Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
1. Why am I taking ARTHREXIN?
ARTHREXIN contains the active ingredient indometacin. ARTHREXIN is used to relieve
pain and reduce inflammation (swelling, redness and soreness) that may occur in the
following conditions: different types of arthritis, muscle and bone injuries, gout,
swelling and pain after setting broken or dislocated bones, and menstrual cramps.
2. What should I know before I take ARTHREXIN?
Do not take if you have ever had an allergic reaction to indometacin 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.
3. What if I am taking other medicines?
Some medicines may interfere with ARTHREXIN and affect how it works.
4. How do I take ARTHREXIN?
Your doctor will tell you how many capsules you need to take each day.
Your dose will depend on the condition being treated and your response to the treatment.
5. What should I know while taking ARTHREXIN?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking ARTHREXIN.
Tell your doctor straight away if you become pregnant while taking ARTHREXIN.
Tell your doctor straight away if you get an infection while taking ARTHREXIN.
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Things you should not do
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Do not take more than the recommended dose or stop using the medicine unless your
doctor tells you.
Do not give your medicine to anyone else, even if they have the same condition as
you.
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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 ARTHREXIN
affects you.
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Looking after your medicine
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Store it in a cool dry place where the temperature stays below 30°C away from moisture,
heat or sunlight.
Keep your capsules in their original container until it is time to take them.
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6. Are there any side effects?
Less serious side effects include stomach upset, loss of appetite, constipation, diarrhoea, hearing disturbances,
headache, dizziness, tiredness, change in mood. Serious side effects include severe stomach pain or tenderness, fast or irregular heart beats, signs of
anaemia, unusual weight gain, swelling of ankles or legs, bleeding or bruising more
easily than normal, yellowing of skin or eyes, dark coloured or cloudy urine, difficulty
urinating, eye problems, signs of frequent or worrying infections, vomiting blood,
bleeding from the back passage, black sticky bowel motions, severe dizziness, seizures,
tightness in chest, or signs of an allergic reaction such as swelling of the face,
lips or tongue, wheezing, shortness of breath, sudden or severe itching.
Active ingredient(s):
indometacin
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking ARTHREXIN. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking ARTHREXIN.
Where to find information in this leaflet:
1. Why am I taking ARTHREXIN?
ARTHREXIN contains the active ingredient indometacin. ARTHREXIN belongs to a group of medicines called Non-Steroidal Anti-Inflammatory
Drugs (or NSAID).
ARTHREXIN is taken to relieve pain and reduce inflammation (swelling, redness and
soreness) that may occur in the following conditions:
different types of arthritis including rheumatoid arthritis, osteoarthritis, gouty
arthritis, ankylosing spondylitis and degenerative joint disease of the hip
gout
muscle and bone injuries such as sprains, strains, low back pain (lumbago) and tendonitis,
such as tennis elbow
pain and swelling after setting broken or dislocated bones
menstrual cramps (period pain).
Although ARTHREXIN can relieve the symptoms of pain and inflammation, it will not
cure your condition.
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.
There is no evidence that it is addictive.
2. What should I know before I take ARTHREXIN?
Warnings
Do not take ARTHREXIN if:
you are allergic to any medicine containing indometacin, aspirin, other NSAID medicines
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 other NSAID
medicines. Some of the symptoms of an allergic reaction may include:
asthma
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 allergic to aspirin or NSAID medicines and use ARTHREXIN, the above symptoms
may be severe.
If you are not sure if you are taking any of these medicines, ask your doctor or pharmacist.
Always check the ingredients to make sure you can take this medicine.
you have an active peptic ulcer (i.e. stomach or duodenal ulcer) or have had peptic
ulcers more than once before.
you have severe heart failure.
you have recently had heart bypass surgery.
you have severe liver failure.
you are vomiting blood or material that looks like coffee grounds.
you are bleeding from the back passage, have black sticky bowel motions or bloody
diarrhoea.
you experience asthma attacks, hives or rash or itching of the nose, throat or eyes
with aspirin or other NSAIDS.
you are pregnant or intend to become pregnant.
you are breastfeeding or intend to breastfeed.
the expiry date (EXP) printed on the pack has passed.
the packaging is torn or shows signs of tampering.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Pregnancy and breastfeeding
Do not take ARTHREXIN if you are pregnant or intend to become pregnant.
The safety of this medicine during pregnancy has not been established. ARTHREXIN may
affect your developing baby if you take it during pregnancy. If it is necessary for
you to take ARTHREXIN, your doctor will discuss the risks and benefits of taking it
during pregnancy.
Women considering pregnancy should not use ARTHREXIN unless advised to by their doctor.
ARTHREXIN may have a reversible inhibitory effect on fertility.
Do not take ARTHREXIN if you are breastfeeding or intend to breastfeed.
