Arthrexin

contains the active ingredient indomethacin

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Arthrexin.

It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking Arthrexin against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, talk to your doctor or pharmacist.

Keep this leaflet with your medicine. You may need to read it again.

What Arthrexin is used for

Arthrexin contains the active ingredient, indomethacin. It belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).

Arthrexin is used to relieve the pain and inflammation (swelling, redness and soreness) that may occur in the following conditions:

• different types of arthritis including rheumatoid arthritis, osteoarthritis, gouty arthritis and ankylosing spondylitis degenerative joint disease of the hip
• gout
• muscle and bone injuries such as bursitis, tendonitis (tennis elbow), sprains and strains, low back pain (lumbago)
• pain and swelling after setting broken or dislocated bones
• 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.

This medicine is not addictive.

It is available only with a doctor's prescription.

There is not enough information to recommend the use of this medicine for children under the age of 2 years.

Before you take Arthrexin

When you must not take it

Do not take Arthrexin if you are allergic to medicines containing:

• any medicines containing indomethacin
• aspirin or other NSAIDs
• any of the ingredients listed at the end of this leaflet.

Many medicines used to treat headache, period pain or other aches and pains contain aspirin or NSAID medicine. If you are not sure if you are taking any of these medicines, ask your pharmacist.

Some of the symptoms of an allergic reaction may include skin rash, itching or hives, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, wheezing or shortness of breath.

If you are allergic to aspirin or NSAID medicines and use Arthrexin, the above symptoms may be severe.

Do not take Arthrexin if:

• 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 have a peptic ulcer (that is, a stomach or duodenal ulcer) or have had a recent history of ulcers
• you have recently had heart bypass surgery
• you have severe heart failure.

Do not take Arthrexin if you are pregnant. Arthrexin may affect your developing baby if you take it during pregnancy.

Do not take Arthrexin if you are breastfeeding or intend to breast-feed. Arthrexin passes into breast milk and may affect your baby.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, dyes or preservatives.

Tell your doctor if you have, or have had, any of the following medical conditions:

• heartburn or indigestion
• stomach ulcers or other stomach problems
• bowel or intestinal problems such as ulcerative colitis
• vomiting blood or bleeding from the back passage
• diabetes
• high blood pressure
• history of chest pain (angina), heart problems or stroke
• swelling of the feet or ankles
• mental disturbances
• epilepsy (seizures or fits)
• Parkinson's disease
• any current infection
• a tendency to bleed or other blood problems
• kidney or liver disease
• asthma.

Tell your doctor if you currently have an infection. If you use Arthrexin while you have an infection, the capsules or 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.

If you have not told your doctor about any of the above, tell him/her before you start taking Arthrexin.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines and Arthrexin may interfere with each other. These include:

• NSAIDs such as aspirin or a group of medicines called coxibs used to relieve pain, swelling and other symptoms of inflammation
• warfarin, a medicine to prevent blood clots
• probenecid, a medicine used for gout
• methotrexate, a medicine used to treat arthritis and certain types of cancers
• cyclosporin, a medicine used to prevent organ transplant rejection or treat immune system problems
• lithium, a medicine used to treat mood swings and some types of depression
• digoxin, a medicine used to treat heart failure or irregular heart beats
• medicines used to treat high blood pressure or heart conditions, including ACE inhibitors or betablockers
• diuretics, also known as fluid or water tablets
• decongestants

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.

If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist. Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Arthrexin.

How to take Arthrexin

How much to take

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.

Your doctor will tell you how many capsules you need to take each day and when to take them. This depends on your condition and whether or not you are taking any other medicines.

Your doctor may start you on a low dose of Arthrexin and then increase the dose if necessary, depending on your response. Tell your doctor of any changes in your condition, as you may require a change in the dose of Arthrexin.

The dose for menstrual cramps (period pain) is usually one 25 mg capsule every eight hours, starting with the onset of bleeding or cramps.

Follow all directions given to you by your doctor and pharmacist carefully.

How to take it

Swallow the capsules with a full glass of water.

When to take it

Take Arthrexin with or immediately after food.

Arthrexin may also be taken with an antacid, if advised by your pharmacist or doctor.

This may help reduce the possibility of stomach and bowel problems.

How long to take it for

Continue taking your medicine for as long as your doctor tells you to. Depending on your condition, you may need Arthrexin 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 needed for a few days only.

For gout, Arthrexin can be stopped when the joint pain disappears.

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 it

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 missed dose 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.

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 the Poisons Information Centre (telephone 13 11 26) for advise, or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much Arthrexin. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

If you take too much Arthrexin, you may experience symptoms such as nausea, vomiting, headache, dizziness, confusion, fatigue, numbness or fits.

While you are 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 become pregnant while taking this medicine, tell your doctor immediately.

If you get an infection while taking Arthrexin, tell your doctor. Arthrexin may hide some of the signs of an infection (such as pain, fever, redness, swelling). You may mistakenly think that you are better or that your infection is not serious.

