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TEMAZEPAM 20 MG TABLETS

Active substance(s): TEMAZEPAM / TEMAZEPAM

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TEVA UK Ref:

Version:

231-30-60844-ZA LBL TEMAZEPAM 20mg TAB 250 TUK
This production drawing is the property of CCL Label A/S and may not be distributed to a third
party without CCL Label A/S's written consent. You may only copy the material to persons within
your organisation for which you hold full responsibility. You must at any time without delay
return such material to CCL Label A/S when requested by CCL Label A/S in writing.

Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

Nyager 11-17 · DK-2605 Brøndby · Phone: +45 43 45 68 00 · Fax: +45 43 43 06 00 · E-mail: cphprepress@cclind.com

No
195 mm
82 mm
N/A
N/A

Colours Used:

1

04 November 2016

S8 (PANTONE® 276C)

S7 (PANTONE® 116 C)

D3 (PANTONE® 306 C)

PANTONE® GREEN C

Braille

Template

TEVA UK Ref:

Version:

231-30-60844-ZA LBL TEMAZEPAM 20mg TAB 250 TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
195 mm
82 mm
N/A
N/A

Colours Used:

1

04 November 2016

S8 (PANTONE® 276C)

S7 (PANTONE® 116 C)

D3 (PANTONE® 306 C)

PANTONE® GREEN C

Braille

Template

TEVA UK Ref:

Version:

231-30-60844-ZA LBL TEMAZEPAM 20mg TAB 250 TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
195 mm
82 mm
N/A
N/A

Colours Used:

1

04 November 2016

S8 (PANTONE® 276C)

S7 (PANTONE® 116 C)

D3 (PANTONE® 306 C)

PANTONE® GREEN C

Braille

Template

Braille reads in Marburg Medium:
Dimensions: 82 x 195 mm

Customer name: TEVA
Att.:

Braille: Yes

#20 MG

Date: 09.02.2010
CCL order no.: 117559
File name: 82x195 (82x134+11) mm 5 bl
Customer Service ref: Jesper Andreasen
Prepress ref: ITB

ANEXAMPLE
#12,5 MG
FILM-COATED TABLETS

Temazepam

No. of leaves: 5
Winding direction: Outside 3

TABLETS
For proofreading of Braille

Leaflet outside (Prima)
11 mm
Tab

134 mm
Front page outside

10 mm
Glue

The colours on print/sample print must not be considered as an exact version of the colours on the final print. Our printing department does not take the responsibility for mistakes, which are not corrected in the proof.
Please note that some Braille characters can vary from country to country. Please check that all Braille characters are as requested.

New advice for drivers - see leaflet inside

250

Braille placement only

Base label (Selfadhesive)

124 mm

10 mm
Glue

tablets

30 mm

ccllabel.dk

134 mm
Page 1

UK Reg'd T.M.

Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the
same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in
this leaflet. See section 4.

Store in a dry place. Protect from light

tablets

TEMAZEPAM 20 mg TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER

Keep out of the sight and reach of children.

EXP.:

New advice for drivers - see leaflet inside

250

Each tablet contains 20 mg of temazepam
Also contains lactose. Dosage: Use as directed by the doctor.
Read the package leaflet before use. 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.

20
temazepam
#20 mg mg
tablets
LOT.:

New advice for drivers - see leaflet inside

11 mm
Tab/Glue

Temazepam

UK Reg'd T.M.

mg

20 mm

Oral use

Keep out of the sight and reach of children.

20

tablets

30 mm

20 mg Tablets

Store in a dry place. Protect from light

Oral use

Each tablet contains 20 mg of temazepam
Also contains lactose. Dosage: Use as directed by the doctor.
Read the package leaflet before use. 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.

