Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
1. Why am I taking TEMAZE?
TEMAZE contains the active ingredient temazepam. TEMAZE is used to treat sleeping
problems, also called insomnia.
2. What should I know before I take TEMAZE?
Do not take if you have ever had an allergic reaction to TEMAZE or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with TEMAZE and affect how it works.
4. How do I take TEMAZE?
The dose of TEMAZE varies from patient to patient.
Your doctor will tell you how many tablets, you need to take each day and when to
take them.
Swallow TEMAZE with a glass of water. It can be taken with or without food.
5. What should I know while taking TEMAZE?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are taking TEMAZE.
Tell your doctor if you feel this medicine is not helping your condition.
If you plan to have surgery (that needs a general anaesthetic), including dental surgery,
tell your doctor or dentist that you are taking TEMAZE.
|
|
Things you should not do
|
Do not stop taking this medicine or change the dose, without first checking with your
doctor.
Do not take TEMAZE for a longer time than your doctor has prescribed.
|
|
Driving or using machines
|
Do not drive or operate machinery until you know how TEMAZE affects you.
TEMAZE may cause drowsiness or dizziness in some people.
|
|
Drinking alcohol
|
Be careful when drinking alcohol while taking TEMAZE.
Combining TEMAZE and alcohol can make you more sleepy, dizzy or light-headed.
|
|
Looking after your medicine
|
Keep your medicine in a cool dry place (store below 30°C for bottle pack and store
below 25°C for blister pack).
Keep your tablets in the bottle or blister pack until it is time to take them.
Keep it where children cannot reach it.
|
6. Are there any side effects?
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking TEMAZE.
Some mild side effects include dizziness, drowsiness, light-headedness, headache, nausea, stomach pain and
dry mouth.
Some serious side effects which may require medical attention include confusion, loss of memory, disorientation,
behavioural or mood changes, signs of frequent infections such as fever, and yellowing
of the eyes and skin (jaundice).
Active ingredient: temazepam
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking TEMAZE. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking TEMAZE.
Where to find information in this leaflet:
1. Why am I taking TEMAZE?
TEMAZE contains the active ingredient temazepam. TEMAZE is a benzodiazepine which is thought to work by acting on the brain chemicals.
TEMAZE is used to treat sleeping problems, also called insomnia.
Ask your doctor if you have any questions about why TEMAZE has been prescribed for
you.
Your doctor may have prescribed TEMAZE for another reason.
2. What should I know before I take TEMAZE?
In general, benzodiazepines such as TEMAZE should be taken for short periods only
(for example 2 to 4 weeks). Continuous long-term use is not recommended unless advised
by your doctor.
The use of benzodiazepines may lead to dependence on the medicine.
Warnings
Do not take TEMAZE if:
you are allergic to temazepam, or any other benzodiazepine medicines or any of the
ingredients listed at the end of this leaflet. Some of the symptoms of an allergic
reaction may include:
skin rash, itching or hives
swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
wheezing or shortness of breath
Always check the ingredients to make sure you can take this medicine.
you have severe and chronic lung disease or breathing difficulties
you have sleep apnoea, a condition where you have breathing problems when you sleep
you suffer from depression with or without anxiety problems. temazepam can increase
the thoughts of death or suicide
the packaging shows signs of tampering or the tablets do not look quite right
the expiry date (EXP) printed on the pack has passed.
Check with your doctor if you:
have any medical conditions, especially the following:
liver, kidney or lung problems
epilepsy, fits or convulsions
severe muscle weakness known as myasthenia gravis
low blood pressure as it may lead to heart or brain complications
any blood disorder
glaucoma (increased pressure in the eye)
depression, psychosis or schizophrenia
drug or alcohol dependence or a past history of these problems.
Your doctor may want to take special care if you have any of these conditions.
take any medicines for any other condition
are allergic to any other medicines, foods, dyes or preservatives
plan to have surgery.
