NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
MOXICAM CMI
contains the active ingredient meloxicam
CONSUMER MEDICINE INFORMATION
What is in this leaflet
Read this leaflet carefully before taking your medicine.
This leaflet answers some common questions about meloxicam. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
This leaflet was last updated on the date at the end of this leaflet. More recent information may be available. The latest Consumer Medicine Information is available from your pharmacist or doctor and may contain important information about the medicine and its use of which you should be aware.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine 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.
Pharmaceutical companies cannot give you medical advice or an individual diagnosis.
Keep this leaflet with the medicine. You may need to read it again.
What Meloxicam Capsules is used for
The name of your medicine is Moxicam. It contains the active ingredient meloxicam.
It is used to treat the symptoms of
Osteoarthritis
rheumatoid arthritis
Both diseases mainly affect the joints causing pain and swelling.
Although meloxicam can relieve the symptoms of pain and inflammation, it will not cure your condition.
How it works
Meloxicam belongs to a family of medicines called Non-Steroidal Anti- inflammatory Drugs (NSAIDs).
These medicines work by relieving pain and inflammation.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed this medicine for another reason.
Before you take Meloxicam Capsules
When you must not take it
Do not take Meloxicam Capsules if you have an allergy to:
any medicine containing meloxicam
any of the ingredients listed at the end of this leaflet
aspirin or any other NSAIDs
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
Do not take meloxicam if:
you are about to undergo a coronary artery bypass graft surgery
you have a disease of the heart with shortness of breath, and swelling of the feet or lips due to fluid build-up
you experience bleeding from the stomach, gut or any other bleeding
you have had a stroke resulting from a bleed in the brain or have a bleeding disorder
you have a galactose intolerance
you have a peptic (stomach) ulcer
you have or have had inflammation of the lining of the stomach or bowel (e.g. Crohn’s Disease or Ulcerative Colitis)
you have severe liver or kidney problems
you are currently taking the following medicines: fluconazole (used to treat fungal infections) or certain sulfur antibiotics (e.g. sulfamethoxazole).
Do not breast-feed if you are taking this medicine.
The active ingredient in meloxicam passes into breast milk and there is a possibility that your baby may be affected.
Do not give this medicine to a child under the age of 18 years.
Safety and effectiveness in children younger than 18 years have not been established.
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.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, food, preservative or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
high blood pressure or fluid retention
diabetes
high cholesterol
heartburn, indigestion, ulcers or other stomach problems
kidney or liver disease
asthma or any other breathing problems.
Tell your doctor if you are pregnant, planning to become pregnant or are using an IUD for birth control.
Your doctor can discuss with you the risks and benefits involved.
Tell your doctor if you currently have an infection.
Meloxicam may hide some of the signs of an infection. This may make you think, mistakenly, that you are better or that it is not serious.
If you have not told your doctor or pharmacist about any of the above, tell them before you start taking meloxicam.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and meloxicam may interfere with each other. These include:
aspirin, salicylates or other NSAIDs
medicines used to thin your blood (e.g. warfarin, heparin and ticlopidine)
medicines used to treat high blood pressure and other heart problems (e.g. ACE inhibitors, angiotensin receptor antagonists and diuretics, also called fluid or water tablets)
When taken together these medicines can cause kidney problems.
lithium, a medicine used to treat some types of depression
antidepressants called selective serotonin reuptake inhibitors (SSRIs)
methotrexate, a medicine used to treat rheumatoid arthritis and some types of cancer
cyclosporin, a medicine used to treat rheumatoid arthritis and certain problems with the immune system
terfenadine and astemizole, medicines used to prevent or relieve the symptoms of allergy, such as hay fever or insect stings
medicines to treat diabetes
cholestyramine, a medicine used to treat high cholesterol levels in the blood
corticosteroids, medicines usually used to treat inflammatory conditions, such as skin rashes and asthma
some medicines used to treat infections (e.g. erythromycin, sulfur antibiotics, ketoconazole, itraconazole)
some medicines used to treat irregular heart beats (e.g. amiodarone and quinidine)
pemetrexed, a medicine used in the treatment of certain lung cancers.
These medicines may be affected by meloxicam or may affect how well it works. You may need different amounts of your medicines, or you may need different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
How to take Meloxicam Capsules
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
How much to take
For the treatment of osteoarthritis
The usual dose of meloxicam is 7.5 mg, taken as a single dose each day.
Depending on the severity of your condition and your response to treatment, your doctor may increase this dose to 15 mg taken as a single dose each day.
For the treatment of rheumatoid arthritis
The usual dose of meloxicam is 15 mg taken as a single dose each day.
Depending on your response, your doctor may reduce this dose to 7.5mg taken as a single dose each day.
The maximum recommended daily dose of meloxicam is 15 mg.
