2. What should I know before receiving REMIFENTANIL VIATRIS?
Do not use if you have ever had an allergic reaction to remifentanil 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 REMIFENTANIL VIATRIS and affect how it works.
4. How REMIFENTANIL VIATRIS is given
REMIFENTANIL VIATRIS can be given in a vein in two ways: as a slow injection, or as
a slow infusion.
REMIFENTANIL VIATRIS will be given to you by an anaesthetist or a doctor. You will
never be expected to give yourself this medication.
5. What should I know while receiving REMIFENTANIL VIATRIS?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you have been given REMIFENTANIL
VIATRIS.
|
|
Driving or using machines
|
If you are discharged early following treatment with REMIFENTANIL VIATRIS, do not
drive or operate machinery.
|
|
Drinking alcohol
|
You must not drink alcohol while using REMIFENTANIL VIATRIS. Alcohol may interfere
with REMIFENTANIL VIATRIS.
Tell your doctor if you drink alcohol.
|
|
Looking after the medicine
|
REMIFENTANIL VIATRIS should be kept in a cool dry place in the original container,
where the temperature stays below 25°C.
|
6. Are there any side effects?
Some common side effects are: slow breathing, breathlessness, slow heartbeat, a drop
in blood pressure, an increase in blood pressure (which may cause a headache, or a
sensation of warmth/flushing), muscle stiffness, shivering, nausea, vomiting, and
aches.
|
WARNING:
Limitations of use
REMIFENTANIL VIATRIS should only be used when your doctor decides that other treatment
options are not able to effectively manage your pain, or you cannot tolerate them.
Hazardous and harmful use
REMIFENTANIL VIATRIS poses risks of abuse, misuse and addiction which can lead to
overdose and death. Your doctor will monitor you regularly during treatment.
Life threatening respiratory depression
REMIFENTANIL VIATRIS can cause life-threatening or fatal breathing problems (slow,
shallow, unusual or no breathing) even when used as recommended. These problems can
occur at any time during use, but the risk is higher when first starting REMIFENTANIL
VIATRIS and after a dose increase, if you are older, or have an existing problem with
your lungs. Your doctor will monitor you and change the dose as appropriate.
Use of other medicines while using REMIFENTANIL VIATRIS
Using REMIFENTANIL VIATRIS with other medicines that can make you feel drowsy such
as sleeping tablets (e.g. benzodiazepines), other pain relievers, antihistamines,
antidepressants, antipsychotics, gabapentinoids (e.g. gabapentin and pregabalin),
cannabis and alcohol may result in low blood pressure, severe drowsiness, decreased
awareness, breathing problems, coma and death. Your doctor will minimise the dose
and duration of use; and monitor you for signs and symptoms of breathing difficulties
and sedation. You must not drink alcohol while using REMIFENTANIL VIATRIS.
|
Active ingredient:
remifentanil (as hydrochloride)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking REMIFENTANIL 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 taking REMIFENTANIL VIATRIS.
Where to find information in this leaflet:
4. How REMIFENTANIL VIATRIS is given
1. Why am I receiving REMIFENTANIL VIATRIS?
REMIFENTANIL VIATRIS contains the active ingredient remifentanil. REMIFENTANIL VIATRIS belongs to a group of medicines called opioids. It differs from
other medicines in this group by its very quick onset and very short duration of action.
REMIFENTANIL VIATRIS is used in the following ways:
As an anaesthetic used with other anaesthetic medicines, to produce and/or maintain
heavy sleep during your operation.
If you are a cardiac patient, it may also be used to help relieve any pain immediately
following your operation.
It may also be used for patients in the Intensive Care Unit to maintain sedation and
relieve pain.
Ask your doctor if you have any questions about why REMIFENTANIL VIATRIS has been
prescribed for you.
Addiction
You can become addicted to REMIFENTANIL VIATRIS even if you receive it exactly as
prescribed. REMIFENTANIL VIATRIS may become habit forming causing mental and physical
dependence. If misused, it may become less able to reduce pain.
Dependence
As with all other opioid containing products, your body might get used to REMIFENTANIL
VIATRIS over time. Using it may result in physical dependence. Physical dependence
means that you may experience withdrawal symptoms if you stop receiving REMIFENTANIL
VIATRIS suddenly.
Tolerance
Tolerance to REMIFENTANIL VIATRIS may develop, which means that the effect of the
medicine may decrease. If this happens, you might need more of the medicine to get
the same effect.
Withdrawal
If you stop receiving this medicine suddenly, your pain may worsen and you may experience
some or all of the following withdrawal symptoms:
nervousness, restlessness, agitation, trouble sleeping or anxiety
body aches, weakness or stomach cramps
loss of appetite, nausea, vomiting or diarrhoea
increased heart rate, breathing rate or pupil size
watery eyes, runny nose, chills or yawning
increased sweating
REMIFENTANIL VIATRIS given to the mother during labour can cause breathing problems
and signs of withdrawal in the newborn.
Call or speak to your doctor straight away if you experience any of the above symptoms.
2. What should I know before receiving REMIFENTANIL VIATRIS?
Warnings
Do not use REMIFENTANIL VIATRIS if:
You are allergic to remifentanil, other pain-relieving medicines which are similar
to fentanyl and which are related to the class of medicines known as opioids, or any
of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may be mild or severe. They may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue, or other parts of the body
rash, itching or hives on the skin
Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
have any other medical conditions
take any medicines for any other condition
have had any adverse reactions during an operation
have had any type of allergic reaction to opioid medicines (e.g. morphine, fentanyl,
pethidine, codeine), or any medicines used during an operation. You probably have
an increased chance of being allergic to REMIFENTANIL VIATRIS if you are allergic
to other opioids.
are allergic to any other medicines, foods, dyes, or preservatives
have or have ever had any of the following medical conditions:
slow heartbeat
low blood pressure
chest or breathing problems
diseases of the gallbladder or bile ducts inside or outside the liver
inflammation of the pancreas (pancreatitis)
If you have not told your doctor about any of the above, tell them before you are
given REMIFENTANIL VIATRIS.
