TEMAZEPAM 10MG TABLETS

Active substance: TEMAZEPAM

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Package leaflet: Information for the patient

Temazepam 10 mg and
20 mg tablets
(Temazepam)

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Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
• 
Keep this leaflet. You may need to read it again.
•  you have further questions, ask your doctor or
If
pharmacist.
• 
This 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.
•  you get any side effects, talk to your doctor or
If
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
W
2.  hat you need to know before you take Temazepam
W
3.  ow to take Temazepam
H
4.  ossible side effects
P
5.  ow to store Temazepam
H
6.  ontents of the pack and other information.
C
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
•  be given before minor surgery and other similar
to
procedures (pre-medication) to make you feel more
relaxed (or less anxious).
2. What you need to know before you take
Temazepam
Do not take Temazepam:
•  you are allergic to temazepam, or any other
if
benzodiazepine medicine (such as diazepam or
nitrazepam), or any of the other ingredients in this
medicine (listed in section 6)
•  you suffer from long term fatigue and muscle
if
weakness (myasthenia gravis)
•  you suffer from irregular breathing whilst asleep
if
(sleep apnoea syndrome)
•  you have severe lung or liver problems
if
•  you are under 18 years old.
if
Warnings and precautions
Talk to your doctor or pharmacist before taking Temazepam:
•  you have a history of alcohol or drug abuse
if
•  you have liver or kidney problems
if
•  you have lung problems
if
•  you are suffering from depression or anxiety
if
associated with depression
•  you find that you need to get up regularly during the
if
night, for example to go to the loo
• if you have a personality disorder such as schizophrenia.
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
•  other medicine to treat nervousness, feeling
any
anxious, or for depression

•  medicine to treat severe mental health illnesses
any
•  isulfiram used in the treatment of alcohol dependence
d
• 
strong pain killers e.g. morphine
• ntihistamines that cause drowsiness, normally used to
a
treat allergies but may also be used to help you sleep
•  medicine to treat Parkinson's disease
any
• 
medicine to treat convulsions or fits (epilepsy)
•  other medicine that can make you feel drowsy or
any
less alert as temazepam may increase this effect
•  contraceptive pill.
the
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, such as lactose, 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.
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.

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Other side effects are:
drowsiness, tiredness or less alert during the next day,
• 
reduced alertness, sleep disturbances (such as restless
sleep)
numbed emotions, depression or worsening of existing
• 
depression
confusion, reduced ability to concentrate, memory
• 
loss (this may also be accompanied by odd or unusual
behaviour)
headaches, dizziness, double vision
• 
low
•  blood pressure, which may make you feel dizzy or
faint when you stand up
muscle weakness or lack of co-ordination
• 
lack of sex drive
• 
dry
•  mouth, stomach pain or diarrhoea
• skin rashes
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
changes 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 or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via
www.mhra.gov.uk/yellowcard
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
Mylan, Potters Bar, Hertfordshire. EN6 1TL, U.K.
Manufacturer
Generics (UK) Ltd. Station Close, Potters Bar, Herts,
EN6 1TL, United Kingdom
Gerard Laboratories, Baldoyle Industrial Estate, Dublin 13,
Ireland.

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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.
Older people
Insomnia
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.
Pre-medication
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 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
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. Possible 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
• 
delusions (beliefs which are not normally consistent
with reality)
• rage
• nightmares
• 
hallucinations (feeling, hearing or seeing things which
are not there)
• 
psychoses (severe thought disturbances)
• 
odd or unusual behaviour.

This leaflet was last revised in: 10/2013

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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.

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