Consumer medicine information

Alodorm

Nitrazepam

BRAND INFORMATION

Brand name

Alodorm

Active ingredient

Nitrazepam

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Alodorm.

SUMMARY CMI

ALODORM™

Consumer Medicine Information (CMI) summary

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

1. Why am I taking ALODORM?

ALODORM contains the active ingredient nitrazepam. ALODORM is used to treat sleeping problems, also called insomnia.

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

2. What should I know before I take ALODORM?

Do not use if you have ever had an allergic reaction to nitrazepam, benzodiazapines or any of the ingredients listed at the end of the CMI, have severe and chronic lung disease or severe liver disease.

Talk to your doctor if you have any other medical conditions, take any other medicines, are pregnant or plan to become pregnant or are breastfeeding, or you have a history of falling or are unsteady when walking.

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

3. What if I am taking other medicines?

Some medicines may interfere with ALODORM 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 take ALODORM?

  • Follow all directions given to you by your doctor. Usual adult dose is 1-2 tablets. For the elderly the usual dose is half to 1 tablet.
  • Take ALODORM before going to bed.

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

5. What should I know while taking ALODORM?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are taking ALODORM.
  • Tell your doctor or a mental health professional immediately if you have any suicidal thoughts or other mood changes.
  • If you become pregnant while you are taking ALODORM, tell your doctor immediately.
Things you should not do
  • Do not stop taking this medicine suddenly as you may experience unpleasant withdrawal symptoms, which may require medical attention.
  • Do not take ALODORM for longer than your doctor says.
Driving or using machines
  • Do not drive or operate machinery until you know how ALODORM affects you.
  • ALODORM causes drowsiness and affects alertness in most people.
Drinking alcohol
  • Do not drink alcohol whilst taking ALODORM as alcohol may increase its effects.
Looking after your medicine
  • Store below 25°C in a cool dry place. Protect from light.
  • Keep out of reach of children.

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

6. Are there any side effects?

Less serious side effects: drowsiness, dizziness, tiredness, confusion, unsteadiness when walking, memory impairment, headache, hangover feeling in the morning, slurred speech, clumsiness, numbed emotions, double vision, inattention, unpleasant dreams and rebound insomnia.
Very serious side effects: swelling of the tongue or throat and difficulty in breathing. These side effects require urgent medical attention.
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

ALODORM™

Active ingredient(s): nitrazepam


Consumer Medicine Information (CMI)

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

Where to find information in this leaflet:

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

1. Why am I taking ALODORM?

ALODORM contains the active ingredient nitrazepam. ALODORM is a benzodiazepine. It is thought to work by its action on brain chemicals.

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

Your doctor may have prescribed ALODORM for another reason.

Ask your doctor if you have any questions about why ALODORM has been prescribed for you.

2. What should I know before I take ALODORM?

Warnings

Do not take ALODORM if:

  • you are allergic to nitrazepam, other benzodiazepines such as diazepam, temazepam, oxazepam, alprazolam and clonazepam or any of the ingredients listed at the end of this leaflet.
    - Some of the symptoms of an allergic reaction may include skin rash, itching or hives; swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing; wheezing or shortness of breath.
    Always check the ingredients to make sure you can use this medicine.
  • you have severe and chronic lung disease (e.g., chronic obstructive airway disease) and have difficulty breathing.
  • you have a severe liver disorder.
  • the expiry date printed on the pack has passed or if the packaging is torn or shows signs of tampering.

Check with your doctor if you:

  • take any medicines for any other conditions.
  • drink alcohol regularly. Alcohol may increase the effects of this medicine.
  • have a history of falling or are unsteady when walking.
  • have any other medical conditions including:
    - liver, kidney, or lung disease
    - epilepsy, fits or convulsions
    - severe muscle weakness known as myasthenia gravis
    - high or low blood pressure
    - glaucoma (increased pressure in the eye)
    - depression, psychosis, or schizophrenia.
    Your doctor may want to take special care if you have any of these conditions.
  • plan to have surgery.

