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 taking ANTENEX?
ANTENEX contains the active ingredient diazepam. ANTENEX is used for anxiety, to relax
muscles, to treat trembling, confusional states or anxiety associated with alcohol
withdrawal, and to treat panic attacks. For more information, see Section
1. Why am I taking ANTENEX? in the full CMI.
2. What should I know before I take ANTENEX?
Do not take ANTENEX if you have ever had an allergic reaction to diazepam, any other
benzodiazepine medicine, or any of the ingredients listed at the end of the CMI. The
use of ANTENEX may lead to dependence on the medicine.
Talk to your doctor if you have any other medical conditions, have drug or alcohol
addiction, drink alcohol, take any other medicines, or are pregnant or plan to become
pregnant or are breastfeeding. For more information, see Section
2. What should I know before I take ANTENEX? in the full CMI.
3. What if I am taking other medicines?
4. How do I take ANTENEX?
Take ANTENEX exactly as your doctor has prescribed. Your doctor will tell you how
many ANTENEX tablets to take each day.
The usual adult dose is between 5 and 40 mg daily. Children, elderly and very ill
patients may need to take less.
ANTENEX should be taken for short periods only (for example, 2-4 weeks), unless advised
by your doctor.
5. What should I know while taking ANTENEX?
Things you should do
|
Remind any doctor, dentist or pharmacist visit that you are taking ANTENEX.
Call your doctor straight away if you become pregnant while taking ANTENEX.
Call your doctor straight away if you have any suicidal thoughts or other mental/mood
changes.
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Things you should not do
|
Do not take ANTENEX for a longer time than your doctor has prescribed.
Do not stop taking ANTENEX or lower the dose without first checking with your doctor,
especially if you have epilepsy.
Do not take any other medicines without first telling your doctor.
Do not let yourself run out of medicine over the weekend or on holidays.
|
Driving or using machines
|
Do not drive or operate machinery until you know how ANTENEX affects you. ANTENEX
may cause drowsiness, dizziness or loss of concentration in some people.
|
Drinking alcohol
|
Alcohol may increase the effects of ANTENEX. Your doctor may suggest that you avoid
alcohol or reduce the amount of alcohol you drink while you are taking ANTENEX.
|
Looking after your medicine
|
Store ANTENEX in a cool, dry place below 30°C, where children cannot reach it.
Keep your tablets in the original packaging until it is time to take them.
|
6. Are there any side effects?
Some of the less side effects include drowsiness, tiredness, dizziness, unsteadiness,
loss of memory, inattentiveness, confusion, lack of concentration, headache, hangover
feeling in the morning, slurred speech, or unpleasant dreams. Serious side effects
include sudden anxiety or excitation, restlessness, agitation, irritability, anger,
abnormal behaviour, hallucinations, delusions, severe sleep disturbances, or difficulties
in breathing, choking or coughing. This is not a complete list of side effects.
Active ingredient:
diazepam
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking ANTENEX. 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 ANTENEX.
Where to find information in this leaflet:
1. Why am I taking ANTENEX?
ANTENEX contains the active ingredient diazepam. ANTENEX belongs to a group of medicines called benzodiazepines, which are thought
to work by their action on brain chemicals.
ANTENEX is used to:
manage anxiety
Anxiety or tension associated with the normal stress of everyday life usually does
not require treatment with medicines.
relieve symptoms associated with alcohol withdrawal such as acute agitation and tremor
relax muscles
treat panic attacks.
Ask your doctor if you have any questions about why ANTENEX has been prescribed for
you. Your doctor may have prescribed ANTENEX for another reason.
2. What should I know before I take ANTENEX?
Warnings
Do not take ANTENEX if:
you are allergic to diazepam, any other benzodiazepine medicine, 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 or airway disease
you have severe liver disease
you have temporary stops in breathing during sleep (sleep apnoea)
you suffer from severe muscle weakness
you have drug or alcohol addiction.
