SUMMARY CMI

TEMTABS

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using TEMTABS?

TEMTABS contains the active ingredient temazepam. TEMTABS is used to treat sleeping problems, also called insomnia.

For more information, see Section 1. Why am I using TEMTABS? in the full CMI.

2. What should I know before I use TEMTABS?

Do not use if you have ever had an allergic reaction to TEMTABS 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.

For more information, see Section 2. What should I know before I use TEMTABS? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with TEMTABS and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use TEMTABS?

• The dose of TEMTABS 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 TEMTABS with a glass of water. It can be taken with or without food.

More instructions can be found in Section 4. How do I use TEMTABS? in the full CMI.

5. What should I know while using TEMTABS?

For more information, see Section 5. What should I know while using TEMTABS? in the full CMI.

6. Are there any side effects?

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

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

TEMTABS

Active ingredient: Temazepam

Consumer Medicine Information (CMI)

This leaflet provides important information about using TEMTABS. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using TEMTABS.

Where to find information in this leaflet:

1. Why am I using TEMTABS?
2. What should I know before I use TEMTABS?
3. What if I am taking other medicines?
4. How do I use TEMTABS?
5. What should I know while using TEMTABS?
6. Are there any side effects?
7. Product details

1. Why am I using TEMTABS?

TEMTABS contains the active ingredient temazepam. TEMTABS is a benzodiazepine which is thought to work by acting on the brain chemicals.

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

2. What should I know before I use TEMTABS?

In general, benzodiazepines such as TEMTABS 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 use TEMTABS if:

• You are allergic to Temazepam or any other benzodiazepine medicines or any of the ingredients listed at the end of this leaflet.
• Always check the ingredients to make sure you can use this medicine.
• You have severe and chronic lung disease or breathing difficulties
• You have sleep apnoea
• You suffer from depression with or without anxiety problems. Temazepam can increase thoughts of death or suicide.
• The packaging shows signs of tampering or the tablets do not look quite right.
• If 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.
• take any medicines for any other condition
• if you are allergic to any other medicines, foods, dyes or preservatives
• if you plan to have surgery.

TEMTABS 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 TEMTABS in patients with epilepsy can cause a temporary increase in the number and severity of seizures.

Your doctor may have prescribed TEMTABS for depression or psychosis. TEMTABS is not recommended as the first choice of treatment for depression and psychosis. It may increase depression, worsen mental illness, suicidal thoughts and actions.

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.

TEMTABS should not be used 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 TEMTABS during pregnancy.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

TEMTABS may pass into breast milk and cause drowsiness and feeding difficulties in the baby. Your doctor will discuss the risks and benefits of taking TEMTABS 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 TEMTABS and affect how it works. These include:

• Other sleeping tablets, sedatives or tranquillisers
• 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.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect TEMTABS.

4. How do I use TEMTABS?

How much to take

• The dose of TEMTABS 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/use TEMTABS

• Your doctor will tell you when to take TEMTABS. This depends on your condition and whether or not you are taking any other medicines.
• TEMTABS 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 the medicine.
• Follow the instructions provided and use TEMTABS until your doctor tells you to stop.

How to take TEMTABS

• Swallow TEMTABS with a glass of water.
• TEMTABS can be taken with or without food.

If you forget to use TEMTABS

TEMTABS should be used regularly at the same time each day. If you forget to take TEMTABS before you go to bed and you wake up late in the night or early in the morning, do not take TEMTABS 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 use too much TEMTABS

If you think that you have used too much TEMTABS, you may need urgent medical attention.

If you take too much TEMTABS 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
  (by calling 13 11 26), 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 using TEMTABS?

Things you should do

• Take TEMTABS exactly as your doctor has prescribed.
• If you have to have any blood tests, tell your doctor that you are taking TEMTABS. 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 TEMTABS.
• Tell your doctor if you feel this medicine is not helping your condition.
• Keep enough TEMTABS to last weekends and holidays.

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.

Remind any doctor, dentist or pharmacist you visit that you are using TEMTABS.

Call your doctor straight away if you:

• feel this medicine is not helping your condition.
• become pregnant while you are taking TEMTABS.

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 stop taking your medicine or change the dose, without first checking with your doctor.
• Do not take TEMTABS for a longer time than your doctor has prescribed.
• 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.

Stopping TEMTABS suddenly may cause some unwanted withdrawal effects. It is more common in patients that have received high doses over longer 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.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how TEMTABS affects you.

TEMTABS may cause drowsiness or dizziness in some people. Even though you take TEMTABS at night, you may still be drowsy or dizzy the next day.

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.

Drinking alcohol

Tell your doctor if you drink alcohol.

Combining TEMTABS 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.

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

Looking after your medicine

• 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 your medicine in a cool dry place where the temperature stays below 30°C

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.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

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.

Do not use this medicine after the expiry date.

6. Are there any 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

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.

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 TEMTABS contains

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

Do not take this medicine if you are allergic to any of these ingredients.

What TEMTABS looks like

TEMTABS 10 mg are white to off-white, round, biconvex tablets with one side plain and the other with a stylised “S”.

Available in blister packs of 25 tablets.

Australian Registration Number: AUST R 91058

Who distributes TEMTABS

In Australia:

Aspen Pharma Pty Ltd
34-36 Chandos Street
St Leonards NSW 2065
(AUST R 91058)

In New Zealand:

Pharmacy Retailing (NZ) Ltd t/a
Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks
Mangere, Auckland

Telephone: (09) 9185 100
Fax: (09) 9185 101

This leaflet was prepared in September 2024.

