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 TORADOL?
TORADOL contains the active ingredient ketorolac trometamol. TORADOL is used to relieve
pain and reduce inflammation (swelling and soreness) that may occur following surgery.
For more information, see Section
1. Why am I using TORADOL? in the full CMI.
2. What should I know before I use TORADOL?
Do not TORADOL if you are pregnant or intend to become pregnant, or if you are breastfeeding
or intend to breastfeed. Do not use TORADOL if you are allergic to TORADOL, aspirin
or any other NSAID medicine, or any of the ingredients listed at the end of this leaflet.
Talk to your doctor if you have any other medical conditions or take any other medicines.
For more information, see Section
2. What should I know before I use TORADOL? in the full CMI.
3. What if I am taking other medicines?
4. How do I use TORADOL?
Your doctor will tell you how many TORADOL tablets to take each day. The usual dose
is 1 tablet every 4 to 6 hours (maximum of 4 tablets per day). More information can
be found in Section
4. How do I use TORADOL? in the full CMI.
5. What should I know while using TORADOL?
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Things you should do
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Call your doctor straight away if you become pregnant while taking TORADOL.
Tell your doctor is you get an infection soon after receiving TORADOL.
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Things you should not do
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Do not receive TORADOL 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 before you drive or use any machines or tools until you know how TORADOL
affects you.
As with other NSAID medicines, TORADOL may cause dizziness or light-headedness in
some people.
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Drinking alcohol
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Tell your doctor if you drink alcohol.
If you drink alcohol, dizziness or light-headedness may be worse.
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Looking after your medicine
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Store below 25°C in a cool, dry place away from young children.
Keep your tablets in the blister pack until it is time to take them.
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6. Are there any side effects?
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: vomiting blood
or material that looks like coffee grounds, bleeding from the back passage, black
sticky bowel motions 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 or hives, fainting, seizures or fits, pain or
tightness in the chest, 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 immediately
if you notice any of the following serious side effects: severe dizziness, spinning
sensation, severe or persistent headache, abnormal vision, bleeding or bruising more
easily than normal, reddish or purplish blotches under the skin, severe pain or tenderness
in any part of the stomach or back, unusual weight gain, swelling of ankles or legs.
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.
Active ingredient:
ketorolac trometamol
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using TORADOL. 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 TORADOL.
Where to find information in this leaflet:
1. Why am I using TORADOL?
TORADOL contains the active ingredient ketorolac trometamol. TORADOL belongs to a family of medicines called Non-Steroidal Anti-Inflammatory Drugs
(NSAIDs).
TORADOL is used to relieve pain and reduce inflammation (swelling and soreness) that
may occur following surgery. Although TORADOL can relieve the symptoms of pain and inflammation, it will not cure
your condition.
Your doctor may have prescribed TORADOL for another purpose.
2. What should I know before I use TORADOL?
Warnings
Do not use TORADOL 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
headache, period pain and other aches and pains contain aspirin or NSAID medicines.
If you are not sure if you are taking any of these medicines, ask your doctor or pharmacist.
If you are allergic to aspirin or NSAID medicines and use TORADOL, these symptoms
may be severe. Symptoms of an allergic reaction to these medicines may include:
asthma, wheezing or shortness of breath
swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
hives, itching or skin rash
fainting
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 (stomach or duodenal ulcer), a recent history of one, or have
had peptic ulcers before
you have had any bleeding disorders
you have asthma
you suffer 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
oxpentifylline, a medicine used to treat certain blood disorders
Do not give TORADOL to a child under 16 years of age.
The safety and effectiveness in children under 16 have not
been established.
If you are not sure if you should be given TORADOL,
contact your doctor.
Check with your doctor if you:
you have any allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes
have any other medical conditions, especially the following:
heartburn, indigestion, stomach ulcers or other stomach problems
kidney or liver disease
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. TORADOL may hide some of the signs of an infection (eg
pain, fever) and may make you think that the infection is not serious or that you
are better
take any medicines for any other condition
plan to have surgery
have ever smoked or been a heavy alcohol drinker
If you have not told your doctor about any of the above, tell them before you are
given TORADOL.
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 take TORADOL if you are pregnant or intend to become pregnant.
TORADOL may affect your developing baby if you take it during pregnancy. If it is
necessary for you to take TORADOL, your doctor will discuss the risks and benefits
of taking it during pregnancy.
TORADOL may impair fertility and is not recommended in women attempting to conceive.
Do not take TORADOL if you are breast-feeding or intend to breast-feed.
TORADOL passes into breast milk. The effect on the baby is not known.
