Consumer medicine information

Temaze

Temazepam

BRAND INFORMATION

Brand name

Temaze

Active ingredient

Temazepam

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Temaze.

What is in this leaflet

This leaflet answers some common questions about Temaze.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking Temaze against the benefits expected for you.

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

Keep this leaflet with your medicine. You may need to read it again.

What Temaze is used for

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

Temaze belongs to a group of medicines called benzodiazepines. These medicines are thought to work by acting on brain chemicals.

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.

Temaze is not recommended for use in children under the age of 16, as its safety and effectiveness have not been established in this age group.

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.

Temaze is available only with a doctor's prescription.

Before you take Temaze

When you must not take it

Do not take Temaze if you are allergic to:

  • temazepam or any other benzodiazepine medicine
  • 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.

Do not take Temaze if you have:

  • severe lung disease or breathing difficulties
  • sleep apnoea, a condition where you have breathing problems when you sleep.

Do not take Temaze after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.

Tell your doctor if you are pregnant or plan to become pregnant. The use of Temaze during pregnancy is not recommended and may increase the risk of complications in your baby. Your doctor will discuss the risks and benefits of taking Temaze during pregnancy.

Tell your doctor if you are breastfeeding or wish to breastfeed. Temaze may pass into the breast milk and may cause drowsiness and feeding difficulties in the baby. Your doctor will discuss the risks and benefits of taking Temaze when breastfeeding.

Tell your doctor if you have, any medical conditions, especially the following:

  • severe muscle weakness known as myasthenia gravis
  • glaucoma (increased pressure in the eye)
  • depression, psychosis or schizophrenia
  • epilepsy (fits or convulsions)
  • low blood pressure
  • liver, kidney or lung problems
  • any blood disorder
  • 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.

Tell your doctor if you drink alcohol regularly. Alcohol may increase the effects of Temaze and make you more drowsy.

If you have not told your doctor about any of the above, tell them before you start taking Temaze.

Taking other medicines

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

Some medicines may be affected by Temaze, or may affect how well it works. These include:

  • other sleeping tablets, sedatives or tranquillisers
  • medicines for depression, schizophrenia and other mental illnesses
  • medicines used to treat epilepsy and fits
  • medicines used to relieve stomach cramps and to prevent motion sickness
  • antihistamines, medicines for allergies, hayfever or colds
  • medicines used to treat Parkinson's disease
  • theophylline, a medicine used to treat asthma
  • muscle relaxants
  • some pain relievers.

Your doctor can tell you what to do if you are taking any of these medicines.

If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist. Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Temaze.

How to take Temaze

Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the pack, ask your doctor or pharmacist.

How much to take

The dose varies from person to person.

The usual starting dose is one 10 mg tablet each night. Your doctor will tell you how many tablets you need to take each day and when to take them. Your doctor may adjust this dose depending on how you respond to this medicine. This depends on your condition and whether or not you are taking any other medicines.

Elderly people over 65 years of age may need smaller doses.

How to take it

Swallow the tablets whole with a full glass of water.

When to take it

Take Temaze tablets one hour before going to bed. Temaze can be taken with or without food.

How long to take Temaze for

Keep taking Temaze for as long as your doctor recommends. Usually, 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.

If you forget to take it

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.

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 not sure what to do or have any questions, ask your doctor or pharmacist.

If you take too much (overdose)

Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much Temaze. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

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

While you are taking Temaze

Things you must do

Before starting any new medicine, tell your doctor or pharmacist that you are taking Temaze.

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

If you become pregnant while taking Temaze, tell your doctor.

If you plan to have surgery (that needs a general anaesthetic), including dental surgery, tell your doctor or dentist that you are taking Temaze.

If you have to have any blood test, tell your doctor that you are taking Temaze.

Visit your doctor regularly so they can check on your progress.

If you feel that Temaze is not helping your condition, tell your doctor.

Things you must not do

Do not drive or operate machinery until you know how Temaze affects you. Temaze may cause drowsiness or dizziness in some people. Even though you take Temaze at night, you may still be drowsy or dizzy the next day. Make sure you know how Temaze affects you before you drive a car, operate machinery or do anything else that could be dangerous. This is very important if you are taking other drugs that also make you drowsy.

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 stop taking Temaze, or change the dose, without checking with your doctor. Stopping Temaze suddenly may cause some unwanted side effects. Your doctor may want you to gradually reduce the amount of Temaze 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 suddenly may make your epilepsy worse.

Do not use Temaze to treat any other conditions unless your doctor tells you to.