20 mg Tablets

MA Holder:
TEVA UK Limited,
Eastbourne BN22 9AG
PL 00289/0149
60844-ZA

Temazepam

250

10 mm
Glue

IN THIS LEAFLET:
1. What Temazepam is and what it is used for
2. Before you take Temazepam
3. How to take Temazepam
4. Possible side effects
5. How to store Temazepam
6. Further information

1
MA Holder:
TEVA UK Limited,
Eastbourne BN22 9AG
PL 00289/0149
60844-ZA

124 mm

PIP 077-6054

11 mm
Tab/Glue

124 mm
Page 6

134 mm
Page 7

Premedication
• Adults: 20-40 mg should be taken 30-60 minutes before surgery.
• Elderly: Lower doses may be required by elderly patients, up to half the normal adult dose may be adequate.
• Children: Temazepam is not recommended for use in children under the age of 18 years.
If you take more Temazepam than you should
If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the
tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to
cause drowsiness, difficulty in controlling movements, slurred speech and involuntary eye movements; coma, low
blood pressure and breathing problems can also occur.
Please take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so that they
know which tablets were consumed.
If you forget to take Temazepam
If you fall asleep without having taken a dose and wake up some hours later, do not take the missed dose. If necessary,
return to your normal dose schedule the following night. Do not take a double dose to make up for a forgotten dose.
If you stop taking Temazepam
You will be told by your doctor to stop taking the tablets as soon as is possible and the dose will be reduced
gradually. You should not stop taking the tablets suddenly or without medical advice. If the tablets are stopped
abruptly or the dose reduced too rapidly you may get unpleasant effects.
These withdrawal effects can include headache, muscle pain, tension, severe anxiety, confusion, depression,
restlessness, irritability and sweating. In severe cases of withdrawal you may experience a feeling of things being
unreal, a feeling of detachment from your surroundings, numbness and tingling in the hands and feet, sounds
seeming to be louder than usual and which can sometimes be painful if the sound is loud, sensitivity to light or touch,
hallucinations, involuntary movements, being sick (vomiting) and fits. In addition, problems with sleeping, feeling
restless and anxious and mood changes may return.
If you experience these or any other unusual effects when you stop taking Temazepam, speak to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4

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Page 8

POSSIBLE SIDE EFFECTS

Like all medicines, Temazepam can cause side effects, although not everybody gets them.
If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your
nearest hospital:
• an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives).
This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.
Tell your doctor immediately if you suffer from:
• behavioural changes such as restlessness, agitation, irritability, aggressiveness, delusions, excitement, rages,
nightmares, hallucinations, confusion, psychiatric disorders and inappropriate behaviour, as your treatment may be
stopped; you are more likely to suffer these effects if you are elderly.
The following side effects are common at the beginning of therapy. These effects are often mild and usually wear off after
a few days treatment:
• daytime drowsiness or drowsiness the following day
• reduced alertness
• loss of co-ordination
• numbed emotions
• confusion
• tiredness
• dizziness
• muscle weakness
• double vision
• light-headedness
The following rare effects may also occur:
• skin reactions e.g. rash
• headache
• spinning sensation (vertigo)

WHAT TEMAZEPAM IS AND WHAT IT IS USED FOR

Temazepam is an anti-anxiety drug which is used in the short-term to help people sleep. It belongs to a group of drugs
called benzodiazepines.
Temazepam is used for:
• short-term treatment of insomnia (difficulty in sleeping) which is severe, disabling or causing extreme distress
• pre-medication before minor surgery or other procedures.

134 mm
Page 2

2

BEFORE YOU TAKE TEMAZEPAM

Do NOT take Temazepam if you:
• are allergic (hypersensitive) to temazepam or other benzodiazepines (e.g. diazepam) or any of the other ingredients of
this medicine (see section 6)
• have difficulty in breathing or lung problems
• have a condition called sleep apnoea syndrome (where breathing stops during sleep)
• have myasthenia gravis (a condition where the muscles become weak and tire easily)
• have severe liver problems
• have a history of mental illness, such as obsessions or phobias (irrational fears)
• suffer from anxiety or psychotic illness. Temazepam tablets may unmask or worsen symptoms
• are breast-feeding
• are a child under the age of 18 years.
Take special care with Temazepam
Talk to your doctor before you start to take this medicine 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 muscle relaxant effect of the tablets
• have long-term lung, kidney or liver problems
• have history of breathing problems. Whilst taking Temazepam tablets your breathing may become less forceful
• have a history of problems with alcohol or drug abuse (your risk of dependence is higher)
• suffer from mental illness, depression or depression with anxiety
• have recently suffered a bereavement (if Temazepam is taken to help sleep during periods of bereavement it may stop
you coming to terms with the loss)
• are or suspect that you are pregnant.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicine including medicines obtained without
a prescription. 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.

