APO-Meloxicam Tablets

What this medicine is used for

The name of your medicine is APO-Meloxicam. It contains the active ingredient, meloxicam.

It is used to treat the symptoms of:

  • osteoarthritis (when the cartilage between two bones becomes damaged)
  • rheumatoid arthritis (when the tissue around a joint becomes thickened and inflamed leading to a build-up of fluid on the joint).

Both diseases mainly affect the joints, causing pain and swelling.

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.

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

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.

Meloxicam does not cure arthritis and it will help you only when you are taking it.

There is no evidence that this medicine is addictive.

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

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

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

Use in children

There is not enough information to recommend using this medicine in children and adolescents under 18 years.

Before you take this medicine

When you must not take it

Do not take this medicine if:

  • You have any of the following problems affecting your digestive system:
a stomach or duodenal ulcer
you are vomiting blood, or material that looks like coffee grounds
you are bleeding from the rectum (back passage), have black, sticky bowel motions (stools)
you have Crohn's Disease or Ulcerative Colitis (inflammation of the lining of the stomach or bowel)
  • You are about to have or have recently had heart (coronary artery) bypass graft surgery
  • You have serious kidney or liver problems
  • You have a condition called severe heart failure (a disease of the heart with shortness of breath, and swelling of the feet or lips due to fluid build-up)
  • You have had a stroke resulting from a bleed in the brain, or have a bleeding disorder in another part of your body
  • You have had an allergic or hypersensitivity reaction to meloxicam, aspirin or any other NSAID medicine, or any of the ingredients listed at the end of this leaflet. Many medicines used to treat headache, period pain and other aches and pains contain aspirin or NSAID medicines.
  • You have had any of the following symptoms after taking aspirin or other NSAIDS: asthma, nasal polyps, swollen face or urticaria
  • You are breast-feeding or intend to breast-feed.
Meloxicam may pass into breast milk and may affect your baby
  • You are currently taking other medicines known as: sulfinpyrazone (used to treat gout), fluconazole (used to treat fungal infections) or certain sulfur antibiotics (e.g. sulfaphenazole or sulfamethoxazole)
  • You are allergic to or have hereditary galactose intolerance. These tablets contain lactose.
  • It has passed the expiry date (EXP) printed on the pack.
  • The packaging is torn, shows signs of tampering or it does not look quite right.

Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body, itching or hives on the skin.

If you think you are having an allergic reaction, contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.

Other serious allergic reactions include Erythema Multiforme (red patches on the arms, legs and face with blisters on the lips and lining of the mouth), Stevens-Johnson syndrome (rash with blisters) and Toxic Epidermal Necrolysis (blisters covering large areas of the body, with peeling or burning of large amounts of skin).

Make especially sure that you tell your doctor if you have had these or any type of skin reaction before.

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

Before you start to take it

Before you start taking this medicine, tell your doctor if:

1. You have allergies, hypersensitivity, or intolerance to:

  • any other medicines including aspirin or other NSAID medicines
  • any other substances, such as foods, preservatives or dyes
  • lactose - this medicine contains lactose.

2. You have or have had any medical conditions, especially the following:

  • high blood pressure or fluid retention
  • diabetes
  • high cholesterol or other risk factors for heart disease
  • heartburn, indigestion, ulcers or other stomach problems such as bleeding from the digestive tract
  • kidney or liver disease
  • heart problems
  • a tendency to bleed
  • asthma or any other breathing problems

3. You are using an IUD (Intra-Uterine Device) for birth control.

4. You are pregnant or planning to become pregnant.

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

Like most NSAIDs, meloxicam is not recommended for use during the last 3 months of pregnancy.

If you are trying to become pregnant, tell your doctor you are taking this medicine. It is not recommended for women who are trying to conceive.

5. You are breast-feeding or planning to breast-feed.

This medicine must not be used whilst breast-feeding.

6. You have recently been vaccinated or plan to get a vaccination.

7. You are planning to have surgery.

8. You are currently receiving or are planning to receive dental treatment.

9. You are taking or are planning to take any other medicines.

This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.

Some medicines may interact with meloxicam. These include:

  • any other 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.
  • aspirin, salicylates or other NSAID medicines
  • medicines used to thin your blood (such as warfarin, heparin and ticlopidine)
  • medicines to treat depression such as lithium and selective serotonin reuptake inhibitors (SSRIs).
  • methotrexate, a medicine used to treat rheumatoid arthritis, psoriasis 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 (e.g. frusemide)
  • medicines used to treat high blood pressure
  • medicines used to treat heart problems (such as amiodarone or quinidine)
  • medicines taken by mouth 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). You should not stop taking corticosteroids suddenly.
  • some medicines used to treat fungal infections (such as fluconazole, ketoconazole, itraconazole)
  • some sulfur antibiotics (such as sulfaphenazole and sulfamethoxazole)
  • some antihistamines (medicines used for allergy, hay fever or insect stings) - e.g. astemizole, terfenadine.

If you are taking any of these you may need a different dose or you may need to take different medicines.

Other medicines not listed above may also interact with meloxicam.

How to take this medicine

Follow carefully all directions given to you by your doctor or pharmacist. Their instructions may be different to the information in this leaflet.

How much to take

Your doctor or pharmacist will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.

For the treatment of osteoarthritis:

The usual dose is 7.5 mg, taken as a single dose each day. Your doctor may increase this to 15 mg once each day if necessary.

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 7.5 mg 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.

Do not stop taking your medicine or change your dosage without first checking with your doctor.

How to take it

Swallow the tablets with some fluid.

