MOXICAM CAPSULES

contains the active ingredient meloxicam


Consumer Medicine Information

What is in this leaflet

Read this leaflet carefully before taking your medicine. This leaflet answers some common questions about meloxicam. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

This leaflet was last updated on the date at the end of this leaflet. More recent information may be available. The latest Consumer Medicine Information is available from your pharmacist or doctor and may contain important information about the medicine and its use of which you should be aware.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you.

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

Pharmaceutical companies cannot give you medical advice or an individual diagnosis.

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

What Meloxicam Capsules is used for

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

It is used to treat the symptoms of

  • Osteoarthritis
  • rheumatoid arthritis

Both diseases mainly affect the joints causing pain and swelling.

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

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.

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.

Before you take Meloxicam Capsules

When you must not take it

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

  • any medicine containing meloxicam
  • any of the ingredients listed at the end of this leaflet
  • 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 meloxicam if:

  • you are about to undergo a 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 have a galactose intolerance
  • you have a peptic (stomach) ulcer
  • you have or have had inflammation of the lining of the stomach or bowel (e.g. Crohn's Disease or Ulcerative Colitis)
  • you have severe liver or kidney problems
  • you are currently taking the following medicines: fluconazole (used to treat fungal infections) or certain sulfur antibiotics (e.g. sulfamethoxazole).

Do not breast-feed if you are taking this medicine. The active ingredient in meloxicam 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, planning to become pregnant or are using an IUD for birth control. Your doctor can discuss with you the risks and benefits involved.

Tell your doctor if you currently have an infection. Meloxicam 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 or pharmacist about any of the above, tell them before you start taking meloxicam.

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 may interfere with each other. These include:

  • aspirin, salicylates or other NSAIDs
  • medicines used to thin your blood (e.g. 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 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
  • medicines 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 rashes and asthma
  • some medicines used to treat infections (e.g. erythromycin, sulfur antibiotics, ketoconazole, itraconazole)
  • some medicines used to treat irregular heart beats (e.g. amiodarone and quinidine)
  • pemetrexed, a medicine used in the treatment of certain lung cancers.

These medicines may be affected by meloxicam or may affect how well it works. You may need different amounts of your medicines, or you may need 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 Capsules

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 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 is 15 mg 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 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 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

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 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 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)

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 (telephone 13 11 26 in Australia) for advice, or 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.

Symptoms of an overdose 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 Meloxicam Capsules

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. 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. Meloxicam 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, tell your doctor. 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.

Things you must not do

Do not take your medicine to treat any other condition 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 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.

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 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)
  • any pain or difficulty experienced when urinating
  • collapse or fainting, shortness of breath or tiredness, fast or irregular heartbeat, chest pain, swollen or sore leg veins
  • severe dizziness
  • severe pain or tenderness in the stomach
  • flaking of the skin
  • 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 you experience any of the following, stop taking meloxicam and contact your doctor immediately or go to the Accident and Emergency department 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.

After taking Meloxicam Capsules

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 in direct sunlight.

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 this medicine 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 they have passed their expiry date, your pharmacist can dispose of the remaining medicine safely.

Product description

What Moxicam 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.

Ingredients

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

In addition, each capsule also contains the following inactive ingredients:

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

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

Australian Registration Numbers

Moxicam 7.5 mg capsules (blister pack): AUST R 232584.

Moxicam 15 mg capsules (blister pack): AUST R 232585.

Sponsor

Alphapharm Pty Limited
(ABN 93 002 359 739)
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: (02) 9298 3999
www.mylan.com.au

This leaflet was prepared onMarch 2017.

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Published by MIMS September 2017