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

ALODORM may increase depression in some people.

Severely disturbed schizophrenics may experience confusion and withdrawal.

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.

ALODORM can cross the placenta and cause side effects in your unborn baby. Withdrawal symptoms have also been reported in newborn babies.

Your doctor will discuss the risks and benefits of taking ALODORM during pregnancy.

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

ALODORM passes into breast milk and may cause your baby to experience drowsiness and have feeding difficulties.

Your doctor will discuss the risks and benefits of taking ALODORM when breastfeeding.

Use in Children

ALODORM is not recommended for children.

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

The safety and effectiveness of this medicine in children have not been established.

Use in the Elderly

Elderly people may be more susceptible to the sedative effects of ALODORM and associated giddiness, unsteadiness, and confusion, which may increase the possibility of a fall.

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 ALODORM and affect how it works. These include:

  • medicines to control fits (epilepsy)
  • cimetidine, a medicine used to treat stomach ulcers and reflux
  • disulfiram, a medicine used to deter the consumption of alcohol.

Medicines that may increase the effect of ALODORM include:

  • other sleeping tablets, sedatives, or tranquillisers
  • medicines for depression
  • medicines for allergies, colds or travel sickness e.g. antihistamines or cold tablets
  • pain relievers such as opioid medicines
  • muscle relaxants.

Taking ALODORM with these medicines may slow down your nervous system more than intended resulting in lethargy, breathing problems, dizziness, confusion, or problems with your vision.

Seek urgent medical attention if life-threatening symptoms such as breathing difficulties, inability to move or coma occur.

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

You may need to take different amounts of your medicine or you may need to take different medicines.

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

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

4. How do I take ALODORM?

How much to take

The dose may vary from person to person. Your doctor will tell you how many tablets you need to take each day.

  • The usual adult dose of ALODORM is 1-2 tablets.
  • For the elderly, the usual dose is half to 1 tablet.
  • Swallow ALODORM whole with a glass of water.
  • Follow the instructions given to you by your doctor and pharmacist carefully and take ALODORM until your doctor tells you to stop.
    They may differ from the information contained in this leaflet. If you do not understand the instructions on the label, ask your doctor or pharmacist.

When to take ALODORM

  • Take ALODORM before going to bed.
  • Do not take ALODORM for longer than your doctor says.

If you forget to take ALODORM

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

If you take too much ALODORM

If you think you or anyone else have taken too much ALODORM, urgent medical attention may be needed.

You should immediately:

  • phone the Poisons Information Centre
    (telephone 13 11 26) for advice, or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

Also report if any other medicines or alcohol has been taken.

If you take too much ALODORM mild symptoms include drowsiness, mental confusion, and lethargy. In more serious cases, symptoms include inability to move, loss of muscle tone, low blood pressure, breathing difficulties, coma and very rarely death.

5. What should I know while taking ALODORM?

Things you should do

  • Take ALODORM exactly as your doctor has prescribed.

If you plan to have surgery that requires a general anaesthetic, tell your doctor or dentist that you are taking ALODORM.

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

  • Tell your doctor if you feel ALODORM is not helping your condition.
  • 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.
  • Visit your doctor regularly. Your doctor needs to check your progress to see whether you need to keep taking ALODORM. You may also need to have tests to check your blood and liver function.

Call your doctor or mental health professional straight away if you:

  • Have any suicidal thoughts or other mood changes. All thoughts of suicide must be taken seriously.
  • If you become pregnant while you are taking ALODORM.

Tell your doctor if you notice any unusual changes in your sleep behaviour such as sleep walking, sleep driving or any other bizarre sleep-related behaviours.

You should not take ALODORM and may need medical attention if you experience these behaviours.

Be careful when taking ALODORM if you are elderly, unwell, or taking other medicines.