When to take it

Take this medicine at the same time each day, either morning or evening. Taking it at the same time each day will have the best effect and will also help you remember when to take it.

Take this medicine immediately after food to avoid the chance of an upset stomach.

How long to take it for

Continue taking your medicine for as long as your doctor tells you.

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

Make sure you have enough to last over weekends and holidays.

Keep in touch with your doctor during this time.

If you forget to take it

If it is almost time for your next dose (e.g. within 2-3 hours), skip the missed dose 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 missed doses.

This may increase the chance of unwanted side effects.

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 (Tel: 13 11 26 in Australia) for advice. Alternatively 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.

If you take too much meloxicam, you may experience any or all of the following:

  • nausea and/or vomiting
  • headache
  • drowsiness
  • blurred vision
  • dizziness
  • fits or seizures
  • low blood pressure
  • difficulty in breathing
  • impaired consciousness, or coma
  • kidney failure

While you are taking this medicine

Things you must do

Tell your doctor that you are taking this medicine if:

  • you are about to be started on any new medicine
  • you plan to have any vaccinations or immunisations
  • you become pregnant or plan to become pregnant, or breast-feed (tell your doctor immediately)
  • you get an infection. 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.
  • you are about to have any blood tests
  • you are going to have surgery (including dental surgery). Meloxicam can affect blood clotting.

Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects. Go to your doctor regularly for a check-up.

Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.

Things you must not do

Do not:

  • give this medicine to anyone else, even if their symptoms seem similar to yours
  • take your medicine to treat any other condition unless your doctor or pharmacist tells you to
  • stop taking your medicine, or change the dosage, without first checking with your doctor.

Things to be careful of

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

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

Be careful when driving or operating machinery until you know how this medicine affects you.

Possible side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking meloxicam or if you have any questions or concerns.

Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.

Tell your doctor or pharmacist if you notice any of the following and they worry you.

This list includes the more common side effects. Mostly, these are mild:

  • stomach upset including nausea, vomiting, heartburn, indigestion, burping. wind, cramps or pain
  • headache, bruising
  • sore throat or discomfort when swallowing
  • 'flu'-like symptoms, including
  • coughing and/or fever or chills
  • constipation or diarrhoea
  • dizziness or light-headedness
  • mild skin rash or itching
  • falls or other accidents around the home or work
  • back pain, muscle spasms or pain, painful or swollen joints
  • clicking sound when joints move
  • trouble sleeping
  • 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
  • flushes, sweating
  • tinnitus (ringing in the ear)
  • giddiness
  • drowsiness
  • rhinitis - itching, stuffy or runny nose; sneezing
  • sinusitis, a condition causing a feeling of tension or fullness of the nose, cheeks and behind your eyes
  • laryngitis, a condition causing
  • hoarseness or loss of voice.

The above list includes the more common side effects. Mostly, these are mild.

Tell your doctor as soon as possible if you notice any of the following.

These may be serious side effects. You may need medical attention. Most of these side effects are rare.

  • blurred vision, problems with your vision or conjunctivitis
  • 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 (urinary tract infection)
  • cloudy urine and a decrease in the amount of urine passed (an effect on your kidneys called interstitial nephritis)
  • infections in your lungs, throat or nose
  • severe pain or tenderness in the stomach
  • fast or irregular heartbeats (also called palpitations)
  • yellowing of the skin and eyes (known as jaundice) with or without unusual tiredness or weakness
  • severe dizziness
  • swelling of your ankles, legs or other parts of your body
  • swollen or sore leg veins
  • signs of anaemia (such as tiredness, being short of breath and looking pale)
  • frequently occurring infections, or bruising easily
  • irritation of your mucous membranes (e.g. sore lips, mouth, eyes or genitals)
  • altered mood, confusion, disorientation.

If you experience any of the following, stop taking your medicine and contact your doctor immediately or go to the Accident and Emergency department at your nearest hospital.

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

  • vomiting of blood or material that looks like coffee grounds
  • bleeding from your back passage (rectum), black sticky motions (stools) or bloody diarrhoea
  • weakness in one part or side of your body, slurred speech or visual disturbances
  • unable to pass urine
  • collapse or fainting, shortness of breath or tiredness and/or chest pain.

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

Allergic reactions

If you think you are having an allergic reaction to meloxicam, stop taking this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.

Symptoms of an allergic reaction may include some or all of the following:

  • cough, shortness of breath, wheezing or difficulty breathing and/or stuffy nose and/or nasal polyps
  • swelling of the face, lips, tongue, throat or other parts of the body
  • sudden or severe rash, itching or hives on the skin
  • fainting
  • hay fever-like symptoms

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

After taking this medicine

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, 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 or pharmacist tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.

Product description

What APO-Meloxicam looks like

APO-Meloxicam 7.5 mg tablets

Pastel yellow, round, biconvex tablets. Engraved "APO" on one side and "7.5" on the other side.

Blister packs of 30 tablets

APO-Meloxicam 15 mg tablets

Pastel yellow, round, flat-faced, bevelled-edge tablets. Scored and engraved "MEL" over "15" on one side, "APO" on the other side.

Blister packs of 30 tablets

Ingredients

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

It also contains the following inactive ingredients:

  • lactose
  • microcrystalline cellulose
  • sodium bicarbonate
  • croscarmellose sodium
  • magnesium stearate
  • colloidal anhydrous silica.

Australian Registration Numbers

APO-Meloxicam 7.5mg tablets

Blister packs

AUST R 127503.

APO-Meloxicam 15mg tablets

Blister packs

AUST R 127510.