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TEMAZEPAM TABLETS 20MG

Active substance(s): TEMAZEPAM / TEMAZEPAM MICRONISED

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Before surgery
• Adults: 20 mg to 40 mg taken one hour before the procedure.
• Elderly: Half the above adult dose - 10 mg to 20 mg taken one
hour before the procedure.
Children and adolescents
Temazepam tablets are not intended for patients under 18 years of
age.

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Patients with breathing difficulties
A lower dose is recommended.

of treatment. Your attending doctor will decide on that after renewed
evaluation of your complaints.

If after a few weeks you notice that the tablets are not working as well
as they did when first starting treatment, you should go and see your
doctor as an adjustment to your dosage may be required. Do not
alter the dose or stop treatment without asking your
doctor. See section 2 for information on tolerance and dependence.

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 if you think a child has swallowed any of the tablets, contact your
nearest hospital casualty department or your doctor immediately. Do
not go unaccompanied to seek medical help. 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.

How long should you take Temazepam tablets?
The duration of administration should be as short as possible. In
general, it could be a few days up to 2 weeks and not exceed 4
weeks, the stepwise withdrawal phase included. Your doctor will
choose a withdrawal regime based on your individual needs.
Certain situations may require prolongation beyond the maximum time

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Temazepam Tablets 10 mg and 20 mg
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.
• If you have any further questions, ask your doctor or 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.
• If 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.

1. What Temazepam tablets are and what they are
used for
Temazepam tablets are sleeping pills (hypnotics) which work by acting on
the brain to cause sleepiness.

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Lot:
EXP:

Oral use. Use as directed by your doctor. Read the package leaflet before use.
Store at or below 25°C in a dry place. Protect from light.
Keep out of the sight and reach of children.
Each tablet contains 20 mg Temazepam BP. Also contains lactose
monohydrate. PL 04416/0270 Sandoz Ltd, Frimley Business
Park, Frimley, Camberley, Surrey, GU16 7SR.

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If you stop taking Temazepam tablets
• Treatment should be gradually withdrawn as the symptoms you are
treated for will return more intense than before (rebound insomnia),
also anxiety (rebound anxiety), restlessness, changes in sleep patterns
and mood changes may occur. These effects will disappear in time.
• You may also experience vivid dreams and broken sleep for some
weeks after withdrawal.
• If you stop taking Temazepam tablets suddenly, you may experience
unpleasant withdrawal effects including: depression, nervousness,

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They may be used for short term treatment of difficulty in sleeping
(insomnia) which is severe, disabling or causing great distress.
They can also be used as a sedative prior to minor surgery or similar
procedures, especially when hospital admission is not required.

2. What you need to know before you take
Temazepam tablets
Do not take Temazepam tablets if you:
• are allergic to active substance, to other benzodiazepines or any of
the other ingredients of this medicine (listed in section 6). An allergic
reaction may include a rash, itching, difficulty breathing or swallowing
or swelling of the face, lips, throat or tongue.

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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. These symptoms may also be experienced
between doses, especially if the dose is high.
• If you have been taking more than you should you may also
experience confusion, convulsions or unusual behaviour. Do not stop
taking your medicine without telling your doctor as he may wish to

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• are 18 years of age or under.
• have severe liver problems.
• suffer from breathing problems whilst sleeping (sleep
apnoea).
• suffer from severe muscle weakness (myasthenia gravis).
• suffer from sudden or severe breathing problems.
• have any long term mental illness including obsessions or
phobias (irrational fears).
• suffer from anxiety with or without depression or psychotic illness.
Temazepam tablets may unmask or worsen symptoms
• are breast-feeding.
• suffer from glaucoma (increased pressure in the eye).

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gradually reduce the number of tablets you take before stopping
them completely.

4. Possible side effects
Like all medicines, this medicine can cause unwanted side effects,
although not everybody gets them.
Stop treatment and contact a doctor immediately 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.

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Warnings and precautions
Talk to your doctor or pharmacist before taking Temazepam
tablets if you:
• are elderly or frail. If you get up at night, take care as there is an
increased risk of falling and consequently of hip fractures due to the
muscle relaxant effect of the tablets.
• 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 breathing problems. Whilst taking
Temazepam tablets your breathing may become less
forceful.
• suffer from or have a history of depression.
• have or have ever had a history of or tendency to alcohol or drug

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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 whites of the eyes caused by liver
or blood problems).
• incontinence
• inability to urinate
• behavioural mood changes such as aggressiveness, delusions (false
beliefs), rage, depression and psychoses.
Tell your doctor or pharmacist if any of the following side effects
occur or if you notice any other effects not listed:

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abuse (see “Dependence” below).
• are or suspect that you are pregnant.
• suffer from a personality disorder.
• suffer from muscle weakness.
Please tell your doctor if you have any of the conditions listed above.
Other considerations
• 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
go and see your doctor as an adjustment to your dosage may be
required.
• Dependence - when taking this type of medicine there is a risk of
dependence, which increases with dose and length of treatment.
There is a greater risk in patients with a history of alcohol or drug abuse.

