remifentanil (as hydrochloride)
CONSUMER MEDICINE INFORMATION
Limitations of use
REMIFENTANIL VIATRIS should only be used when your doctor decides that other treatment
Hazardous and harmful use
REMIFENTANIL VIATRIS poses risks of abuse, misuse and addiction which can lead to
Life threatening respiratory depression
REMIFENTANIL VIATRIS can cause life-threatening or fatal breathing problems (slow,
Use of other medicines while using REMIFENTANIL VIATRIS
Using REMIFENTANIL VIATRIS with other medicines that can make you feel drowsy such
Table of Contents
What is in this leaflet
This leaflet contains answers to some common questions about REMIFENTANIL VIATRIS.
It does not contain all the information available on REMIFENTANIL VIATRIS.
It does NOT take the place of talking to your doctor or your pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking
REMIFENTANIL VIATRIS against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What REMIFENTANIL VIATRIS is used for
REMIFENTANIL VIATRIS is 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.
REMIFENTANIL VIATRIS may also be used for patients in the Intensive Care Unit to maintain
sedation and relieve pain.
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.
Your doctor may have prescribed REMIFENTANIL VIATRIS for another reason.
Ask your doctor if you have any questions about why REMIFENTANIL VIATRIS has been
prescribed for you.
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 abused it may become less able to reduce pain.
As with all other opioid containing products, your body may become used to you using
REMIFENTANIL VIATRIS. Using it may result in physical dependence. Physical dependence
means that you may experience withdrawal symptoms if you stop receiving REMIFENTANIL
Tolerance to REMIFENTANIL VIATRIS may develop, which means that the effect of the
medicine may decrease. If this happens, more may be needed to maintain the same effect.
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
REMIFENTANIL VIATRIS given to the mother during labour can cause breathing problems
and signs of withdrawal in the newborn.
Before you are given REMIFENTANIL VIATRIS
When you must not receive it
Do not use REMIFENTANIL VIATRIS if you have an allergy to:
any medicine containing remifentanil
any of the ingredients listed at the end of this leaflet
other pain-relieving medicines which are similar to fentanyl and which are related
to the class of medicines known as opioids
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.
Before you receive REMIFENTANIL VIATRIS
You must tell your doctor if:
you have had any adverse reactions during an operation
you have had any type of allergic reaction to opioid medicines (e.g., morphine, fentanyl,
pethidine, codeine), or to 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.
you are allergic to any other medicines, foods, dyes or preservatives
you have or have ever had any of the following medical conditions:
slow heart beat
low blood pressure
chest or breathing problems.
you are pregnant, intend to become pregnant, are breastfeeding or plan to breast feed.
Like most medicines, REMIFENTANIL VIATRIS is not recommended in pregnancy and breast-feeding.
However, your doctor will discuss the possible risks and benefits of being given REMIFENTANIL
VIATRIS if you are pregnant or breast-feeding.
If you have not told your doctor about any of the above, tell them before you are
given REMIFENTANIL VIATRIS.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any
that you get without a prescription from a pharmacy, supermarket or health food shop.
Tell your doctor if you have recently been taking medicines for blood pressure or
heart problems (known as beta-blockers or calcium channel blockers).
Some medicines, such as benzodiazepines, other pain relievers, antihistamines antidepressants
and alcohol, may interfere with REMIFENTANIL VIATRIS. Your doctor or pharmacist will
be able to tell you what to do when being given REMIFENTANIL VIATRIS with other medicines.
How REMIFENTANIL VIATRIS is given
REMIFENTANIL VIATRIS can be given into 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
While you are using REMIFENTANIL VIATRIS
Things to be careful of
If you are discharged early, following treatment with REMIFENTANIL VIATRIS or any
other anaesthetic agents, do not drive or operate machinery.
All medicines have unwanted side effects. Sometimes they are serious, most of the
time they are not. In cases of serious side effects, you may need prompt medical attention.
REMIFENTANIL VIATRIS can cause the following commonly reported side-effects:
slow heart beat
drop in blood pressure
increased blood pressure which may cause a headache or sensation of warmth/flushing
Do not be alarmed by this list of possible side effects. You may not experience any
of them. If you need to know more about the drug, please consult your doctor. Also
please be sure to tell your doctor of any unusual effects or symptoms.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice anything else that is making you feel unwell, even
if it is not on this list.
This is not a complete list of all possible side-effects. Others may occur in some
people and there may be some side-effects not yet known.
After using REMIFENTANIL VIATRIS
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
What it looks like
REMIFENTANIL VIATRIS is a white to off-white powder and is supplied in a glass vial.
REMIFENTANIL VIATRIS is available in packs of 5 vials.
Each vial contains 1 mg, 2 mg or 5 mg of remifentanil (as hydrochloride).
hydrochloric acid (for pH adjustment).
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 December 2022.
Australian registration numbers:
1 mg - AUST R 163901
2 mg - AUST R 163902
5 mg - AUST R 163903