Medication Guide App

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.

• 
Keep this leaflet. You may need to read it again.
•  you have any further questions, ask your doctor or
If
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.
•  any of the side effects gets serious, or if you notice
If
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
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:
•  the short term treatment of insomnia (difficulty
for
sleeping), which is severe, disabling or distressing.
•  a pre-medication before minor surgery or
as
investigative procedures, especially when hospital
admission is not required.

2 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).
• are 18 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

•  ependence - when taking this medicine there is a
D
risk of dependence, which increases with the dose and
length of treatment and also in patients with a history
of alcoholism and drug abuse.
• olerance – if after a few weeks, you notice that the
T
tablets are not working as well as they did when first
starting treatment, you should speak to your doctor.

•  ithdrawal – treatment should be gradually
W
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.’
•  emory loss may be experienced several hours after
M
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.
•  o not drive while taking this medicine until you know
D
how it affects you.
•  t is an offence to drive if this medicine affects your
I
ability to drive.
• However, you would not be committing an offence if:
-  he medicine has been prescribed to treat a medical
T
or dental problem and
-  ou have taken it according to the instructions given
Y
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

Temazepam 10mg and 20mg Tablets PIL - UK
item no: AAAH3049

dimensions: 150 x 270

print proof no: 2

pharmacode:

origination date: 30.09.14

min pt size: 7

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 01.10.14

Technical Approval

revised by: S.Anson

date sent: 30.09.14

supplier: Surepharm

technically app. date: 30.09.14

Non Printing Colours
1.
2.
3.

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.
•  efore surgery - 20-40mg half to one hour before
B
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-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.

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

•  you stop taking Temazepam tablets suddenly,
If
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.
•  you have been taking more than you should you
If
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.

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:
• ffects more common at the start of therapy:
E
drowsiness, numbed emotions, reduced alertness,
confusion, tiredness, headache, dizziness, muscle
weakness, lack of co-ordination, double vision, slurred
speech or breathing difficulties.
•  sychological effects: restlessness, agitation,
P
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.
•  ther effects: stomach upset, changes in sexual desire,
O
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.

5 
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.

Continued top of next column
AAAH3049

Actavis, Barnstaple, EX32 8NS, UK

Temazepam 10mg and 20mg Tablets PIL - UK
item no: AAAH3049

dimensions: 150 x 270

print proof no: 2

pharmacode:

origination date: 30.09.14

min pt size: 7

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 01.10.14

Technical Approval

revised by: S.Anson

date sent: 30.09.14

supplier: Surepharm

technically app. date: 30.09.14

Non Printing Colours
1.
2.
3.

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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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