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 TORADOL and affect how it works. These include:
aspirin, salicylates or other NSAID medicines (such as ibuprofen or naproxen)
warfarin, a medicine used to stop blood clots
probenecid, a medicine used to treat gout
oxpentifylline, a medicine used to treat certain blood disorders
lithium, a medicine used to treat some types of depression
selective serotonin reuptake inhibitors (SSRIs), medicines used to treat depression
(such as fluoxetine, paroxetine or citalopram)
thiothixene, a medicine used to treat psychosis
diuretics, also called fluid or water tablets
phenytoin, a medicine used to treat epilepsy
carbamazepine, a medicine used to treat epilepsy
methotrexate, a medicine used to treat arthritis and some cancers
heparin, a medicine used to treat blood disorders
medicines used to treat high blood pressure, including ACE inhibitors, angiotensin
receptor antagonists and beta-blockers.
certain antibiotics called aminoglycosides
You may need to use different amounts of your medicine, or you may need to use different
medicines. Your doctor will advise you.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect TORADOL.
4. How do I use TORADOL?
How much to take
Your doctor will tell you how many TORADOL tablets to take each day.
The usual dose is 1 tablet every 4 to 6 hours (maximum of 4 tablets per day). If you
are over 65 years old or have reduced kidney function, your doctor may prescribe a
lower dose.
Do not take at higher doses. This may increase the occurrence of side effects.
Swallow TORADOL tablets whole with a glass of water.
Follow the instructions provided and use TORADOL until your doctor tells you to stop.
When to take TORADOL
Take TORADOL tablets every 4 to 6 hours (maximum of 4 tablets per day).
If you are not sure when to take TORADOL, ask your doctor.
How long to take TORADOL
Do not take TORADOL for longer than 5 days. Prolonged use may increase the occurrence of side effects.
If you are not sure how long to take TORADOL, ask your doctor.
If you forget to take TORADOL
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Otherwise, take it as soon as you remember and then go back to taking it as you would
normally.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you use too much TORADOL
If you take too much TORADOL, you may have pain or tenderness in the stomach, stomach
upset including nausea (feeling sick), vomiting, heartburn, indigestion or cramps.
If you think that you have used too much TORADOL, 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.
If you are not sure what to do, contact your doctor or pharmacist.
5. What should I know while using TORADOL?
Call your doctor straight away if you:
become pregnant while receiving TORADOL
get an infection soon after receiving TORADOL. TORADOL may hide some of the signs
of an infection and may make you think, mistakenly, that the infection is not serious
or that you are better. Signs of an infection may include fever, pain, swelling and
redness.
Remind any doctor, dentist or pharmacist you visit that you are using TORADOL.
If you are going to have surgery tell your doctor you are being given TORADOL.
Things you should not do
Do not give TORADOL to anyone else, even if they have the same condition as you.
Do not use TORADOL to treat other complaints unless your doctor tells you to.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how TORADOL
affects you.
As with other NSAID medicines, TORADOL may cause dizziness or light-headedness in
some people. Make sure you know how you react to TORADOL before you drive a car, operate
machinery, or do anything else that could be dangerous if you are dizzy or light-headed.
If this occurs do not drive.
Drinking alcohol
Tell your doctor if you drink alcohol.
If you drink alcohol, dizziness or light-headedness may be worse.
Looking after your medicine
Keep your tablets in the blister pack until it is time to take them. If you take the
tablets out of the blister pack they will not keep well.
Keep the tablets in a cool dry place where the temperature stays below 25°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
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.
Other side effects not listed here may occur in some people. Tell your doctor if you
notice anything else that is making you feel unwell.
Less serious side effects
Serious side effects
Very serious side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are receiving TORADOL.
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.
TORADOL is not addictive.
What TORADOL contains
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Active ingredient
(main ingredient)
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each TORADOL tablet contains 10 mg ketorolac trometamol
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Other ingredients
(inactive ingredients)
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microcrystalline cellulose
lactose monohydrate
magnesium stearate
Opadry White YS-1-7002
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Potential allergens
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TORADOL does not contain sucrose, gluten, tartrazine or any other azo dyes.
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Do not take this medicine if you are allergic to any of these ingredients.
What TORADOL looks like
The tablets are white to creamy white film coated tablets engraved with "KET 10" on
one side.
TORADOL 10mg tablets come in blister packs of 20 tablets (AUST R 42060)
TORADOL is also available as an injection.
Who distributes TORADOL
TORADOL is supplied in Australia by:
Clinect Pty Ltd
120 - 132 Atlantic Drive
Keysborough VIC 3173
Australia
Customer enquiries: 1 800 899 005
Sponsor:
Atnahs Pharma Australia Pty Ltd
Level 10
10 Shelley Street,
SYDNEY, NSW, 2000, Australia
This leaflet was prepared in August 2022.