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 using KETORAL?
KETORAL contains the active ingredient ketorolac trometamol. KETORAL is used to relieve
pain and reduce inflammation (swelling and soreness) that may occur in the initial
period following surgery. For more information, see Section
1. Why am I using KETORAL? in the full CMI.
2. What should I know before I use KETORAL?
Do not use KETORAL if you are pregnant or intend to become pregnant, or if you are
breastfeeding or intend to breastfeed. Do not use if you have ever had an allergic
reaction to any medicine containing ketorolac trometamol, aspirin or any other NSAID
medicine, or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section
2. What should I know before I use KETORAL? in the full CMI.
3. What if I am taking other medicines?
4. How do I use KETORAL?
Your doctor will decide what dose you will receive depending on your weight, the severity
of the pain and your response to the treatment. If you are over 65 years old or have
reduced kidney function, your doctor may prescribe a lower dose.
5. What should I know while using KETORAL?
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Things you should do
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Tell your doctor immediately if you become pregnant while taking this medicine.
Remind any doctor, dentist or pharmacist you visit that you have recently been given
KETORAL.
Tell your doctor if you get an infection soon after getting KETORAL.
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Things you should not do
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Do not receive KETORAL for longer than 5 days. Prolonged use may increase the occurrence
of side effects.
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Driving or using machines
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Be careful driving or operating machinery until you know how KETORAL affects you.
As with other NSAID medicines, KETORAL may cause dizziness or light-headedness in
some people.
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Drinking alcohol
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Tell your doctor if you have ever been a heavy alcohol drinker
If you drink alcohol, dizziness or light-headedness may be worse.
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Looking after your medicine
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KETORAL will be stored in the pharmacy or on the ward.
It is kept in a cool dry place, protected from light, where the temperature stays
below 30°C.
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6. Are there any side effects?
If any of the following happen, tell your doctor or nurse immediately or go to Accident
and Emergency at your nearest hospital: vomiting blood or material that looks like
coffee grounds, bleeding from the back passage (rectum), black sticky bowel motions
(stools) or bloody diarrhoea, swelling of the face, lips or tongue which may cause
difficulty in swallowing or breathing, asthma, wheezing, shortness of breath, sudden
or severe itching, skin rash, hives, fainting, seizures or fits, pain or tightness
in the chest or palpitations or flu-like symptoms with a rash on the face then an
extended rash with a high temperature and enlarged lymph nodes. Tell your doctor or
nurse immediately if you notice any of the following: severe pain or tenderness in
any part of the stomach or back, severe dizziness, spinning sensation, hearing loss
or ringing in the ears, severe or persistent headache, abnormal vision, bleeding or
bruising more easily than normal, reddish or purplish blotches under the skin, skin
rash, severe blisters and bleeding in the lips, eyes, mouth, nose and genitals, unusual
weight gain, swelling of ankles or legs.
Active ingredient(s):
ketorolac trometamol
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using KETORAL. 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 KETORAL.
Where to find information in this leaflet:
1. Why am I using KETORAL?
KETORAL contains the active ingredient ketorolac trometamol. KETORAL belongs to a group of medicines called non-steroidal anti- inflammatory drugs
(NSAIDs).
KETORAL is used to relieve pain and reduce inflammation (swelling and soreness) that
may occur in the initial period following surgery.
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.
2. What should I know before I use KETORAL?
Warnings
Do not use KETORAL if:
you are allergic to ketorolac trometamol, aspirin or any other NSAID medicine, or
any of the ingredients listed at the end of this leaflet. Many medicines used to treat
headaches, period pain and other aches and pains contain aspirin or are a NSAID medicine.
If you are not sure if you are taking any of these medicines, ask your doctor before
you are given KETORAL. 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
Always check the ingredients to make sure you can use this medicine.
you are pregnant or intend to become pregnant.
you are breastfeeding or intend to breastfeed.
you have kidney disease
you have severe liver disease
you have severe heart failure
you have recently had or are about to have heart bypass surgery
you have a peptic ulcer (i.e. stomach or duodenal ulcer), a recent history of one
or have had peptic ulcers before
you have or have had any bleeding disorders
you have asthma
you suffer from dehydration
you have nasal polyps syndrome, angioedema or bronchospasm (breathing difficulties)
you have a history of Stevens-Johnsons Syndrome (a rare skin condition with severe
blisters and bleeding in the lips, eyes, mouth, nose and genitals)
you are receiving the following medicines:
other NSAID medicines
probenecid, a medicine used to treat gout
lithium, a medicine used to treat some types of depression
pentoxifylline (oxpentifylline), a medicine used to treat certain blood disorders
Do not give this medicine to a child under the age of 16 years.
Safety and effectiveness in children younger than 16 years have not been established.