If you have to have any other blood tests, tell your doctor that you are taking Arthrexin. Arthrexin may affect the results of some tests.

Things you must not do

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.

Things to be careful of

Be careful driving or operating machinery until you know how Arthrexin affects you. Arthrexin may cause drowsiness, dizziness or lightheadedness in some people. If any of these occur, do not drive, operate machinery or do anything else that could be dangerous.

If you drink alcohol, the dizziness or lightheadness may be worse.

Arthrexin can increase blood pressure in some people, so your doctor will want to check your blood pressure from time to time.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Arthrexin. 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.

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.

Do not be alarmed by the following list of side effects. You may not experience any of them.

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:

• headache, dizziness, lightheadedness
• stomach upset such as nausea (feeling sick), vomiting, indigestion, cramps, loss of appetite, wind
• heartburn or pain behind or below the breastbone (possible symptoms of an ulcer in the tube that carries of food from the throat to the stomach)
• stomach or abdominal pain
• constipation, diarrhoea
• sore mouth or tongue
• altered taste sensation
• drowsiness, disorientation, forgetfulness
• change in mood such as depression, anxiety or irritability
• strange or disturbing thoughts or moods
• shakiness, sleeplessness, nightmares
• tingling or numbness of the hands or feet
• feeling of fast or irregular heart beat
• unusual weight gain or swelling of arms, hands, feet, ankles or legs due to fluid build-up
• symptoms of sunburn (such as redness, itching, swelling, blistering of the lips, eyes, mouth, and/or skin) that happen more quickly than normal
• skin inflammation with flaking or peeling
• vision disorders (e.g. blurred or double vision)
• buzzing or ringing in the ears, difficulty hearing
• hypertension (high blood pressure)
• hair loss or thinning
• application site irritation, painful rectum or discomfort in the rectum (back passage) or worsening of haemorrhoids (piles) when using the suppositories
• These are the more common side effects of Arthrexin.

Some of the stomach upsets, such as nausea and heartburn, may be reduced by taking Arthrexin with food or an antacid, if advised by your doctor or pharmacist. Headache may occur in the first few days of treatment. If this worries you or continues, contact your doctor.

Stop taking Arthrexin and tell your doctor immediately or go to Accident and Emergency at the nearest hospital if you notice any of the following:

• red or purple skin (possible signs of blood vessel inflammation)
• severe pain or tenderness in the stomach, vomiting blood or material that looks like coffee grounds, bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea (possible stomach problems)
• rash, skin rash with blisters, itching or hives on the skin; swelling of the face, lips, mouth, tongue, throat, or other part of the body which may cause difficulty to swallow, low blood pressure (hypotension), fainting, shortness of breath (possible allergic reaction)
• wheezing, troubled breathing, or feelings of tightness in the chest (signs of asthma)
• yellowing of the skin and/or eyes (signs of hepatitis/liver failure)
• persistent nausea, loss of appetite, unusual tiredness, vomiting, pain in the upper right abdomen, dark urine or pale bowel motions (possible liver problems)
• constant "flu-like" symptoms including chills, fever, sore throat, aching joints, swollen glands, tiredness or lack of energy, bleeding or bruising more easily than normal (possible blood problem)
• painful red areas, large blisters, peeling of layers of skin, bleeding in the lips, eyes, mouth, nose or genitals, which may be accompanied by fever and chills, aching muscles and feeling generally unwell (possible serious skin reaction)
• signs of a possible effect on the brain, such as sudden and severe headache, stiff neck (signs of viral meningitis), severe nausea, dizziness, numbness, difficulty in speaking, paralysis (signs of cerebral attack), convulsions (fits)
• change in the colour or amount of urine passed, frequent need to urinate, burning feeling when passing urine, blood or excess of protein in the urine (possible kidney disorders)
• chest pain (which may be a sign of a heart attack)

Tell your doctor if you notice anything that is making you feel unwell.

Some people may have other side effects not yet known or mentioned in this leaflet.

After taking Arthrexin

Storage

Keep your tablets in the pack until it is time to take them. If you take the tablets out of the pack they may not keep well.

Keep your tablets in a cool dry place where the temperature stays below 30°C.

Do not store Arthrexin or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it 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 Arthrexin, or your capsules have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

Arthrexin is a white capsule marked IN-25.

Each bottle contains 50 capsules.

Ingredients

The active ingredient in Arthrexin is indomethacin. Each Arthrexin capsule contains 25 mg of indomethacin.

The capsules also contain:

• lactose
• sodium starch glycollate
• sodium lauryl sulfate
• magnesium stearate
• colloidal anhydrous silica
• gelatin
• titanium dioxide CI 77891.

The capsules are gluten free.

Manufacturer

Arthrexin is made in Australia by:
Alphapharm Pty Limited
(ABN 93 002 359 739)
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: (02) 9298 3999

Australian registration numbers:
Arthrexin 25 mg capsule bottle - AUST R 17586

This leaflet was prepared on
18 November 2011.

Published by MIMS/myDr March 2012

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