5

HOW TO STORE TEMAZEPAM

Keep out of the sight and reach of children.
These tablets should be stored in a dry place, protected from light in the package or container supplied. Do not transfer
them to another container.
Do not use Temazepam after the expiry date that is stated on the outer packaging. 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 ingredient is temazepam.
• The other ingredients are microcrystalline cellulose, lactose anhydrous, croscarmellose sodium, magnesium stearate
and the colour, titanium dioxide (E171).
What Temazepam Tablets look like and contents of the pack:
• Temazepam Tablets 20 mg are white to pale yellow, flat, bevel edged tablets with a breakline on one side and “5K2” on
the reverse.
• The product is available in pack sizes of 7, 10, 14, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112, 120, 150, 160, 168, 250, 500 and
1000 tablets.
Not all pack sizes may be marketed.
The Marketing Authorisation holder: TEVA UK Limited, Eastbourne, BN22 9AG
Company Responsible for Manufacture: TEVA Pharmaceutical Works Private Limited Company
H-4042 Debrecen, Pallagi út 13., Hungary.
This leaflet was last revised: November 2016
PL 00289/0148-0149
60844-ZA

134 mm
Page 3

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Page 4

134 mm
Page 5 (Front page inside)

The following medicines may increase the sedating effect of Temazepam tablets:
• medicines to treat mental illness (antipsychotics)
• medicines to treat depression, such as phenelzine and amitriptyline
• other sleeping pills, such as zopiclone
• anxiolytic or sedative drugs, such as diazepam
• narcotics (strong pain killers) such as codeine, morphine. Feelings of excitement (euphoria) may increase, which in turn
increase the chance on physical or mental dependence
• medicines used to treat epilepsy
• anaesthetics (used during surgery)
• sedative antihistamines, such as promethazine
• medicines used to treat high blood pressure, such as doxazosin and lofexidine
• nabilone (used to treat vomiting and nausea).
• cisapride (used for stomach disorders)
• muscle relaxants, such as baclofen and tizanidine
Zidovudine and ritonavir (retroantiviral drugs used to treat HIV infection and AIDS) – may cause an increase in
concentration of temazepam in the blood.
Theophylline (used to treat asthma) – may decrease the effect of temazepam.
Disulfiram (used to treat alcohol dependence) – inhibits the metabolism of temazepam and increases the risk of
temazepam poisoning.
Fluvoxamine (used to treat depression) – increases the concentration of temazepam in the blood.
Cimetidine (used to treat stomach ulcers) – decreases the blood concentration of temazepam in the blood.
Rifampicin (an antibacterial drug) – increases the metabolism of temazepam and decreases the temazepam blood concentration.
Clozapine medicines used to treat psychoses
Temazepam:
• increases or decreases the level of phenytoin
• increases the effects of sodium oxybate (used to treat narcolepsy with cataplexy – sleep disorders with sudden and
transient loss of muscle tone).
• possibly reduces the effects of levodopa (used to treat Parkinson’s disease).

