Consumer medicine information

Mogadon

Nitrazepam

BRAND INFORMATION

Brand name

Mogadon

Active ingredient

Nitrazepam

Schedule

Mogadon®

Mogadon^®

 Consumer Medicine Information (CMI) summary

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

 1. Why am I using Mogadon?

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

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

 2. What should I know before I use Mogadon?

Do not use if you have ever had an allergic reaction to Mogadon, benzodiazepines, 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, or are pregnant or plan to become pregnant or are breastfeeding, drink alcohol, or you have a history of falling or are unsteady when walking.

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

 3. What if I am taking other medicines?

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

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

 4. How do I use Mogadon?

Usual adult dose is 1-2 tablets. For the elderly the usual dose is half to 1 tablet.
Take Mogadon before going to bed.

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

 5. What should I know while using Mogadon?

Things you should do	Remind any doctor, dentist, mental health professional or pharmacist you visit that you are using Mogadon. 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 Mogadon, tell your doctor immediately.
Things you should not do	Do not stop using this medicine suddenly as you may experience unpleasant withdrawal symptoms, which may require medical attention. Do not use Mogadon for longer than your doctor says.
Driving or using machines	Do not drive or operate machinery until you know how Mogadon affects you. Mogadon causes drowsiness and affects alertness in most people.
Drinking alcohol	Do not drink alcohol whilst using Mogadon as alcohol may increase its effects.
Looking after your medicine	Store below 30°C in a cool dry place. Keep out of reach of children

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

 6. Are there any side effects?

Common side effects include 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.

Serious side effects include 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.

Mogadon^®

Active ingredient: Nitrazepam

 Consumer Medicine Information (CMI)

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

Where to find information in this leaflet:

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

 1. Why am I using Mogadon?

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

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

 2. What should I know before I use Mogadon?

Warnings

Do not use Mogadon 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. 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.

Check with your doctor if you:

Take any other 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
- fits or convulsions
- severe muscle weakness known as myasthenia gravis
- high or low blood pressure
- glaucoma (high pressure in the eye)
- depression, psychosis, or schizophrenia.

Mogadon 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.

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

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

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

Use in 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 Mogadon 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 Mogadon and affect how it works including:

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

Medicines that may increase the effect of Mogadon include:

other sleeping tablets, sedatives, or tranquillisers
medicines for depression
medicines for allergies, e.g., antihistamines or cold tablets
pain relievers
muscle relaxants.

Taking Mogadon 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 Mogadon.

 4. How do I use Mogadon?

How much to take

The usual adult dose of Mogadon is 1-2 tablets.
For the elderly, the usual dose is half to 1 tablet.
Swallow Mogadon whole with a glass of water.
Follow the instructions provided on the pack and use Mogadon until your doctor tells you to stop.

When to take Mogadon

Take Mogadon before going to bed.
Do not use Mogadon for longer than your doctor says.

If you forget to use Mogadon

Mogadon should be used regularly at the same time each day.

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

If you use too much Mogadon

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

You should immediately:

phone the Poisons Information Centre
(by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.

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

If you take too much Mogadon 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 using Mogadon?

Things you should do

Use Mogadon exactly as your doctor has prescribed.

Tell your doctor if you feel Mogadon 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.

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 Mogadon.

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 may need medical attention if you experience these behaviours.

Be careful when taking Mogadon 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 using Mogadon.

Things you should not do

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

Mogadon is usually 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 using this medicine suddenly or change your dose without first checking with your doctor.

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

Stopping this medicine 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 Mogadon 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 Mogadon 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 Mogadon affects you.

Mogadon causes drowsiness and affects alertness in most people.

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

Drinking alcohol

Tell your doctor if you drink alcohol.

Combining Mogadon and alcohol can make you more sleepy, dizzy, lightheaded or increase the risk of sleep disorders.

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

Looking after your medicine

Follow the instructions in the carton on how to take care of your medicine properly.

Keep your tablets in their blister pack until it is time to take them.
Store below 30°C and protect from light.

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 windowsills.

Keep it where young children cannot reach it.

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 may need medical attention.

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

Less serious side effects

Less serious side effects	What 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.

Serious side effects

Serious side effects	What to do
Allergic reactions: 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 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 Mogadon contains

Active ingredient (main ingredient)	Nitrazepam 5 mg
Other ingredients (inactive ingredients)	Lactose Maize starch Magnesium stearate
Potential allergens	Lactose

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

Mogadon does not contain gluten, sucrose, tartrazine, or any other azo dyes.

What Mogadon looks like

Mogadon tablets are white, marked ICN on the upper face and a single break bar on the lower face.

Mogadon comes in a blister pack containing 25 tablets.

Registration number: AUST R 13751.

Who distributes Mogadon

iNova Pharmaceuticals (Australia) Pty Limited
ABN: 13 617 871 539
Level 10, 12 Help Street
Chatswood NSW 2067
Tel: 1800 630 056

^®= Registered Trademark

This leaflet was prepared in October 2022

Published by MIMS December 2022

BRAND INFORMATION

Brand name

Mogadon

Active ingredient

Nitrazepam

Schedule

1 Name of Medicine

Nitrazepam.

