SUMMARY CMI
Amiodarone Juno
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 being given Amiodarone Juno?
Amiodarone Juno contains the active ingredient amiodarone hydrochloride. Amiodarone Juno is an antiarrhythmic used to stabilize and control an irregular heartrate.
For more information, see Section 1. Why am I being given Amiodarone Juno? in the full CMI.
2. What should I know before I am given Amiodarone Juno?
Do not use if you
- have ever had an allergic reaction to amiodarone or iodine, or any of the ingredients listed at the end of the CMI.
- have or have had any thyroid problems
- have heart problems (low blood pressure/fainting, heart disease or failure), shock, severe problems breathing
- are pregnant or intend to become pregnant or are breastfeeding.
Talk to your doctor if you have any other medical conditions, take any other medicines.
For more information, see Section 2. What should I know before I am given Amiodarone Juno? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with Amiodarone Juno and affect how it works. Medicines used for the treatment of blood pressure, heart problems, immune suppressants and some anaesthetics may interfere with Amiodarone Juno.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
4. How will I be given Amiodarone Juno?
- Your doctor will decide how much Amiodarone Juno you are given.
- Your doctor may adjust your dosage depending on your condition
More instructions can be found in Section 4. How will I be given Amiodarone Juno? in the full CMI.
5. What should I know while I am given Amiodarone Juno?
Things you should do |
|
Things you should not do | Do not stop using this medicine suddenly without checking with your doctor. |
Things to be careful of | Always use sunscreen and wear a hat and protective clothing when you are outdoors. Do not use a sunlamp. |
For more information, see Section 5. What should I know while I am given Amiodarone Juno? in the full CMI.
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.
Treatment with amiodarone may cause serious lung, liver and eye damage and may worsen heart problems. Serious side effects may include changes to heartbeat such as pounding, rapid or very slow heartbeat; allergic reaction; blurring or deterioration of vision, sensitisation of eyes to light; severe blisters and bleeding in the lips, eyes, mouth, nose and genitals; yellow skin or eyes, faintness, light-headedness; nausea, vomiting, stomach pain, unusual tiredness, passing dark-coloured urine; clumsiness and lack of coordination, affecting balance and manner of walking, limb or eye movements/speech; chest pain, cough or spitting up blood.
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.
FULL CMI
Amiodarone Juno
Active ingredient(s): amiodarone hydrochloride
Consumer Medicine Information (CMI)
This leaflet provides important information about using Amiodarone Juno. 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 Amiodarone Juno.
Where to find information in this leaflet:
1. Why am I being given Amiodarone Juno?
2. What should I know before I am given Amiodarone Juno?
3. What if I am taking other medicines?
4. How will I be given Amiodarone Juno?
5. What should I know while I am given Amiodarone Juno?
6. Are there any side effects?
7. Product details
1. Why am I being given Amiodarone Juno?
Amiodarone Juno contains the active ingredients amiodarone hydrochloride and belongs to a group of medicines called antiarrhythmic agents.
This medicine is used to control a fast or irregular heartbeat
It works by lengthening the gap between one heartbeat and the next, helping to bring the heart rate to a slower and more regular pace.
Your doctor may have prescribed this medicine for another reason.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
2. What should I know before I am given Amiodarone Juno?
Warnings
Do not use Amiodarone Juno if you:
- are allergic to amiodarone or iodine or any of the ingredients listed at the end of this leaflet.
Allergy symptoms may include rash, itching, swelling, coughing or an asthma attack or hay fever. - have or have had thyroid problems
- have heart problems that may cause you to faint. If you have a pacemaker, your doctor may allow the use of it
- have any of the following:
- low blood pressure
- severe problems in breathing
- heart disease or failure
- shock.
Check with your doctor if you:
- have or have had any medical conditions, especially the following:
- other heart conditions
- blood pressure problems
- liver problems
- thyroid problems - take any medicines for any other conditions.
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
Do not use this medicine if you are pregnant or intending to become pregnant.
This medicine is best avoided in the 3 months before getting pregnant and during pregnancy.
Do not breastfeed if you are using this medicine as it can be found in breast milk
If you are breastfeeding, alternative feeding arrangements such as bottle feeding should be made for your baby.
Your doctor will discuss the possible risks and benefits of using Amiodarone Juno during pregnancy and breast feeding.
Children and neonates
Amiodarone Juno is not recommended for use in children.
Do not use this medicine in neonates (children less than one month of age) or premature neonates.