Do not give Temaze to anyone else, even if they have the same condition as you.

Things to be careful of

Be careful when drinking alcohol while taking Temaze. Combining Temaze and alcohol can make you more sleepy, dizzy or lightheaded, 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 whilst 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.

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 taking Temaze. Temaze helps most people with sleeping problems, but it may have unwanted side effects in some people.

All medicines can 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.

If you are over 65 years of age, you may have an increased chance of getting side effects.

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

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

Tell your doctor if you notice any of the following and they worry you:

  • daytime drowsiness, tiredness
  • clumsiness, lack of coordination
  • dizziness, headache
  • lightheadedness or feeling faint
  • upset stomach, nausea, vomiting, dry mouth
  • depression, irritability, vivid dreams
  • weakness, leg cramps
  • tremor,
  • blurred vision
  • unpleasant dreams
  • slurred speech
  • tingling or numbness of the hands or feet
  • change in libido or sex drive.

Tell your doctor as soon as possible if you notice any of the following:

  • loss of memory, confusion, disorientation
  • behavioural or mood changes such as sudden outbursts of anger and increased excitement
  • yellowing of the eyes and skin (jaundice)
  • dark coloured urine
  • fast, irregular or pounding heart beats
  • unusual bleeding or bruising
  • frequent infections such as fever, severe chills, sore throat or mouth ulcers.

The above list includes serious side effects which may require medical attention. Serious side effects are rare.

Tell your doctor immediately or go to Accident and Emergency at the nearest hospital if you notice any of the following:

  • hallucinations
  • difficulty breathing
  • any type of skin rash, itching or hives
  • swelling of the face, lips or tongue, difficulty swallowing or breathing.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

Tell your doctor if you notice anything that is making you feel unwell. Other side effects not listed above may also occur in some patients. Some of these side effects can only be found when your doctor does tests from time to time to check your progress.

After taking Temaze

Storage

Keep Temaze 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.

Keep your tablets in the pack until it is time to take them. If you take the tablets out of the pack they will not keep well.

Keep Temaze tablets in a cool dry place where the temperature stays below 30°C. Store the tablets in the original container and protect from light.

Do not store Temaze or any other medicine in the bathroom or near a sink.

Do not leave Temaze in the car or on window sills. Heat and dampness can destroy some medicines.

Disposal

If your doctor tells you to stop taking Temaze, or your medicine has passed its expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

Temaze tablets are 5.5 mm flat bevel edged white to off-white tablets and marked "TE" over "10" on one side and a Greek alpha symbol on the other.

Each bottle contains 25 tablets.

Ingredients

The active ingredient in Temaze is temazepam.

Each Temaze tablet contains 10 mg of temazepam. The tablets contain the following excipients:

  • lactose monohydrate
  • maize starch
  • microcrystalline cellulose
  • magnesium stearate.

Temaze also contains sugars (as galactose and lactose) and sulfites.

The tablets are gluten free.

Manufacturer

Temaze is made in Australia by:

Alphapharm Pty Limited
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.mylan.com.au

Australian registration numbers:
AUST R 63863

This leaflet was prepared in May 2020.

Temaze_cmi\May20/00

Published by MIMS July 2020

BRAND INFORMATION

Brand name

Temaze

Active ingredient

Temazepam

Schedule

S4

 

1 Name of Medicine

Temazepam.

6.7 Physicochemical Properties

Chemical structure.

Chemical name: 7-chloro- 1,3-dihydro- 3-hydroxy- 1-methyl- 5-phenyl- 2H-1,4-benzodiazepin-2-one.
Structural formula:
Molecular formula: C16H13ClN2O2.
Molecular weight: 300.7.
Temazepam is a white or almost white, odourless crystalline powder. It is sparingly soluble in ethanol 96% and freely soluble in dichloromethane, but is practically insoluble in water.

CAS number.

846-50-4.

2 Qualitative and Quantitative Composition

Each Temaze tablet contains 10 mg of temazepam.
Temaze also contains sugars (as galactose and lactose) and sulfites. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Temazepam 10 mg tablet: 5.5 mm flat bevel edged white to off-white tablet, debossed "TE over 10" on one side and "α" on the other.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Temazepam is a benzodiazepine derivative which hastens the onset of sleep and increases total sleeping time in short-term use.
The exact mechanism of action of benzodiazepines has not yet been elucidated, however, benzodiazepines appear to work through several mechanisms. Benzodiazepines presumably exert their effects by binding to specific receptors at several sites within the central nervous system, either by potentiating the effects of synaptic or pre-synaptic inhibition mediated by gamma-aminobutyric acid (GABA), or by directly affecting the action potential generating mechanisms.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Pharmacokinetic studies have shown that temazepam is well absorbed and has a relatively short elimination half-life of approximately 10 hours (range 5-15 hours). Peak plasma levels of the drug occur 30 to 120 minutes after administration of the tablets. With multiple dosing, steady state is obtained by the third day and there is little or no accumulation of parent drug or metabolites.