TEMAZE is not recommended for use in children under 16 years of age, as its safety
and effectiveness have not been established in this age group.
Suddenly stopping TEMAZE in patients with epilepsy can cause a temporary increase
in the number and severity of seizures.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
TEMAZE should not be taken during pregnancy.
It should be avoided during the first trimester of pregnancy as it may increase the
risk of defects present at birth.
It may cause unwanted effects in the newborn baby if taken during the late phase of
pregnancy or during childbirth, such as low muscle strength, shallow breathing and
feeding problems.
Your doctor will discuss the risks and benefits of taking TEMAZE during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
TEMAZE may pass into breast milk and cause drowsiness and feeding difficulties in
the baby. Your doctor will discuss the risks and benefits of taking TEMAZE when breastfeeding.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with TEMAZE and affect how it works. These include:
other sleeping tablets, sedatives or tranquilisers
medicines for depression, schizophrenia and other mental illnesses
medicines to treat epilepsy and fits
medicines for allergies, for example antihistamines or cold tablets
medicines used to treat Parkinson's disease
theophylline, a medicine used to treat asthma
muscle relaxants
some pain relievers such as opioid medicines
medicines taken to relieve stomach cramps and to prevent motion sickness.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect TEMAZE.
4. How do I take TEMAZE?
Follow all directions given to you by your doctor and pharmacist carefully. They may
differ from the information contained in this leaflet.
How much to take
The dose of TEMAZE varies from patient to patient.
Your doctor will tell you how many tablets you need to take each day. This depends
on your condition and whether or not you are taking any other medicines.
The usual starting dose is one 10 mg tablet each night.
Elderly people over 65 years of age may need smaller doses.
When to take TEMAZE
Take TEMAZE tablets one hour before going to bed.
Your doctor will tell you when to take TEMAZE.
This depends on your condition and whether or not you are taking any other medicines.
How long to take TEMAZE for
Keep taking TEMAZE for as long as your doctor recommends.
TEMAZE is usually used for short periods only (such as 2 to 4 weeks).
Continuous long-term use is not recommended unless advised by your doctor. The use
of benzodiazepines may lead to dependence on this medicine.
How to take TEMAZE
Swallow TEMAZE with a glass of water.
TEMAZE can be taken with or without food.
If you forget to take TEMAZE
TEMAZE should be taken regularly at the same time each day. If you forget to take
TEMAZE before you go to bed and you wake up late in the night or early in the morning,
do not take TEMAZE as you may have trouble waking in the morning.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
This may increase the chance of you getting an unwanted side effect.
If you are unsure about whether to take your next dose, speak to your doctor or pharmacist.
If you take too much TEMAZE
If you think that you or anyone else has taken too much TEMAZE, urgent medical attention
may be needed.
If you take too much TEMAZE you may feel drowsy, confused, tired, dizzy, have difficulty
breathing, feel weak, have low blood pressure, lack mobility and coordination, be
unconscious, or rarely it may be fatal.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while taking TEMAZE?
Things you should do
Take TEMAZE exactly as your doctor has prescribed.
If you have any blood tests, tell your doctor that you are taking TEMAZE. It may affect
the result of some tests.
Visit your doctor regularly so they can check on your progress. Your doctor will check
your condition to see whether you should continue to take TEMAZE.
Tell your doctor if you feel this medicine is not helping your condition.
Keep enough TEMAZE to last weekends and holidays.
Before starting any new medicine, tell your doctor or pharmacist that you are taking
TEMAZE.
If you plan to have surgery (that needs a general anaesthetic), including dental surgery,
tell your doctor or dentist that you are taking TEMAZE.
Be careful if you are elderly, unwell or taking other medicines.
Some people may experience side effects such as drowsiness, confusion, dizziness and
unsteadiness, which may increase your risk of a fall.
Remind any doctor, dentist or pharmacist you visit that you are taking TEMAZE.
Call your doctor straight away if you:
feel this medicine is not helping your condition.
become pregnant while you are taking TEMAZE.
