Ketoral

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

ketorolac trometamol
Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about KETORAL. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking KETORAL against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor.
Keep this leaflet with your medicine.
You may need to read it again.

What KETORAL is used for

KETORAL contains ketorolac trometamol as the active ingredient. It belongs to a group of medicines called non-steroidal anti- inflammatory drugs (NSAIDs).
KETORAL helps 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.
This medicine is not addictive.
This medicine is available only with a doctor's prescription.

Before you are given KETORAL

When you must not be given it

Do not receive KETORAL if you have an allergy to:
any medicine containing ketorolac trometamol
aspirin or any other NSAID medicine
any of the ingredients listed at the end of this leaflet
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
If you are not sure if you are taking any of these medicines, ask your doctor before you are given KETORAL.
Many medicines used to treat headaches, period pain and other aches and pains contain aspirin or are a NSAID medicine.
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.
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
You must not be given KETORAL if:
you have kidney disease
you have severe liver disease
you have severe heart failure
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.
You must not be given KETORAL for more than 5 days.
Do not receive this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

Before you start to take it

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:
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
Tell your doctor if you intend to become pregnant.
KETORAL may impair fertility and is not recommended in women attempting to conceive.
Tell your doctor if you 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.
Tell your doctor if you plan to have surgery.
Tell your doctor if you 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 KETORAL.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you get without a prescription from a 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
These medicines may be affected by KETORAL 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 has more information on medicines to be careful with or avoid while you are receiving this medicine.

How you are given 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 take too much (overdose)

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.

While you are receiving KETORAL

Things you must do

If you become pregnant while taking this medicine, tell your doctor immediately.
Tell all doctors, dentists and pharmacists who are treating you that you have recently been given KETORAL.
Tell your doctor if you 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.

Things to be careful of

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

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.
Tell your doctor or nurse if you notice any of the following and they worry you:
stomach upset including nausea (feeling sick), heartburn, indigestion
pain in the stomach, wind, diarrhoea
constipation
dizziness, headache
drowsiness
depression or anxiety
insomnia
sweating
skin rash or hives
aching muscles, muscle tenderness or weakness not caused by exercise
pain at site of injection
dry mouth
feeling extremely thirsty
passing more or less urine than normal
The above list includes the more common side effects of your medicine. They are usually mild.
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
The above list includes serious side effects. You may need urgent medical attention. Serious side effects are rare.
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
These side effects are rare but may be serious. You may need urgent medical attention or hospitalisation.
Tell your doctor or nurse if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.

After receiving KETORAL

Storage

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.

Product description

What it looks like

KETORAL is a sterile, clear to slightly yellow solution in a glass syringe.
KETORAL is available in packs of 5 pre-filled syringes.

Ingredients

KETORAL contains 30 mg/mL of ketorolac trometamol as the active ingredient.
It also contains the following inactive ingredients:
ethanol
sodium chloride
sodium hydroxide or hydrochloric acid
water for injections
KETORAL does not contain sucrose, gluten, tartrazine or any other azo dyes.

Sponsor

Alphapharm Pty Limited
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.mylan.com.au
 
Australian registration number:
AUST R 144524
 
This leaflet was prepared in
July 2019.
 
ketoral_cmi\Jul19/00