Distribution.

Approximately 96% of unchanged drug is bound to plasma proteins.

Metabolism.

Temazepam is metabolised principally in the liver where most drug is directly conjugated to the glucuronide and excreted in the urine. Some drug is demethylated to oxazepam and eliminated as the glucuronide. The glucuronides of temazepam have no demonstrable CNS activity.

Excretion.

Following a single oral dose, 80% of the dose appears in the urine, mostly as the conjugates, and 12% of the dose appears in the faeces. Less than 2% of the dose is excreted unchanged in the urine.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

4 Clinical Particulars

4.1 Therapeutic Indications

Temaze is indicated for: adjunctive therapy in the short-term management of insomnia in adults.

4.3 Contraindications

Temaze is contraindicated in:
patients with a known hypersensitivity to benzodiazepines or to any of the components 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

Hypotension.

Although hypotension has occurred rarely, Temaze 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.

Amnesia.

Transient amnesia or memory impairment has been reported in association with the use of benzodiazepines.

Myasthenia gravis.

Temazepam could increase the muscle weakness in myasthenia gravis and should be used with caution in this condition.

Acute narrow-angle glaucoma.

Caution should be used in the treatment of patients with acute narrow angle glaucoma (because of atropine-like side effects).

Blood dyscrasia.

In rare instances some patients taking benzodiazepines have developed blood dyscrasias. As with other benzodiazepines, periodic blood counts are recommended.

Depression, psychosis and schizophrenia.

Temaze is not recommended as primary therapy in patients with depression and psychosis. In such conditions, psychiatric assessment and supervision are necessary if benzodiazepines are indicated. Benzodiazepines may increase depression in some patients, and may contribute to deterioration in severely disturbed schizophrenics with confusion and withdrawal. Suicidal tendencies may be present or uncovered and protective measures may be required.

CNS and/or paradoxical reactions.

As with other benzodiazepines and CNS active drugs, three idiosyncratic symptom clusters, which may overlap, have been described.
Amnestic symptoms: anterograde amnesia with appropriate or inappropriate behaviour;
Confusional states: disorientation, derealisation, depersonalization and/or clouding of consciousness; and
Agitational states: sleep disturbances, restlessness, irritability, aggression and excitation.
Temazepam should be discontinued if confusion or agitation occurs.
Paradoxical reactions such as acute rage, stimulation or excitement may occur; should such reactions occur, Temaze should be discontinued. Such reactions may be more likely to occur in children and the elderly.

Elderly or debilitated patients.

Such patients may be particularly susceptible to the sedative effects of benzodiazepines and associated giddiness, ataxia and confusion, which may increase the possibility of a fall. Temaze 10 mg is the recommended starting dose for these patients.

Impaired respiratory function.

Use of benzodiazepines, including temazepam, may lead to potentially fatal respiratory depression. Caution in the use of Temaze is recommended in patients with respiratory depression. In patients with chronic obstructive pulmonary disease, benzodiazepines can cause increased arterial carbon dioxide tension and decreased arterial oxygen tension.

Epilepsy.

Abrupt withdrawal of benzodiazepines in patients with convulsive disorders may be associated with a temporary increase in the frequency and/or severity of seizures.

Abuse.

Caution must be exercised in administering Temaze to individuals known to be addiction prone or those whose history suggests they may increase the dosage on their own initiative. It is desirable to limit repeat prescription without adequate medical supervision.

Dependence.

The use of benzodiazepines, including temazepam, may lead to physical and psychological dependence as defined by the presence of a withdrawal syndrome on discontinuation of the drug. The risk of dependence increases with higher doses and longer term use and is further increased in patients with a history of alcoholism or drug abuse or in patients with significant personality disorders. Temazepam may have abuse potential, especially in patients with a history of drug and/or alcohol abuse.

Duration of treatment.

In general, benzodiazepines should be prescribed for short periods only (e.g. 2 to 4 weeks). Continuous long-term use of Temaze is not recommended. There is evidence that tolerance develops to the sedative effects of benzodiazepines. After as little as one week of therapy, withdrawal symptoms can appear following the cessation of recommended doses (e.g. rebound insomnia following cessation of a hypnotic benzodiazepine).