Check with your doctor if you:
have any other medical conditions, including:
liver, kidney or lung disease
high or low blood pressure
glaucoma (high pressure in the eye)
depression, schizophrenia or other mental illness
epilepsy (fits)
history of alcohol or drug abuse.
take any medicines for any other condition
drink alcohol. Alcohol may increase the effects of ANTENEX
take Central Nervous System (CNS) depressants
Combining ANTENEX and CNS depressants may cause severe sedation, difficulties breathing
and/or heart problems (respiratory and/or cardiovascular depression), coma and death.
are allergic to any other medicines, foods, dyes or preservatives
plan to have surgery.
ANTENEX is not recommended as first choice of treatment in patients with depression,
and/or psychosis as it can increase your risk of suicide.
Benzodiazepines are not recommended as the only treatment of severe mental illnesses
and should not be used alone to treat depression.
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
Tell your doctor if you are pregnant or plan to become pregnant.
ANTENEX may affect your unborn baby if you take it during pregnancy.
ANTENEX may cause complications to newborn infants. It may cause low blood pressure,
poor muscle tone, reduced respiratory function and low body temperature 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 prolonged use of this class of drug.
Your doctor will discuss the risks and benefits of taking ANTENEX during pregnancy.
Tell your doctor if you are breastfeeding or plan to breastfeed.
ANTENEX is not recommended for use in breastfeeding. ANTENEX may pass into breast
milk and may cause drowsiness and/or feeding difficulties in your baby.
Use in children
Do not give ANTENEX to children under the age of six months.
Dependence
The use of benzodiazepines (such as ANTENEX) may lead to dependence on the medicine.
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 ANTENEX and affect how it works, and some medicines
may be affected by ANTENEX. These include:
other sleeping tablets, sedatives or tranquillisers
medicines for depression
other medicines for anxiety
medicines used to treat epilepsy, control fits or convulsions (e.g. phenytoin)
antihistamines, medicines for allergies, hayfever, colds or travel sickness
pain relievers
muscle relaxants
cimetidine and omeprazole- a medicine used to treat reflux or stomach ulcers
disulfiram - a medicine used in alcohol abuse
cisapride - a medicine used to treat gastric reflux
ketoconazole - a medicine used to treat fungal infections
opioids - a medicine used to treat severe pain e.g. morphine, pethidine.
Combining ANTENEX and opioids may cause severe sedation, difficulties in breathing
(respiratory depression), coma and may be life-threatening.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ANTENEX.
4. How do I take ANTENEX?
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
How much to take
Take ANTENEX exactly as your doctor has prescribed. Your doctor will tell you how
many ANTENEX tablets to take each day and when to take them. The dose varies from
person to person depending on age, the condition being treated and whether or not
you are taking any other medicines.
The usual adult dose is between 5 and 40 mg daily. Children, elderly, those with kidney
or liver problems and very ill patients may need to take less.
Follow the instructions provided and take ANTENEX until your doctor tells you to stop
When to take ANTENEX
ANTENEX can be taken up to three times a day. Your doctor will tell you how much you
need to take.
How to take ANTENEX
Tablets should be swallowed whole with a glass of water.
The tablets can be taken with or without food.
How long to take ANTENEX for
Take ANTENEX only for as long as your doctor recommends.
Usually, ANTENEX should be taken for short periods only (for example 2 to 4 weeks).
Continuous long-term use is not recommended unless advised by your doctor.
If you forget to take ANTENEX
ANTENEX should be used regularly at the same time each day.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Otherwise, take the missed dose as soon as you remember, and then go back to taking
your tablets as you would normally.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you take too much ANTENEX
If you think that you or anyone else has taken too much ANTENEX, urgent medical attention
may be needed. If you take too much ANTENEX, you may feel drowsy, tired, confused,
dizzy, have difficulty breathing, feel weak or become unconscious.
Benzodiazepines increase the effect of CNS depressants. When ANTENEX is combined with
other CNS depressants, the effects of overdose are likely to be severe and may prove
fatal.
You should immediately:
phone the Poisons Information Centre
(Australia 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.
5. What should I know while taking ANTENEX?
Things you should do
Tell all doctors, dentists and pharmacists who are treating you that you are taking
ANTENEX.
If you plan to have surgery that requires general anaesthetic, tell your doctor or
dentist that you are taking ANTENEX.
If you have a thyroid function test, tell your doctor that you are taking ANTENEX.
ANTENEX may affect the results of this test.
Be sure to keep all of your appointments with your doctor so that your progress can
be checked.
You may need to have tests to check your blood and liver function. Also, your doctor
can advise you on whether you need to keep taking ANTENEX.
Tell your doctor of any problems or difficulties during or after taking ANTENEX.
Call your doctor straight away if you:
become pregnant while taking ANTENEX
for any reason, have not taken your medicine exactly as prescribed
Otherwise your doctor may think that it was not effective and change your treatment
unnecessarily.
feel the tablets are not helping your condition
have any suicidal thoughts or other mental/mood changes.
All thoughts of suicide must be taken seriously. Tell your doctor or a mental health
professional.
Things you should not do
Do not take any other medicines whether they require a prescription or not without
first telling your doctor.
Do not take ANTENEX for a longer time than your doctor has prescribed. ANTENEX should
be taken for short periods only (for example, 2-4 weeks) unless advised by your doctor.
Do not stop taking ANTENEX or lower the dose without first checking with your doctor.
Stopping this medicine suddenly may cause some unwanted effects. Your doctor will
explain how you should slowly reduce your dose of ANTENEX before you can stop taking
it completely.
Do not let yourself run out of medicine over the weekend or on holidays.
Do not suddenly stop taking ANTENEX if you suffer from epilepsy. Stopping this medicine
suddenly may make your epilepsy worse.
Do not give ANTENEX to anyone else even if their symptoms seem similar to yours.
Do not use ANTENEX to treat other complaints unless your doctor says to.
Things to be careful of
Be careful if you are elderly, unwell or taking other medicines.
You may have an increased chance of getting side effects such as drowsiness, confusion,
dizziness and unsteadiness, which may increase the risk of a fall.
Avoid drinking grapefruit juice as it may affect the absorption of ANTENEX.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how ANTENEX
affects you.
ANTENEX may cause drowsiness, dizziness or loss of concentration in some people and
therefore may affect alertness. Make sure you know how you react to ANTENEX before
your drive a car or operate machinery or do anything else that could be dangerous
if you are drowsy, dizzy or not alert. Children should be careful when riding bicycles
or climbing trees.
Drinking alcohol
Tell your doctor if you drink alcohol.
Alcohol may increase the effects of ANTENEX. Your doctor may suggest that you avoid
alcohol or reduce the amount of alcohol you drink while you are taking ANTENEX.
Combining ANTENEX and alcohol may cause severe sedation, difficulties breathing and/or
heart problems (respiratory and/or cardiovascular depression), coma and death.
Looking after your medicine
Keep your tablets in the original packaging until it is time to take them.
Store below 30°C.
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.
Heat and dampness can destroy some medicines.
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 or if the packaging is torn or shows
signs of tampering.
6. Are there any side effects?
All medicines can have side effects. You may not experience any of them. 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.
Some people, such as children and the elderly, may have an increased chance of getting
some 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 ANTENEX contains
Active ingredient
(main ingredient)
|
diazepam 2 mg or 5 mg per tablet
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Other ingredients
(inactive ingredients)
|
lactose monohydrate
maize starch
magnesium stearate
pregelatinised maize starch (ANTENEX 2 only)
quinoline yellow aluminium lake (ANTENEX 5 only)
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Potential allergens
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sulfites, galactose and sugars as lactose
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Do not take this medicine if you are allergic to any of these ingredients.
What ANTENEX looks like
ANTENEX 2 is an 8 mm, flat bevelled edged, white tablet marked "DM/2" on one side,
“G” on reverse (AUST R 17582).
ANTENEX 5 is an 8 mm, flat bevelled edged, very pale yellow tablet marked "DM/5" on
one side, “G” on reverse (AUST R 17583).
Who distributes ANTENEX
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in September 2024.
TRADE NAME® is a Viatris company trade mark.
ANTENEX_cmi\Sep24/00