• enhances the blood pressure lowering effect of anti-hypersensitive medicines (e.g. moxonidine, beta-blockers).
Important information about some of the ingredients of Temazepam
• Patients who are intolerant to lactose should note that Temazepam Tablets contain a small amount of lactose. If your
doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Important safety messages about Temazepam:
• When taking this medicine there is a risk of dependence (a need to keep taking the medicine). The risk increases with
the dose and length of treatment period. The risk is greater if you have ever had a history of alcohol or drug abuse, or
suffer from a personality disorder.
• Close medical supervision is required when taking this medicine. Your doctor will ensure that you take the lowest
effective dose and this should be taken for the shortest possible time and not exceed 4 weeks.
• You may become tolerant to the effects of Temazepam after you have been taking it repeatedly for a few weeks (see
section 3, How to take Temazepam).
• When stopping this medicine you may experience withdrawal effects (see section 3, If you stop taking Temazepam).
• Behavioural effects may occur while taking Temazepam (see section 4, Possible Side Effects).
• To reduce the risk of amnesia (loss of memory), you should make sure that you are able to have an uninterrupted sleep
of at least 7-8 hours.
• If you have been given Temazepam for premedication, you should be accompanied home.
Taking Temazepam with food and drink
Do NOT drink alcohol while taking these tablets, as taken together they could make you feel very drowsy which could be
dangerous.
Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant or breast-feeding, ask your doctor or pharmacist for advice before
taking this medicine.
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 and feeding difficulties. If this medicine is taken regularly in late
pregnancy, your baby may develop withdrawal symptoms.

Driving and using machines
Your tablets may make you feel drowsy during the day, make you forgetful and impair your concentration, vision and
muscle function. Also you will be less alert if you have not been able to sleep for long enough. If affected, do NOT drive or
operate machinery.
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:
• 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.

BRAILLE READS: temazepam #20 mg Tablets

REG0211516

134 mm
Page 9

• stomach upset (indigestion, diarrhoea, constipation)
• vivid dreams or nightmares
• sleep disturbance
• changes in sex drive
• depression
• impaired muscular function
• dry mouth
• memory loss
• yellowing of your skin or the whites of your eyes (jaundice)
• difficulty passing urine leading to pain and discomfort.
• low blood pressure
• a very fast, uneven or forceful heartbeat (palpitation)
• salivation changes
• visual disturbance
• slurred speech (dysarthria)
• shaking
• incontinence
• blood disorders
• abnormal results in liver function tests.
Use (even at therapeutic dosages) may lead to physical dependence; sudden discontinuation of treatment may result in
withdrawal effects and recurrence of problems.
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.

Leaflet inside (Sekunda)

PIP 077-6054

20 mm

UK Reg'd T.M.

mg

5 017007 364146

20

Store in a dry place. Protect from light

Oral use

temazepam
#20 mg
tablets

2, 3 and 4.5 mm)

Keep out of the sight and reach of children.

20 mg Tablets
• All pictures have to be placed in 100% - 300 dpi
• Include all pictures and fonts
• Tolerances for text and important graphic:
2 mm
• Remember blee d - 2 mm
• Please put Braille in the center of the tolerance area (tolerances for braille:

Each tablet contains 20 mg of temazepam
Also contains lactose. Dosage: Use as directed by the doctor.
Read the package leaflet before use. 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.

Temazepam

MA Holder:
TEVA UK Limited,
Eastbourne BN22 9AG
PL 00289/0149
60844-ZA

Peel Here

PIP 077-6054

Overlaminated Fix-a-Form

Version 0.2

Approved

Page 1 of 2

3

HOW TO TAKE TEMAZEPAM

Always take Temazepam exactly as your doctor has told you. You will be given the lowest effective dose for the shortest
possible time. If there is anything you are not sure about check with your doctor or pharmacist.
The tablets should be swallowed preferably with a glass of water.
Your doctor will decide the correct dosage; the usual dose is:
Insomnia
• Adults: 10-20 mg should be taken when going to bed or up to 30 minutes before going to bed. Very occasionally, the dose
may be increased to 30-40 mg daily.
• Elderly patients: the dose is 10 mg daily. Very occasionally, this may be increased to 20 mg daily.
• Children: Temazepam is NOT recommended for use in children under the age of 18 years.
For patients who have certain problems with blood vessels or their liver the dosage may be lower.
Do NOT change the dose yourself.

11 mm
Tab/Glue

THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.2 mockup-label-pil-uk-debrecen-pl-00289-0149-temazepam-20mg-tablets

APPROVALS
Signed by
Darryl Hill

REG0211516

Meaning of Signature
Regulatory Affairs Approval

Version 0.2

Approved

Server Date
21-Apr-2017 08:12:48 AM

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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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