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 Moxicam?
Moxicam contains the active ingredient Meloxicam. Moxicam is used to treat the symptoms
of osteoarthritis and rheumatoid arthritis.
2. What should I know before I use Moxicam?
Do not use Moxicam if you have ever had an allergic reaction to meloxicam 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 Moxicam and affect how it works.
4. How do I use Moxicam?
Follow the instructions provided by your doctor and pharmacist.
For osteoarthritis, the usual dose of Moxicam is 7.5 mg once daily.
For rheumatoid arthritis, the usual dose of Moxicam is 15 mg once daily.
Swallow Moxicam whole with a full glass of water with or immediately after food.
5. What should I know while using Moxicam?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Moxicam.
If you are going to have surgery, tell the nurse, surgeon, or anaesthetist that you
are taking Moxicam as it can slow down blood clotting.
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Things you should not do
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Do not stop taking Moxicam or lower the dosage without checking with your doctor.
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Driving or using machines
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Be careful driving or operating machinery until you know how Moxicam affects you.
This medicine may cause dizziness, drowsiness or blurred vision in some people. If
you have any of these symptoms, do not drive, operate machinery or do anything else
that could be dangerous.
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Looking after your medicine
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Keep Moxicam in a cool dry place where the temperature stays below 25°C.
Keep it where children cannot reach it.
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6. Are there any side effects?
Common side effects: aching muscles, allergic reactions, back pain, being sick, blood
in the urine, burping, chest tightness, constipation, cough, cramps, dehydration,
dizziness, drowsiness, excessive sweating, fatigue, feeling sick, fluid retention,
flu-like symptoms, headache, heartburn, increased appetite, increased blood pressure,
itching or flaking skin, joint pain, loose stools, muscle spasms/ tenderness/ weakness,
pain, passing wind, reflux, runny or blocked nose, shortness of breath, sore mouth/throat,
stomach upset, trouble sleeping, upper respiratory tract infections.
Serious side effects: asthma, blurred vision, heartbeat irregularities, infection,
photosensitivity, rash, severe skin reactions, sharp chest pain, swelling of skin/mucous
membranes/stomach/intestines/liver, ulcers, urine changes.
Active ingredient(s):
Meloxicam
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Moxicam. 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 Moxicam.
Where to find information in this leaflet:
1. Why am I using Moxicam?
Moxicam contains the active ingredient meloxicam. Moxicam belongs to a group of medicines called nonsteroidal anti-inflammatory drugs
(NSAIDs). These medicines work by relieving pain, swelling, and redness.
Moxicam is used to treat the symptoms of:
Osteoarthritis (OA) is a chronic disorder that causes damage to the cartilage and surrounding tissues
and is characterized by pain, stiffness, and loss of function.
Rheumatoid arthritis (RA) is an inflammatory arthritis in which joints, usually including those of the hands
and feet, are inflamed, resulting in swelling, pain, and often destruction of joints.
Both diseases mainly affect the joints causing pain and swelling.
Although Moxicam can relieve the symptoms of pain and inflammation, it will not cure
your condition.
2. What should I know before I use Moxicam?
Warnings
Do not use Moxicam if:
you are allergic to:
meloxicam, Aspirin or any other non steroidal anti inflammatory drugs (NSAIDs).
or any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
Are under 18 years of age
Are pregnant or think you may be pregnant (see Pregnancy and Breastfeeding)
Are breastfeeding (see Pregnancy and Breastfeeding)
Are going to have or have just had heart bypass surgery
Have galactose intolerance (a rare genetic condition)
Have a hole in or experience bleeding from the stomach, gut or any other bleeding
Have uncontrolled heart failure
Have severe liver problems
Have severe, non-dialysis kidney disease
Have had a stroke due to a bleed in the brain
Have a stomach ulcer
Have or have had inflammation of the stomach lining
Have an inflammatory bowel disease such as Crohn's disease or ulcerative colitis now
or in the past
Are taking any of these medicines:
fluconazole (a medicine used to treat fungal infections) or
certain sulfur antibiotics (e.g. sulfamethoxazole)
methotrexate (a medicine used to treat diseases of the immune system and some cancers).
