Consumer medicine information

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.

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 abused it may become less able to reduce pain.

Dependence
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 VIATRIS suddenly.

Tolerance
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.

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.

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 you have.

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.

Side effects

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 breathing
• breathlessness
• slow heart beat
• drop in blood pressure
• increased blood pressure which may cause a headache or sensation of warmth/flushing
• muscle stiffness
• shivering
• nausea
• vomiting
• aches

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

Storage

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.

Product description

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.

Ingredients

Each vial contains 1 mg, 2 mg or 5 mg of remifentanil (as hydrochloride).

Inactive ingredients:

• glycine
• hydrochloric acid (for pH adjustment).

Supplier

Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30 - 34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276

This leaflet was prepared in December 2022.

Australian registration numbers:

REMIFENTANIL VIATRIS 1 mg - AUST R 163901

REMIFENTANIL VIATRIS 2 mg - AUST R 163902

REMIFENTANIL VIATRIS 5 mg - AUST R 163903

REMIFENTANIL VIATRIS_cmi\Dec22/00

Published by MIMS February 2023

Boxed Warnings

Limitations of use. Because of the risks associated with the use of opioids, Remifentanil Viatris should only be used in patients for whom other treatment options, including non-opioid analgesics, are ineffective, not tolerated or otherwise inadequate to provide appropriate management of pain (see Section 4.4 Special Warnings and Precautions for Use).
Hazardous and harmful use. Remifentanil Viatris poses risks of hazardous and harmful use which can lead to overdose and death. Assess the patient's risk of hazardous and harmful use before prescribing and monitor the patient regularly during treatment (see Section 4.4 Special Warnings and Precautions for Use).
Life threatening respiratory depression. Serious, life-threatening or fatal respiratory depression may occur with the use of Remifentanil Viatris. Be aware of situations which increase the risk of respiratory depression, modify dosing in patients at risk and monitor patients closely, especially on initiation or following a dose increase (see Section 4.4 Special Warnings and Precautions for Use).
Concomitant use of benzodiazepines and other central nervous system (CNS) depressants, including alcohol. Concomitant use of opioids with benzodiazepines, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, cannabis or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Limit dosages and durations to the minimum required; and monitor patients for signs and symptoms of respiratory depression and sedation. Caution patients not to drink alcohol while taking Remifentanil Viatris.

1 Name of Medicine

Remifentanil (as hydrochloride).

2 Qualitative and Quantitative Composition

Each Remifentanil Viatris powder for injection vial contains 1 mg, 2 mg or 5 mg of remifentanil (as hydrochloride) as the active ingredient.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Remifentanil Viatris is a sterile, endotoxin free, non-pyrogenic, preservative-free, white to off-white lyophilised powder for intravenous injection or infusion.

4 Clinical Particulars

4.9 Overdose

Overdosage is manifested by an extension of the pharmacologically predictable actions of Remifentanil Viatris.
In the event of overdose or suspected overdose, take the following actions: discontinue administration of Remifentanil Viatris, maintain a patent airway, initiate assisted or controlled ventilation with oxygen, and maintain adequate cardiovascular function. If depressed respiration is associated with muscle rigidity, a neuromuscular blocking agent may be required to facilitate assisted or controlled respiration. Intravenous fluids and vasopressor agents for the treatment of hypotension and other supportive measures may be employed.
Intravenous administration of naloxone may be given as a specific antidote to manage severe respiratory depression and muscle rigidity.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Remifentanil was not mutagenic in bacterial assays for gene mutations (Salmonella typhimurium histidine reversion assay), chromosomal aberrations (mouse micronucleus and Chinese hamster ovary chromosome) and a DNA repair assay (rat hepatocytes). However, a positive result was obtained in the mouse lymphoma L5178Y/tk^+/- assay in the presence of metabolic activation.
Carcinogenicity. There is no information currently available on the carcinogenic potential of remifentanil.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSREMIFE.gif Chemical name: 1-(2-methoxycarbonyl-ethyl)-4-(phenylpropionyl-amino)-piperidine-4-carboxylic acid methyl ester hydrochloride.
Molecular formula: C₂₀H₂₈N₂O₅.HCl.
Molecular weight: 412.9.
CAS number. 13539-07-2.

7 Medicine Schedule (Poisons Standard)

S8 (Controlled Drug).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/REMVIAST.gif