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Common - drowsiness the following day • numbed emotions •
reduced alertness • dizziness • confusion • fatigue • tiredness • shaky
movements • double vision • co-ordination disturbances • muscle
weakness • lightheadedness • memory loss.

reported mainly in elderly patients. When these reactions occur, you
should tell your doctor and stop taking Temazepam tablets.
Psychological dependence may occur, meaning you think that you
cannot ever sleep without taking Temazepam tablets.

Rare - vivid dreams • restless sleep • awareness of abnormal heartbeat
• skin reactions • changes in sex drive • sedation • impaired muscular
functions • dry mouth • stomach upsets (indigestion, diarrhoea,
constipation) • changes in the blood (identified by blood tests)
• reduced urine output • visual disturbances • headache • ‘spinning’
sensation • low blood pressure • salivation changes • difficulty in
speaking • shaking.

Use (even at therapeutic dosages) may lead to physical dependence,
sudden discontinuation of treatment may result in withdrawal effects
and recurrence of problems.

Other behavioural mood changes such as restlessness, agitation,
irritability, nightmares, hallucinations, sleepwalking have also been

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• 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 7-8 hours of
uninterrupted sleep after taking Temazepam tablets.
• Psychiatric and “paradoxical” reactions - Temazepam tablets
can cause behavioural side effects such as restlessness, agitation,
irritability, aggressiveness, delusions (false beliefs), rages, nightmares,
hallucinations, psychoses, sleepwalking, inappropriate behaviour,
increased insomnia and other adverse behavioural effects.
• Minor surgery – if you have been given Temazepam tablets as a
sedative prior to minor surgery you should make arrangements to be

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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
(www.mhra.gov.uk/yellowcard). By reporting side effects you can
help provide more information on the safety of this medicine.

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accompanied home.
• Sleep behaviour - complex sleep behaviour-related events such as
“sleep driving” (driving while not fully awake with no memory of the
event) have been reported in patients taking temazepam. The risk of
these behaviours increases when alcohol is consumed. Tell your
doctor immediately if you suffer from any sleep behaviour-related
events as your medicine may need to be changed.
Other medicines and Temazepam Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines. Temazepam tablets may influence the
effect and/or side effects of other medicines. If you see another doctor
or go into hospital, particularly if you are having an operation under
anaesthesia tell the doctor which medicines you use.

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5. How to store Temazepam tablets
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
product packaging. The expiry date refers to the last day of that month.
Store at or below 25°C in a dry place. Protect from light.
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 protect the environment.

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What Temazepam Tablets contains
• The active substance (the ingredient that makes the medicine work) is
temazepam. Each tablet contains either 10mg or 20mg of the active
ingredient.
• The other ingredients are lactose monohydrate, maize starch,
pregelled starch, sodium starch glycollate, microcrystalline cellulose
and magnesium stearate.

What Temazepam Tablets looks like and contents of the
pack
Temazepam 10 mg tablets are round, white to pale yellow tablets with
TEM 10 on one side and plain on the other.
Temazepam 20 mg tablets are round, white to pale yellow tablets with
TEM 20 on one side and plain on the other.

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New advice for drivers – see leaflet inside. This medicine can
make you feel sleepy. Do not drive while taking this medicine until you
know how it makes you feel. See the leaflet inside for more information.

This leaflet was last revised in 05/2016.

Oral use. Use as directed by your doctor. Read the package leaflet before use.
Store at or below 25°C in a dry place. Protect from light.

They are supplied in plastic containers of 28, 30, 56, 60, 84, 100, 168,
200, 250 and 500 tablets.

Keep out of the sight and reach of children.
Each tablet contains 20 mg Temazepam BP. Also contains lactose
monohydrate. PL 04416/0270 Sandoz Ltd, Frimley Business
Park, Frimley, Camberley, Surrey, GU16 7SR.

Not all pack sizes may be marketed.

• antivirals e.g. zidovudine and ritonavir
• theophylline used to treat asthma
• muscle relaxants (baclofen and tizanidine)
• disulfiram used to treat alcoholism
• fluvoxamine used to treat depression
• cimetidine used to treat stomach ulcers
• rifampicin an antibacterial drug.
• sodium oxybate used to treat narcolepsy with cataplexy - sleep
disorders with sudden and transient loss of muscle tone.
• levodopa used to treat Parkinson’s disease
• antihypertensive medicines (e.g. moxonidine, alpha blockers (e.g.
doxazosin), beta-blockers) - enhanced blood pressure lowering
effect.
• clozapine used to treat schizophrenia.