All thoughts of suicide must be taken seriously. Tell your doctor or a mental health
professional immediately if you have any suicidal thoughts or other mental/mood changes.
Things you should not do
Do not take TEMAZE for a longer time than your doctor has prescribed.
TEMAZE should be taken for short periods only (for example 2 to 4 weeks) unless advised
otherwise by your doctor.
Do not use this medicine to treat any other complaints unless your doctor tells you
to.
Do not give it to anyone else, even if they have the same condition as you.
Do not stop taking your medicine or change the dose, without first checking with your
doctor.
Stopping TEMAZE suddenly may cause some unwanted withdrawal effects. It is more common
in patients that have received high doses over long periods of time.
Withdrawal symptoms include insomnia, anxiety, unusual mood, panic attacks, dizziness,
light sensitivity, confusion, (seeing or hearing things that are not real (hallucinations),
vomiting, sweating, fits (convulsions), a feeling of loss of identity/feeling detached
from yourself (depersonalisation or derealisation) and loss of short-term memory.
Your doctor may want you to gradually reduce the amount you are taking before stopping
completely. This may help reduce the possibility of unwanted side effects.
If you suffer from epilepsy, do not suddenly stop taking TEMAZE. Stopping this medicine
may make your epilepsy worse.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how TEMAZE
affects you.
TEMAZE may cause drowsiness or dizziness in some people. Even though you may take
TEMAZE at night, you may still be drowsy or dizzy the next day.
Make sure you know how you react to TEMAZE before you drive a car, operate machinery,
or do anything else that could be dangerous if you are drowsy, dizzy or not alert.
This is very important if you are taking other drugs that also make you drowsy.
Drinking alcohol
Tell your doctor if you drink alcohol.
Combining TEMAZE and alcohol can make you more sleepy, dizzy or light-headed or increase
the risk of sleep walking and some other related sleep behaviours which may include
sleep-driving, making phone calls, or preparing and eating food while asleep.
This risk is also increased if you take more than the recommended dose.
Your doctor may suggest that you avoid alcohol or reduce the amount of alcohol you
drink while you are taking TEMAZE.
Looking after your medicine
Keep your tablets in the bottle or blister pack until it is time to take them, otherwise
they may not keep well.
Store below 30°C (bottle pack).
Store below 25°C (blister pack).
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If your doctor tells you to stop taking TEMAZE or the tablets have passed their expiry
date, ask your pharmacist what to do with any tablets left over.
Do not take this medicine after the expiry date.
6. Are there any side effects?
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking TEMAZE even if you do not think that it is connected with the medicine.
Do not be alarmed by this list of possible side effects. You may not experience any
of them.
If you are over 65 years of age, you may have an increased chance of getting side
effects.
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Very serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Some of these side effects can only be found when your doctor does tests from time
to time to check your progress.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What TEMAZE contains
|
Active ingredient
(main ingredient)
|
temazepam 10 mg
|
|
Other ingredients
(inactive ingredients)
|
lactose monohydrate
microcrystalline cellulose
maize starch
magnesium stearate
Sunset Yellow FCF Aluminium Lake (blister pack tablets only)
|
|
Potential allergens
|
sugars as lactose and traces of sulfites
|
Do not take this medicine if you are allergic to any of these ingredients.
What TEMAZE looks like
TEMAZE 10 mg (bottle pack): 5.5 mm flat bevel edged white to off-white tablet, debossed
TE over 10 on one side, alpha symbol on the reverse. (AUST R 63863).
Each bottle pack contains 25 tablets.
TEMAZE 10 mg (blister pack): 5.5 mm flat bevel edged light orange tablet, debossed
TE over 10 on one side, alpha symbol on the other. (AUST R 408408).
Each blister pack contains 25 tablets.
Who distributes TEMAZE
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in October 2024.
TEMAZE® is a Viatris company trade mark
TEMAZE_cmi\Oct24/00