Had any of the following reactions after taking aspirin or an NSAID:
asthma
nasal polyps (painless growths inside the nose or sinuses)
swelling of the face, lips, mouth, tongue or throat (which may cause difficulty in
swallowing or breathing)
hives or an itchy rash
Check with your doctor if you have:
any allergies to other medicines, foods, preservatives, or colours
a current infection
advanced or chronic kidney disease
any problems with your
heart or blood vessels
liver
blood pressure
fluid retention
diabetes
high cholesterol
any clotting or bleeding disorder
asthma.
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
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Tell your doctor immediately if you become pregnant while taking Moxicam.
Birth control
Tell your doctor if you are using an intrauterine device (IUD) to prevent pregnancy.
NSAID medicines, like Moxicam, may decrease the effectiveness of the birth control
device.
Children and adolescents
The safety and effectiveness in adolescents or children younger than 18 years have
not been established.
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 Moxicam and affect how it works. These include:
other non-steroidal anti-inflammatory drugs (NSAIDs): aspirin, celecoxib, diclofenac,
etoricoxib, ibuprofen, indometacin, ketoprofen, mefenamic acid, naproxen, piroxicam,
rofecoxib, salicylates, or sulindac.
warfarin or heparin, medicines used to thin the blood
furosemide, other diuretics or medicines used to treat high blood pressure
Amiodarone or quinidine, two medicines used to treat fast, slow or irregular heart
beats
Ciclosporin, a medicine used to treat inflammatory conditions suppress the immune
system
Ketoconazole and itraconazole, medicines used to treat fungal infections
Erythromycin, a commonly used broad-spectrum antibiotic
Lithium, a tablet used to treat mood disorders
Cortisone, dexamethasone, prednisolone, prednisone, or any other steroid medicine
used to treat inflammatory conditions (e.g. skin rashes or asthma)
Pemetrexed, a medicine injected into a vein that is used to treat some lung cancers
Sulfonylureas, oral medicines used to treat diabetes
citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline, medicines
used to treat depression and anxiety (called SSRIs).
Medicines that may
reduce
the effect of Moxicam include:
Cholestyramine, a medicine used for lowering blood fats (cholesterol).
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Moxicam.
4. How do I use Moxicam?
How much to take
The dose depends on your condition and any medicines that you are taking.
Osteoarthritis (OA)
The usual starting dose for osteoarthritis is 7.5 mg, taken as a single dose each
day. Depending on your response, your doctor may increase the single daily dose to
15 mg.
Rheumatoid arthritis (RA)
The usual dose for rheumatoid arthritis is 15 mg taken as a single dose each day.
If needed, your doctor may reduce the single daily dose to 7.5 mg.
Ask your doctor for more information if you have been advised to take a different
dose.
Patients with kidney problems undergoing dialysis should not take more than 7.5 mg
each day.
Follow the instructions provided and use Moxicam until your doctor tells you to stop.
Do not exceed the maximum recommended daily dose of 15 mg.
When to take Moxicam
Moxicam should be swallowed whole with a full glass of water with or immediately after
food. This may help reduce the risk of getting an upset stomach.
Take Moxicam once a day, at about the same time each day. Taking it at the same time
each day will help you remember when to take it.
If you forget to use Moxicam
Moxicam should be used regularly at the same time each day. If you miss taking your
dose at the usual time, and it is 2-3 hours before 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, 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 Moxicam
If you think that you have used too much Moxicam, 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.
The symptoms of an overdose may include:
nausea and/or vomiting
headache
drowsiness and/or dizziness
blurred vision
fits or seizures
fainting, feeling weak, light-headed, tired, confused and having blurred vision (signs
of low blood pressure)
difficulty in breathing
being unaware of what happens to you or around you
changes in amount of urine, fluid retention, confusion, and/or nausea.
5. What should I know while using Moxicam?
Things you should do
If you are going to have surgery, tell the nurse, surgeon, or anaesthetist that you
are taking Moxicam. Moxicam can slow down blood clotting and put you at risk of bleeding.
Keep your medical appointments so that your progress can be monitored.
Your doctor may want to perform tests now and then to detect any side effects, such
as anaemia.
Continue taking Moxicam for as long as your doctor tells you.
Talk to your doctor or pharmacist if you do not feel any better after several days
of taking Moxicam.
Remind any doctor, dentist or pharmacist you visit that you are using Moxicam.
Things you should not do
Do not stop using this medicine your medicine or lower the dosage without speaking
to your doctor first.
