Cipla Isoprenaline

Cipla Isoprenaline

Active ingredient(s): Isoprenaline

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Consumer Medicine Information (CMI)

This leaflet provides important information about using Cipla Isoprenaline. 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 Cipla Isoprenaline.

Where to find information in this leaflet:

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

1. Why am I using Cipla Isoprenaline?

Cipla Isoprenaline contains the active ingredient isoprenaline. It belongs to a group of medicines called synthetic sympathomimetic amines. Cipla Isoprenaline helps improve the efficiency with which your heart pumps blood around your body. Cipla Isoprenaline works by strengthening your heart muscles and increasing the heartbeat rate.

Cipla Isoprenaline is used to treat heart block and cardiac arrest. Cipla Isoprenaline is intended to be used in hospitals only.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another reason.

This medicine is available only with a doctor’s prescription.

2. What should I know before I use Cipla Isoprenaline?

Warnings

Do not use Cipla Isoprenaline if:

• you are allergic to isoprenaline, any medicine containing isoprenaline or any of the ingredients listed at the end of this leaflet.
• Always check the ingredients to make sure you can use this medicine.

Some of the symptoms of an allergic reaction 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

You must not be given Cipla Isoprenaline if you have any of the following:

• fast heart rate
• fast, slow or irregular heart beat caused by digitalis toxicity
• medicines used to treat unusual heart beat, such as inotropic therapy
• recently suffered a heart attack
• a feeling of tightness, pressure or heaviness in the chest

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

• asthma
• diabetes
• hyperthyroidism
• other heart 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

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.

Your doctor can discuss with you the risks and benefits involved.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Cipla Isoprenaline may interfere with each other. These include:

• combined use of adrenaline and digitalis, medicines used to stimulate the heart
• inhalational anaesthetics such as halothane and cyclopropane
• medicines used to treat certain mental and emotional conditions such as chlorpromazine or monoamine oxidase inhibitors
• slow injection of isoprenaline in combination with aminophylline, theophylline and intravenous corticosteroids.

These medicines may be affected by Cipla Isoprenaline or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

4. How do I use Cipla Isoprenaline?

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

How much is given

Your doctor will decide what dose you will receive. The dosage will depend on your condition.

How it is given

Cipla Isoprenaline will normally be given to you as an injection under the skin, or into the vein, muscle or heart.

If you take too much Cipla Isoprenaline

As Cipla Isoprenaline is given to you under the supervision of your doctor, it is very unlikely that you will receive too much. However, if you experience any severe side effects after being given Cipla Isoprenaline, tell your doctor immediately or go to Accident and Emergency at the nearest hospital.

You may need urgent medical attention.

In case of overdose, immediately contact the Poisons Information Centre for advice (telephone 13 11 26 in Australia).

Symptoms of Cipla Isoprenaline overdose include the side effects listed below in the ‘Side Effects’ section, but are usually of a more severe nature.

5. What should I know while using Cipla Isoprenaline?

Things you should do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Cipla Isoprenaline.

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

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

It may affect other medicines used during surgery.

If you become pregnant while taking this medicine, tell your doctor immediately.

If you are about to have any blood tests, tell your doctor that you are taking this medicine.

It may interfere with the results of some tests.

Keep all of your doctor’s appointments so that your progress can be checked.

Driving or using machines

Be careful driving or operating machinery until you know how Cipla Isoprenaline affects you.

This medicine may cause dizziness and light-headedness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Drinking alcohol

Be careful when drinking alcohol while you are taking this medicine.

If you drink alcohol, dizziness or light-headedness may be worse.

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

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 continues or gets worse, talk to your doctor.

Looking after your medicine

• Cipla Isoprenaline will be stored in the pharmacy or on the ward. The ampoule is stored below 25°C. It should be protected from light. Keep in original outer carton.
• From a microbiological point of view, the product should be used immediately. To reduce microbiological hazard, use as soon as practicable after dilution. If storage is necessary, hold at 25°C for not more than 8 hours. The diluted infusion solution should be used within 8 hours and any residue discarded.

When to discard your medicine

Product is for single use in one patient only. Discard any residue.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

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.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you being given Cipla Isoprenaline.

This medicine helps most people with heart block and cardiac arrest, but it may have unwanted side effects in a few people. All medicines can have side effects.

Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Some unwanted effects may occur when being treated with Cipla Isoprenaline. These include:

• nervousness
• headache, dizziness or light-headedness
• restlessness
• palpitations, sweating
• mild tremors, weakness
• hot flashed, flushing of the skin
• fast heart beat
• ringing in the ears (tinnitus)
• nausea and vomiting

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also 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 Cipla Isoprenaline contains

Active ingredient (main ingredient)	0.2 mg/1 mL of isoprenaline hydrochloride
Other ingredients (inactive ingredients)	citric acid disodium edetate hydrochloride acid or sodium hydroxide used to adjust pH sodium chloride sodium citrate dehydrate water for injections

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

This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

What Cipla Isoprenaline looks like

Cipla Isoprenaline is a clear, colourless solution. It is available as 1 mL glass ampoules in packs of 25 and 5 mL glass ampoules in packs of 10.

Australian Registration Number

0.2 mg/1 mL ampoules
AUST R 356387

1.0 mg/5 mL ampoules
AUST R 379570

Who distributes Cipla Isoprenaline

Cipla Australia Pty Ltd
Level 1, 132-136 Albert Road,
South Melbourne, VIC 3205.
drugsafety@Cipla.com
Toll Free number: 1800 569 074

This leaflet was prepared in January 2022.