PACKAGE LEAFLET: INFORMATION FOR THE USER

Meloxicam 7.5 mg Tablets Meloxicam 15 mg Tablets

Meloxicam

In this leaflet:

1.    What Meloxicam tablets are and what they are used for.

2.    What you need to know before you take Meloxicam

3.    How to take Meloxicam tablets.

4.    Possible side effects.

5.    How to store Meloxicam tablets.

6.    Contents of the pack and other information

What Meloxicam tablets are and what they are used for

Meloxicam belongs to the group of non-steroidal anti-inflammatory drugs (NSAID) used for the treatment of pain and to reduce inflammatory conditions in muscles and joints.

Meloxicam tablets have been approved for:

•    the short-term treatment of the symptoms of flare-ups of osteoarthrosis (joint disease where the cartilage is lost)

•    the long-term treatment of the symptoms of rheumatoid arthritis

•    the long-term treatment of the symptoms of a similar condition called ankylosing spondylitis (inflammation of the spine).

What you need to know before you take Meloxicam

Do not take Meloxicam tablets:

•    during the last trimester of pregnancy.

•    For children and adolescents aged under 16 years

•    if you are allergic (hypersensitive) to meloxicam or any of the other ingredients of Meloxicam tablets

•    if you are allergic to acetylsalicylic acid (e.g. aspirin) or other non-steroidal anti-inflammatory drugs (NSAID)

•    if you have, or have had, recurrent ulcer of the stomach or duodenum (small intestine)

•    if you have bleeding in the bowels, bleeding from vessels in the brain or other bleeding disorders

•    if you have severe liver problems

•    if you have severe kidney failure and you are not receiving dialysis

•    if you suffer from severe heart failure.

Take special care with Meloxicam tablets and talk to your doctor:

•    if you have a history of problems with your stomach or gut

•    if you are elderly

•    if you have recently undergone major surgery

•    if you have liver, kidney or heart problems

•    if you suffer from raised potassium levels in the blood

•    if you have a history of asthma

•    if you have an IUD (intra-uterine device e.g. coil) fitted for contraception

•    if you notice blood in your faeces (stools)

•    if you notice any skin reaction

•    if you have to take a blood or urine test, always mention that you are taking meloxicam

•    if you are trying to become pregnant or undergoing investigations of infertility as meloxicam can impair fertility

•    if you have a history of stomach or gut ulcer or inflammation.

Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.

If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.

Meloxicam, as with other non-steroidal anti-inflammatory drugs (NSAID) may mask the symptoms of an underlying infectious disease.

Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Meloxicam, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk.

Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).

These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin.

The highest risk for occurrence of serious skin reactions is within the first weeks of treatment.

If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Meloxicam, you must not be re-started on Meloxicam at any time.

If you develop a rash or these skin symptoms, stop taking Meloxicam, seek urgent advice from a doctor and tell him that you are taking this medicine.

Taking other medicines:

Tell your doctor if you are taking any of the following:

•    anticoagulants, to stop your blood clotting, such as warfarin, heparin and ticlopidine

•    other non-steroidal anti-inflammatory drugs (NSAID) such as aspirin

•    lithium (for mental illness)

•    methotrexate (for psoriasis and some cancers)

•    thrombolytics (for heart conditions to dissolve blood clots)

•    cholestyramine (for reducing cholesterol)

•    ciclosporin or tacrolimus (an immunosuppressant)

•    diuretics (water tablets)

•    medicines to treat high blood pressure.

•    corticosteroids (for asthma, inflammation and after organ transplant surgery).

•    Selective Serotonin Reuptake Inhibitors (SSRIs) - a class of compounds typically used as antidepressants in the treatment of depression, anxi disorders, and some personality disorders.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

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Taking Meloxicam tablets with food and drink

Meloxicam tablets should be swallowed whole with water during a meal.    $

Pregnancy and breast-feeding:

Ask your doctor before taking meloxicam during the first two trimesters of pregnancy. Because of an increased risk of complications for mother and child, do not take meloxicam during the last trimester of pregnancy.

The use of meloxicam is not recommended while breast-feeding. Ask your doctor before taking meloxicam if you are breastfeeding.

Driving and using machines:

Meloxicam tablets may cause side effects that may affect a person's ability to drive and use machinery. Examples of side effects include visual disturbances, drowsiness or dizziness. If you suffer from any of these side effects it is advisable to refrain from driving or using machinery.

Important information about some of the ingredients of Meloxicam tablets:

This drug contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3.    How to take Meloxicam tablets

Always take Meloxicam tablets exactly as your doctor has told you. You should check with your doctor or your pharmacist if you are not sure.

The recommended dose for the treatment of the symptoms of flare-ups of osteoarthrosis is 7.5 mg/day (one 7.5 mg tablet or half a 15 mg tablet). This may be increased by your doctor to 15 mg/day (two 7.5 mg tablets or one 15 mg tablet) if the effect is too weak.

The recommended dose for the treatment of the symptoms of rheumatoid arthritis and ankylosing spondylitis is 15 mg/day (two 7.5 mg tablets or one 15 mg tablet). This may be reduced to 7.5 mg/day (one 7.5 mg tablet or half a 15 mg tablet) depending on your response to treatment.

Never exceed a dose of 15 mg a day.

In dialysis patients with severe kidney failure, dosage should not exceed one tablet of 7.5 mg a day.

No dose reduction is required in patients with mild to moderate renal impairment (i.e. patients with a creatinine clearance of greater than 25 ml/min).

If you are elderly your doctor may recommend a lower dose. The recommended dose for long term treatment of rheumatoid arthritis and ankylosing spondylitis in elderly patients is 7.5 mg per day. Patients with increased risks for adverse reactions should start treatment with 7.5 mg per day. Children and adolescents under the age of 16 years should not take Meloxicam tablets.

No dose reduction is required in patients with mild to moderate hepatic impairement.

Take Meloxicam tablets orally as a single dose with water and together with a meal.

Meloxicam is not appropriate for the treatment of patients requiring relief from acute pain.

Duration of treatment:

Your doctor will advise you of the duration of treatment.

If you take more Meloxicam tablets than you should:

Contact your doctor or local emergency ward. Take this leaflet and any tablets you still have with you. Symptoms of overdose include feeling tired and drowsy, nausea, vomiting, stomach pain, gastrointestinal bleeding, high blood pressure, kidney failure, liver problems, breathing difficulties, coma, convulsions, heart problems and severe allergic reactions.

If you forget to take Meloxicam tablets:

If you forget to take a dose, take it as soon as you remember it unless it is nearly time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Meloxicam tablets:

Stopping your medicine before finishing the course of treatment may cause your pain or inflammation to get worse. It is important not to stop taking your medicine without prior discussion with your doctor.

If you have any further questions on the use of this product, ask you doctor or pharmacist.

Possible side effects

Like all medicines, Meloxicam tablets can cause side effects, although not everybody gets them. The following side effects have been reported:

Very common side effect (may affect more than 1 in 10 people) include: indigestion, feeling sick, vomiting, stomach and abdominal pain, constipation, wind, diarrhoea.

Common side effects (may affect up to 1 in 10 people) include: light-headedness, headache, and swelling especially of the lower limbs.

Uncommon side effects (may affect up to 1 in 100 people) include: blood changes, anaemia (looking pale and feeling abnormally tired), vertigo, drowsiness, somnolence, cardiac failure, increased blood pressure, feeling flushed, blood in your faeces (stools), ulcers of the stomach and small intestine, inflammation of the oesophagus (food pipe) symptoms include heartburn and a difficulty swallowing, sore mouth or mouth ulcers, erucation, changes to kidney or liver function tests, itchy swollen skin, sodium and water retention and increased levels of potassium in the blood, allergic reactions, rash and pruritus.

Rare side effects (may affect up to 1 in 1,000 people) include: severe allergic reaction, mood disorders, difficulty sleeping, nightmares, feeling confused, palpitations (abnormal heart beat) eyesight problems such as blurred vision, asthma attacks, pain due to tearing of the stomach or gut wall, inflamed stomach or colon, ringing in the ears, severe skin reactions (such as rash, fever and blistering).,

Very rare side effect (may affect up to 1 in 10,000 people) include: hepatitis (liver problems), gastrointestinal perforation, acute reneal failure in particular in patients with risk factors

Not known (frequency cannot be estimated from the available data): skin sensitivity to light and confusional state and disorientation.

Seek immediate medical advice if symptoms of anaphylactic reactions (for example swelling of the face and lips or difficulty in breathing) or serious skin reactions occur.

Meloxicam may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis). It is important to inform your doctor about your medicine.

Medicines such as meloxicam may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    How to store Meloxicam tablets

Keep out of the reach and sight of children.

Do not use Meloxicam tablets after the expiry date which is stated on the blister and the carton. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    Contents of the pack and other information

What Meloxicam tablets contain:

The active substance is meloxicam. Each 7.5 mg tablet contains meloxicam 7.5 mg. Each 15 mg tablet contains meloxicam 15 mg.

The other ingredients are microcrystalline cellulose, pregelatinised maize starch, lactose monohydrate, maize starch, sodium citrate, colloidal anhydrous silica and magnesium stearate.

What Meloxicam tablets look like and contents of the pack:

Meloxicam tablets are pale yellow, round tablets with a score on one side. They come in packs of 7, 10, 14, 15, 20, 28, 30, 50, 60, 100, 140, 280, 300, 500 or 1000 tablets (not all pack sizes may be marketed).

Marketing Authorisation Holder and Manufacturer:

The marketing authorisation holder is Chanelle Medical, Loughrea, Co. Galway, Ireland. The manufacturer is Chanelle Medical, Loughrea, Co. Galway, Ireland.

This medicinal product is authorised in the Member States of the EEA under the following names:

Denmark    Meloxicam Chanelle Medical Tabletter 7,5 mg & 15 mg

Finland    Meloxicam Orion 7.5 mg & 15 mg Tabletti

Ireland    Meloxicam Chanelle Medical 7.5 mg & 15 mg Tablets

Portugal    Meloxicam Pharmakern 7,5 mg & 15 mg Comprimidos

This leaflet was last approved in: 11/2012.