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?
Sleep related breathing disorder
REMIFENTANIL VIATRIS may cause sleep-related breathing disorders.
This includes disorders such as sleep apnoea (breathing pauses during sleep) and sleep
related hypoxemia (low oxygen levels in the blood). Symptoms can include:
breathing pauses during sleep
night awakening due to shortness of breath
difficulties to maintain sleep or excessive drowsiness during the day
If you or another person observe these symptoms, contact your doctor.
Adrenal insufficiency
This means that your adrenal glands (small glands above your kidneys) are not able
to make certain important hormones. Symptoms can include:
nausea (feeling sick)
vomiting
anorexia
fatigue
weakness
dizziness
low blood pressure
Your doctor may request blood tests to determine if this is occurring in your body.
Endocrine effects (hormonal effects)
Opioid drugs like REMIFENTANIL VIATRIS, may affect the hypothalamic-pituitary-adrenal
axis (HPA) (the body's stress response system), or the hypothalamic-pituitary-gonadal
(HPG) axis (the reproductive hormonal system). Symptoms can include:
low libido
impotence (erectile dysfunction)
absence of the menstrual cycle in women
infertility
Tell your doctor if you experience any of these symptoms.
Gastrointestinal disorder
Problems with your oesophagus (food pipe) may occur as a result of using opioid medicines
such as REMIFENTANIL VIATRIS. Symptoms can include:
difficulty swallowing (dysphagia)
regurgitation (reflux)
chest pain
Tell your doctor if you experience any of these symptoms.
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Like most medicines, REMIFENTANIL VIATRIS is not recommended in pregnancy and breastfeeding.
However, your doctor will discuss the possible risks and benefits of being given REMIFENTANIL
VIATRIS if you are pregnant or breastfeeding.
Using REMIFENTANIL VIATRIS for a long-time during pregnancy can cause the baby to
have withdrawal symptoms after birth.
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 REMIFENTANIL VIATRIS and affect how it works. These
include:
Benzodiazepines, other pain relievers, antihistamines, antipsychotics, gabapentinoids
(e.g. gabapentin and pregabalin), or cannabis. Your doctor or pharmacist will be able
to tell you what to do when being given REMIFENTANIL VIATRIS.
Tell your doctor if you have recently been taking medicines for blood pressure or
heart problems (known as beta-blockers or calcium channel blockers).
Serotonin syndrome
Tell your doctor if you are using antidepressants such as monoamine oxidase inhibitors
(MAOIs) before you start using REMIFENTANIL VIATRIS. Using these medicines with opioids
may cause various symptoms related to serotonin syndrome.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect REMIFENTANIL VIATRIS.
4. How REMIFENTANIL VIATRIS is given
REMIFENTANIL VIATRIS can be given in a vein in two ways:
as a slow injection, or
as a slow infusion
REMIFENTANIL VIATRIS will be administered by an anaesthetist or other highly trained
doctor. You will never be expected to give yourself this medication. The dosage will
vary according to many factors such as your body weight and the type of operation
you have.
If you have been given too much REMIFENTANIL VIATRIS
If you or someone else has received too much REMIFENTANIL VIATRIS (overdose) and experience
one or more of the symptoms below, urgent medical attention is required.
Keep the person awake by talking to them or gently shaking them every now and then.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
Symptoms of an overdose may include:
slow, unusual or difficult breathing
drowsiness, dizziness or unconsciousness
slow or weak heartbeat
nausea or vomiting
convulsions or fits (twitching or jerking)
Other signs of overdose can also include problems with the 'nervous system' caused
by damage to the white matter of the brain (known as toxic leukoencephalopathy).
5. What should I know while receiving REMIFENTANIL VIATRIS?
Driving or using machines
If you are discharged early following treatment with REMIFENTANIL VIATRIS or any other
anaesthetic agents, do not drive or operate machinery.
Drinking alcohol
Tell your doctor if you drink alcohol.
You must not drink alcohol while using REMIFENTANIL VIATRIS. Alcohol may interfere
with REMIFENTANIL VIATRIS.
Looking after the medicine
REMIFENTANIL VIATRIS should be kept in a cool dry place in the original container,
where the temperature stays below 25°C.
The reconstituted solution should be used immediately, but if necessary, can be kept
in a refrigerator between 2°C and 8°C for not more than 24 hours after mixing. Do
not freeze.
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.
Common 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 REMIFENTANIL VIATRIS contains
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Active ingredient
(main ingredient)
|
remifentanil
|
|
Other ingredients
(inactive ingredients)
|
glycine
hydrochloric acid
|
Do not take this medicine if you are allergic to any of these ingredients.
What REMIFENTANIL VIATRIS looks like
REMIFENTANIL VIATRIS is a white to off-white powder and is supplied in a glass vial.
This medicine is available in packs of 5 vials.
Australian registration numbers
REMIFENTANIL VIATRIS 1 mg vial - AUST R 163901
REMIFENTANIL VIATRIS 2 mg vial - AUST R 163902
REMIFENTANIL VIATRIS 5 mg vial - AUST R 163903
Who distributes REMIFENTANIL 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 September 2025.
REMIFENTANIL VIATRIS_cmi\Sep25/00