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.
3. What if I am taking other medicines?
Some medicines may interfere with Mogadon and affect how it works.
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.
5. What should I know while using Mogadon?
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Things you should do
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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.
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Things you should not do
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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.
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Driving or using machines
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Do not drive or operate machinery until you know how Mogadon affects you.
Mogadon causes drowsiness and affects alertness in most people.
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Drinking alcohol
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Do not drink alcohol whilst using Mogadon as alcohol may increase its effects.
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Looking after your medicine
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Store below 30°C in a cool dry place.
Keep out of reach of children
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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.
Active ingredient:
Nitrazepam
Full 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?
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
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
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Active ingredient
(main ingredient)
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Nitrazepam 5 mg
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Other ingredients
(inactive ingredients)
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Lactose
Maize starch
Magnesium stearate
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Potential allergens
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Lactose
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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