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 Amiodarone Juno and affect how it works. Tell your doctor if you are using any other medicines including:
- medicines for your heart
- medicines for your blood pressure
- medicines which reduce the activity of your immune system such as cyclosporin, cortisone or tacrolimus
- diuretics (water tablets)
- antibiotics, including intravenous erythromycin and pentamidine
- stimulant laxatives, e.g. Bisacodyl, castor oil, senna
- MAO inhibitors (a type of medicine used to treat depression)
- antipsychotics (medicines used to treat certain mental and emotional conditions)
- phenytoin (a medicine used to treat epilepsy)
- warfarin and other medicines which thin the blood
- simvastatin and other statins (medicines used to lower cholesterol)
- colchicine (a medicine used to treat gout)
- digoxin (a medicine used to treat heart conditions)
- medicines to treat a fast or irregular heartbeat such as flecainide and sotalol
- fentanyl (a medicine used to treat pain)
- sildenafil (Viagra)
- triazolam (a medicine used to treat insomnia)
- ergotamine (a medicine used to treat migraine)
- general anaesthesia
- lignocaine (a topical anaesthetic)
- amphotericin B (a medicine used to treat fungal infections)
- antiviral medication e.g. sofosbuvir, daclatasvir, simeprevir, ledipasvir.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Amiodarone Juno.
4. How will I be given Amiodarone Juno?
How Amiodarone Juno is given
Amiodarone Juno must only be given by a doctor or nurse. Your doctor will decide what dose and how long you will receive it. This depends on your infection and other factors, such as your weight.
The usual dose is 5 mg/kg given slowly over a period of 20 minutes to 2 hours
Further doses may also be given based upon your response to the treatment.
If you are given too much Amiodarone Juno
As your doctor will supervise how much Amiodarone Juno you are given, you are unlikely to have an overdose.
If you think that you have been given too much Amiodarone Juno, you may need urgent medical attention.
You should immediately:
- phone the Poisons Information Centre
(by calling 13 11 26), 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 I am given Amiodarone Juno?
Things you should do
Be sure to keep all of your doctor appointments so that your progress can be checked.
To help prevent unwanted side effects, your doctor may need to perform the following tests, depending on the length of treatment with this medicine:
- ECG
- eye tests
- chest X-rays
- liver function tests
- thyroid tests
Inform your doctors, dentists and pharmacists you are being treated with this medicine
Tell your doctor if you become or intend to become pregnant while using this medicine.
Things you should be careful of
Always use a 30+ sunscreen and wear a hat and protective clothing when you are outdoors.
Do not use a sunlamp.
Using Amiodarone Juno injection may make your skin more sensitive to the sun or sunlamps. This can range from an increased tendency to tan, to intense redness and swelling of the skin.
If you are going to have surgery, tell the anaesthetist that you are using Amiodarone Juno injection.
This medicine may affect some of the medicines that may be needed, such as general anaesthetics.
Tell your doctor or medical professional that you are using Amiodarone Juno before you are given any medical procedure or any new medicines.
Things you should not do
Do not stop using this medicine suddenly unless instructed by your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Amiodarone Juno affects you.
Looking after your medicine
The hospital will store Amiodarone Juno under the correct recommended conditions.
It should be kept in a cool, dry place away from moisture, heat or light where the temperature stays below 25°C.
Do not use this medicine after the expiry date.
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.
Treatment with amiodarone may cause lung, liver and eye damage and may worsen heart problems. Your doctor will monitor you very carefully for side effects. This will involve blood tests to check how well your liver and thyroid are functioning. It will also involve regular chest X-rays, ECGs and eye tests.
Your doctor will tell you how often you need to have these tests. This will depend on how long you are on Amiodarone Juno Injection for and what dose you are on.
Less serious side effects
Less serious side effects | What to do |
| Speak to your doctor if you have any of these less serious side effects and they worry you. |
Serious side effects
Serious side effects | What to do |
| 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. |
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 Amiodarone Juno contains
Active ingredient (main ingredient) | Amiodarone hydrochloride |
Excipients (inactive ingredients) |
|
Do not take this medicine if you are allergic to any of these ingredients.
What Amiodarone Juno looks like
Amiodarone Juno is a clear, slightly yellow solution for intravenous administration contained in colourless glass ampoules
Amiodarone Juno is supplied in the following presentation
AMIODARONE JUNO amiodarone hydrochloride 150mg/3mL solution for injection ampoule. Each box contains 10 ampoules.
(AUST R 233673)
Who distributes Amiodarone Juno
Juno Pharmaceuticals Pty Ltd
15-17 Chapel Street
Cremorne VIC 3121
www.junopharm.com.au
This leaflet was prepared in March 2025
Published by MIMS April 2025