Consumer medicine information

APO-Temazepam

Temazepam

BRAND INFORMATION

Brand name

APO-Temazepam

Active ingredient

Temazepam

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using APO-Temazepam.

What is in this leaflet

This leaflet answers some common questions about APO-TEMAZEPAM. 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 APO-TEMAZEPAM 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 APO-TEMAZEPAM is used for

APO-TEMAZEPAM is used to treat sleeping problems, also called insomnia.

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

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

In general, benzodiazepines such as APO-TEMAZEPAM 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 it

When you must not take it

Do not take APO-TEMAZEPAM if:

  1. you are allergic to:
  • APO-TEMAZEPAM or any of the ingredients listed at the end of this leaflet.
  • any other medicine from the benzodiazepine group of medicines. Some of the symptoms of an allergic reaction may include skin rash, itching, hives or other serious allergic reaction which is rare and its symptoms can include swelling of the face, tongue, throat or voice box and difficulty in breathing. If any of these symptoms occur, you should seek medical attention as soon as possible.
  1. you have severe lung disease or breathing difficulties.
  2. you have sleep apnoea, a condition where you have breathing problems when you sleep.

Do not take APO-TEMAZEPAM if the packaging is torn or shows signs of tampering.

Do not take APO-TEMAZEPAM 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 APO-TEMAZEPAM 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.
  1. you are pregnant or planning to become pregnant
Do not take APO-TEMAZEPAM if you are pregnant or planning to become pregnant unless you and your doctor have discussed the risks and benefits involved.
  1. you are breastfeeding or planning to breastfeed
Do not take APO-TEMAZEPAM if you are breastfeeding or planning to breastfeed unless you and your doctor have discussed the risks and benefits involved.
APO-TEMAZEPAM may pass into breast milk and cause drowsiness and/or feeding difficulties in the baby.
  1. 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.
  1. you drink alcohol regularly.
Alcohol may increase the effects of APO-TEMAZEPAM.
  1. You plan to have surgery

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

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 APO-TEMAZEPAM. These include:

  • other sleeping tablets, sedatives or tranquillisers
  • medicines for depression, schizophrenia and other mental illnesses
  • medicines for allergies for example antihistamines or cold tablets
  • medicines used to treat Parkinson’s disease
  • theophylline, a medicine used to treat asthma
  • pain relievers
  • muscle relaxants
  • medicines to control fits

Your doctor will advise you what to do if you are taking any of these medicines.

Check with your doctor or pharmacist if you are not sure whether you are taking any of these medicines.

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

How to take it

How much to take

The dose of APO-TEMAZEPAM 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 APO-TEMAZEPAM tablets whole with a glass of water. Do not chew them.

APO-TEMAZEPAM may be taken with or without food.

When to take it

Take APO-TEMAZEPAM 30 minutes before going to bed in the evening.

How long to take it

Do not take APO-TEMAZEPAM for longer than your doctor says. APO-TEMAZEPAM 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 APO-TEMAZEPAM as long as your doctor recommends it.

If you forget to take it

If you forget to take APO-TEMAZEPAM before you go to bed and you wake up late in the night or early morning, do not take any APO-TEMAZEPAM 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 APO-TEMAZEPAM. 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.

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

While you are taking it

Things you must do

Take APO-TEMAZEPAM exactly as your doctor has prescribed.

Tell all doctors, dentists and pharmacists who are treating you that you are taking APO-TEMAZEPAM.

If you become pregnant while you are taking APO-TEMAZEPAM, tell your doctor immediately.

Visit your doctor regularly. Your doctor needs to check your progress and see whether you need to keep taking APO-TEMAZEPAM.

Tell your doctor if you feel APO-TEMAZEPAM is not helping your condition.

Always discuss with your doctor any problems or difficulties during or after taking APO-TEMAZEPAM.

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 APO-TEMAZEPAM to last weekends and holidays.

Things you must not do

Do not drive or operate machinery until you know how APO-TEMAZEPAM affects you. APO-TEMAZEPAM may cause drowsiness or dizziness in some people and therefore may affect alertness.

