Mobic (Meloxicam) Drug / Medicine Information

Tablets and Capsules

Meloxicam

Consumer Medicine Information (CMI)

What MOBIC is used for

MOBIC is used to treat the symptoms of:

osteoarthritis

rheumatoid arthritis

Both diseases mainly affect the joints causing pain and swelling.

Although MOBIC can relieve symptoms such as pain and inflammation, it will not cure your condition.

MOBIC 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 MOBIC has been prescribed for you.

Your doctor may have prescribed MOBIC for another reason.

Before you take MOBIC

When you must not take it

Do not take MOBIC if you have an allergy to:

the active ingredient, meloxicam, or any of the other ingredients in MOBIC (all of these ingredients are listed at the end of this leaflet). This includes rare inherited conditions of galactose intolerance.

aspirin or any other NSAID medicine

Some of the symptoms of an allergic reaction may include:

rash, itching or hives on the skin

swelling of the face, lips, tongue or other parts of the body

shortness of breath, wheezing or troubled breathing.

Ask your doctor if you are unsure if you are allergic to these ingredients.

Do not take MOBIC if:

you are about to undergo 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 are breastfeeding, or intend to breastfeed

The active ingredient in MOBIC may pass into breast milk and may affect your baby.

you currently have a peptic (stomach) ulcer

you have Crohn's Disease or Ulcerative Colitis

you have severe liver or kidney problems

you are currently taking other medicines known as: sulfinpyrazone (used to treat gout), fluconazole (used to treat fungal infections) or certain sulfur antibiotics (eg. sulfaphenazole or sulfamethoxazole).

Do not give MOBIC to children and adolescents under 18 years of age.

Do not take MOBIC if the packaging is torn or shows signs of tampering.

Do not take MOBIC if the EXPIRY DATE printed on the pack has passed.

Before you start to take it

You must tell your doctor or pharmacist if:

you have any allergies to any other medicines, including aspirin or other NSAID medicines

you have or have had any medical conditions, especially the following:

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

you are using an IUD for birth control

you are pregnant or intend to become pregnant

If it is necessary for you to take MOBIC, your doctor will discuss the risks and benefits of taking it during pregnancy.

you are taking MOBIC 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 them before you start taking MOBIC.

Taking other medicines

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

There may be interference between MOBIC and some medicines. 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

diuretics, also called fluid or water tablets

medicines used to treat high blood pressure

medicines used to treat heart problems

medicines to treat diabetes

cholestyramine, a medicine used to treat high cholesterol levels in the blood

corticosteroids (drugs usually used to treat inflammatory conditions, such as skin rash and asthma)

some medicines used to treat fungal infections

some sulfur antibiotics

some medicines used to treat irregular heart beats

some antihistamines (medicines used to prevent or relieve the symptoms of allergy, such as hay fever or insect stings).

These medicines may be affected by MOBIC or may affect how well MOBIC works. Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking MOBIC.

Taking MOBIC

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 MOBIC is 7.5 mg, 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 MOBIC is 15 mg taken as a single dose each day.

Depending on your response, your doctor may reduce this dose to 7.5 mg taken as a single dose each day.

The maximum recommended daily dose of MOBIC 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 tablets or capsules with fluid.

It is best to take MOBIC immediately after food to avoid the chance of an upset stomach.

Try to take MOBIC at the same time each day, either morning or evening.

How long to take it

Keep taking MOBIC every day until your doctor tells you to stop.

MOBIC will not cure your condition but it should help control pain, swelling and stiffness.

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 the 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 try to make up for missed doses by taking more than one dose at a time.

If you are not sure what to do, check with your doctor or pharmacist.

If you have taken too much (overdose)

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

Signs of an overdose with MOBIC 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 MOBIC

Things you must do

If you become pregnant while taking MOBIC, tell your doctor immediately.

If you are about to start any new medicines, tell your doctor and pharmacist that you are taking MOBIC.

