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TEMTABS(R)

Temazepam Tablets

Consumer Medicine Information

CLICK HERE TO BUY APO-TEMAZEPAM TAB 10MG 25

What is in this leaflet

This leaflet answers some common questions about TEMTABS. It does not contain all of the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking TEMTABS against the benefits this medicine is expected to have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What TEMTABS is used for

TEMTABS is used to treat sleeping problems, also called insomnia.

Your doctor, however, may have prescribed TEMTABS for another purpose. Ask your doctor if you have any questions about why TEMTABS has been prescribed for you.

TEMTABS belongs to a group of medicines called benzodiazepines. They are thought to work by their action on brain chemicals.

In general, benzodiazepines such as TEMTABS should be taken for short periods only (for example 2 – 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.

This medicine is available only with a doctor`s prescription.

Before you take TEMTABS

When you must not take it

Do not take TEMTABS if:

1.you are allergic to:
TEMTABS or any of the ingredients listed at the end of this leaflet
any other medicine from the benzodiazepine group of medicines
2.you have severe lung disease or breathing difficulties.
3.you have sleep apnoea, a condition where you have breathing problems when you sleep

Do not take TEMTABS if the packaging is torn or shows signs of tampering.

Do not take TEMTABS after the expiry date (EXP) printed on the pack.

If you take it after the expiry date has passed, it may not work as well or have no effect at all.

Do not give this medicine to children unless advised by the child`s doctor.

The safety and effectiveness of TEMTABS in children under 16 years have not been established.

Before you take it

You must tell your doctor if:

1.you have any allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes
2.you are pregnant or planning to become pregnant

Do not take TEMTABS if you are pregnant or planning to become pregnant unless you and your doctor have discussed the risks and benefits involved.

3.you are breastfeeding or planning to breastfeed

Do not take TEMTABS if you are breastfeeding or planning to breastfeed unless you and your doctor have discussed the risks and benefits involved.

TEMTABS may pass into breast milk and cause drowsiness and/or feeding difficulties in the baby.

4.you have or have had any other medical conditions including:
liver, kidney or lung disease
blood disorders
fits or convulsions
severe muscle weakness known as myasthenia gravis
low blood pressure
glaucoma (high pressure in the eye)
depression, psychosis or schizophrenia
5.you drink alcohol regularly.

Alcohol may increase the effects of TEMTABS.

If you have not told your doctor about any of the above, tell them before you take any TEMTABS.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may interfere with TEMTABS. These include:

other sleeping tablets, sedatives or tranquillisers
medicines for depression
medicines for allergies for example antihistamines or cold tablets
pain relievers
muscle relaxants
medicines to control fits

These medicines may increase the effects of TEMTABS. You may need to take different amounts of your medicine or you may need to take different medicines. Your doctor will advise you.

Your doctor or pharmacist may have more information on medicines to be careful with or avoid while taking TEMTABS.

How to take TEMTABS

How much to take

The dose of TEMTABS may be different for each person. Your doctor will decide the right dose for you.

The recommended dose is 10 to 30 mg taken 30 minutes before going to bed.

If you are elderly or unwell 10 mg is the usual starting dose.

How to take it

Swallow TEMTABS tablets whole with a glass of water. Do not chew them.

TEMTABS may be taken with or without food.

When to take it

Take TEMTABS 30 minutes before going to bed in the evening.

How long to take it

Do not take TEMTABS for longer than your doctor says.

TEMTABS is usually used for short periods only (for example 2 – 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.

Continue taking TEMTABS as long as your doctor recommends it.

If you forget to take it

If you forget to take TEMTABS before you go to bed and you wake up late in the night or early morning, do not take any TEMTABS as you may have trouble waking in the morning. If you have any questions about this, ask your doctor or pharmacist.

Do not try to make up for missed doses by taking more than one dose at a time.

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 have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to casualty at your nearest hospital, if you think that you or anyone else may have taken too much TEMTABS. Do this even if there are no signs of discomfort or poisoning. Also report any other medicine or alcohol which has been taken. You may need urgent medical attention. Keep telephone numbers for these places handy.

If you take too much TEMTABS you may feel drowsy, confused, tired, dizzy, have difficulty breathing, feel weak or become unconscious.

While you are taking TEMTABS

Things you must do

Take TEMTABS exactly as your doctor has prescribed.