6.7 Physicochemical Properties

Chemically nitrazepam is 1,3-dihydro-7-nitro-5-phenyl-2H-1-benzodiazepine-2 one. It is a pale yellow, crystalline substance, insoluble in water. It has a molecular weight of 281.27.

Chemical structure.

CAS number.

146-22-5.

2 Qualitative and Quantitative Composition

Nitrazepam 5 mg tablets.
Mogadon tablets contain lactose. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Cylindrical, biplanar, white tablet. Imprint - upper face: "ICN" and two arcs, lower face: single break bar.

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, an endogenous inhibitor neurotransmitter.
Taken in the evening in recommended doses Mogadon induces sleep lasting 6-8 hours.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

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

Bioavailability.

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

Distribution.

Nitrazepam is lipophilic and readily crosses body membranes.
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 the 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 litre/hour in young and 4.7 ± 1.5 litre/hour in elderly patients.

Excretion.

Nitrazepam is mainly excreted as urinary metabolites. During the first 120 hours after a single radio-labelled 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-amino nitrazepam and 7-acetamido nitrazepam. 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.

4 Clinical Particulars

4.1 Therapeutic Indications

Insomnia, organic and inorganic in origin.

4.3 Contraindications

Patients with known hypersensitivity to benzodiazepines.
Patients with chronic obstructive airway disease with incipient respiratory failure.
Patients with severe hepatic insufficiency.

4.4 Special Warnings and Precautions for Use

Hypotension.

Although hypotension has occurred only rarely, Mogadon 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, Use in the elderly).

Amnesia.

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

Myasthenia gravis.

Mogadon 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 dycrasias.

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

Depression, psychosis and schizophrenia.

Mogadon 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, stimulation or excitement may occur. Should such reactions occur, Mogadon should be discontinued.

Impaired respiratory function.

Caution in the use of Mogadon is recommended in patients with respiratory depression. In patients with chronic obstructive pulmonary disease, benzodiazepines can cause increased arterial carbon dioxide tension and decreased oxygen tension.

Epilepsy.

Abrupt withdrawal of benzodiazepines in persons 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 Mogadon 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. 2-4 weeks) see Section 4.2 Dose and Method of Administration. Continuous long-term use of Mogadon 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 range from insomnia, anxiety, dysphoria, palpitations, panic attacks, vertigo, myoclonus, akinesia, hypersensitivity to light, sound and touch, abnormal body sensations (e.g. feeling 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 state, delirium, hallucinations, hyperthermia, psychosis, vomiting and sweating. Such manifestations of withdrawal, especially the more serious ones, are more common in patients who have received excessive doses over a prolonged period. However, withdrawal symptoms have been reported following abrupt discontinuation of benzodiazepines taken continuously at therapeutic levels. Accordingly, Mogadon 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 for relatively short periods.

Dose tapering.

Following the prolonged use of Mogadon at therapeutic doses, withdrawal from the medication should be gradual. An individualised timetable should 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 in sleep disturbance can occur after use of Mogadon (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 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. Discontinuation of sedative-hypnotics should be strongly considered for patients who have 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.

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.
In elderly, bed-ridden patients, bronchial hypersecretion and excessive salivation leading to aspiration/pneumonia may occur (see Section 4.8 Adverse Effects (Undesirable Effects)).

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 has been reported with benzodiazepine administration.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The benzodiazepines, including Mogadon, 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, narcotic analgesics and anaesthetics (see Section 4.4 Special Warnings and Precautions for Use).
Mogadon undergoes oxidative metabolism, and consequently may interact with disulfiram or cimetidine resulting in increased plasma levels of Mogadon. 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, reduced respiratory function and hypothermia in the newborn infant. 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.
Caution should be exercised when Mogadon is given to nursing women. Mogadon is excreted in human breast milk and may cause drowsiness and feeding difficulties in the infant.

4.8 Adverse Effects (Undesirable Effects)

Mogadon is usually well tolerated.

More common reactions.

CNS depression including drowsiness, dizziness, fatigue, confusion, ataxia, impairment of memory, headache, hangover feeling in the morning, vertigo, 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. Depressed or increased dreaming, disorientation, severe sedation, retrograde amnesia, headache, hypothermia, delirium tremens have also been reported.
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 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.

4.2 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 recommended.

4.7 Effects on Ability to Drive and Use Machines

As with all patients taking CNS-depressant medications, patients receiving Mogadon should be warned not to operate dangerous machinery or motor vehicles until it is known that they do not become drowsy or dizzy from Mogadon 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 drugs should either be eliminated or given in reduced dosage in the presence of Mogadon (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

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 useful 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, magnesium stearate, starch - maize.

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 light.

6.5 Nature and Contents of Container

PVC/PVDC/Aluminium Blister pack: 4's^#, 25's, 30's^#, 100's^#.
^# Not currently distributed in Australia.

6.6 Special Precautions for Disposal

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

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Consumer medicine information

Mogadon

Nitrazepam

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BRAND INFORMATION

Mogadon Tablets 5 mg