For patients with kidney problems undergoing dialysis, the maximum recommended daily dose is 7.5 mg.
Ask your doctor for more information if you have been advised to take a different dose.
How to take it
Swallow the meloxicam capsules whole, with a full glass of water.
When to take it
Take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
Take your medicine with or straight after food.
This may help reduce the possibility of stomach upset.
How long to take it
Continue taking your medicine for as long as your doctor tells you.
This medicine helps control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well.
If you forget to take it
If it is almost time for your next dose (e.g. within 2-3 hours), skip the dose you missed and take your next dose at the usual time.
Otherwise take it 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 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)
If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26 in Australia) for advice, or go to the Accident and Emergency Department at your nearest hospital.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Symptoms of an overdose may include:
nausea and/or vomiting
headache
drowsiness and/or dizziness
blurred vision
fits or seizures
low blood pressure
difficulty in breathing
impaired consciousness
kidney failure.
While you are taking Meloxicam Capsules
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking meloxicam. 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 meloxicam.
Meloxicam can slow down blood clotting.
If you become pregnant while taking this medicine, tell your doctor immediately.
If you get an infection while using meloxicam, tell your doctor.
Meloxicam may hide some of the signs of an infection (e.g. pain, fever, redness and swelling). You may think, mistakenly, that you are better or that the infection is not serious.
Things you must not do
Do not take your medicine to treat any other condition 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.
Things to be careful of
Be careful driving or operating machinery until you know how meloxicam 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.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking meloxicam.
This medicine helps most people but it may have unwanted side effects in a few people. All medicines 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 lists of side effects. You may not experience any of them.
Not all of these side effects have been reported with meloxicam but have been seen with similar medicines.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
stomach upset including: nausea, vomiting, heartburn, indigestion, belching, cramps or pain
headache
flu-like symptoms, runny or blocked nose, cough, sore mouth or throat, discomfort when swallowing
constipation, diarrhoea or wind
dizziness or light-headedness
skin rashes, which may be caused by exposure to sunlight, can blister and may take on the appearance of a severe burn, or itching
increase in blood pressure
tinnitus (ringing in the ear).
The above list includes the more common side effects of your medicine. These side effects are usually mild.
Tell your doctor immediately if you notice any of the following:
blurred vision
any change in the amount or colour of your urine (red or brown)
any pain or difficulty experienced when urinating
collapse or fainting, shortness of breath or tiredness, fast or irregular heartbeat, chest pain, swollen or sore leg veins
severe dizziness
severe pain or tenderness in the stomach
flaking of the skin
yellowing of the skin and eyes (known as jaundice)
swelling of your ankles, legs or other parts of your body
signs of anaemia (such as tiredness, being short of breath and looking pale)
irritation of your mucous membranes (e.g. lips, mouth, eyes or genitals).
These are rare but serious side effects. You may need urgent medical attention.
If you experience any of the following, stop taking meloxicam and contact your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
vomiting of blood or material that looks like coffee grounds
bleeding from your back passage (rectum), black sticky motions (stools) or bloody diarrhoea
swelling of the face, lips or tongue which may make swallowing or breathing difficult
asthma, wheezing or shortness of breath
sudden or severe itching, skin rash or hives
weakness in one part or side of your body, slurred speech, blurred vision or visual disturbances
These are rare but very serious side effects. You may need urgent medical attention or hospitalisation.
Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.
Other side effects not listed above may occur in some patients.
After taking Meloxicam Capsules
Storage
Keep your medicine in its original packaging until it is time to take it.
If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 25°C.
Do not store your medicine in direct sunlight.
Do not store your medicine, 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 this medicine 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 or pharmacist tells you to stop taking this medicine or they have passed their expiry date, your pharmacist can dispose of the remaining medicine safely.
Product description
What Moxicam looks like
They are available in the following strengths:
7.5 mg capsule: Light green/Light green, size ‘2’ hard gelatin capsules filled with light yellow coloured granules.
15 mg capsule: Light green/Light yellow, size ‘2’ hard gelatin capsules filled with light yellow coloured granules.
Ingredients
Each capsule contains either 7.5 mg or 15 mg of the active ingredient meloxicam.
In addition, each capsule also contains the following inactive ingredients:
lactose monohydrate
maize starch
sodium citrate
magnesium stearate
Brilliant Blue FCF
Sunset Yellow FCF
gelatin
titanium dioxide
quinolone yellow (15 mg strength only)
This medicine is gluten-free, sucrose – free, tartrazine-free and free of other azo dyes.
They are available in PVC/PVDC/Al blister packs of 30 capsules
Australian Registration Numbers
Moxicam 7.5 mg capsules (blister pack): AUST R 232584.
Moxicam 15 mg capsules (blister pack): AUST R 232585.
Sponsor
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
www.mylan.com.au
This leaflet was prepared on
March 2017.
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