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Toradol Tablets

contains the active ingredient ketorolac trometamol
Consumer Medicine Information
 

 

What is in this leaflet

This leaflet answers some common questions about TORADOL tablets. 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 TORADOL tablets against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.

What TORADOL is used for

TORADOL belongs to a family of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
TORADOL relieves pain and reduces 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.
Ask your doctor if you have any questions why TORADOL has been prescribed for you.
This medicine is available only with a doctor's prescription.
TORADOL is not addictive.

Before you take TORADOL

When you must not take it

Do not take TORADOL if:

1.you have an allergy to:

TORADOL or any ingredients listed at the end of this leaflet
aspirin or any other NSAID medicine
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 pharmacist.
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
If you are allergic to aspirin or NSAID medicines and take TORADOL, these symptoms may be severe.

2.you are pregnant, or intend to become pregnant

TORADOL may affect your developing baby if you take it during pregnancy.

3.you are breast-feeding or intend to breast-feed

TORADOL passes into breast milk. The effect on the baby is not known.

4.you have kidney disease

5.you have severe liver disease

6.you have severe heart failure

7.you have recently had or are about to have heart bypass surgery

8.you have a peptic ulcer (i.e. stomach or duodenal ulcer), a recent history of one, or have had peptic ulcers before

9.you have had any bleeding disorders

10.you have asthma

11.you suffer dehydration

12.you have nasal polyps syndrome, angioedema or bronchospasm (breathing difficulties)

13.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).

14.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

15.the packaging is torn or shows signs of tampering.

16.the expiry date (EXP) printed on the pack has passed.

If you take this medicine after the expiry date has passed, it may not work as well.
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 start taking TORADOL, contact your doctor.

Before you start to take it

Tell your doctor if:

1.you have any allergies to:

any other medicines
any other substances, such as foods, preservatives or dyes

2.you intend to become pregnant

TORADOL may impair fertility and is not recommended in women attempting to conceive. If it is necessary for you to take TORADOL, your doctor will discuss the risks and benefits of taking it during pregnancy.

3.you have or have had any 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.

4.you 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.

5.you plan to have surgery

6.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 take any TORADOL.

Taking other medicines

Tell your doctor if you are taking any other medicines including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and TORADOL may interfere with each other. 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
These medicines may be affected by TORADOL, or may affect how well it works. You may need to take different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking TORADOL.
Ask your doctor or pharmacist if you are not sure about this list of medicines.

How to take TORADOL

How much to take

Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet.
Take TORADOL exactly as your doctor has prescribed.
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.

When to take it

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 that 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 take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much TORADOL.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
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 are not sure what to do, contact your doctor or pharmacist.

While you are using TORADOL

Things you must do

If you become pregnant while taking TORADOL, tell your doctor immediately.
Tell all doctors, dentists and pharmacists who are treating you that you are taking TORADOL.
If you are going to have surgery tell your doctor you are taking TORADOL.
If you get an infection while taking TORADOL, tell your doctor.
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.

Things you must 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.

Things to be careful of

Be careful driving or operating machinery 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. If you drink alcohol, dizziness or light-headedness may be worse.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking TORADOL.
TORADOL 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 treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
stomach upset including nausea (feeling sick), heartburn, indigestion
pain in the stomach or wind
dizziness
headache
skin rash or hives
aching muscles, muscle tenderness or weakness, not caused by exercise
These side effects of TORADOL are usually mild.
Tell your doctor immediately if you notice any of the following:
severe pain or tenderness in any part of the stomach or back
severe dizziness, spinning sensation
severe or persistent headache
abnormal vision
bleeding or bruising more easily than normal, reddish or purplish blotches under the skin
unusual weight gain, swelling of ankles or legs
These are serious side effects. You may need urgent medical attention. Serious side effects are rare.
If any of the following happen, stop taking TORADOL and tell your doctor 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 or hives
fainting, seizures or fits
pain or tightness in the chest
These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.
Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.
Ask your doctor or pharmacist if you don't understand anything in this list.
Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using TORADOL

Storage

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.
Do not store TORADOL or any other medicine, in a bathroom or near a sink.
Do not leave it in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep TORADOL where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking TORADOL, or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product Description

What TORADOL looks like

The tablets are white to creamy white, round, bi-convex, film-coated tablets imprinted in black ink with "KET 10" on one side.

Ingredients

Active ingredient:
ketorolac trometamol
each TORADOL tablet contains 10 mg ketorolac trometamol
Inactive ingredients:
microcrystalline cellulose
lactose
magnesium stearate [470]
the proprietary ingredients: Opadry White YS-1-7002 (coating-contains additives 171 & 464) and Opacode Black S-1-17823.
TORADOL does not contain sucrose, gluten, tartrazine or any other azo dyes.
TORADOL comes in packs of 20 tablets.
TORADOL is also available as an injection.

Sponsor

Atnahs Pharma Australia Pty Ltd
Level 10
10 Shelley Street,
SYDNEY, NSW, 2000, Australia

Supplier

TORADOL is supplied in Australia by:
Clinect Pty Ltd
Level 3
484 St Kilda Road
Melbourne, VIC, 3004
Customer enquiries: 1 800 899 005
Please check with your pharmacist for the latest Consumer Medicine Information.
Australian Registration Number:
10 mg tablets: AUST R 42060
This leaflet was prepared August 2015