Published by MIMS November 2024

1 Name of Medicine

Temazepam.

2 Qualitative and Quantitative Composition

Temtabs tablets contain temazepam 10 mg as the active ingredient.

Excipients with known effect.

3 Pharmaceutical Form

Temtabs 10 mg are a white to off-white, round, biconvex tablet, with stylised "S" on one side and plain on the other side.

4 Clinical Particulars

4.1 Therapeutic Indications

Adjunctive therapy in the short-term management of insomnia in adults.

4.2 Dose and Method of Administration

Dosage should be individualised for maximum beneficial effect. For use as a hypnotic, the usual adult dose is 10-30 mg taken one-half hour before retiring. In elderly or debilitated patients, 10 mg Temtabs is the initial recommended dosage.
The need for continued therapy with Temtabs in patients who have been taking medication for several weeks should be evaluated periodically.
Temtabs is not recommended for children.

4.3 Contraindications

Patients with a known hypersensitivity to benzodiazepines or to any of the formulation.
Patients with chronic obstructive airways disease with incipient respiratory failure.
Patients with sleep apnoea.
Temazepam should not be used as monotherapy to treat depression, or symptoms of anxiety associated with depression, due to a risk of suicide (see Section 4.4 Special Warnings and Precautions for Use).

4.4 Special Warnings and Precautions for Use

Although hypotension has occurred rarely, Temtabs should be administered with caution to patients in whom a drop in blood pressure might lead to cardiac or cerebral complications. This is particularly important in elderly patients.
Transient amnesia or memory impairment has been reported in association with the use of benzodiazepines.
Temtabs could increase the muscle weakness in myasthenia gravis and should be used with caution in this condition.
Caution should be used in the treatment of patients with acute narrow angle glaucoma (because of atropine-like side effects).

Depression, psychosis and schizophrenia.

CNS and/or paradoxical reactions.

Impaired respiratory function.

Epilepsy.

Abuse.

Dependence.

Duration of treatment.

Tolerance.

Withdrawal.

Dose tapering.

Somnambulism and associated behaviours.

Angioedema.

Concomitant use with alcohol/CNS depressants.

Use in renal impairment/hepatic impairment and blood dyscrasias.

Use in the elderly or debilitated patients.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The benzodiazepines, including Temtabs, produce additive CNS depressant effects when co-administered with other medications which themselves produce CNS depression, e.g. barbiturates, alcohol, sedatives, tricyclic antidepressants, non-selective MAO inhibitors, phenothiazines and other antipsychotics, skeletal muscle relaxants, antihistamines or narcotic analgesics and anaesthetics.
The cytochrome P450 system has not been shown to be involved in the disposition of Temtabs and, unlike many benzodiazepines, pharmacokinetic interactions involving the P450 system have not been observed with Temtabs.
The anticholinergic effects of other drugs including atropine and similar drugs, antihistamines and antidepressants may be potentiated.
Interactions have been reported between some benzodiazepines and anticonvulsants, with changes in the serum concentration of the benzodiazepine or anticonvulsant. It is recommended that patients be observed for altered responses when benzodiazepines and anticonvulsants are prescribed together, and that serum level monitoring of the anticonvulsant be performed more frequently.
Minor EEG changes, usually low voltage fast activity, of no known clinical significance, have been reported with benzodiazepine administration.
Administration of theophylline or aminophylline may reduce the sedative effects of benzodiazepines.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

As with all patients taking CNS depressant medications, patients receiving Temtabs should be warned not to operate dangerous machinery or motor vehicles until it is known that they do not become drowsy or dizzy from Temtabs therapy. Abilities may be impaired on the day following use. In sleep laboratory studies in volunteers, doses of 10 and 20 mg did not significantly affect morning performance; however, the 30 mg dose produced impairment of psychomotor behaviour on the morning following night time administration. Patients should be advised that their tolerance for alcohol and other CNS depressants will be diminished and that these medications should either be eliminated or given in reduced dosage in the presence of Temtabs.

4.8 Adverse Effects (Undesirable Effects)

Reporting suspected adverse effects.

4.9 Overdose

Overdosage of benzodiazepines is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion, lethargy, dysarthria and paradoxical reactions. In more serious cases, symptoms may include ataxia, CNS depression, hypotonia, hypotension, respiratory depression, cardiovascular depression, coma and, very rarely, proves fatal.
Following overdosage with oral benzodiazepines, activated charcoal may be given to reduce absorption, if given within one or two hours after ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via nasogastric tube, once the airway is protected. Hypotension and respiratory depression should be managed according to general principles.
Haemoperfusion and haemodialysis are not useful in benzodiazepine intoxication. The benzodiazepine antagonist flumazenil may be used in hospitalised patients for the reversal of acute benzodiazepine effects. Please consult the flumazenil product information prior to usage.

Treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Metabolism and excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Lactose monohydrate, microcrystalline cellulose, maize starch and magnesium stearate.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C. Protect from moisture.

6.5 Nature and Contents of Container

Pack sizes of 5, 10 and 25 tablets in PVC/PVdC/Al blisters.

Note.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Temazepam is a white, odourless crystalline powder; it is sparingly soluble in alcohol and freely soluble in chloroform, but insoluble in water. The molecular weight is 300.8.
Temazepam is a 1,4 benzodiazepine with the chemical name 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1-4-benzodiazepin-2-one.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes