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 MIDAZOLAM VIATRIS?
MIDAZOLAM VIATRIS contains the active ingredient Midazolam. MIDAZOLAM VIATRIS is used
as a sedative during some short medical procedures.
2. What should I know before I use MIDAZOLAM VIATRIS?
Do not use if you have ever had an allergic reaction to Midazolam or any of the ingredients
listed at the end of the CMI.
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.
3. What if I am taking other medicines?
Some medicines may interfere with MIDAZOLAM VIATRIS and affect how it works.
4. How do I use MIDAZOLAM VIATRIS?
MIDAZOLAM VIATRIS may be given to you as an injection into a vein or muscle. It may
also be given through an infusion set in an intensive care unit. Other medications
may also be given at the same time.
Your doctor will adjust the dose necessary for you. This depends on which medical
procedure you will be having, your age, weight and your general health. Elderly patients
may need to receive less.
5. What should I know while using MIDAZOLAM VIATRIS?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using MIDAZOLAM VIATRIS.
Tell your doctor if you are taking any other medicines or have any conditions listed
in section 2 of the full CMI prior to taking MIDAZOLAM VIATRIS.
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Things you should not do
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Do not take any other medicines whether they require a prescription or not without
first telling your doctor.
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Driving or using machines
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Do not drive or operate machinery until you know how MIDAZOLAM VIATRIS affects you.
MIDAZOLAM VIATRIS may cause drowsiness, dizziness, fatigue, confusion and affect alertness.
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Drinking alcohol
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Do not have any alcohol for at least 12 hours after you have been given MIDAZOLAM
VIATRIS
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Looking after your medicine
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MIDAZOLAM VIATRIS will be stored in the pharmacy or on the ward.
It is kept in a cool dry place where the temperature stays below 25°C.
It should be protected from light.
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6. Are there any side effects?
Tell your doctor or pharmacist as soon as possible if you do not feel well after you
have received MIDAZOLAM VIATRIS, especially if you are over 60 years of age or have
pre-existing heart and lung conditions. All medicines can have side effects. Sometimes
they are serious, most of the time they are not. All medical procedures which involve
the use of an anaesthetic have risk which your doctor will discuss with you. In elderly,
or high-risk patients, death has resulted rarely due to heart attack or a slowdown
of the heart and lungs. 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(s):
midazolam
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using MIDAZOLAM VIATRIS. 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 MIDAZOLAM VIATRIS.
Where to find information in this leaflet:
1. Why am I using MIDAZOLAM VIATRIS?
MIDAZOLAM VIATRIS contains the active ingredient midazolam. MIDAZOLAM VIATRIS belongs to a group of medicines called benzodiazepines. They are
thought to work by their action on brain chemicals. MIDAZOLAM VIATRIS can cause sedation,
hypnosis, amnesia and/or anaesthesia, depending on the dose.
MIDAZOLAM VIATRIS may be injected as a sedative during some short medical procedures.
MIDAZOLAM VIATRIS may be given to you by injection before an operation to produce
sleepiness or drowsiness and to relieve anxiety.
If you are in an intensive care unit, you may receive an infusion of MIDAZOLAM VIATRIS
over several hours or days as a sedative.
Your doctor, however, may have prescribed MIDAZOLAM VIATRIS for another purpose.
Ask your doctor if you have any questions about why MIDAZOLAM VIATRIS has been prescribed
for you.
MIDAZOLAM VIATRIS is only given by a doctor trained to use this medicine. If you will
be receiving MIDAZOLAM VIATRIS during surgery, your doctor will give you the medicine
and closely follow your progress.
This medicine is available only with a doctor's prescription.
2. What should I know before I use MIDAZOLAM VIATRIS?
Warnings
Do not use MIDAZOLAM VIATRIS if:
you are allergic to midazolam, 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 muscle weakness, also known as myasthenia gravis
you have a condition called acute narrow angle glaucoma
you are suffering from shock, coma or acute alcoholic intoxication
you are less than eight years of age.
The safety and effectiveness of MIDAZOLAM VIATRIS in children less than eight years
of age has not been established.
Check with your doctor if you have any other medical conditions including:
liver, kidney, heart or lung disease
high or low blood pressure
mental disorders including; depression, psychosis or schizophrenia
epilepsy (fits or convulsions)
history of alcohol or drug abuse
are pregnant, intend to become pregnant or breastfeed
if you are allergic to any other medicines, foods, dyes or preservatives
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.
MIDAZOLAM VIATRIS is not recommended for use in pregnant women, especially in the
third (last) trimester or during labour unless there is no safer alternative.
MIDAZOLAM VIATRIS crosses the placenta and use in the third (last) trimester has resulted
in serious and potentially fatal effects in newborns. These include irregular heart
rates, muscle weakness, low body temperature, difficulty breathing, difficulty sucking.
The newborn may also show signs of dependency and withdrawal after birth.
If there is a need to use MIDAZOLAM VIATRIS when you are pregnant, your doctor will
discuss the risks and benefits to you and the unborn baby.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
If you are breastfeeding while taking MIDAZOLAM VIATRIS, monitor your baby for excessive
sedation, poor feeding and poor weight gain, and seek medical attention if you notice
these signs.
You should pump and discard breastmilk for at least 4 to 8 hours after receiving midazolam.
If you drink alcohol or use illicit (illegal) drugs regularly
MIDAZOLAM VIATRIS can cause physical dependency, especially if you have a history
of drug or alcohol abuse, when used long-term. Your dose may be reduced gradually
to overcome this effect.
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 and MIDAZOLAM VIATRIS may interfere with each other. These include:
other sleeping tablets, sedatives or tranquillisers
anaesthetics
fluvoxamine, nefazodone and other medicines for depression
medicines to control fits such as sodium valproate
medicines for allergies or colds such as antihistamines
pain relievers
chlorzoxazone and other muscle relaxants
cimetidine, a medicine used to treat ulcers
disulfiram, a medicine used in alcohol abuse
erythromycin and clarithromycin, common antibiotics
diltiazem, verapamil and atorvastatin, medicines used to treat high blood pressure
or heart conditions
ketoconazole, fluconazole, posaconazole and itraconazole, medicines used to treat
fungal infections
ritonavir, saquinavir and other HIV protease inhibitors, medicines used to treat HIV
bicalutamide, a medicine used in the treatment of prostate cancer and for excessive
hair loss particularly in women
aprepitant, a medicine used for treatment of nausea (feeling sick) and vomiting associated
with chemotherapy
goldenseal, a complementary medicine
These medicines may be affected by MIDAZOLAM VIATRIS or may affect how well MIDAZOLAM
VIATRIS works.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect MIDAZOLAM VIATRIS.
Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.
They also know of other medicines to be careful with or avoid while using MIDAZOLAM
VIATRIS.
4. How am I given MIDAZOLAM VIATRIS?
How MIDAZOLAM VIATRIS is given
MIDAZOLAM VIATRIS may be given to you as an injection into a vein or muscle. It may
also be given through an infusion set in an intensive care unit. Other medications
may also be given at the same time.
How much is given
Your doctor will adjust the dose necessary for you. This depends on which medical
procedure you will be having, your age, weight and your general health. Elderly patients
may need to receive less.
When and how long is MIDAZOLAM VIATRIS given
MIDAZOLAM VIATRIS may be given once before a medical procedure, or continuously by
infusion for patients in an intensive care unit.
MIDAZOLAM VIATRIS will be stopped once there is no further need for sedation.
If have been given too much MIDAZOLAM VIATRIS
If you think that you have been given too much MIDAZOLAM VIATRIS, you may feel drowsy,
tired, confused, dizzy, feel weak or become unconscious. If used in combination with
other similar medicines, the effects of overdose may be serious and potentially fatal.