Some people may experience side effects such as drowsiness, confusion, dizziness, and unsteadiness. These may increase the risk of a fall.

Remind any doctor, mental health professional, dentist, or pharmacist you visit that you are taking ALODORM.

Things you should not do

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

ALODORM 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.

Do not stop taking ALODORM suddenly or change your dose without first checking with your doctor.

Your doctor will slowly reduce your dose of ALODORM before you can stop taking it completely.

Stopping ALODORM suddenly may cause some unwanted effects including:

  • insomnia
  • dizziness
  • anxiety or panic attacks
  • feeling dissatisfied with life
  • feeling 'outside of your body' or a sense of unreality
  • delusional beliefs
  • palpitations
  • involuntary movements
  • extra sensitive to light, sound, and touch
  • abnormal body sensations (e.g., feeling of motion, metallic taste)
  • short-term memory loss.

In severe cases you may experience:

  • convulsions
  • tremor
  • abdominal and muscle cramps
  • confusion
  • delirium, hallucinations, or psychosis
  • high temperature or sweating
  • vomiting.

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

Stopping ALODORM suddenly may make your epilepsy worse.

Do not take ALODORM to treat any other complaints unless your doctor says to.

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

Driving or using machines

Do not drive or use any machines or tools until you know how ALODORM affects you.

This is very important if you are taking other drugs that also make you drowsy.

ALODORM causes drowsiness and affects alertness in most people, and may cause dizziness in some.

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

Things to be careful of

Some sleep medicines may cause short-term memory loss. When this occurs, a person may not remember what has happened for several hours after taking the medicine. This is usually not a problem since most people fall asleep after taking the medicine. To reduce this risk, ensure that you are able to get a full night's sleep (7 to 8 hours) before you need to be active again.

Drinking alcohol

Be careful drinking alcohol while taking ALODORM.

Tell your doctor if you drink alcohol.

Alcohol may increase the effects of ALODORM.

Combining ALODORM and alcohol can make you more sleepy, dizzy, lightheaded or increase the risk of sleep disorders. These include sleep-walking and some other related sleep behaviours such as 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 ALODORM.

Looking after your medicine

  • Keep your tablets in bottle until it is time to take them.
  • Store below 25°C. Protect from light.

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.

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

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

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 be serious and may need medical attention such as complex sleep behaviours.

Tell your doctor if you notice any unusual changes in your sleep behaviour or if you do not feel well while you are taking ALODORM.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

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

Less serious side effects

Less serious side effectsWhat to do
  • drowsiness
  • dizziness
  • fatigue
  • confusion
  • unsteadiness when walking
  • impairment of memory
  • headache
  • hangover feeling in the morning
  • slurred speech
  • clumsiness, lack of coordination
  • numbed emotions
  • reduced alertness
  • muscle weakness
  • double vision
  • inattention
  • unpleasant dreams
  • rebound insomnia.
Speak to your doctor if you have any of these less serious side effects and they worry you.

Very serious side effects

Very serious side effectsWhat to do
  • swelling of the tongue or throat
  • difficulty in breathing.
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these very serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

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 ALODORM contains

Active ingredient
(main ingredient)
Nitrazepam 5 mg
Other ingredients
(inactive ingredients)
  • lactose monohydrate
  • maize starch
  • pregelatinised maize starch
  • purified talc
  • colloidal anhydrous silica
  • magnesium stearate.
Potential allergensSugars as lactose and sulfites

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

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

What ALODORM looks like

ALODORM is a 12 mm, flat bevel edged, white tablet marked “NM/5” on one side and “G” on the other.

(AUST R 54009)

Each bottle contains 25 tablets.

Who distributes ALODORM

Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276

This leaflet was prepared in July 2024.

ALODORM™ is a Viatris company trade mark

ALODORM_cmi\Jul24/00

Published by MIMS September 2024

BRAND INFORMATION

Brand name

Alodorm

Active ingredient

Nitrazepam

Schedule

S4

 

1 Name of Medicine

Nitrazepam.

