Solution for injection 0.1 mg/mL (0.01 %)

Consumer Medicine Information

What is in this leaflet

Please read this leaflet carefully before you are given Phenylephrine BNM.
This leaflet answers some common questions about Phenylephrine BNM. It does not contain all the available information. The most up-to-date Consumer Medicine Information can be downloaded from www.ebs.tga.gov.au.
Reading this leaflet does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks associated with giving you Phenylephrine BNM against the benefits this medicine is expected to have for you.
If you have any concerns about being given this medicine, ask your doctor, pharmacist or nurse.
Keep this leaflet with the medicine.
You may want to read it again.

What Phenylephrine BNM is used for

Phenylephrine BNM contains phenylephrine hydrochloride. It works by causing constriction (narrowing) of your blood vessels.
It belongs to a group of medicines called vasoconstrictors.
Phenylephrine BNM is used to help increase your blood pressure and slow down your heart, for example, during surgery.
Your doctor may have prescribed this medicine for another reason.
Ask your doctor if you have any questions about why it has been prescribed for you.
Phenylephrine BNM is only available with a doctor's prescription.
Phenylephrine BNM is not addictive.

Before you are given Phenylephrine BNM

Phenylephrine BNM is not suitable for everyone.

When you must not be given it

You must not be given Phenylephrine BNM if you are allergic to:
Phenylephrine
any of the ingredients listed at the end of this leaflet.
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 Phenylephrine BNM if you have:
very high blood pressure
a very fast heart beat (palpitations).
Do not use it after the expiry date printed on the pack.
If you are given this medicine after the expiry date has passed, it may not work as well.
Do not use it if the packaging is torn or shows signs of tampering.
If you are not sure whether you should be given Phenylephrine BNM, talk to your doctor.

Before you are given it

Tell your doctor or pharmacist if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any medical conditions, especially the following:
thyroid disease
slow heart rate
other heart disease
severe arteriosclerosis (a disease of the arteries).
Tell your doctor if you are pregnant or intend to become pregnant.
Your doctor will discuss the risks and benefits of being given Phenylephrine BNM during pregnancy.
Tell your doctor if you are breast-feeding or plan to breastfeed.
Your doctor will discuss the risks and benefits of being given Phenylephrine BNM when breastfeeding.
If you have not told your doctor or nurse about any of the above, tell them before you are given Phenylephrine BNM.

Taking other medicines

Tell your doctor 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 Phenylephrine BNM may interfere with each other. These include:
certain medicines to treat depression (such as monoamine oxidase inhibitors and tricyclic antidepressants).
halothane anaesthetics (a type of medicine used as an anaesthetic).
certain medicines (such as oxytocin) used to stimulate labour in pregnant women.
certain medicines which restrict your blood vessels such as metaraminol.
The above medicines may be affected by Phenylephrine BNM, 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 being given Phenylephrine BNM.

How Phenylephrine BNM is given

How it is given

Phenylephrine BNM will be given by slow injection into a vein.
Your doctor will determine how you will be given this medicine. It may depend on why you need to use this drug.
Phenylephrine BNM must only be given by a doctor or nurse.

How much will be given

Your doctor will decide what dose
and how long you will receive Phenylephrine BNM. The dose will be different, depending on how your doctor gives you Phenylephrine BNM and why you are being given it.
The need for more doses will depend on how well your body responds to the treatment. Your doctor will decide how many injections you need, and how often you should receive them.

While you are being given Phenylephrine BNM

Things you must do

Your doctor will monitor your blood pressure closely while you are being given Phenylephrine BNM.
If you are about to be started on any new medicine, tell your doctor and pharmacist that you are being given Phenylephrine BNM.
Likewise, tell any other doctors, dentists and pharmacists who are treating you that you are being given this medicine.

Things to be careful of

Be careful driving or operating machinery until you know how Phenylephrine BNM affects you.
Make sure you know how you react to Phenylephrine BNM before you drive, operate machinery or do anything else that could be dangerous.
Be careful when drinking alcohol while you are taking this medicine.

In case of overdose

If you are given too much (overdose)

As Phenylephrine BNM is given to you in hospital under the supervision of your doctor, it is very unlikely that you will receive too much.
Immediately tell your doctor or nurse if you think that you or anyone else has taken or been given too much Phenylephrine BNM.
If you are not in a hospital, immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26 in Australia), or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have been given too much Phenylephrine BNM.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Symptoms of an overdose may include sensation of fullness in the head, tingling in the hands or feet and irregular or fast heartbeat.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given or after receiving Phenylephrine BNM.
Like all medicines, Phenylephrine BNM may occasionally cause side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Ask your doctor or nurse to answer any questions you may have.
Tell your doctor or nurse if you notice any of the following and they worry you:
headache
restlessness
excitability.
These are mild side effects.
Tell your doctor immediately if you notice any of the following:
fast or irregular heartbeats (also called palpitations)
very slow pulse
sensation of fullness in the head
tingling in the hands or feet.
These are very serious side effects. You may need urgent medical attention. Serious side effects are rare.
Tell your doctor or nurse if you notice anything else that is making you feel unwell.
Other side effects not listed above may also occur in some patients.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.

After receiving Phenylephrine BNM

Storage

Phenylephrine BNM should only be given to you in hospital. It will be stored in a cool dry place away from the light, where the temperature stays below 25°C.
The ampoules should not be taken out of the box until just before they are to be used. This is because the medicine is affected by light.

Disposal

Any Phenylephrine BNM which has passed its expiry date, or is left in the container after use, will be disposed of in a safe manner by your doctor, nurse or pharmacist.
This is not all the information available on Phenylephrine BNM.
If you have any more questions or are not sure about anything, ask your doctor of pharmacist.

Product description

What it looks like

Phenylephrine BNM is a clear colourless sterile solution in a glass ampoule.
It is available in glass ampoules of 5 mL in pack size of 10 ampoules per carton.

Ingredients

Active ingredient:
phenylephrine hydrochloride
Inactive ingredients:
sodium chloride
hydrochloric acid
water for injections.
The solution is preservative free and sulfite free.

Sponsor details

Boucher & Muir Pty Ltd
Level 9, 76 Berry Street
North Sydney NSW 2060
AUST R 294004

Date of preparation

This leaflet was prepared on
4 October 2018