Consumer medicine information

MELOXICAM-GA Tablets


Consumer Medicine Information

What is in this leaflet

Please read this leaflet carefully before you take MELOXICAM-GA tablets.

This leaflet answers some common questions about MELOXICAM-GA. It does not contain all available information, nor does it take the place of talking to you doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking MELOXICAM-GA against the benefits this medicine is expected to have for you.

You should ask your doctor or pharmacist if you have any questions about MELOXICAM-GA or if you have any trouble before, during or after taking MELOXICAM-GA.

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

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

What MELOXICAM-GA is used for

MELOXICAM-GA contains the active ingredient meloxicam and is used to treat the symptoms of rheumatoid arthritis and osteoarthritis, which affects the joints causing pain and swelling.

MELOXICAM-GA belongs to a family of medicines called Non-Steroidal Anti-inflammatory Drugs (NSAIDs). These medicines work by relieving pain and inflammation.

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

Your doctor may have prescribed MELOXICAM-GA for another reason.

Ask your doctor if you have any questions about why MELOXICAM-GA has been prescribed to you.

This medicine is only available with a doctor’s prescription.

There is no evidence that MELOXICAM-GA is addictive.

Before you take MELOXICAM-GA

When you must not take MELOXICAM-GA

Do not take MELOXICAM-GA if you have an allergy to:

  • The active ingredient, meloxicam, or any of the other ingredients in MELOXICAM-GA. This includes rare inherited conditions of galactose intolerance.
  • aspirin or any other NSAID medicine.

If you are not sure if you have these allergies, you should raise those concerns with your doctor or pharmacist.

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.

Do not take MELOXICAM-GA 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 MELOXICAM-GA may pass into the 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 taking other medicines

such as sulfinpyrazone (used to treat gout), fluconazole (used to treat fungal infections) or certain sulfur antibiotics (e.g. sulfaphenazole or sulfamethoxazole).

  • the packaging is torn or shows

signs of tampering

  • the expiry date on the pack has passed.

If you take this medicine after the expiry date has passed, it may not work as well (or it may make you feel sick).

Do not give MELOXICAM-GA to children and adolescents under 18 years of age.

Before you start to take MELOXICAM-GA

You must tell your doctor or pharmacist if:

  1. you have any allergies to foods, dyes, preservatives or any other medicines, including aspirin or other NSAID medicines.
  2. 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
  1. you are using an IUD for birth control
  2. you are breastfeeding, pregnant or trying to become pregnant.

Like most NSAIDs, MELOXICAM-GA is not recommended for use during the last 3 months of pregnancy. It may affect your developing baby if you take it while you are pregnant.

You are taking Meloxicam-GA together with any medicines used to treat high blood pressure and some other heart problems such a 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 MELOXICAM-GA.

Taking other medicines

Before taking MELOXICAM-GA, 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 MELOXICAM-GA 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)
  • medicines used to treat fungal infections
  • some sulfur antibiotics
  • medicines used to treat irregular heart beats
  • antihistamines (medicines used to prevent or relieve the symptoms of allergy, such as hay fever or insect stings).

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

Children

MELOXICAM-GA is not recommended for use in children and adolescents under 18 years of age.

How to take MELOXICAM-GA

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-GA 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 MELOXICAM-GA 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 MELOXICAM-GA 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 MELOXICAM-GA

Swallow the tablets with fluid.

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

Try to take MELOXICAM-GA at the same time each day, either morning or evening.

How long to take MELOXICAM-GA

Keep taking Meloxicam-GA everyday until your doctor tells you to stop.

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

You may need to take MELOXICAM-GA for a long time. Do not stop taking MELOXICAM-GA tablets, or change the dose, without first checking with your doctor.

If you forget to take MELOXICAM-GA

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 trouble remembering to take your medicine, ask your pharmacist for some hints.

If you have taken too much MELOXICAM-GA

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) or go to casualty at your nearest hospital if you think that you or anyone else may have taken too much MELOXICAM-GA.

Do this even if there are no signs of discomfort or poisoning.

If you have taken too much MELOXICAM-GA, you may have the following:

  • 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 using MELOXICAM-GA

Things you must do

If you become pregnant while taking MELOXICAM-GA, tell your doctor immediately.

Tell your doctor and pharmacist if you are about to start any new medicines that you are taking MELOXICAM-GA.

If you are going to have surgery, including dental surgery, tell your doctor or dentist that you are taking MELOXICAM-GA. MELOXICAM-GA can slow down blood clotting.

If you get an infection while using MELOXICAM-GA, tell your doctor. MELOXICAM-GA 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 to be careful of

Be careful driving or operating machinery until you know how MELOXICAM-GA affects you. As with other NSAID medicines, MELOXICAM-GA may cause dizziness, drowsiness or blurred vision in some people.

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

Side effects

Tell you doctor or pharmacist as soon as possible if you do not feel well while you are taking MELOXICAM-GA.

You should be aware that all medicines carry some side effects and that all possible risks may not be known at this stage despite thorough testing. If they occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.

Check with your doctor as soon as possible if you have any problems while taking MELOXICAM-GA, 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 or discomfort when swallowing
  • ‘flu’-like symptoms, including coughing
  • constipation, diarrhoea or wind
  • dizziness or light-headedness
  • skin rash or itching
  • back pain, muscle spasms or pain, painful or swollen joints
  • clicking sound when joints move
  • 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 ear)

These side effects are usually mild, but if they persist, consult your doctor.

Tell your doctor immediately 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
  • 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 MELOXICAM-GA 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 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 Meloxicam-GA but have been seen with similar medicines.

In addition, unexpected effects, not listed above, can occur with any medicine.

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 using MELOXICAM-GA

Storage

Keep your MELOXICAM-GA tablets in their pack until it is time to take them

If you take the tablets out of their packaging, they may not keep well.

Keep MELOXICAM-GA in a cool dry place where the temperature stays below 25°C.

Do not store it or any other medicine in the bathroom or near a sink.

Do not leave it in the car or on windowsills.

MELOXICAM-GA should not be stored in direct sunlight or heat. Dampness and heat can destroy some medicines.

Keep your tablets 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

If your doctor tells you to stop taking MELOXICAM-GA or the tablets have passed their expiry date, ask your pharmacist or doctor what to do with the any tablets that are leftover.

Product description

What is MELOXICAM-GA

MELOXICAM-GA tablets come in two strengths, 7.5 mg and 15 mg.

MELOXICAM-GA 7.5 mg tablets are pale yellow coloured, circular, flat bevelled uncoated tablet, with central breakline on one side and plain on the other side.

MELOXICAM-GA 15 mg tablets are pale yellow coloured, circular, flat bevelled uncoated tablet, with central breakline on one side and plain on the other side.

MELOXICAM-GA tablets are available in packs of 30 tablets.

Ingredients

Each tablet contains either 7.5 mg or 15 mg of the active ingredient meloxicam.

The tablets also contain the inactive ingredients maize starch, lactose, microcrystalline cellulose, Pregelatinised maize starch, sodium citrate, colloidal anhydrous silica and magnesium stearate.

MELOXICAM-GA does not contain gluten or sucrose.

Supplier

Ascent Pharma Pty Ltd
151-153 Clarendon Street
South Melbourne, VIC 3205.
www.ascentpharma.com.au

For further information call 1800 554 414

MELOXICAM-GA 7.5 mg AUST R 124395

MELOXICAM-GA 15 mg AUST R 124397

This leaflet was last updated in September 2010.

Published by MIMS May 2011