If you are going to have surgery, including dental surgery, tell your doctor or dentist that you are taking MOBIC.

MOBIC can slow down blood clotting.

If you get an infection while using MOBIC, tell your doctor.

MOBIC may hide some of the signs of an infection (eg. pain, fever, redness and swelling). You may think, mistakenly, that you are better or that the infection is not serious.

Things to be careful of

Be careful driving or operating machinery until you know how MOBIC affects you.

As with other NSAID medicines, MOBIC may cause dizziness, drowsiness or blurred vision in some people.

Make sure you know how you react to MOBIC before you drive a car, operate machinery, or do anything else that could be dangerous if you are not alert.

Side effects

You should be aware that all medicines carry some risks and that all possible risks may not be known at this stage despite thorough testing.

Check with your doctor as soon as possible if you have any problems while taking MOBIC, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

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

sore mouth or throat, discomfort when swallowing

constipation, diarrhoea or wind

dizziness or light-headedness

skin rash or itching

skin rashes, which may be caused by exposure to sunlight, can blister and may take on the appearance of a severe burn

increase in blood pressure

tinnitus (ringing in the ear).

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 (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 (eg. lips, mouth, eyes or genitals).

These are rare but serious side effects. You may need urgent medical attention.

If any of the following happen, STOP taking MOBIC and tell your doctor immediately or go to 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, blurred vision or visual disturbances.

These are rare but very serious side effects. You may need urgent medical attention or hospitalisation.

Not all of these side effects have been reported with MOBIC but have been seen with similar medicines.

Other side effects not listed above may occur in some people.

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

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After taking MOBIC

Storage

Keep your tablets or capsules in their pack until it is time to take them.

If you take them out of their packaging, they will not keep well.

Keep MOBIC in a cool dry place where the temperature stays below 25 degrees C.

MOBIC should not be stored in direct sunlight or heat.

Keep your tablets or capsules where children cannot reach them.

A locked cupboard at least one-and-one-half metres above the ground is a good place to store medicines.

Disposal

Your pharmacist or doctor should be able to safely dispose of any unused MOBIC.

Product Description

What MOBIC looks like

MOBIC is the brand name of your medicine. It is available as tablets and capsules.

MOBIC tablets come in two strengths:

MOBIC 7.5 mg tablets are pastel-yellow, round tablets, marked 59D on one side with break bar, and company logo on the other.

Available in blister packs of 30 tablets.

Australian Registration Number: AUST R 77694

MOBIC 15 mg tablets are pastel-yellow, round tablets, marked 77C on one side with break bar, and company logo on the other.

Available in blister packs of 30 tablets.

Australian Registration Number: AUST R 77695.

MOBIC capsules come in two strengths:

MOBIC 7.5 mg capsules are pale green capsules.

Available in blister packs of 30 capsules.

Australian Registration Number: AUST R 77698.

MOBIC 15 mg capsules are pale yellow/pale green capsules.

Available in blister packs of 30 capsules.

Australian Registration Number: AUST R 77699.

MOBIC is available only with a doctor's prescription.

Ingredients

The active ingredient in MOBIC is meloxicam:

each MOBIC 7.5 mg tablet and capsule contains 7.5 mg of meloxicam

each MOBIC 15 mg tablet and capsule contains 15 mg of meloxicam

The tablets also contain:

sodium citrate

lactose

microcrystalline cellulose

povidone

crospovidone

colloidal anhydrous silica

magnesium stearate.

The capsules also contain:

sodium citrate

lactose

maize starch

magnesium stearate

gelatin

indigo carmine CI73015

iron oxide yellow CI77492

titanium dioxide

purified water.

MOBIC does not contain gluten or sucrose.

Manufacturer

MOBIC is supplied in Australia by:

BOEHRINGER INGELHEIM

PTY LIMITED

(ABN 52 000 452 308)

78 Waterloo Road

North Ryde NSW 2113

^®= Registered Trademark

This leaflet was revised on 1 September 2009.