You may need urgent medical attention.
You should immediately:
tell the doctor or nurse on duty if you think you have been given too much of MIDAZOLAM
VIATRIS, or
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.
Ask your doctor if you have any concerns.
Your doctor has information on how to recognise and treat an overdose.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using MIDAZOLAM VIATRIS?
Things you should do
Call your doctor straight away if you:
feel MIDAZOLAM VIATRIS is not helping you
experience serious side effects listed in section 6
Remind any doctor, dentist or pharmacist you visit that you are using MIDAZOLAM VIATRIS.
Things you should not do
Do not take any other medicines whether they require a prescription or not without
first telling your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how MIDAZOLAM
VIATRIS affects you.
MIDAZOLAM VIATRIS may cause dizziness, drowsiness, dizziness, fatigue, confusion and
forgetfulness in some people and therefore may affect alertness. Make sure you know
how you react to MIDAZOLAM VIATRIS before you drive a car or operate machinery, or
do anything else that could be dangerous if you are drowsy, dizzy or not alert.
Drinking alcohol
Tell your doctor if you drink alcohol.
Do not have any alcohol for at least 12 hours after you have been given MIDAZOLAM
VIATRIS.
Alcohol may increase the risk of fall and fracture due to dizziness and unsteadiness,
a possible side effect of MIDAZOLAM VIATRIS.
Looking after your medicine
MIDAZOLAM VIATRIS will be stored in the pharmacy or on the ward.
It is kept in a cool dry place where the temperature stays below 25°C. It should not
be stored in the refrigerator.
It should be protected from light.
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.
In elderly, or high-risk patients, death has resulted on rare occasions, due to heart
attack or a slowdown of the heart and lungs. These life-threatening diseases are more
common in adults over 60 years of age and with pre- existing heart and lung conditions
when a high dose of MIDAZOLAM VIATRIS is administered or when the injection is given
too rapidly. If you belong to these high-risk groups seek medical attention immediately
if you notice heart or breathing issues.
Less serious side effects
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Less serious side effects
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What to do
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drowsiness, tiredness, reduced alertness
dizziness, unsteadiness – there is a risk of fall and fracture which is increased
in those taking sedatives, alcohol and in the elderly
loss of memory, inattentiveness, confusion, lack of concentration, lethargy
headache, hangover feeling in the morning
slurred speech
unpleasant dreams
blurred vision
pain, redness or hardness at the injection site
muscle stiffness or inflammation of the vein
coughing, hiccups
constipation
nausea/feeling sick with or without vomiting
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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difficulty breathing or wheezing
changes in pulse rate and blood pressure
sudden anxiety, excitation or agitation, involuntary movements such as muscle tremors
hallucinations, unusual mood or delusions
severe sleep disturbances
allergic reaction - sudden signs such as rash, itching or hives on the skin, swelling
of the face, lips, tongue which may cause difficulty in swallowing or breathing and
other parts of the body
withdrawal symptoms including withdrawal convulsions
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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.
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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 MIDAZOLAM VIATRIS contains
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Active ingredient
(main ingredient)
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midazolam
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Other ingredients
(inactive ingredients)
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sodium chloride
water for injections
small amounts of hydrochloric acid and sodium hydroxide to adjust the acidity of the
solution.
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Do not take this medicine if you are allergic to any of these ingredients.
What MIDAZOLAM VIATRIS looks like
MIDAZOLAM VIATRIS is a clear colourless solution and available in the following strengths:
MIDAZOLAM VIATRIS 5 mg/ 5 mL - AUST R 160206
MIDAZOLAM VIATRIS 5 mg/mL - AUST R 160207
MIDAZOLAM VIATRIS 15 mg/ 3 mL - AUST R 160205
MIDAZOLAM VIATRIS 50 mg/ 10mL - AUST R 160208
Who distributes MIDAZOLAM VIATRIS
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 January 2024.
MIDAZOLAM VIATRIS_cmi\Jan24/00