Make sure you know how you react to APO-TEMAZEPAM 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 APO-TEMAZEPAM at night, you may still be drowsy or dizzy the next day.

Do not take APO-TEMAZEPAM for a longer time than your doctor has prescribed. APO-TEMAZEPAM should be taken for short periods only (for example 2 to 4 weeks), unless advised otherwise by your doctor.

Do not stop taking APO-TEMAZEPAM 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 APO-TEMAZEPAM before you can stop taking it completely.

Do not suddenly stop taking APO-TEMAZEPAM 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 APO-TEMAZEPAM to anyone else, even if their symptoms seem similar to yours.

Things to be careful of

Be careful when drinking alcohol while taking APO-TEMAZEPAM. Combining APO-TEMAZEPAM 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 while asleep.

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

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 APO-TEMAZEPAM. APO-TEMAZEPAM 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 APO-TEMAZEPAM. 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
  • feeling tired

These are the more common side effects of APO-TEMAZEPAM.

Less common or rare side effects of APO-TEMAZEPAM include:

  • unsteadiness
  • confusion and loss of memory
  • faintness
  • shaking or tremors and weakness
  • leg cramps
  • skin rashes
  • swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
  • feeling sick or vomiting
  • dry mouth
  • irritability
  • outbursts of anger and increased excitement
  • depression
  • sleep disturbances
  • hallucinations
  • blurred vision
  • low blood pressure
  • wheezing or shortness of breath
  • fast or irregular heartbeats
  • unpleasant dreams
  • slurred speech
  • change in libido or sex drive
  • signs of frequent infections such as fever, chills, sore throat or mouth ulcers
  • yellowing of the eyes and skin (jaundice).

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, APO-TEMAZEPAM. Some people may get other side effects while using APO-TEMAZEPAM.

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 taking it

Storage

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

Keep APO-TEMAZEPAM tablets in a cool, dry place where the temperature stays below 30°C.

Do not store APO-TEMAZEPAM 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 APO-TEMAZEPAM 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

APO-TEMAZEPAM comes in one tablet strength.

APO-TEMAZEPAM 10 mg tablets are white, 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 APO-TEMAZEPAM is temazepam.

Each APO-TEMAZEPAM 10 mg tablet contains 10 mg temazepam

APO-TEMAZEPAM 10 mg tablets also contain:

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

APO-TEMAZEPAM tablets do not contain gluten, sucrose, tartrazine or any other azo dyes.

Supplier

Apotex Pty Ltd
66 Waterloo Road
North Ryde NSW 2113

Australian Registration Number:

APO-TEMAZEPAM 10 mg tablets AUST R 153123

This leaflet was revised on 6 December 2019.

Published by MIMS May 2020

BRAND INFORMATION

Brand name

APO-Temazepam

Active ingredient

Temazepam

Schedule

S4

 

Notes

Distributed by Apotex Pty Ltd

1 Name of Medicine

Temazepam.

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.
APO-Temazepam (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.

Molecular formula.

C16H13ClN2O2

Molecular weight.

300.8

Chemical structure.


CAS number.

846-50-4.

2 Qualitative and Quantitative Composition

Each tablet contains temazepam 10 mg as the active ingredient.

List of excipients with known effect.

Lactose monohydrate. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

APO-Temazepam 10 mg are white, round, biconvex tablet, with stylised "S" on one side and plain on the other side.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

APO-Temazepam 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 or by directly affecting the action potential generating mechanisms.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Pharmacokinetic studies have shown that APO-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.

Metabolism and excretion.

With multiple dosing, steady state is obtained by the third day, and there is little or no accumulation of parent drug or metabolites.
APO-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 APO-Temazepam have no demonstrable CNS activity. 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. Approximately 96% of unchanged drug is bound to plasma proteins.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

4 Clinical Particulars

4.1 Therapeutic Indications

APO-Temazepam is indicated for:
Adjunctive therapy in the short term management of insomnia in adults.

