Active substance: TEMAZEPAM

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Temazepam 10 mg and
20 mg tablets

Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
•  eep this leaflet. You may need to read
it again.
•  f you have further questions, ask your
doctor or pharmacist.
•  his medicine has been prescribed for
you only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours.
•  f you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet:
1.  hat Temazepam is and what it is used for
2.  hat you need to know before you
take Temazepam
3.  ow to take Temazepam
4.  ossible side effects
5.  ow to store Temazepam
6.  ontents of the pack and
other information.
1.  hat 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:
•  ifficulty sleeping (insomnia), when your
lack of sleep is causing you a lot of distress
•  o be given before minor surgery and other
similar procedures (pre-medication) to make
you feel more relaxed (or less anxious).
2.  hat you need to know before you
take Temazepam
Do not take Temazepam:
• f 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)
• f you suffer from long term fatigue and
muscle weakness (myasthenia gravis)
• f you suffer from irregular breathing
whilst asleep (sleep apnoea syndrome)
• f you have severe lung or liver problems
• f you are under 18 years old.


Warnings and precautions
Talk to your doctor or pharmacist before
taking Temazepam:
• f you have a history of alcohol or drug abuse
• f you have liver or kidney problems
• f you have lung problems
• f you are suffering from depression or
anxiety associated with depression
• f you find that you need to get up
regularly during the night, for example to
go to the loo
• f you have a personality disorder such as
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:
•  ther medicine to help you get to sleep
e.g. nitrazepam, chloral hydrate
•  ny other medicine to treat nervousness,
feeling anxious, or for depression
•  ny medicine to treat severe mental
health illnesses
•  isulfiram used in the treatment of
alcohol dependence
•  trong pain killers e.g. morphine
•  ntihistamines that cause drowsiness,
normally used to treat allergies but may
also be used to help you sleep
•  ny medicine to treat Parkinson's disease
•  edicine to treat convulsions or
fits (epilepsy)
•  ny other medicine that can make you feel
drowsy or less alert as temazepam may
increase this effect
•  he contraceptive pill.
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.
The medicine can affect your ability to drive
as it may make you sleepy or dizzy.
•  o not drive while taking this medicine
until you know how it affects you.
•  t is an offence to drive if this medicine
affects your ability to drive.
•  owever, 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.
Temazepam 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.  ow 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.
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 older people.
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.
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.
The recommended dose is 20-40 mg, half
an hour to one hour before your procedure.
Older people
Older people usually require smaller doses
of 10 mg half an hour before going to
bed, but in certain cases the dose may be
increased to 20 mg.


Package leaflet: Information for the patient

The recommended dose is 10-20 mg, half
an hour to one hour before your procedure.
Use in 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
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, lightheadedness 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
You should only stop taking this medicine
when your doctor tells you. Do not
suddenly stop. If this happens you may
suffer from side effects such as feeling
nervous, depressed, irritable, suffer
from sleep problems, sweating, being
sick,confusion, psychosis, fits or shaking.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4.  ossible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
In some patients, particularly older people,
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
•  elusions (beliefs which are not normally
consistent with reality)
• rage
• nightmares
•  allucinations (feeling, hearing or seeing
things which are not there)
•  sychoses (severe thought disturbances)
•  dd or unusual behaviour.

5.  ow 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.  ontents 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
Mylan, Potters Bar, Hertfordshire. EN6 1TL,
Generics (UK) Ltd. Potters Bar, Hertfordshire,
Gerard Laboratories, Baldoyle Industrial
Estate, Dublin 13, Ireland.

Other side effects are:
•  rowsiness, tiredness or less alert during
the next day, reduced alertness, sleep
disturbances (such as restless sleep)
•  umbed emotions, depression or
worsening of existing depression
•  onfusion, reduced ability to concentrate,
memory loss (this may also be
accompanied by odd or unusual behaviour)
•  eadaches, dizziness, double vision
• ow blood pressure, which may make you
feel dizzy or faint when you stand up
•  uscle weakness or lack of co-ordination
• ack of sex drive
•  ry mouth, stomach pain or diarrhoea
• skin rashes
•  nusual 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
•  hanges in the way your liver works (this
may show up in blood tests).
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
By reporting side effects you can help
provide more information on the safety of
this medicine.

This leaflet was last revised in:


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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.