Temazepam Tablets 20mg
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 effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
_1| What Temazepam tablets are and what they are used for H| Before you take H| How to take 3 Possible side effects HI How to store HI Further information
_1| What Temazepam tablets are and what they are used for
Temazepam tablets are sedatives which may be used:
♦ for the short term treatment of insomnia (difficulty sleeping), which is severe, disabling or distressing.
♦ as a pre-medication before minor surgery or investigative procedures, especially when hospital admission is not required.
^1 Before you take
Do not take Temazepam tablets if you:
♦ have ever had an allergic reaction to temazepam or any of the ingredients in the tablet. An allergic reaction may include a rash, itching, difficulty breathing or swallowing or swelling of the face, lips, throat or tongue (see section 6 for list of ingredients).
♦ are18 years of age or under.
♦ have any long term mental illness including obsessions or phobias (irrational fears)
♦ suffer from anxiety with or without depression (as treatment with temazepam may unmask depression or worsen existing depression)
♦ suffer from sudden or severe breathing problems
♦ have severe liver disease
♦ suffer from muscle weakness (myasthenia gravis)
♦ suffer from glaucoma (increased pressure in the eye)
♦ suffer from a condition where you stop breathing temporarily while asleep (sleep apnoea).
Check with your doctor or pharmacist before taking Temazepam tablets if you:
♦ have any mental illness such as depression or personality disorders
♦ have suffered a loss or bereavement (temazepam can affect the way in which you react to this)
♦ have any long-term kidney or liver problems
♦ have a history of alcoholism or drug abuse.
Other considerations
♦ Dependence - when taking this medicine there is a risk of dependence, which increases with the dose and length of treatment and also in patients with a history of alcoholism and drug abuse.
♦ Tolerance - if after a few weeks, you notice that the tablets are not working as well as they did when first starting treatment, you should speak to your doctor.
♦ Withdrawal - treatment should be gradually withdrawn. Withdrawal symptoms occur with Temazepam tablets even when normal doses are given for short periods of time. See Section 3, 'If you stop taking Temazepam tablets'
♦ Memory loss may be experienced several hours after taking temazepam. if possible, to reduce the risk allow 7 to 8 hours of uninterrupted sleep after taking,
Taking other medicines
Check with your doctor or pharmacist if you are
taking any of the following:
♦ other medicines which act on the brain causing sedation including:
- medicines to treat severe mental illness e.g. chlorpromazine, olanzapine
- strong painkillers e.g. morphine
- medicines to treat depression or anxiety e.g. amitriptyline, fluoxetine, phenelzine
- medicines to make you sleep e.g diazepam, zolpidem
- anaesthetics
- sedative antihistamines e.g. chorphenamine
- lofexidine and nabilone
- medicines which lower high blood pressure (in particular moxonidine or alpha blockers e.g. doxazosin)
- muscle relaxants (baclofen and tizanidine)
- disulfiram used to treat alcoholism
♦ medicines to treat epilepsy (hydantoins, phenytoin, or barbiturates)
♦ antivirals (zidovudine and ritonavir)
♦ medicines used to treat Parkinsonism (levodopa)
♦ clozapine used to treat schizophrenia.
Taking Temazepam tablets with alcohol
Do not drink alcohol while you are taking Temazpem tablets. Alcohol may increase the sedative effects and make you very sleepy.
Pregnancy and breast-feeding
Do not take this medicine 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 may develop symptoms such as low body temperature, floppiness, and breathing and feeding difficulties or withdrawal symptoms (see section. 3 'if you stop taking Temazepam tablets')
Driving and using machines
Temazepam tablets may make you sleepy or affect your concentration, vision, memory or muscle function. This may affect your performance at skilled tasks e.g. driving and operating machinery. These effects may still occur the next day. Make sure you are not affected before you drive or operate machinery.
The medicine 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.
Continued over page
Continued top of next column AAAH3049
important information about some of the ingredients of Temazepam tablets
Temazepam tablets 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
Always take Temazepam tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Swallow the tablets whole with a glass of water. Adults:
♦ insomnia - 10-20mg before going to bed. Your doctor may increase this to 30-40mg.
Long term use of temazepam is not recommended. Improvement is often noticed after a short time and treatment should not usually exceed 4 weeks. However, in some cases your doctor may advise you to continue treatment for at least 6 months.
