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MELOXICAM 7.5 mg TABLETS MELOXICAM 15 mg TABLETS

Meloxicam

PACKAGE LEAFLET: INFORMATION FORTHE USER

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET:

1.    What Meloxicam is and what it is used for

2.    What you need to know before you take Meloxicam

__ 3. How to take Meloxicam

4.    Possible side effects

5.    How to store Meloxicam

6.    Contents of the pack and other information

OWHAT MELOXICAM IS AND WHAT IT IS USED FOR

Meloxicam belongs to a group of drugs called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), which are used to reduce inflammation and pain in the joints and muscles.

Meloxicam is used for:

•    Short-term treatment of the symptoms of osteoarthritis (excessive wear on joints) when this condition flares up

•    Long-term treatment of the symptoms of rheumatoid arthritis

•    Long-term treatment of the symptoms of ankylosing spondylitis (inflammation of the joints between the spine and pelvis).

WHAT YOU NEED TO KNOW BEFORE YOU TAKE MELOXICAM

Do not take Meloxicam

Do not take meloxicam in the following circumstances:

•    allergy (hypersensitivity) to meloxicam or to any of the other ingredients of this medicine (listed in section 6)

•    allergy (hypersensitivity) to aspirin or other anti-inflammatory medicines (NSAIDs)

•    any of the following signs after taking aspirin or other NSAIDs:

•    wheezing, chest tightness, breathlessness (asthma)

•    nasal blockage due to swellings in the lining in your nose (nasal polyps)

•    skin rashes/nettle rash (urticaria)

•    sudden skin or mucosal swelling, such as swelling around the eyes, face, lips, mouth or throat, possibly making breathing difficult (angioneurotic oedema)

•    after previous therapy with NSAIDs and a history of:

•    bleeding in your stomach or intestines

•    holes (perforations) in your stomach or intestines

•    ulcers or bleeding in your stomach or intestines

•    recent or history of stomach or intestinal ulcers or bleeding (ulceration or bleeding occurring at least twice)

•    severely impaired liver function

•    non-dialysed severe kidney failure

•    recent bleeding in the brain (cerebrovascular bleeding)

•    any kind of bleeding disorders

•    severe heart failure

•    during the last three months of pregnancy

•    if you are breast-feeding

•    children and adolescents under 16 years of age.

Warnings and precautions

Medicines such as Meloxicam may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose. Do not take Meloxicam for longer than it is prescribed for you (see section 3 "How to take Meloxicam").

If you have heart problems, previous stroke or think that you might be at risk of these conditions, you should discuss your treatment with your doctor or pharmacist. For example if you:

•    have high blood pressure (hypertension)

•    have high levels of sugar in the blood (diabetes mellitus)

•    have high levels of cholesterol in the blood (hypercholesterolemia)

•    are a smoker.

Meloxicam is not appropriate if you require immediate relief from acute pain.

NSAIDs including meloxicam may mask the symptoms (e.g. fever) of an underlying infection. If you develop signs of infection, or if the symptoms worsen, you should contact your doctor.

If you are a woman, meloxicam may make it more difficult to conceive. Tell your doctor if you are planning to become pregnant or are having problems conceiving. You should not take meloxicam if you are undergoing fertility treatment.

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 month 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.

Your doctor may want to monitor your liver and kidneys during your treatment with meloxicam, in order to make sure they are working properly.

As it will be necessary to adjust the treatment, it is important to ask for your doctor's advice before you take meloxicam in the following cases:

•    history of inflammation of the gullet (oesophagitis), inflammation of the stomach (gastritis) or any other disease of the digestive tract, e.g. ulcerative colitis, Crohn's disease

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^ POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Meloxicam and consult a doctor or your nearest hospital immediately if you notice:

Any allergic (hypersensitivity) reactions, which may appear in the form of:

•    skin reactions, such as itching (pruritus), blistering or peeling of the skin, which can be severe (Steven-Johnson Syndrome and toxic epidermal necrolysis), lesions of soft tissues (mucosal lesions) or erythema multiforme.