2 Qualitative and Quantitative Composition

Each tablet contains 5 mg of nitrazepam as the active ingredient.

Excipients with known effect.

Sugars as lactose and trace quantities of sulfites.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Alodorm 5 mg tablet: 12 mm, flat bevel edged, white tablet marked "NM/5" on one side and "G" on the other.

4 Clinical Particulars

4.1 Therapeutic Indications

Insomnia, organic and inorganic in origin.

4.2 Dose and Method of Administration

Adults.

1 to 2 tablets (5 to 10 mg) before retiring. This average dosage may be increased if necessary up to 20 mg for in-patients.

Elderly patients.

½ to 1 tablet.

Children.

Not approved for use as a hypnotic in children.

4.3 Contraindications

Alodorm is contraindicated in:
patients with known hypersensitivity to benzodiazepines;
patients with chronic obstructive airway disease with incipient respiratory failure;
severe liver insufficiency.

4.4 Special Warnings and Precautions for Use

Hypotension.

Although hypotension has occurred only rarely, Alodorm 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 (see Section 4.4 Special Warnings and Precautions for Use, Use in the elderly).

Amnesia.

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

Myasthenia gravis.

Nitrazepam 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).

Bronchial hypersecretion and excessive salivation.

In infants and young children, as well as in elderly, bedridden patients, bronchial hypersecretion and excessive salivation leading to aspiration/pneumonia may occur (see Section 4.8 Adverse Effects (Undesirable Effects)).

Blood dyscrasias.

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

Depression, psychosis and schizophrenia.

Alodorm is not recommended as primary therapy in patients with depression and/or 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.

Paradoxical reactions.

Paradoxical reactions such as restlessness, agitation, irritability, aggressiveness, delusion, nightmares, psychoses, inappropriate behaviour and other adverse behavioural effects, acute rage and stimulation or excitement may occur; should such reactions occur, Alodorm should be discontinued.

Impaired respiratory function.

Caution in the use of Alodorm 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 Alodorm 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 and tolerance.

The use of benzodiazepines may lead to dependence, as defined by the presence of a withdrawal syndrome on discontinuation of the drug. 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.

Duration of treatment.

In general, benzodiazepines should be prescribed for short periods only (e.g. 2 to 4 weeks) (see Section 4.2 Dose and Method of Administration). Continuous long-term use of Alodorm 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).

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 insomnia, anxiety, dysphoria, palpitations, panic attacks, vertigo, myoclonus, akinesia, hypersensitivity to light, sound and touch, abnormal body sensations (e.g. feelings of motion, metallic taste), depersonalisation, derealisation, delusional beliefs, hyperreflexia and loss of short term memory, to a major syndrome which may include convulsions, tremor, abdominal and muscle cramps, confusional states, delirium, hallucinations, hyperthermia, psychosis, vomiting and sweating. 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, Alodorm 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 Alodorm 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 Alodorm (see Section 4.4 Special Warnings and Precautions for Use, Dependence and tolerance).

Somnambulism and associated behaviours.

Complex behaviours have been reported with sedative hypnotics. These events can occur in sedative-hypnotic 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. Discontinuation of sedative-hypnotics should be strongly considered for patients who reported complex behaviours whilst not fully awake after taking a sedative-hypnotic.

Angioedema.

Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics. Some patients have had additional symptoms such as dyspnoea, throat closing, or nausea and vomiting that suggest anaphylaxis. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal and patients should be advised to contact the emergency department of their nearest hospital as soon as possible.

Concomitant use of opioids.

Concomitant use of nitrazepam and opioids may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of nitrazepam with opioids should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe nitrazepam concomitantly with opioids, the lowest effective dose should be used, and the duration of treatment should be as short as possible (see Section 4.2 Dose and Method of Administration).
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers (where applicable) to be aware of these symptoms (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Lactose intolerance.