4.3 Contraindications

Known hypersensitivity to benzodiazepines or to any of the formulation.
Chronic obstructive airways disease with incipient respiratory failure.
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, APO-Temazepam 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.

APO-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).

Depression, psychosis and schizophrenia.

APO-Temazepam 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, APO-Temazepam should be discontinued. Such reactions may be more likely to occur in children and the elderly.

Impaired respiratory function.

Use of benzodiazepines, including temazepam, may lead to potentially fatal respiratory depression. Caution in the use of APO-Temazepam 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 APO-Temazepam 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. 2-4 weeks). Continuous long-term use of APO-Temazepam 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, hyperreflexia, numbness/tingling 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, APO-Temazepam 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 APO-Temazepam 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 APO-Temazepam (see Section 4.4 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 naïve 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 and other CNS depressants.

The concomitant use of temazepam with alcohol and/or 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 renal impairment.

Patients with impaired renal function should use benzodiazepine medication with caution and dosage reduction may be advisable. As with other benzodiazepines, periodic blood counts are recommended.

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 blood counts and 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.

Blood dyscrasias.

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

Use in 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. APO-Temazepam 10 mg is the recommended starting dose for these 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 APO-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 APO-Temazepam and, unlike many benzodiazepines, pharmacokinetic interactions involving the P450 system have not been observed with APO-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 APO-Temazepam is given to breast feeding women.
APO-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.

More common reactions.

Nervous system.

Dizziness, headache, vertigo, sedation, fatigue, drowsiness, ataxia.

Less common reactions.

Body as a whole.

Asthenia.

Biochemical.

Elevated SAP, AST, BUN, bilirubin; proteinuria, neutrophil leucocytosis.

Cardiovascular.

Palpitation, tachycardia.

Dermatological.

Allergic skin reactions including macular rash and pruritus.

Gastrointestinal.

Dry mouth, nausea, vomiting, gastrointestinal upset.

Miscellaneous.

Loss of taste.

Musculo-skeletal.

Leg cramps, weakness.

Nervous system.

Confusion, disorientation, muzziness, sciatica, tremor, faintness, change in libido, impotence, decreased orgasm.

Ocular.

Blurred vision.

Pulmonary.

Breathlessness.

Psychiatric.

Unmasking of depression, irritability, vivid dreams.

Frequency undetermined.

Body as a whole.

Hypersensitivity reactions, anaphylactic/oid reactions, SIADH, hyponatraemia, hypothermia.

Cardiovascular.

Hypotension, lowering in blood pressure.

Digestive.

Constipation, jaundice.

Haemotological/lymphatic.

Thrombocytopaenia, agranulocytosis, pancytopaenia.

Nervous system and special senses.

Extrapyramidal symptoms, visual disturbance (including diplopia), dysarthria/slurred speech, convulsions/seizures, amnesia, disinhibition, euphoria, coma, suicidal ideation/attempt (benzodiazepine effects on the CNS are dose dependent, with more severe CNS depression occurring with higher doses).

Respiratory.

Respiratory depression, apnoea, worsening of sleep apnoea (the extent of respiratory depression with benzodiazepines is dose dependent, with more severe depression occurring with higher doses), worsening of obstructive pulmonary disease.

Dermatological.

Alopecia.
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 and contact Apotex Medical Information Enquiries/Adverse Drug Reaction Reporting on 1800 195 055.

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 APO-Temazepam is the initial recommended dosage.
The need for continued therapy with APO-Temazepam in patients who have been taking medication for several weeks should be evaluated periodically.
APO-Temazepam 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 APO-Temazepam should be warned not to operate dangerous machinery or motor vehicles until it is known that they do not become drowsy or dizzy from APO-Temazepam 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 APO-Temazepam is highly recommended for patients who report a "sleep-driving" episode (see Section 4.4, Somnambulism and associated behaviour).

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.
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.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

7 Medicine Schedule (Poisons Standard)

S4.

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 size of 25 tablets in PVC/PVdC/Al blisters.

6.6 Special Precautions for Disposal

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

Summary Table of Changes