♦ Before surgery - 20-40mg half to one hour before surgery or investigative procedures. It is recommended that you should be accompanied home if you receive temazepam treatment before surgery or investigative procedures.
Elderly and patients with brain and blood-vessel-related disease: Half the above adult doses. It is important to take this medicine exactly as directed by the doctor.
Children: Not recommended for children less than 18 years old.
Patients with breathing difficulties: a lower dose is recommended.
Do not alter the dose or stop treatment without asking your doctor. See section 2 for information on tolerance and dependence.
if you forget to take Temazepam tablets
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember it and then take the next dose at the right time.
if you take more Temazepam tablets than you should
If you (or someone else) swallow a lot of the tablets at the same time, or you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. Signs of overdose include drowsiness, confusion, weakness and, in more serious cases, lack of coordination or muscle tension, low blood pressure, breathing difficulties, coma and very rarely death.
if you stop taking Temazepam tablets
♦ If you stop taking Temazepam tablets suddenly, you may experience unpleasant withdrawal effects including: depression, nervousness, confusion, tension, headache, anxiety, dizziness, loss of concentration
or appetite, tremor, feeling or being sick, ringing in the ears, stomach cramps, heart or blood pressure disturbances, sleeplessness, irritability, sweating and diarrhoea, derealisation (feeling of unreality to the world around), depersonalisation (feeling of unreality to the self, that the mind is separated from body), painful sensitivity to sound, loss of feeling and tingling of the hands and feet, hypersensitivity to light, noise and physical contact, muscle pain and restlessness.
♦ If you have been taking more than you should you may also experience confusion, convulsions or unusual behaviour. Do not stop taking your medicine without telling your doctor as he may wish to gradually reduce the number of tablets you take before stopping them completely.
♦ Treatment should be gradually withdrawn to prevent the symptoms you are being treated for from returning more severely than before (rebound insomnia)
and to prevent you experiencing anxiety (rebound anxiety) and other symptoms such as mood changes, restlessness or changes in sleep patterns.
♦ You may also experience vivid dreams and broken sleep for some weeks after withdrawal.
Continued top of next column AAAH3049
~4| Possible side effects
Like many medicines, Temazepam tablets may occasionally cause side-effects in some patients, particularly when you first start taking it.
Stop treatment and contact a doctor at once if you have the following symptoms of an allergic reaction
♦ itchy skin, rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.
Contact your doctor if you develop:
♦ sore throats, infections, bruising or nose bleeds as these may be signs of changes in the number and types of blood cells. Your doctor may wish to give you a blood test.
♦ Jaundice (yellowing of the skin or eyes).
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
♦ Effects more common at the start of therapy:
drowsiness, numbed emotions, reduced alertness, confusion, tiredness, headache, dizziness, muscle weakness, lack of co-ordination, double vision, slurred speech or breathing difficulties.
♦ Psychological effects: restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations (seeing things that are not real), mental illness (psychoses causing mood swings, hallucinations, depression, paranoia), inappropriate behaviour or other behavioural effects. These effects may be quite severe and are more likely to occur in children and the elderly.
♦ Other effects: stomach upset, changes in sexual desire, skin rashes, difficulty passing water, dry mouth, tremor, loss of bladder control, sight problems, increase in the amount of saliva, low blood pressure, memory loss, depression, difficulty speaking.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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
By reporting side effects you can help provide more information on the safety of this medicine.
How to store
Keep out of the sight and reach of children.
Store the tablets below 250C. Store in the original package to protect from moisture. Keep the blister in the outer carton to protect from light.
Do not use after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
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 tablets contain:
♦ The active substance (the ingredient that makes the tablet work) is temazepam.
♦ Each tablet contains either 10mg or 20mg of temazepam.
♦ The other ingredients are: lactose, maize starch, povidone, magnesium stearate and colloidal silica.
What Temazepam tablets look like and contents of the pack:
Temazepam tablets are white to off-white uncoated tablets.
Pack size 28 tablets
Marketing Authorisation Holder
Actavis, Barnstaple, EX32 8NS, UK.
Manufacturer
Surepharm Services Limited, Unit 2H, Bretby Business Park, Ashby Road East, Bretby, Burton-on-Trent,
DE15 0YZ, United Kingdom
This leaflet was last revised in September 2014
If you would like a leaflet with larger text, please contact 01271 385257.
Actavis, Barnstaple, EX32 8NS, UK