Alodorm contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take Alodorm.

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 have had elevation of liver enzymes. As with other benzodiazepines, periodic liver function tests are recommended.

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.

Geriatric or debilitated 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. (Also see Section 4.4 Special Warnings and Precautions for Use, Bronchial hypersecretion and excessive salivation).

Paediatric use.

Not approved for use as a hypnotic in children (See Section 4.8 Adverse Effects (Undesirable Effects)).

Effects on laboratory tests.

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

The benzodiazepines, including nitrazepam, 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 (see Section 4.4 Special Warnings and Precautions for Use).
The concomitant use of nitrazepam with opioids increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dosage and duration of concomitant use should be limited (see Section 4.4 Special Warnings and Precautions for Use).
Nitrazepam undergoes oxidative metabolism, and consequently may interact with disulfiram or cimetidine, resulting in increased plasma levels of nitrazepam. Patients should be observed closely for evidence of enhanced benzodiazepine response during concomitant treatment with either disulfiram or cimetidine; some patients may require a reduction in benzodiazepine dosage.
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.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category C)
Benzodiazepines cross the placenta and may cause hypotonia, respiratory depression and hypothermia in the newborn infant. Continuous treatment during pregnancy and administration of high doses in conjunction with delivery should be avoided. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs.

Australian categorisation definition of category C.

Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human foetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.
Caution should be exercised when Alodorm is given to a breastfeeding woman. Nitrazepam is excreted in human breast milk, and may cause drowsiness and feeding difficulties in the infant.

4.7 Effects on Ability to Drive and Use Machines

As with all patients taking CNS depressant medications, patients receiving Alodorm should be warned not to operate dangerous machinery or motor vehicles until it is known that they do not become drowsy or dizzy from Alodorm therapy. Abilities may be impaired on the day following use. 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 Alodorm (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

4.8 Adverse Effects (Undesirable Effects)

Alodorm is usually well tolerated.

More common reactions.

CNS depression including drowsiness, dizziness, fatigue, impairment of memory, ataxia, headache, confusion, vertigo, hangover feeling in the morning, slurred speech, decreased physical performance, numbed emotions, reduced alertness, muscle weakness, double vision and inattention have been reported. Unpleasant dreams and rebound insomnia have also been reported.

Less common reactions.

Rarely, hypotension, faintness, palpitation, rash or pruritus, gastrointestinal disturbances, changes in libido.
Very infrequently, paradoxical reactions may occur, e.g. excitement, stimulation, hallucinations, hyperactivity and insomnia. Also depressed or increased dreaming, disorientation, severe sedation, retrograde amnesia, headache, hypothermia, delirium tremens.
Hypersecretion of saliva and bronchial mucus has occurred with doses of 0.7 mg/kg/day. In infants and young children, as well as in the elderly, bed-ridden patients, bronchial hypersecretion and excessive salivation leading to aspiration/ pneumonia may occur.

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.

4.9 Overdose

Symptoms.

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 and lethargy. In more serious cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, coma, and very rarely, death.

Treatment.

In the management of overdosage with any medication, it should be borne in mind that multiple agents may have been taken.
Activated charcoal may reduce absorption of the drug if given within one to two hours of 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. Cardiac and vital signs monitoring is recommended, along with general symptomatic and supportive measures. 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).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Nitrazepam is a member of the group of benzodiazepine agonists and exhibits sedative, anxiolytic, anticonvulsant and muscle relaxant effects. This is presumed to be the result of facilitating the action in the brain of gamma-aminobutyric acid (GABA), an endogenous inhibitor neurotransmitter.
Taken in the evening in recommended doses, nitrazepam induces sleep lasting 6 to 8 hours.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Nitrazepam is well and fairly rapidly absorbed from the gastrointestinal tract. There is considerable interindividual variation in the rate of absorption with the time to reach peak plasma concentrations following oral administration about 2 hours (0.5 to 5 hours). The drug crosses the blood-brain barrier, the placenta, and is excreted in milk.
Peak plasma levels following a 10 mg single oral dose are about 68 to 108 nanogram/mL and following a 5 mg single oral dose about 25 to 50 nanogram/mL. Twelve hours after oral administration of 5 mg of nitrazepam, blood levels are about 12 to 38 nanogram/mL.

