myasthenia gravis) • if you suffer from irregular breathing whilst asleep (sleep apnoea syndrome) • if you have severe lung or liver problems
- if you have a genetic disease called spinocerebellar ataxia (SCA)
- if you have a dependence on alcohol or drugs (including sedatives and painkillers) • if you are under 18 years old.
Warnings and precautions
Talk to your doctor or pharmacist before taking Temazepam:
- if you have liver or kidney problems
- if you have lung problems
- if you are suffering from depression or anxiety associated with depression • if you find that you need to get up regularly during the night, for example to go to the loo • if you have a personality disorder such as schizophrenia
- if you have a history of convulsions, fits or seizures.
- are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs, or if you have ever had a history of struggling to control your alcohol or drug intake.
- have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
- feel you need to take more of Temazepam to get the same level of symptom control, this may mean you are developing tolerance to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative medication.
Taking this medicine regularly, particularly for a long time, can lead to physical dependence and addiction. Your prescriber should have explained how long you will be taking it for and, when it is appropriate to stop, how to do this safely. When your treatment is stopped, it is usually done gradually over a period which is specific to you and may occur over a period of weeks to months.
Physical dependence and addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include:
- headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Do not stop taking your tablets suddenly. This could lead to more serious symptoms such as loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have also experienced numbness or tingling of the arms or legs, tinnitus (ringing sounds in the ears), oversensitivity to light, sound and touch, uncontrolled or overactive movements, twitching, shaking, feeling sick, being sick, stomach upsets or stomach pain, loss of appetite, agitation, abnormally fast heartbeats, panic attacks, dizziness or feeling that you are about to fall, memory loss, hallucinations, feeling stiff and unable to move easily, feeling very warm, convulsions (sudden uncontrolled shaking or jerking of the body).
Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.
Benzodiazepines should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of benzodiazepines, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.
Other medicines and Temazepam
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, or the following:
- other medicine to help you get to sleep e.g. nitrazepam, chloral hydrate • any other medicine to treat nervousness, feeling anxious, or for depression • any medicine to treat severe mental health illnesses
- disulfiram used in the treatment of alcohol dependence
- strong pain killers e.g. morphine
- antihistamines that cause drowsiness, normally used to treat allergies but may also be used to help you sleep
- any medicine to treat Parkinson's disease
- medicine to treat convulsions or fits (epilepsy)
- medicine to treat blood pressure or irregular heartbeat
- rifampicin, a medicine used to treat bacterial infections
- any other medicine that can make you feel drowsy or less alert as temazepam may increase this effect
- the contraceptive pill.
Concomitant use of temazepam and sedative medicines such as benzodiazepines or related drugs 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 temazepam together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
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.
Temazepam with alcohol
Do not drink alcohol while you are taking Temazepam as it may make you feel more sleepy.
Pregnancy and breast-feeding
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 take this medicine. Do not take Temazepam if you are pregnant, might become pregnant or are breast-feeding. However, 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, floppiness, and breathing difficulties when born. If this medicine is taken regularly in late pregnancy, your baby may develop withdrawal symptoms.
If taken whilst breast-feeding, temazepam may be present in the breast milk.
Driving and using machines
Temazepam may make you sleepy or affect your concentration, memory or how your muscles work. This may affect your ability to drive or operate machinery. Do not drive or operate machinery until you are sure you are not affected.
Temazepam contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Temazepam
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your prescriber should have discussed with you how long the course of tablets will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms. The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
If you take Temazepam for sleeping difficulties (insomnia) 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 slowly before you stop taking Temazepam. Reducing your dose slowly will help to reduce the risk of side effects from withdrawal of the product.
It is also 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 suffer from unwanted side effects such as memory loss or feeling drowsy. You may also behave strangely or differently to how you would normally behave. Also, as this medicine is a muscle relaxant, people who have taken Temazepam and get up during the night are at greater risk of falling and fracturing their hip. The risk of this occurring is greater in the elderly. 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 recommended 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.
Pre-medication
The recommended dose is 20-40 mg, half an hour to one hour before your procedure.
Elderly
Insomnia
Older people usually require smaller doses of 10 mg half an hour before going to bed t, but in certain cases the dose may be increased to 20 mg.
Pre-medication
The recommended dose is 10-20 mg, half an hour to one hour before your procedure.
Children and adolescents
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 your doctor may recommended that you take 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, confusion and a general feeling of sluggishness (lethargy). In more serious cases of overdose, symptoms include uncontrollable movements, floppiness, shallow or slow breathing, dizziness, light-headedness or fainting on standing up or unconsciousness (including coma, which can, rarely, become fatal).
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
Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. This may occur over a period of weeks to months. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.
