TEMAZEPAM 10 MG TABLETS

Active substance: TEMAZEPAM

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231-30-60838-Y LBL TEMAZEPAM 10mg TAB 500 TUK
Version:

2

Dimensions:

10 September 2012

PL Number(s),
PL 00289/0148. TEVA UK Limited Licence
MA Holder & Packer: Packed at Debrecen/Godollo, in Hungary.
Reason for revision:

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

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F. P. Code: 231-10-36413
EAN code: 50 17007 36413 9
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500

Braille placement only

mg

500

Tablets

124 mm

10 mm
Glue

temazepam
10
#10 mg mg
tablets
500

Tablets

30 mm

134 mm
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134 mm
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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.
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.

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 reaction e.g. rash
• headache
• spinning sensation (vertigo)
• 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 (palpitations)
• 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.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

134 mm
Page 1

TEMAZEPAM 10 mg TABLETS

BRAILLE READS: temazepam #10 mg Tablets

UK Reg'd T.M.

Oral Use

EXP.:

10

124 mm
Page 6

4

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

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5

HOW TO STORE TEMAZEPAM

Keep out of the reach and sight 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 10 mg are white to pale yellow, flat, bevel edged tablets with a breakline
on one side and “5K1” on the reverse.
• The product is available in 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.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited,
Eastbourne, BN22 9AG.
This leaflet was last revised: August 2012.
PL 00289/0148
60838-Y

Leaflet inside (Sekunda)

11 mm
Tab/Glue

10 mg Tablets

LOT.:

Oral Use

MA Holder:
TEVA UK Limited,
Eastbourne, BN22 9AG.

10 mg Tablets

20 mm

Temazepam

UK Reg'd T.M.

Temazepam

30 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
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

MA Holder:
TEVA UK Limited,
Eastbourne, BN22 9AG.

10 mm
Glue

Each tablet contains 10 mg of temazepam. Also contains lactose.
DOSAGE: Use as directed by the doctor.
Please read the enclosed package leaflet before use.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
Store in a dry place. Protect from light.

124 mm

PL 00289/0148
60838-Y

11 mm
Tab/Glue

Each tablet contains 10 mg of temazepam. Also contains lactose.
DOSAGE: Use as directed by the doctor.
Please read the enclosed package leaflet before use.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
Store in a dry place. Protect from light.

20 mm

1
PL 00289/0148
60838-Y

Base label (Selfadhesive)

Tablets

ccllabel.dk

10

temazepam
#10 mg
tablets

5 017007 364139

Oral Use

PL 00289/0148
60838-Y

10 mg Tablets

MA Holder:
TEVA UK Limited,
Eastbourne, BN22 9AG.

Temazepam

10 mm
Glue

UK Reg'd T.M.

134 mm
Front page outside

Each tablet contains 10 mg of temazepam. Also contains lactose.
DOSAGE: Use as directed by the doctor.
Please read the enclosed package leaflet before use.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
Store in a dry place. Protect from light.

Peel Here

11 mm
Tab

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.

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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 of 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.
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.

2

BEFORE YOU TAKE TEMAZEPAM

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.

11 mm
Tab/Glue

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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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