Things to be careful of
Tell your doctor if you get an infection while using Moxicam. Moxicam may hide some
of the signs of an infection, such as pain, fever, redness and swelling. You may think,
mistakenly, that you have improved or that the infection is not serious.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Moxicam
affects you.
Moxicam may cause dizziness or blurred vision in some people. If you have any of these
symptoms, do not drive, operate machinery or do anything else that could be dangerous
in some people.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
Store Moxicam 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.
Less serious side effects
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Less serious side effects
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What to do
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General problems:
Flu-like symptoms: runny or blocked nose, cough, sore mouth or throat, discomfort
when swallowing
fatigue
fluid retention in lower body
swelling of hands, ankles or feet
allergic reaction.
Gut and digestion:
indigestion (stomach upset) including heartburn/reflux, feeling sick (nausea), vomiting,
burping or passing more wind than usual, cramps, pain, constipation, loose stools
(diarrhoea).
Nervous system:
headache
dizziness
spinning sensation
trouble sleeping
drowsiness.
Skin:
itching or flaking
excessive sweating that's not related to heat or exercise
irritation of the moist internal linings of the body such as the mucous membranes
(e.g. lips, mouth, throat, nasal passages, eyelids, intestines or genitals).
Breathing:
cough
shortness of breath, chest tightness.
Nutrition:
dehydration
increased appetite.
Muscle and bone:
back pain
pain or swelling in or near a joint
muscle spasms
aching muscles, muscle tenderness or weakness, not caused by exercise
pain in extremity.
Infections:
runny or stuffy nose, sneezing, or swelling of the lining of the nose
swelling of the air-filled spaces in your forehead, cheeks or nasal passages.
Urine:
blood in the urine.
Blood:
increased blood pressure (BP) over several days (if self-checked at home with a suitable
BP machine).
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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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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Gut and bowel:
bleeding from the back passage, black sticky stools or bloody diarrhoea
severe pain or tenderness in the stomach
vomiting of blood or material that looks like coffee grounds
Liver:
yellowing of the skin or the
whites of the eyes
pain in the abdomen
loss of appetite.
Kidney and bladder:
any pain or difficulty when urinating
any change in the amount or colour of urine.
Eyes:
blurred vision or difficulty seeing.
Lungs:
sharp chest pain, usually worse when you inhale or cough.
Heart:
fast or irregular heartbeat
chest pain
swollen ankles or legs (oedema of the lower limbs).
Severe allergic reaction:
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.
Severe skin and soft tissue reactions:
sudden unexplained bruising or blood spots under the skin that were not caused by
an injury
itching, blistering or peeling of the skin, which can be potentially life-threatening
rashes which may be caused by sunlight, can blister, and may take on the appearance
of a severe burn
swelling of skin or mucosa, such as swelling around the eyes, face and lips, mouth
or throat, possibly making breathing difficult.
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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 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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Signs of a stroke
weakness or numbness or paralysis of the face, arm or leg on either or both sides
of the body
slurred speech
difficulty speaking or understanding
loss of vision, sudden blurring or decreased vision in one or both eyes
Headache, usually severe and fast onset or unexplained change in the pattern of headaches.
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Call an ambulance (dial 000) at once if you experience these 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 Moxicam contains
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Active ingredient
(main ingredient)
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meloxicam
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Other ingredients
(inactive ingredients)
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lactose monohydrate,
maize starch,
sodium citrate,
magnesium stearate,
Brilliant Blue FCF,
Sunset Yellow FCF,
Gelatin
titanium dioxide and quinolone yellow (15 mg strength only).
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Potential allergens
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Sugars as lactose
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Do not take this medicine if you are allergic to any of these ingredients.
Moxicam does not contain gluten or sucrose.
What Moxicam looks like
Moxicam is the brand name of your medicine. It is available as capsules in two strengths.
Available in PVC/PVDC/Al blister packs of 30 capsules
MOXICAM 7.5 mg capsules: Light green/Light green, size ‘2’ hard gelatin capsules filled with light
yellow coloured granules.
MOXICAM 15 mg capsules: Light green/Light yellow, size ‘2’ hard gelatin capsules filled with light
yellow coloured granules with score line between ‘F’ and ‘2’ debossed on one side
and plain on the other side.
Moxicam 7.5 - AUST R 232584
Moxicam 15 - AUST R 232585
Who distributes Moxicam
Moxicam is supplied in Australia by:
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 October 2024