The active ingredient in ARTHREXIN passes into breast milk and there is a possibility
that your baby may be affected.
Use in children
ARTHREXIN should not be given to children under 2 years of age.
The safety of this medicine in children under 2 years of age has not been established.
Use in elderly
Elderly patients may be more sensitive to the effects or side effects of this medicine.
Tell your doctor if you:
are allergic to any other medicines, including aspirin and other NSAID medicines,
foods, dyes or preservatives.
have or have had any of the following medical conditions:
heartburn, indigestion, stomach ulcer or other stomach problems
bowel or intestinal problems such as ulcerative colitis
kidney or liver disease
high blood pressure or heart disease
history of chest pain (angina), heart problems or stroke
history of swelling in the feet or ankles
a tendency to bleed or other blood problems
diabetes mellitus or sugar diabetes
psychiatric problems
seizures or fits (epilepsy)
Parkinson's disease
asthma
eye disease.
currently have an infection.
ARTHREXIN may hide some of the signs of an infection. This may make you think, mistakenly,
that you are better or that it is less serious than it might be.
Signs of an infection include fever, pain, swelling or redness.
If you have not told your doctor about any of the above, tell them before you start
taking ARTHREXIN.
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?
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 ARTHREXIN and affect how it works. These include:
aspirin, salicylates or other NSAID medicines (e.g. ibuprofen or diflunisal)
anticoagulants such as warfarin, a medicine used to prevent blood clots
cardiac glycosides such as digoxin, a medicine used to treat heart failure or irregular
heart beats
lithium, a medicine used to treat mood swings and some types of depression
probenecid, a medicine used to treat gout
diuretics, also called fluid or water tablets
some medicines used to treat high blood pressure or heart conditions, including ACE
inhibitors or betablockers or medicines used in combination with a thiazide diuretic
decongestants
ciclosporin, a medicine used to prevent organ transplant rejection or suppress the
immune system
methotrexate, a medicine used to treat arthritis and certain types of cancers
corticosteroids, an anti-inflammatory medicine
mifepristone, a medicine used for medical abortion
quinolone antibiotics and vancomycin
gold preparations.
These medicines may be affected by ARTHREXIN 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 taking ARTHREXIN.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ARTHREXIN.
4. How do I take ARTHREXIN?
Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the pack, ask your doctor or pharmacist
for help.
How much to take
Your doctor will tell you how many capsules you need to take each day.
The dose will depend on the condition being treated and your response to the treatment.
Your initial dose will be maintained or adjusted until a satisfactory response is
noted.
The dose varies from patient to patient. The usual dose is between 50 mg and 200 mg
per day, given in divided doses.
Elderly patients may need smaller doses.
The dose for menstrual cramps (period pain) is usually one 25 mg capsule every eight
hours, starting with the onset of bleeding or cramps.
Tell your doctor of any changes in your condition, as you may require a change in
the dose of ARTHREXIN.
How to take it
Swallow the capsules whole with a full glass of water.
ARTHREXIN may also be taken with food, milk or an antacid, if advised by your doctor
or pharmacist. This may help reduce the possibility of stomach and bowel problems.
When to take it
Take ARTHREXIN with or immediately after food.
How long to take it
Continue taking your medicine for as long as your doctor tells you to.
Depending on your condition, you may need this medicine for a few days, a few weeks
or for longer periods.
As with other NSAID medicines, if you are using ARTHREXIN for arthritis, it will not
cure your condition but it should help to control pain, swelling and stiffness. If
you have arthritis, ARTHREXIN should be taken every day for as long as your doctor
prescribes.
For sprains and strains, ARTHREXIN is usually only needed for a few days.
For gout, ARTHREXIN can be stopped when all symptoms subside.
For menstrual cramps, ARTHREXIN should be taken at the start of bleeding or cramps
and continued for as long as the cramps last.
If you forget to take ARTHREXIN
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 the capsule as soon as you remember, and then go back to taking your
medicine as you would normally.
Do not take a double dose to make up for the dose you missed.
This may increase the chance of you getting an unwanted side effect.
If you are not sure whether to skip the dose, talk to your doctor or pharmacist.
If you have trouble remembering to use your medicine, ask your pharmacist for some
hints.
If you take too much ARTHREXIN
If you think that you or anyone else has taken too much ARTHREXIN, urgent medical
attention may be needed.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, 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.
Symptoms of an overdose may include nausea, vomiting, intense headache, dizziness,
confusion, fatigue, numbness or fits.
5. What should I know while taking ARTHREXIN?
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking ARTHREXIN.
Tell any other doctors, dentists and pharmacists who treat you that you are taking
this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine.
ARTHREXIN may cause prolonged bleeding and may need to be stopped before surgery.
If you are about to have any blood tests, tell your doctor that you are taking this
medicine.