Tolerance.

Tolerance as defined by a need to increase the dose in order to achieve the same therapeutic effect seldom occurs in patients receiving recommended doses under medical supervision. Tolerance to sedation may occur with benzodiazepines especially in those with drug seeking behaviour.

Withdrawal.

Withdrawal symptoms similar in character to those noted with barbiturates and alcohol have occurred following abrupt discontinuation of benzodiazepines. These symptoms can range from headache, nausea, diarrhoea, loss of appetite, insomnia, anxiety, tensions, depression, restlessness, irritability, rebound phenomena, dysphoria, dizziness, abdominal cramps, agitation, palpitations, tachycardia, panic attacks, vertigo, myoclonus akinesia, hypersensitivity to light, sound and touch, abnormal body sensations (e.g. feelings of motion, metallic taste), depersonalisation, derealisation, hyperacusis, delusional beliefs, hyper-reflexia, numbness/tingling of extremities and loss of short-term memory, to a major syndrome which may include convulsions/seizures, tremor, abdominal and muscle cramps, confusional states, delirium, hallucinations, hyperthermia, psychosis, vomiting and sweating. Convulsions/seizures may be more common in patients with pre-existing seizure disorders or who are taking other drugs that lower the seizure threshold such as antidepressants. Such manifestations of withdrawal, especially the more serious ones, are more common in those patients who have received excessive doses over a prolonged period. However, withdrawal symptoms have also been reported following abrupt discontinuation of benzodiazepines taken continuously at therapeutic levels. Accordingly, Temaze should be terminated by tapering the dose to minimise occurrence of withdrawal symptoms. Patients should be advised to consult with their physician before either increasing the dose or abruptly discontinuing the medication.
Rebound phenomena have been described in the context of benzodiazepine use. Rebound insomnia and anxiety mean an increase in the severity of these symptoms beyond pre-treatment levels following cessation of benzodiazepines. Rebound phenomena in general possibly reflect re-emergence of pre-existing symptoms combined with withdrawal symptoms described earlier. Some patients prescribed benzodiazepines with very short half-lives (in the order of 2 to 4 hours) may experience relatively mild rebound symptoms in between their regular doses. Withdrawal/rebound symptoms may follow high doses taken for relatively short periods.

Dose tapering.

Following the prolonged use of Temaze at therapeutic doses, withdrawal from the medication should be gradual. An individualised withdrawal timetable needs to be planned for each patient in whom dependence is known or suspected. Periods from four weeks to four months have been suggested. As with other benzodiazepines, when treatment is suddenly withdrawn, a temporary increase of sleep disturbance can occur after use of Temaze (see Section 4.4 Special Warnings and Precautions for Use, Dependence).

Somnambulism and associated behaviours.

Complex behaviours such as "sleep driving" (i.e. driving while not fully awake after taking a sedative-hypnotics, with amnesia for the event) have been reported with sedative hypnotics. These events can occur in sedative-hypnotics naive as well as in sedative-hypnotic experienced persons. These events can occur at normal therapeutic doses, and the risk appears to be increased when sedative-hypnotics are combined with alcohol or other CNS depressants or used at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of sedative-hypnotics should be strongly considered for patients who report a "sleep driving" episode. Other complex behaviours (e.g. preparing and eating food, making phone calls or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with "sleep driving", patients usually do not remember these events.

Angioedema.

Angioedema involving the tongue, glottis and larynx has been reported in some patients after taking the first or subsequent doses of sedative-hypnotics. These cases of angioedema may cause airway obstruction and be fatal; this has required medical therapy in emergency departments for some patients. Additional symptoms have been reported in some patients including dyspnoea, throat closing, or nausea and vomiting suggesting anaphylaxis.

Concomitant use with alcohol/CNS depressants.

The concomitant use of temazepam with alcohol or/and CNS depressants should be avoided. Such concomitant use has the potential to increase the clinical effects of temazepam which may include severe sedation, clinically relevant respiratory and/or cardiovascular depression (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Use in hepatic impairment.

Patients with impaired hepatic function should use benzodiazepine medication with caution and dosage reduction may be advisable. In rare instances some patients taking benzodiazepines have had elevations of liver enzymes. As with other benzodiazepines, periodic liver function tests are recommended. The use of temazepam may worsen hepatic encephalopathy; therefore, temazepam should be used with caution in patients with severe hepatic insufficiency and/or encephalopathy.