Bioavailability.

In one study comparing oral with intravenous administration, bioavailability varied from 53 to 94% (average 78%).

Distribution.

Nitrazepam is lipophilic and readily crosses body membranes.
Cerebrospinal fluid (CSF) concentration of nitrazepam is about 10% total plasma level and similar to the protein free fraction in plasma. One study observed accumulation of nitrazepam in CSF.
Nitrazepam is found in saliva at lower concentrations than protein free levels in serum.
Nitrazepam has been shown to cross the placenta and reach concentrations between 50 and 90% of the concentration in maternal plasma. It is excreted in breast milk.
The volume of distribution has been found to be significantly higher in elderly immobilised patients than in young controls, whereas the volume of distribution in healthy elderly subjects was found to be similar to young healthy subjects.

Protein binding.

Nitrazepam is approximately 87% bound to plasma protein.

Metabolism.

Nitrazepam is metabolised to a significant extent by the liver and the primary route of elimination is urinary excretion of these metabolites. Thus, hepatic or renal disease may require alteration of nitrazepam dosage.
The major pathway is conversion to 7-aminonitrazepam and then to 7-acetamido nitrazepam with subsequent hydroxylation. Opening of the diazepine ring to form 2-amino-5-nitrobenzophenone has also been reported. These metabolites have very weak pharmacological activity.
There is no evidence of nitrazepam dependent enzyme induction or inhibition during long-term treatment.
Total plasma clearance has been estimated as 4.1 ± 2.0 L/hour in young and 4.7 ± 1.5 L/hour in elderly patients.

Excretion.

Nitrazepam is mainly excreted as urinary metabolites. During the first 120 hours after a single radiolabelled 10 mg oral dose, the total renal elimination was 70%. Only 1% or less of the administered dose is excreted as unchanged nitrazepam.
The main urinary excretion products are free or conjugated 7-aminonitrazepam and 7-acetamidonitrazepam. Individual variation of the total excreted metabolites is high, ranging between 17 and 99% of the administered dose. Of this, the conjugated metabolites made up an average of 57%.
One faecal excretion study indicates the possibility of limited biliary excretion of the metabolites.

Half-life.

Nitrazepam is eliminated relatively slowly from the body. Following oral administration, half-life has been estimated to be from 16 to 48 hours (average 27 hours). The half-life in CSF appears to be about twice as long as that in plasma.
Elimination half-life has been estimated to be significantly higher in elderly debilitated patients as opposed to healthy elderly subjects and young subjects.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

The tablet contains lactose monohydrate, maize starch, pregelatinised maize starch, purified talc, colloidal anhydrous silica, 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 25°C. Protect from light.

6.5 Nature and Contents of Container

Container type: HDPE bottle with PP child resistant cap.
Pack size: 25, 50, 1000 tablets.
Some strengths, pack sizes and/or pack types may not be marketed.

Australian register of therapeutic goods (ARTG).

AUST R 54009 - Alodorm nitrazepam 5 mg tablet bottle.

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.

6.7 Physicochemical Properties

Chemical structure.

Chemical name: 7-nitro-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one.
Structural formula:
Molecular formula: C15H11N3O3.
Molecular weight: 281.3.
Nitrazepam is a yellow, crystalline powder which is odourless and tasteless. It is almost insoluble in water, soluble in 120 parts of alcohol (95%), in 45 parts of chloroform, and in 900 parts of ether. Nitrazepam has a melting point of 226°-229°C.

CAS number.

146-22-5.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes