Chemmart Meloxicam

CHEMMART MELOXICAM TABLETS

Contains the active ingredient, meloxicam

Consumer Medicine Information

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.

The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available.

Ask your doctor or pharmacist:

if there is anything you do not understand in this leaflet,

if you are worried about taking your medicine, or

to obtain the most up-to-date information

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

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

Keep this leaflet with your medicine. You may want to read it again.

The name of your medicine is Chemmart Meloxicam. 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 symptoms such as pain and inflammation, it will not cure your condition.

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.

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.

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

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

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

Do not take this medicine 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 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)

You are breastfeeding or intend to breastfeed

Meloxicam may pass into breast milk and affect your baby.

You have had any of the following symptoms after taking aspirin or other NSAIDS: asthma, nasal polyps, swollen face or urticaria

You are hypersensitive to, or have had an allergic reaction to, meloxicam, aspirin or any other NSAID, or any of the ingredients listed at the end of this leaflet. This includes rare inherited conditions of galactose intolerance. These tablets contain lactose

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.

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.

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

1.You have allergies to:

any other medicines including aspirin or other NSAID medicines

lactose – this medicine contains lactose

any other substances, such as foods, preservatives or dyes.

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

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. Do not take this medicine whilst pregnant until you and your doctor have discussed the risks and benefits involved.

5.You are planning to have surgery.

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

7.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)

lithium, a medicine used to treat some types of mood disorders

antidepressants called 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

pemetrexed, used to treat lung cancer

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 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 (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. 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.

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

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.

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

Swallow the tablets with some fluid.

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

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.

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

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

If it is almost time for your next dose, 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 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

Tell your doctor that you are taking this medicine if:

you are about to be started on any new medicine

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.

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.

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

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:

stomach upset including nausea, vomiting, heartburn, indigestion, burping. wind, cramps or pain

headache

sore throat or discomfort when swallowing

‘flu’-like symptoms, including

coughing and/or fever or chills

constipation or diarrhoea

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

increase in blood pressure

tinnitus (ringing in the ear).

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

These may be serious side effects and you may need medical attention

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 pain or tenderness in the stomach

yellowing of the skin and eyes (known as jaundice)

severe dizziness

swelling of your ankles, legs or other parts of your body

signs of anaemia (such as tiredness, being short of breath and looking pale).

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. 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

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

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

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

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.

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

Chemmart 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

Chemmart 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

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.

Chemmart Meloxicam 7.5mg tablets

Blister packs

AUST R 127502.

Chemmart Meloxicam 15mg tablets

Blister packs

AUST R 127507.

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie ParkNSW 2113

This leaflet was last updated in April 2015.