ESMOLOL JUNO

ESMOLOL JUNO

Active ingredient(s): Esmolol (ES-moe-lol) hydrochloride

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Consumer Medicine Information (CMI)

This leaflet provides important information about using esmolol. 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 Esmolol Juno.

Where to find information in this leaflet:

1. Why am I using Esmolol Juno?
2. What should I know before I use Esmolol Juno?
3. What if I am taking other medicines?
4. How do I use Esmolol Juno?
5. What should I know while using Esmolol Juno?
6. Are there any side effects?
7. Product details

1. Why am I using Esmolol Juno?

Esmolol Juno is used as a short-term treatment for irregular heartbeat before, during or after surgery. It is also used in emergency situations.

Irregular heartbeat, also known as arrhythmia, means that there is a disturbance of the heart’s normal rhythm or beat. Arrhythmia may be caused by a number of factors, including some heart diseases, an overactive thyroid gland, or chemical imbalances. Esmolol Juno helps restore the heart’s normal rhythm.

Esmolol Juno belongs to a group of medicines called beta-blockers.

2. What should I know before I use Esmolol Juno?

Warnings

Do not use ESMOLOL JUNO if:

• you are allergic to esmolol hydrochloride 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 are allergic to any other beta-blocker medicines
• you have a very slow or irregular heart beat
• you have heart disease or certain other heart conditions
• you are taking certain heart medicines, called calcium channel blockers or calcium antagonists, such as verapamil
• you are receiving emergency treatment for shock or severely low blood pressure.

You should not be given Esmolol Juno if the solution Is discoloured, cloudy, turbid, or particles or a precipitate is present.

The solution is normally a clear, colourless to light yellow solution.

You should not be given this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

If this medicine is used after the expiry date it may not work as well.

Check with your doctor if you:

• have allergies to any other medicines, foods, preservatives or dyes
• have or have had any of the following medical conditions:
  – low blood pressure
  – any other heart problem
  – history of severe life threatening allergic reactions
  – asthma, wheezing, difficulty breathing or other lung problems
  – diabetes
  – low sugar levels in the blood
  – kidney problems.

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.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

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 Esmolol Juno and affect how it works.

These include:

• other beta-blocker medicines, including beta-blocker eye drops
• verapamil, a calcium channel blocker or calcium antagonist which is used to treat high blood pressure and chest pain
• reserpine, a medicine used to treat high blood pressure
• succinylcholine a muscle relaxant used during surgery
• warfarin, a medicine used to prevent blood clots
• digoxin, a medicine used to treat heart failure
• morphine, a medicine used for pain relief
• medicines commonly used during surgery or in emergency situations such as dopamine, adrenaline, noradrenaline and certain anaesthetics.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Esmolol Juno.

4. How do I use Esmolol Juno?

How much to use

• your doctor will decide the appropriate dose for you.

When to use ESMOLOL JUNO

• you will be given esmolol injections as directed by your doctor.

How to use Esmolol Juno

• this medicine must only be given by a doctor or nurse
• it is given as a slow injection into the vein.

If you use too much ESMOLOL JUNO

ESMOLOL JUNO must only be given by a doctor or nurse so an overdose is not likely to occur.

Symptoms of an overdose may include:

• dizziness, faintness or lightheadedness
• chest pain
• drowsiness and loss of consciousness.

Your doctor has information on how to recognise and treat an overdose. Ask your doctor if you have any concerns.

5. What should I know while using Esmolol Juno?

Things you should do

If you are about to be started on any new medicines, remind your doctor or pharmacist that you have recently been given Esmolol Juno.

Tell any other doctors or dentists, and pharmacists who treat you that you have been given this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you have been given this medicine.

It may affect other medicines used during the surgery.

If you plan to become pregnant, tell your doctor that you have been given this medicine. Your doctor can discuss with you the risks and benefits involved.

If you have a severe allergic reaction to foods, medicines or insect stings, tell your doctor immediately.

If you have a history of allergies, there is a chance that Esmolol Juno may cause allergic reactions to be worse and more difficult to treat.

If you are being treated for diabetes, make sure you check your blood sugar level regularly and report any changes to your doctor.

Esmolol Juno may change how well your diabetes is controlled. It may also cover up some of the symptoms of low blood sugar, called hypoglycaemia, such as fast heart beat. Esmolol Juno may make low blood sugar last longer. Your doses of diabetic medicines, including insulin, may need to change.

Be sure to keep all of your doctor’s appointments so that your progress can be checked.

Remind any doctor, dentist or pharmacist you visit that you are using Esmolol Juno.

Things to be careful of

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly.

You may feel light-headed or dizzy after you are given Esmolol Juno. Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure. If this problem gets worse or continues, talk to your doctor.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how esmolol hydrochloride affects you.

Esmolol may cause dizziness in some people.

Drinking alcohol

Tell your doctor if you drink alcohol.

Alcohol may increase the side effects of some medicines.

Looking after your medicine

Esmolol Juno will be stored in the pharmacy or on the ward of a hospital. The injection is kept in a cool dry place, protected from light, where the temperature stays below 25°C. Store in the original packaging.

When to discard your medicine

Esmolol Juno will be opened for use on you. It will be used only once and then it will be discarded. It will never be stored after it is opened nor used for more than one person.

Getting rid of any unwanted medicine

Any unwanted medicine will be disposed of in safe manner by our doctor, nurse or pharmacist.

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.

Less serious side effects

Less serious side effects	What to do
tiredness, drowsiness, sweating, decreased alertness weakness, lack of energy shakiness, trembling, muscle stiffness headache aches and pains changes in mood such as anxiety, agitation, depression confusion stomach upset, diarrhoea or constipation loss of appetite, feeling sick, vomiting dry mouth, change in taste sensation runny or blocked nose flushed or pale skin.	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
dizziness or light-headedness (sometimes with fainting), especially on standing up skin reactions at the injection site (e.g., swelling, redness or burning sensation, change in skin colour or hardness) visual disturbances (e.g., blurred vision) difficulty in speaking fever and chills.	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.

Very serious side effects

Serious side effects

What to do

abnormal thinking or hallucinations (seeing, feeling or hearing things that are not there) shortness of breath, sometimes with tiredness, weakness and reduced ability to exercise, swelling of the feet or legs due tofluid build up chest pain, changes in heart rate (fast, slow or irregular), palpitations swelling of the face, lips, tongue or throat which may cause difficulty in swallowing or breathing, which may be signs of a serious allergic reaction chest tightness, wheezing, rattly breathing a change in the amount or frequency of urine passed tingling or pins and needles in the hands and feet coldness, burning or numbness or pain and the arms and/or legs seizures, fits or convulsions.

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these very 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 Esmolol Juno contains

Active ingredient (main ingredient)	Esmolol hydrochloride
Other ingredients (inactive ingredients)	Sodium acetate trihydrate Glacial acetic acid Sodium chloride Hydrochloric acid/Sodium hydroxide Water for injections

Do not take this medicine if you are allergic to any of these ingredients.

What ESMOLOL JUNO looks like

A clear, colourless to light yellow solution in a coloured glass vial with a rubber stopper and flip off top.

Australian registration numbers:

Esmolol Juno 100 mg in 10 mL vial – AUST R 373831

Who distributes ESMOLOL JUNO

Juno Pharmaceuticals Pty Ltd
42 Kelso Street,
Cremorne, VIC. 3121
Australia.

www.junopharm.com.au

This leaflet was prepared in December 2022.