TEMAZEPAM TABLETS 20MG

Active substance: TEMAZEPAM MICRONISED

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Temazepam 10mg and 20mg tablets
Read all of this leaflet carefully before you
start taking this medicine.

• 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withdrawn.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,

•  eep this leaflet. You may need to read it again.
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•  f you have any further questions, ask your doctor or
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pharmacist.
•  his medicine has been prescribed for you. Do not
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pass it on to others. It may harm them, even if their
symptoms are the same as yours.
•  f any of the side effects gets serious, or if you notice
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any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

Taking other medicines

Check with your doctor or pharmacist if you are
taking any of the following:
•  ther medicines which act on the brain causing
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sedation including:
-  edicines to treat severe mental illness e.g.
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chlorpromazine, olanzapine
-  trong painkillers e.g. morphine
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-  edicines to treat depression or anxiety e.g.
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amitriptyline, fluoxetine, phenelzine
-  edicines to make you sleep e.g diazepam, zolpidem
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-  naesthetics
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-  edative antihistamines e.g. chorphenamine
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- ofexidine and nabilone
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-  edicines which lower high blood pressure (in
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particular moxonidine or alpha blockers e.g.
doxazosin)
-  uscle relaxants (baclofen and tizanidine)
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-  isulfiram used to treat alcoholism
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•  edicines to treat epilepsy (hydantoins, phenytoin, or
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barbiturates)
•  ntivirals (zidovudine and ritonavir)
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•  edicines used to treat Parkinsonism (levodopa)
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•  lozapine used to treat schizophrenia.
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In this leaflet:
1 
What Temazepam tablets are and what
they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information

1 
What Temazepam tablets are and what
they are used for

Temazepam tablets are sedatives which may be used:
•  or the short term treatment of insomnia (difficulty
f
sleeping), which is severe, disabling or distressing.
•  s a pre-medication before minor surgery or
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investigative procedures, especially when hospital
admission is not required.

2 Before you take

Taking Temazepam tablets with alcohol

Do not take Temazepam tablets if you:

Do not drink alcohol while you are taking Temazpem
tablets. Alcohol may increase the sedative effects and
make you very sleepy.

•  ave ever had an allergic reaction to temazepam or
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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).
•  re 18 years of age or under.
a
•  ave any long term mental illness including
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obsessions or phobias (irrational fears)
•  uffer from anxiety with or without depression (as
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treatment with temazepam may unmask depression or
worsen existing depression)
•  uffer from sudden or severe breathing problems
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•  ave severe liver disease
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•  uffer from muscle weakness (myasthenia gravis)
s
•  uffer from glaucoma (increased pressure in the eye)
s
•  uffer from a condition where you stop breathing
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temporarily while asleep (sleep apnoea).

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.

Check with your doctor or pharmacist before
taking Temazepam tablets if you:

•  ave any mental illness such as depression or
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personality disorders
•  ave suffered a loss or bereavement (temazepam can
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affect the way in which you react to this)
•  ave any long-term kidney or liver problems
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•  ave a history of alcoholism or drug abuse.
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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.


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.

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.

Continued over page

Continued top of next column
AAAG2634

Temazepam 10mg and 20mg tablets leaflet - UK

colours/plates:
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item no:
print proof no:
origination date:

AAAG2634
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21.11.13

originated by:
approved for print/date

26.02.14

150 x 270

min pt size:

revised by:
supplier:

jh
IL/Surepharm

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DR

revision date:

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Technical Approval
date sent:

21.11.13

technically app. date:

09.12.13

1.
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* Please note the technical approval is provided by the supplier and is valid on the date indicated
Any technical chanages made by the supplier after approval are not the responsibility of the Artwork Studio

Adults:
• Insomnia - 10-20mg before going to bed. Your doctor

may increase this to 30-40mg.
 ong term use of temazepam is not recommended.
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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.

Contact your doctor if you develop:
•  ore throats, infections, bruising or nose bleeds as
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these may be signs of changes in the number and
types of blood cells. Your doctor may wish to give you a
blood test.
•  aundice (yellowing of the skin or eyes).
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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.

Elderly and patients with brain and blood-vesselrelated 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.

Reporting of side effects

If you forget to take Temazepam tablets

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

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.

By reporting side effects you can help provide more
information on the safety of this medicine.

If you take more Temazepam tablets than you
should

5 
How to store

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.

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.

If you stop taking Temazepam tablets

•  f you stop taking Temazepam tablets suddenly,
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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.
•  f you have been taking more than you should you
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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.
•  reatment should be gradually withdrawn to prevent
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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.
•  ou may also experience vivid dreams and broken
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sleep for some weeks after withdrawal.

6 
Further information

What Temazepam tablets contain:

•  he active substance (the ingredient that makes the
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tablet work) is temazepam.
•  ach tablet contains either 10mg or 20mg of
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temazepam.
•  he other ingredients are: lactose, maize starch,
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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 February 2014

4 
Possible side effects

Like many medicines, Temazepam tablets may
occasionally cause side-effects in some patients,
particularly when you first start taking it.

If you would like a
leaflet with larger
text, please contact
01271 385257.

Stop treatment and contact a doctor at once if you
have the following symptoms of an allergic reaction
• tchy skin, rash, swelling of the face, lips, tongue or
i
throat, or difficulty breathing or swallowing.

Continued top of next column
AAAG2634

Actavis, Barnstaple, EX32 8NS, UK

Temazepam 10mg and 20mg tablets leaflet - UK

colours/plates:
1. Black

item no:
print proof no:
origination date:

AAAG2634
10
21.11.13

originated by:
approved for print/date

26.02.14

150 x 270

min pt size:

revised by:
supplier:

jh
IL/Surepharm

2.
3.

pharmacode:

4.
7pt

5.
6.

DR

revision date:

dimensions:

Non Printing Colours

Technical Approval
date sent:

21.11.13

technically app. date:

09.12.13

1.
2.
3.

* Please note the technical approval is provided by the supplier and is valid on the date indicated
Any technical chanages made by the supplier after approval are not the responsibility of the Artwork Studio

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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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