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TEMAZEPAM 10MG TABLETS

Active substance: TEMAZEPAM

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Transcript
(Temazepam)

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
K
again.
•  f you have further questions, ask your
I
doctor or pharmacist.
•  his medicine has been prescribed for you
T
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
I
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
W
2.  hat you need to know before you take
W
Temazepam
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.  hat Temazepam is and what it is used
W
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
d
lack of sleep is causing you a lot of distress
•  o be given before minor surgery and other
t
similar procedures (pre-medication) to make
you feel more relaxed (or less anxious).
2.  hat you need to know before you take
W
Temazepam
Do not take Temazepam:
• f you are allergic to temazepam, or any
i
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
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muscle weakness (myasthenia gravis)
• f you suffer from irregular breathing whilst
i
asleep (sleep apnoea syndrome)
• f you have severe lung or liver problems
i
i
• 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
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• f you have liver or kidney problems
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• f you have lung problems
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• f you are suffering from depression or
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anxiety associated with depression
• f you find that you need to get up regularly
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during the night, for example to go to the
loo
• f you have a personality disorder such as
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schizophrenia.

1122111

TBC

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
o
e.g. nitrazepam, chloral hydrate
•  ny other medicine to treat nervousness,
a
feeling anxious, or for depression
•  ny medicine to treat severe mental health
a
illnesses
•  isulfiram used in the treatment of
d
alcohol dependence
•  trong pain killers e.g. morphine
s
•  ntihistamines that cause drowsiness,
a
normally used to treat allergies but may also
be used to help you sleep
•  ny medicine to treat Parkinson's disease
a
•  edicine to treat convulsions or fits
m
(epilepsy)
•  ny other medicine that can make you feel
a
drowsy or less alert as temazepam may
increase this effect
•  he contraceptive pill.
t
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.

Do not take Temazepam if you are pregnant,
might become pregnant or are breastfeeding. 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
D
you know how it affects you.
•  t is an offence to drive if this medicine
I
affects your ability to drive.
•  owever, you would not be committing an
H
offence if:
  he medicine has been prescribed to
*T
treat a medical or dental problem and
  ou have taken it according to the
*Y
instructions given by the prescriber or
in the information provided with the
medicine and
 t was not affecting your ability to drive
*i
safely

1122111

Temazepam 10 mg and
20 mg tablets

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.

TBC

Package leaflet: Information for the patient

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.
H
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.
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.

432008
0000000

Date: 04 Jun 2014
Description Temazepam 10/20mg All
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 432008

SAP No. N/A

Superceded Affiliate Item Code N/A
TrackWise PR No. 432008
MA No.

04569/0331
04569/0332

Vendor Job No. 230697
Proof No. 1
Client Market UK

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code TBC

Barcode Info N/A

Sign-offs

No. of colours
Colours

1

Time: 13:49
Page Count

Black

1/2

PMS
xxx

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 480mm

Body Text Size 10.5 pt

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, 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
P
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:
•  estlessness
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•  gitation
a
• rritability
i
•  ggressiveness
a
•  elusions (beliefs which are not normally
d
consistent with reality)
•  age
r
•  ightmares
n
•  allucinations (feeling, hearing or seeing
h
things which are not there)
•  sychoses (severe thought disturbances)
p
•  dd or unusual behaviour.
o

5.  ow to store Temazepam
H
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
C
informationWhat 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, UK
Manufacturer
Generics (UK) Ltd. Station Close, Potters Bar,
Herts, EN6 1TL, UK.
Gerard Laboratories, Baldoyle Industrial
Estate, Dublin 13, Ireland.
Mylan Hungary Kft, H-2900 Komarom,
Mylan utca 1, Hungary.

Other side effects are:
•  rowsiness, tiredness or less alert during
d
the next day, reduced alertness, sleep
disturbances (such as restless sleep)
•  umbed emotions, depression or worsening
n
of existing depression
•  onfusion, reduced ability to concentrate,
c
memory loss (this may also be accompanied
by odd or unusual behaviour)
•  eadaches, dizziness, double vision
h
• ow blood pressure, which may make you
l
feel dizzy or faint when you stand up
•  uscle weakness or lack of co-ordination
m
• ack of sex drive
l
•  ry mouth, stomach pain or diarrhoea
d
•  kin rashes
s
•  nusual bruising or bleeding or an increase
u
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
c
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
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this
medicine.

This leaflet was last revised in:
05/2014

Date: 04 Jun 2014
Description Temazepam 10/20mg All
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 432008

SAP No. N/A

Superceded Affiliate Item Code N/A
TrackWise PR No. 432008
MA No.

04569/0331
04569/0332

Vendor Job No. 230697
Proof No. 1
Client Market UK

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code TBC

Barcode Info N/A

Sign-offs

No. of colours
Colours

1

432008
0000000

Time: 13:49
Page Count

Black

2/2

PMS
xxx

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 480mm

Body Text Size 10.5 pt

Expand view ⇕

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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