Use in renal impairment.

Patients with impaired renal function should use benzodiazepine medication with caution and dosage reduction may be advisable.

Use in the elderly.

See Section 4.4 Special Warnings and Precautions for Use, Elderly or debilitated patients.

Paediatric use.

The safety and effectiveness of temazepam has not been established in children less than 16 years of age.

Effects on laboratory tests.

No interference with laboratory tests have been identified or reported with the use of temazepam.
Minor EEG changes, usually low voltage fast activity, of no known clinical significance, have been reported with benzodiazepine administration.

4.5 Interactions with Other Medicines and Other Forms of Interactions

CNS depressants.

The benzodiazepines, including temazepam, 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.

Cytochrome P450.

The cytochrome P450 system has not been shown to be involved in the disposition of temazepam and, unlike many benzodiazepines, pharmacokinetic interactions involving the P450 system have not been observed with temazepam.

Anticonvulsants.

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.

Theophylline/aminophylline.

Administration of theophylline or aminophylline may reduce the sedative effects of benzodiazepines.

Potentiation of anticholinergic effects.

The anticholinergic effects of other drugs including atropine and similar drugs, antihistamines and antidepressants may be potentiated.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Fertility in male and female rats was not adversely affected by temazepam.
(Category C)
Temazepam should not be used during pregnancy.
Benzodiazepines cross the placenta and may cause hypoactivity, hypotonia, reduced respiratory function, apnoea, feeding problems, hypothermia and impaired metabolic response to cold stress in the newborn infant of mothers who have received benzodiazepines during the late phase of pregnancy or at delivery. Continuous treatment during pregnancy and administration of high doses in connection with delivery should be avoided. Withdrawal symptoms in newborn infants have been reported with this class of drugs.
The use of benzodiazepines during the first trimester of pregnancy should almost always be avoided. An increased risk of congenital malformations associated with the use of benzodiazepines during the first trimester of pregnancy has been suggested in several studies. In humans, umbilical cord blood samples indicate placental transfer of benzodiazepines and their glucuronide metabolites. If the drug is prescribed to a woman of child-bearing potential, she should be warned to contact her physician regarding discontinuation of the drug if she intends to become or suspects that she is pregnant.

Non-teratogenic effects.

The use of benzodiazepines during the last phase of pregnancy or at delivery may require ventilation of the infant at birth.
In animal studies, an increased perinatal mortality has been seen following concomitant administration of temazepam and diphenhydramine to rabbits in the later stages of gestation compared with rabbits that received either drug alone. It is recommended that the use of temazepam be avoided in pregnant women receiving antihistamines.
Caution should be exercised when Temaze is given to breast feeding women.
Temazepam is believed to be excreted in human breast milk, and may cause drowsiness and feeding difficulties in the infant.

4.8 Adverse Effects (Undesirable Effects)

All adverse reactions reported with temazepam are common with other benzodiazepine compounds. See Table 1.
Paradoxical reactions such as anxiety, agitation, hostility, aggression, rage, sleep disturbances/insomnia, sexual arousal, hallucinations, stimulation and excitement rarely occur (see Section 4.4 Special Warnings and Precautions for Use).

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

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 to 30 mg, taken one-half hour before retiring. In elderly or debilitated patients, 10 mg Temaze is the initial recommended dosage (see Section 4.4 Special Warnings and Precautions for Use, Elderly or debilitated patients).
The need for continued therapy with Temaze in patients who have been taking medication for several weeks should be evaluated periodically.
Temaze is not recommended for children.

4.7 Effects on Ability to Drive and Use Machines

As with all patients taking CNS depressant medications, patients receiving Temaze should be warned not to operate dangerous machinery or motor vehicles until it is known that they do not become drowsy or dizzy from Temaze 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. Discontinuation of Temaze is highly recommended for patients who report a "sleep driving" episode (see Section 4.4 Special Warnings and Precautions for Use, Somnambulism and associated behaviours).

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.

Treatment.

In the management of overdosage with any medication, it should be borne in mind that multiple agents may have been taken. For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
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 a 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.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

6 Pharmaceutical Particulars

6.1 List of Excipients

The tablets also contain lactose monohydrate, maize starch, microcrystalline cellulose 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. Store in original container. Protect from light.

6.5 Nature and Contents of Container

Available in blister packs (PVC/PVDC/Al) or bottles (HDPE bottle with PP cap)* of 25's*, 30's and 50's.
* Marketed in Australia.

6.6 Special Precautions for Disposal

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

Summary Table of Changes