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Meloxicam Sandoz Tablets

meloxicam tablets
Consumer Medicine Information
 

 

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about Meloxicam Sandoz.
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 risk of you taking Meloxicam Sandoz against the benefits it is expected to 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 MELOXICAM SANDOZ IS USED FOR

This medicine is used to treat the symptoms of:
osteoarthritis
rheumatoid arthritis.
Both diseases mainly affect the joints causing pain and swelling.
Although Meloxicam Sandoz can relieve symptoms such as pain and inflammation, it will not cure your condition.
It contains the active ingredient meloxicam. 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 it for another reason.
This medicine is available only with a doctor's prescription.

BEFORE YOU TAKE MELOXICAM SANDOZ

When you must not take it

Do not take this medicine if you have an allergy to:
meloxicam, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description. This includes rare inherited conditions of galactose intolerance.
any other similar medicines, such as aspirin or any other NSAID medicine.
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 this medicine if you have or have had any of the following medical conditions:
disease of the heart with shortness of breath, and swelling of the feet or lips due to fluid build-up
bleeding from the stomach, gut or any other bleeding
tendency to bleed or other bleeding problems such as a stroke resulting from a bleed in the brain
peptic (stomach) ulcer
Crohn's disease or ulcerative colitis, which are diseases of the bowel
severe liver or kidney problems.
Do not take this medicine if you are also taking other medicines known as:
sulfinpyrazone, a medicine used to treat gout
fluconazole, a medicine used to treat fungal infections
certain sulphur antibiotics such as sulfaphenazole or sulfamethoxazole.
Do not take this medicine if you are about to undergo coronary artery bypass graft surgery.
Do not take this medicine if you are pregnant.
It may affect your developing baby if you take it during pregnancy.
Do not breastfeed if you are taking this medicine.
The active ingredient in Meloxicam Sandoz 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 16 years.
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, foods, preservatives 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 using an Intra Uterine Device (IUD) for birth control.
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.
Your doctor can discuss with you the risks and benefits involved.
Tell your doctor if you are taking Meloxicam Sandoz together with any medicines used to treat high blood pressure and some other heart problems such as ACE inhibitors, angiotensin receptor antagonists and diuretics (also called fluid or water tablets). When taken together these medicines can cause kidney problems.
If you have not told your doctor or pharmacist about any of the above, tell him/her before you start taking Meloxicam Sandoz.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from a pharmacy, supermarket or health food shop.
Some medicines and Meloxicam Sandoz may interfere with each other. These include:
aspirin, salicylates or other NSAID medicines
medicines used to thin your blood such as warfarin, heparin and ticlopidine
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 (a painful joint disease) 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
diuretics, also called fluid or water tablets
medicines used to treat high blood pressure
medicines used to treat heart problems
medicines used 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 rash and asthma)
some medicines used to treat fungal infections (e.g. ketoconazole, itraconazole)
some sulfur antibiotics
some medicines used to treat irregular heart beats (e.g. amiodarone and quinidine)
some antihistamines, medicines used to prevent or relieve the symptoms of allergy, such as hay fever or insect stings
Pemetrexed, a medicine used in the treatment of certain lung cancers.
These medicines may be affected by Meloxicam Sandoz 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 this medicine.

HOW TO TAKE MELOXICAM SANDOZ

Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions, ask your doctor or pharmacist for help.

How much to take

For the treatment of osteoarthritis.
The usual dose of Meloxicam Sandoz is 7.5mg taken as a single dose each day.
However, your doctor will prescribe a dose suitable for your condition.
For the treatment of rheumatoid arthritis.
The usual dose of Meloxicam Sandoz is 15mg 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 Sandoz is 15mg.
For patients with kidney problems undergoing dialysis, the maximum recommended daily dose is 7.5mg.
Ask your doctor or pharmacist if you are unsure of the correct dose for you.
They will tell you exactly how much to take.
Follow the instructions they give you.
If you take the wrong dose, Meloxicam Sandoz may not work as well and your problem may not improve.

How to take it

Swallow the tablets with a glass of water or another liquid.
The tablets can be broken in half. If you need to break Meloxicam Sandoz, hold the tablet with both hands and snap along the break line.

When to take Meloxicam Sandoz

Take your medicine during or immediately after a meal, at about the same time each day.
If you take it on an empty stomach, it may cause stomach upset.