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Temazepam with alcohol
Do not drink alcohol while you are taking Temazepam tablets. Alcohol
may increase the sedating effects and make you feel very sleepy.
Pregnancy and breast-feeding
Do not take this medicine 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 taking this medicine. It is especially
important not to use Temazepam tablets during the first three months of
pregnancy. If for urgent medical reasons, Temazepam tablets are taken
during late pregnancy or during labour the baby may show withdrawal
symptoms (low body temperature, floppiness and breathing and
feeding difficulties) after birth because of physical dependence (see
section. 3 “If you stop taking Temazepam tablets”).

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Temazepam will appear in breast milk in small amounts, therefore
breast-feeding mothers should not take this medicine.
Driving and using machines
Temazepam tablets may make you feel drowsy or affect your
concentration, vision, memory or muscle function. This feeling may
persist the next day or be even worse when you sleep for less than
7 to 8 hours after taking your medication.
The medicine can affect your ability to drive as it may make you
sleepy or dizzy.
• Do not drive while taking this medicine until you know how it affects
you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:

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250 tablets

Temazepam 20 mg Tablets

Marketing authorization holder and Manufacturer
Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16
7SR, UK.

POM

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Check with your doctor or pharmacist if you are taking any
of the following:
• medicines to treat severe mental illness e.g. chlorpromazine,
olanzapine
• medicines to treat depression or anxiety e.g. amitriptyline, fluoxetine,
phenelzine
• medicines to make you sleep e.g. diazepam, zolpidem
• medicines to treat anxiety and other tranquillizers
• strong pain killers e.g. codeine, morphine.
• medicines used to treat epilepsy (hydantoins, phenytoin, or
barbiturates)
• anaesthetics (used during surgery)
• antihistamine medicines which cause sleepiness e.g. chorphenamine
• lofexidine and nabilone

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6. Contents of the pack and other information

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Page 1 - Top visible panel

- 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 tablets contain lactose
If you have been told you have an intolerance to some sugars, tell
your doctor or pharmacist before taking this medicine.

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SZ00000LL000

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3. How to take Temazepam tablets
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
The tablet should be taken together with liquid.
The recommended dose is:
Insomnia
• Adults: 10 mg to 20 mg taken at bedtime. This dose must not
be exceeded. In extreme cases the dose may be increased to
30 mg - 40 mg by your doctor.

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250 tablets

New advice for drivers – see leaflet inside. This medicine can
make you feel sleepy. Do not drive while taking this medicine until you
know how it makes you feel. See the leaflet inside for more information.

POM

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uninterrupted sleep. If this is not possible, take the next dose before bed
time the next night.
Do not take a double dose to make up for a forgotten tablet. If you are
worried ask your pharmacist or doctor for advice.

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Temazepam 20 mg Tablets

SZ00000LL000

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In this leaflet
1. What Temazepam tablets are and what they are used for
2. What you need to know before you take Temazepam tablets
3. How to take Temazepam tablets
4. Possible side effects
5. How to store Temazepam tablets
6. Contents of the pack and other information

PACKAGE LEAFLET: INFORMATION FOR THE USER

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If you forget to take Temazepam tablets
If you forget to take a dose at bedtime but remember during the night,
only take the missed dose if you are still able to have 7-8 hours of

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Peel Here But Do Not Remove

• Elderly or frail patients and patients with brain and
blood-vessel-related disease or liver or kidney
disease: Half the above adult dose. A lower dose of 5 mg at
night may be used. This dose may be increased to 10 mg or in
extreme cases to 20 mg, by your doctor.

13

Draft: 44003837
Laetus code: supplier to add
Mat.no.: supplier to add

temazepam
#20 mg
tablets

additional leaflet label information:

Artwork Proof Box

Ref: N024 - PIQ to update to label leaflet + responses + new cutter
Proof no.
001.1

Date prepared:
29/04/2016

Colours:
Pantone 541
Pantone 559

Pantone 165
Black

Dimensions: 45 x 898 mm

Font size:
5.5pt
Fonts:
FuturaCEEF

Base label:

45 mm x 115 mm

Leaflet page 1:

45 mm x 69 mm

Right hand opening:
Left hand opening:
Overall leaflet size:

45 mm x 898 mm

Page widths:

69, 66, 65, 64, 64,
63, 65, 64, 64, 64,
64, 63, 63, 60

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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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