Meloxicam Sandoz®

meloxicam capsules


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 risks of you taking Meloxicam Sandoz against the benefits they expect it will 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 this medicine is used for

The name of your medicine is Meloxicam Sandoz. It contains the active ingredient meloxicam.

It is used to treat the symptoms of

  • osteoarthritis
  • rheumatoid arthritis.

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

Meloxicam Sandoz 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.

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

There is no evidence that this medicine is addictive.

Before you take this medicine

When you must not take it

Do not take Meloxicam Sandoz if you have an allergy to:

  • any medicine containing meloxicam
  • any of the ingredients listed at the end of this leaflet
  • any other similar medicines (such as 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 this medicine if you:

  • are about to undergo a coronary artery bypass graft surgery
  • have a disease of the heart with shortness of breath, and swelling of the feet or lips due to fluid build-up
  • experience bleeding from the stomach, gut or any other bleeding
  • had a stroke resulting from a bleed in the brain or have a bleeding disorder
  • have a galactose intolerance
  • have a peptic (stomach) ulcer
  • have or have had inflammation of the lining of the stomach or bowel (e.g. Crohn’s Disease or Ulcerative Colitis)
  • have severe liver or kidney problems
  • are currently taking the following medicines: fluconazole (used to treat fungal infections) or certain sulfur antibiotics (e.g. sulfamethoxazole).

Do not take this medicine if you are pregnant. It may affect your developing baby if you take it during pregnancy.

Do not breast-feed 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 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 or intend to become pregnant. Like most NSAID medicines, Meloxicam Sandoz is not recommended for use during pregnancy. If there is a need to consider Meloxicam Sandoz during your pregnancy, your doctor will discuss with you the benefits and risks of using it.

Tell your doctor if you are using an IUD (intrauterine device) for birth control. NSAID medicines, like Meloxicam Sandoz, may decrease the effectiveness of IUDs.

Tell your doctor if you currently have an infection. Meloxicam Sandoz 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 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 your 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)
  • 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 (a painful joint disease) and some types of cancer
  • ciclosporin, 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 used 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 (e.g. erythromycin, sulfur antibiotics, ketoconazole, itraconazole)
  • some medicines used to treat irregular heartbeats (e.g. amiodarone and quinidine)
  • 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 this medicine

Follow carefully all directions given to you by your doctor or pharmacist. They may differ from the information in this leaflet.

How much to take

For the treatment of osteoarthritis
The usual dose of Meloxicam Sandoz 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 Sandoz 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 Sandoz 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 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 for

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 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 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)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) 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 with meloxicam 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 this medicine

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, tell the surgeon or anaesthetist 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.

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

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.

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 Sandoz 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 Sandoz.

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 Sandoz 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) or 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 dizziness
  • severe pain or tenderness in the stomach
  • 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 any of the following happen, 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.

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.

Storage and disposal

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 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 or pharmacist 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 Meloxicam Sandoz 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.

Not all strengths/presentations may be available.

Ingredients

Active ingredients:

Meloxicam Sandoz 7.5 mg – 7.5 mg meloxicam

Meloxicam Sandoz 15 mg – 15 mg meloxicam.

Inactive ingredients:

  • lactose monohydrate
  • maize starch
  • sodium citrate dihydrate
  • magnesium stearate
  • Brilliant Blue FCF
  • Sunset Yellow FCF
  • gelatin
  • titanium dioxide
  • quinoline yellow (15 mg strength only)

This medicine contains sugar (as lactose) and sulphites. 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.

Supplier

Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road,
Macquarie Park, NSW 2113,
Australia
Tel: 1800 726 369

This leaflet was revised in 22 February 2019.

Australian Register Numbers

Meloxicam Sandoz 7.5 mg capsules: AUST R 199661 (blisters).

Meloxicam Sandoz 15 mg capsules: AUST R 199662 (blisters).

Published by MIMS April 2019