How long to take Meloxicam Sandoz

Continue taking your medicine for as long as your doctor tells you.
This medicine helps to control your condition, but does not cure it.

If you forget to take it

Take your dose as soon as you remember, and continue to take it as you would normally.
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Do not take a double dose to make up for the dose that you missed.
This may increase the chance of you getting an unwanted side effect.
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 have taken too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone Australia 13 11 26 or New Zealand 0800 POISON or 0800 764766) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Meloxicam Sandoz. 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
blurred vision
dizziness
fits or seizures
low blood pressure
difficulty in breathing
impaired consciousness
kidney failure.

WHILE YOU ARE TAKING MELOXICAM SANDOZ

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 Sandoz.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
If you are going to have surgery, including dental surgery, tell your doctor or dentist that you are taking Meloxicam Sandoz.
Meloxicam Sandoz can slow down blood clotting.
If you become pregnant while taking this medicine, tell your doctor immediately.
Tell your doctor if you get an infection while taking your medicine.
Meloxicam Sandoz 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.
Keep all of your doctor's appointments so that your progress can be checked.

Things you must not do

Do not take Meloxicam Sandoz 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 Meloxicam Sandoz affects you.
As with other NSAID medicines, this medicine may cause dizziness, drowsiness or blurred vision in some people. If you have any of those 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 Sandoz.
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.
Do not be alarmed by the following lists 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:
stomach upset including nausea, vomiting, heartburn, indigestion, belching, cramps or pain
headache or dizziness
sore throat or discomfort when swallowing
flu-like symptoms, including coughing
constipation, diarrhoea or wind
dizziness or light-headedness, falls or other accidents around the home or work
skin rash or itching
back pain, muscle pain, muscle spasms, painful or swollen joints
clicking sound when joints move
trouble sleeping or nightmares
laryngitis, a condition causing hoarseness or loss of voice
skin rashes, which may be caused by exposure to sunlight, can blister and may take on the appearance of severe burn
increase in blood pressure
tinnitus (ringing in the ear).
These side effects are usually mild.
Tell your doctor as soon as possible if you notice any of the following:
infections in your lungs, throat, or nose
sinusitis, a condition causing a feeling of tension or fullness of the nose, cheeks and behind your eyes
blurred vision
infections in your urinary tract, e.g. the need to pass urine more frequently than normal, any change in the amount or colour of your urine (red or brown) or painful urination
collapsing or fainting, shortness of breath or tiredness, fast or irregular heartbeat (also called palpitations), chest pain, swollen or sore leg veins
severe pain or tenderness in the stomach
severe dizziness
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).
The above list includes serious side effects that may require medical attention. Serious side effects are rare.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency 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 or visual disturbances.
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.
Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.
Other side effects not listed above may also occur in some people.

AFTER TAKING MELOXICAM SANDOZ

Storage

Keep your medicine in the original container.
If you take it out of its original container it may not keep well.
Keep your medicine in a cool dry place where the temperature stays below 25°C.
Do not store Meloxicam Sandoz 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 this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

PRODUCT DESCRIPTION

What it looks like

Meloxicam Sandoz comes in two types of tablets:
Meloxicam Sandoz 7.5mg - pale yellow coloured, circular, flat, bevelled, uncoated tablets with a central break line on one side and plain on the other.
Meloxicam Sandoz 15mg - pale yellow coloured, circular, flat, bevelled, uncoated tablets with a central break line on one side and plain on the other.
Available in blisters of 30 tablets.

Ingredients

Active ingredient:
Meloxicam Sandoz 7.5mg - 7.5mg meloxicam
Meloxicam Sandoz 15mg - 15mg meloxicam
Inactive ingredients:
starch - maize
starch - pregelatinised maize
silica - colloidal anhydrous
sodium citrate dihydrate
lactose monohydrate
cellulose - microcrystalline
magnesium stearate.
This medicine does not contain gluten or sucrose.

Supplier

Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road,
Macquarie Park, NSW 2113, Australia
Tel: 1800 634 500
Novartis New Zealand Ltd
Private Bag 65904 Mairangi Bay
Auckland 0754
New Zealand
Tel: 0800 354 335
This leaflet was revised in August 2016.
Australian Register Numbers
Meloxicam Sandoz 7.5mg tablets: AUST R 127084
Meloxicam Sandoz 15mg tablets: AUST R 127718