Withdrawal symptoms such as:
- headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Do not stop taking your tablets suddenly. This could lead to more serious symptoms such as loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have also experienced numbness or tingling of the arms or legs, tinnitus (ringing sounds in the ears), oversensitivity to light, sound and touch, uncontrolled or overactive movements, twitching, shaking, feeling sick, being sick, stomach upsets or stomach pain, loss of appetite, agitation, abnormally fast heartbeats, panic attacks, dizziness or feeling that you are about to fall, memory loss, hallucinations, feeling stiff and unable to move easily, feeling very warm, convulsions (sudden uncontrolled shaking or jerking of the body).
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. In some patients, particularly the elderly, Temazepam can cause unusual reactions.
Contact a doctor immediately if you experience any of the following side effects:
Rare (may affect up to 1 in 1,000 people):
- unusual bruising or bleeding or an increase in the number of infections (such as sore throat) that you may get – this may be a sign of changes in the number of different types of blood cells as seen in blood tests
Not known (frequency cannot be estimated from the available data):
- serious sudden allergic reaction with symptoms that include feeling dizzy or faint, rash, itchy skin, swelling of the face, lips, tongue or throat that may cause difficulty breathing or swallowing
- attempting to harm or kill yourself, thoughts about harming or killing yourself • serious, life-threatening, difficulty breathing
Other possible side effects:
Very common (may affect more than 1 in 10 people):
- tiredness or less alert during the next day
Common (may affect up to 1 in 10 people):
- depression or worsening of existing depression
- confusion
- dizziness
- drowsiness
- lack of co-ordination
- feeling weak, feeling tired
Uncommon (may affect up to 1 in 100 people):
- lack of sex drive, problems getting or keeping an erection, a change in the ability to obtain orgasm or in the quality of the sensation
- emotional disorder
- feeling sick (nausea)
- slow response to stimuli
- lack of attention
Rare (may affect up to 1 in 1,000 people):
- low blood pressure
- abnormal liver function levels as shown in blood tests
Not known (frequency cannot be estimated from the available data):
- overproduction of a hormone causing fluid retention with symptoms that include weakness, tiredness or confusion (syndrome of inappropriate antidiuretic hormone secretion (SIADH))
- low blood levels of sodium which can causes tiredness and confusion, muscle twitching, fits or coma
- restlessness
- agitation
- irritability
- aggressiveness
- delusions (beliefs which are not normally consistent with reality) • rage
- nightmares
- hallucinations (feeling, hearing or seeing things which are not there) • hostility
- sexual arousal problems
- anger
- sleeping problems (such as restless sleep, difficulty sleeping)
- drug dependence
- addiction
- severe thought disturbances (psychoses)
- odd or unusual behaviour
- numbed emotions
- reduced ability to concentrate, memory loss headaches
- eyesight problems (such as double vision, blurred vision)
- muscle weakness
- dry mouth
- upset stomach pain , difficulty or delay emptying bowels
- coma
- unusual, uncontrollable, movements, including trembling and shaking of the hands and fingers, twisting movements of the body, shuffling walk and stiffness of the arms and legs
- convulsion, fit or seizure
- shaking
- a feeling of spinning or whirling when you are not actually moving (vertigo) • difficulty speaking
- temporarily stopping breathing while awake or sleeping
- a lung condition with symptoms that include long-term breathing problems, shortness of breath, chronic cough (COPD)
- yellowing of the skin and the whites of the eyes (jaundice)
- increased enzyme levels as shown in blood tests
- hair loss (alopecia)
- abnormally low body temperature
- skin rashes
- anxiety
Drug Withdrawal:
When you stop taking Temazepam, you may experience drug withdrawal symptoms, which include:
- headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Do not stop taking your tablets suddenly. This could lead to more serious symptoms such as loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have also experienced numbness or tingling of the arms or legs, tinnitus (ringing sounds in the ears), oversensitivity to light, sound and touch, uncontrolled or overactive movements, twitching, shaking, feeling sick, being sick, stomach upsets or stomach pain, loss of appetite, agitation, abnormally fast heartbeats, panic attacks, dizziness or feeling that you are about to fall, memory loss, hallucinations, feeling stiff and unable to move easily, feeling very warm, convulsions (sudden uncontrolled shaking or jerking of the body).
How do I know if I am tolerant or addicted?
If you notice any of the following signs whilst taking Temazepam, it could be a sign that you have become addicted.
- You may feel the need to keep taking the medication for longer than your doctor recommended
- You feel you need to use more than the recommended dose
- You are using the medicine for reasons other than prescribed
- When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again
If you notice any of these signs, it is important you talk to your prescriber. Reporting of side effects
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 the 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.
5. How to store Temazepam
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 bottle, container, blister or carton after 'EXP'. The expiry date refers to the last day of that month. Store below 25°C.
Bottles: Keep the container tightly closed and replace the cap immediately after use in order to protect from moisture.
Blisters: Store in the original package in order to protect from moisture. 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 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 to 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
Viatris,
Station Close,
Potters Bar,
EN6 1TL,
United Kingdom.
Manufacturer
Generics (UK) Ltd. Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom.
Gerard Laboratories, Baldoyle Industrial Estate, Dublin 13, Ireland.
Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1, Hungary.