Keep all of your doctor's appointments so that your progress can be checked.
Tell your doctor straight away if you:
become pregnant while using ARTHREXIN.
you get an infection while taking ARTHREXIN.
ARTHREXIN may hide some of the signs of an infection and may make you think, mistakenly,
that you are better or that it is less serious than it might be.
Signs of an infection include fever, pain, swelling or redness.
Things you should not do
Do not take more than the recommended dose unless your doctor tells you to.
Do not take ARTHREXIN to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not stop taking your medicine or lower the dosage without checking with your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how ARTHREXIN
affects you.
As with other NSAID medicines, this medicine may cause dizziness or light-headedness
in some people. If this occurs, do not drive, operate machinery or do anything else
that could be dangerous.
If you drink alcohol, the dizziness or light-headedness may be worse.
Drinking alcohol
If you drink alcohol, the dizziness or light-headedness may be worse.
Things to be aware of
ARTHREXIN can increase blood pressure in some people, so your doctor will want to
check your blood pressure from time to time.
As blurred vision is a possible side effect of long term therapy with ARTHREXIN, patients
should visit their optometrist for regular eye checks.
Looking after your medicine
Keep your capsules in their original pack until it is time to take them.
Store below 30°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.
Heat or dampness can destroy some medicines.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date or if the packaging is torn or shows
signs of tampering.
6. Are there any side effects?
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking ARTHREXIN.
ARTHREXIN helps most people with pain or inflammation, but it may have unwanted side
effects in a few people. If you are over 65 years of age, have liver or kidney problems
or are diabetic, you may have an increased chance of getting 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.
Do not be alarmed by the following list of side effects.
You may not experience any of them.
Less serious side effects
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Less serious side effects
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What to do
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Gastrointestinal-related:
stomach upset or pain including nausea (feeling sick), vomiting, cramps, loss of appetite
heartburn or indigestion (possible symptoms of an ulcer in the tube that carries food
from the throat to the stomach)
Some of the stomach upset, such as nausea and heartburn, may be reduced by taking
the capsules with food or an antacid, if advised by your doctor or pharmacist.
constipation, diarrhoea
Nervous system-related:
hearing disturbances such as buzzing or ringing in the ears
headache, dizziness, light-headedness may occur in the first few days of treatment.
If this worries you or continues, contact your doctor
tiredness
change in mood such as depression, anxiety or irritability
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
These are the more common side effects of ARTHREXIN.
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Serious side effects
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Serious side effects
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What to do
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Gastrointestinal-related:
severe pain or tenderness in the stomach
Heart and blood-related:
fast or irregular heartbeats, also called palpitations
signs of anaemia, such as tiredness, being short of breath, looking pale
unusual weight gain or swelling of ankles or legs
Kidney or liver-related:
bleeding or bruising more easily than normal
yellowing of the skin and eyes, also called jaundice
dark coloured or cloudy urine or pain in the kidney region
difficulty in passing water (urinating) or a sudden decrease in the amount of urine
passed
Nervous system-related:
eye problems such as blurred vision or difficulty seeing
drowsiness, disorientation, forgetfulness
shakiness, sleeplessness, nightmares
tingling or numbness of the hands or feet
Other:
signs of frequent or worrying infections such as fever, severe chills, sore throat
or mouth ulcers
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Tell your doctor immediately if you notice any of these serious side effects.
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Very serious side effects
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Very serious side effects
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What to do
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Gastrointestinal-related:
vomiting blood or material that looks like coffee grounds. This may occur at any time
during use and without warning
bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea.
This may occur at any time during use and without warning
Allergic reaction-related:
swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
sudden or severe itching, skin rash or hives, blistering or peeling of the skin
asthma, wheezing, shortness of breath
Other:
severe dizziness, light-headedness or fainting
seizures or fits
pain or tightness in the chest
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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.
This list includes very serious but rare side effects
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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.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What ARTHREXIN contains
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Active ingredient
(main ingredient)
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Indometacin, 25 mg
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Other ingredients
(inactive ingredients)
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Lactose monohydrate
Sodium starch glycollate
Sodium lauryl sulfate
Magnesium stearate
Empty Hard Gelatin Capsules Bovine Size 3 White-Opaque/White-Opaque G3ICSRA0399 (ARTG
PI No: 140186)
Opacode Black A-10259 (ARTG PI No: 1659)
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Potential allergens
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Sulfites and sugars as lactose
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Do not take this medicine if you are allergic to any of these ingredients.
What ARTHREXIN looks like
ARTHREXIN capsules are white opaque hard gelatin capsules, marked "IN-25" on both
body and cap. Each carton contains 50 capsules (AUST R 353404).
Who distributes ARTHREXIN
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in June 2024.
ARTHREXIN™ is a Viatris company trade mark
ARTHREXIN_cmi\Jun24/02