Tell all doctors, dentists and pharmacists who are treating you that you are taking TEMTABS.

If you become pregnant while you are taking TEMTABS, tell your doctor immediately:

Visit your doctor regularly.

Your doctor needs to check your progress and see whether you need to keep taking TEMTABS.

Tell your doctor if you feel TEMTABS is not helping your condition.

Always discuss with your doctor any problems or difficulties during or after taking TEMTABS.

Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.

Otherwise your doctor may think that it was not effective and change your treatment unnecessarily.

Keep enough TEMTABS to last weekends and holidays.

Things you must not do

Do not drive or operate machinery until you know how TEMTABS affects you.

TEMTABS may cause drowsiness or dizziness in some people and therefore may affect alertness.

Make sure you know how you react to TEMTABS before you drive a car, operate machinery, or do anything else that could be dangerous if you are drowsy, dizzy or not alert.

Even if you take TEMTABS at night, you may still be drowsy or dizzy the next day.

Do not take TEMTABS for a longer time than your doctor has prescribed.

TEMTABS should be taken for short periods only (for example 2 to 4 weeks), unless advised otherwise by your doctor.

Do not stop taking TEMTABS or change the dose, without first checking with your doctor.

Stopping this medicine suddenly may cause some unwanted effects. Your doctor will slowly reduce your dose of TEMTABS before you can stop taking it completely.

Do not suddenly stop taking TEMTABS if you suffer from epilepsy.

Stopping this medicine suddenly may make your epilepsy worse.

Do not use this medicine to treat any other complaints unless your doctor says to.

Do not give TEMTABS to anyone else, even if their symptoms seem similar to yours.

Things to be careful of

Be careful when drinking alcohol while taking TEMTABS.

Combining TEMTABS and alcohol can make you more sleepy, dizzy or lightheaded.

Your doctor may suggest that you avoid alcohol or reduce the amount of alcohol you drink while you are taking TEMTABS.

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 the risk of a fall.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using TEMTABS.

TEMTABS helps most people with insomnia, but it may have unwanted side effects in some people.

All medicines may have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

If side effects do happen, they are more likely to happen when you first start taking TEMTABS. These side effects may go away during treatment as your body adjusts to the dose. However, tell your doctor if you notice any of the following and they worry you:

dizziness
headache
mild daytime drowsiness

These are the more common side effects of TEMTABS.

Less common or rare side effects of TEMTABS include:

unsteadiness
confusion
faintness
shaking or tremors
weakness
leg cramps
skin rashes
feeling sick or vomiting
dry mouth
loss of taste
irritability
outbursts of anger and increased excitement
depression
sleep disturbances
memory loss
blurred vision
low blood pressure
feeling out of breath
fast or irregular heartbeats

Other side effects not listed above may occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell when you are taking, or soon after you have finished taking, TEMTABS.

Some people may get other side effects while using TEMTABS.
Ask your doctor or pharmacist if you don`t understand anything in this list.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using TEMTABS

Storage

Keep your tablets in their blister pack until it is time to take them.

If you take the tablets out of the blister pack they may not keep well.

Keep TEMTABS tablets in a cool, dry place where the temperature stays below 30 degrees C.

Do not store TEMTABS tablets or any other medicines, in a bathroom or near a sink. Do not leave it in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking TEMTABS or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets left over.

Product description

What it looks like

TEMTABS 10 mg tablets are orange, round, biconvex tablets, with stylised “S” on one side and plain on the other side. The tablets come in blister packs of 25.

Ingredients

The active ingredient in TEMTABS is temazepam.

Each TEMTABS 10 mg tablet contains 10 mg temazepam.

TEMTABS 10 mg tablets also contain:

lactose
cellulose – microcrystalline
maize starch
magnesium stearate

The colouring agent is sunset yellow (CI 15985) lake.

TEMTABS tablets do not contain gluten, sucrose, tartrazine or any other azo dyes.

Sponsor

Fawns & McAllan Pty Ltd
(A.C.N. 004 296 066)
1408 Centre Road
Clayton Victoria 3168
Australia
Phone: (03) 9839 2800
Australian Registration Number
TEMTABS 10 mg tablets
AUST R 91058
This leaflet was prepared on 17th August 1999 and updated on 24th January 2003 and 2nd February 2004.

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Temtabs Tablets 10MG Pack Of 25