Check with your doctor if you:
you have allergies to any other medicines, foods, preservatives or dyes.
have had any of the following medical conditions:
heartburn, indigestion, stomach ulcers or other stomach problems
kidney or liver disease
blood disorders
skin reactions due to another medicine
asthma or breathing disorders
a reaction to any other NSAID medicine
heart failure
high blood pressure or heart problems
swelling of the ankles or feet
inflammatory bowel disease, such as Crohn's disease
currently have an infection. KETORAL may hide some of the signs of an infection (e.g.
pain, fever) and may make you mistakenly think that the infection is not serious or
that you are better.
plan to have surgery.
you have ever smoked or been a heavy alcohol drinker.
take any medicines for any other condition
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
You must not be given this medicine if
you are pregnant or intend to become pregnant.
It may affect your developing baby if you take it during pregnancy.
KETORAL may impair fertility and is not recommended in women attempting to conceive.
You must not be given this medicine if
you are breastfeeding or intend to breastfeed.
The active ingredient in KETORAL passes into breast milk and there is a possibility
that your baby may be affected
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 and KETORAL may interfere with each other. These include:
aspirin, salicylates or other NSAID medicines (e.g. ibuprofen, naproxen)
medicine used to treat some types of depression (e.g. lithium, fluoxetine, paroxetine,
citalopram)
thiothixene, a medicine used to treat psychosis
alprazolam, a medicine used to treat anxiety
probenecid, a medicine used to treat gout
diuretics, also called fluid or water tablets
medicines used to treat epilepsy (e.g. phenytoin, carbamazepine)
methotrexate, a medicine used to treat arthritis and some cancers
warfarin, a medicine used to stop blood clots
medicines used to treat blood disorders (e.g. pentoxifylline (oxpentifylline), heparin)
medicines used to treat high blood pressure including ACE inhibitors, angiotensin
receptor antagonists and beta-blockers
certain antibiotics called aminoglycosides
You may need different amounts of your medicines, or you may need to take different
medicines. Your doctor has more information on medicines to be careful with or avoid
while you are receiving this medicine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect KETORAL.
4. How do I use KETORAL?
How much to be given
Your doctor will decide what dose you will receive depending on your weight, the severity
of the pain and your response to the treatment.
If you are over 65 years old or have reduced kidney function, your doctor may prescribe
a lower dose.
How to be given it
KETORAL is a sterile, clear, slightly yellow liquid.
It is given as an injection into a muscle by a doctor or trained nurse.
It must not be injected directly into the veins (intravenously).
How long you will be given it
KETORAL should not be given for longer than 5 days.
Prolonged use may increase the occurrence of side effects.
If you use too much KETORAL
As KETORAL is given to you under the supervision of your doctor or nurse, it is very
unlikely that you will receive too much.
However, if you experience any side effects after being given KETORAL, tell your doctor
or nurse immediately.
Symptoms of overdose may include stomach pain, nausea and vomiting.
5. What should I know while using KETORAL?
Things you should do
Call your doctor straight away if you:
become pregnant while taking this medicine
get an infection soon after getting KETORAL.
This medicine may hide some of the signs of an infection and may make you think that
the infection is not serious or that you are better. Signs of an infection may include
fever, pain, swelling and redness.
Tell all doctors, dentists and pharmacists who are treating you that you have recently
been given KETORAL.
Driving or using machines
Be careful driving or operating machinery until you know how KETORAL affects you.
As with other NSAID medicines, this medicine may cause dizziness or light-headedness
in some people. Make sure you know how you react to this medicine before you drive
a car, operate machinery or do anything else that could be dangerous.
Drinking alcohol
If you drink alcohol, dizziness or light-headedness may be worse.
Looking after your medicine
KETORAL will be stored in the pharmacy or on the ward. It is kept in a cool dry place,
protected from light, where the temperature stays below 30°C.
6. Are there any side effects?
Tell your doctor or nurse as soon as possible if you do not feel well while you are
being given KETORAL.
This medicine helps most people with pain after surgery, 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 list of side effects. You may not experience any
of them.
Ask your doctor or nurse to answer any questions you may have.
Less serious side effects
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.
7. Product details
This medicine is only available with a doctor's prescription.
What KETORAL contains
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Active ingredient
(main ingredient)
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30 mg/mL of ketorolac trometamo
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Other ingredients
(inactive ingredients)
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ethanol
sodium chloride
sodium hydroxide or hydrochloric acid
water for injections
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Do not take this medicine if you are allergic to any of these ingredients.
What KETORAL looks like
KETORAL is a sterile, clear to slightly yellow solution in a glass syringe. (AUST
R 144524).
Who distributes KETORAL
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 November 2021.
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