Erythema multiforme is a serious allergic reaction causing spots, red welts or purple or blistered areas. It can also affect the mouth, eyes and other moist body surfaces

•    swelling of skin or mucosa, such as swelling around the eyes, face and lips, mouth or throat, possibly making breathing difficult, swollen ankles or legs (oedema of the lower limbs)

•    shortness of breath or asthma attack

•    inflammation of the liver (hepatitis). This can cause symptoms such as:

•    yellowing of the skin or the eyeballs (jaundice)

•    pain in the abdomen

•    loss of appetite.

Any side effects of the digestive tract, especially:

•    bleeding (causing tar-coloured stools)

•    ulceration of your digestive tract (causing abdominal pain).

Bleeding of the digestive tract (gastrointestinal bleeding), formation of ulcers or formation of a hole in the digestive tract (perforation) may sometimes be severe and potentially fatal, especially in elderly.

If you have previously suffered from any symptoms of the digestive tract due to long term use of NSAIDs, seek medical advice immediately, especially if you are elderly. Your doctor may monitor your progress whilst on treatment.

If affected by visual disturbances do not drive or operate machinery.

General side effects of non-steroidal anti-inflammatory medicines (NSAIDs)

The use of some non-steroidal anti-inflammatory drugs (NSAIDs) may be associated with a small increased risk of occlusion of arterial vessels (arterial thrombotic events), e.g. heart attack (myocardial infarction) or stroke (apoplexy), particularly at high doses and in long term treatment.

Fluid retention (oedema), high blood pressure (hypertension) and heart failure (cardiac failure) have been reported in association with NSAID treatment.

The most commonly-observed side effects affect the digestive tract (gastrointestinal events):

•    ulcers of the stomach and upper part of the small bowels (peptic/gastroduodenal ulcers)

•    a hole in the wall of the bowels (perforation) or bleeding of the digestive tract (sometimes fatal, particularly in the elderly).

The following side effects have been reported after NSAID administration:

•    feeling sick (nausea) and being sick (vomiting)

•    loose stools (diarrhoea)

•    flatulence

•    constipation

•    indigestion (dyspepsia)

•    abdominal pain

•    tar-coloured stool due to bleeding in the digestive tract (maleana)

•    vomiting of blood (haematemesis)

•    inflammation with building of ulcers in the mouth (ulcerative stomatitis)

•    worsening of inflammation of the large bowels (exacerbation of colitis)

•    worsening of inflammation of the digestive tract (exacerbation of Crohn's disease).

Less frequently, inflammation of the stomach (gastritis) has been observed.

Side effects of meloxicam

Very common (may affect more than 1 in 10 people):

•    indigestion (dyspepsia)

•    feeling sick (nausea) or being sick (vomiting)

•    abdominal pain

•    constipation

•    flatulence

•    loose stools (diarrhoea).

Common (may affect 1 to 10 in 100 people):

•    headache.

Uncommon (may affect up to 1 in 100 people):

•    dizziness (light-headedness)

•    a feeling of dizziness of spinning (vertigo)

•    somnolence (drowsiness)

•    anaemia (reduction of the concentration of the red blood pigment haemoglobin)

•    increase in blood pressure (hypertension)

•    flushing (temporary redness of the face and neck)

•    sodium and water retention

•    increased potassium levels (hyperkalaemia). This can lead to symptoms such as:

•    changes in your heartbeat (arrythmias)

•    palpitations (when you feel your heartbeat more than usual)

•    muscle weakness

•    eructation

•    inflammation of the stomach (gastritis)

•    bleeding of the digestive tract

•    inflammation of the mouth (stomatitis)

•    immediate allergic (hypersensitivity) reactions

•    itching (pruritus)

•    skin rash

•    swelling caused by fluid retention (oedema), including swollen ankles/legs (oedema of the lower limbs)

•    sudden skin or mucosal swelling, such as swelling around the eyes, face, lips, mouth or throat, possibly making breathing difficult (angioneurotic oedema)

•    momentary disturbance of liver function tests (e.g. raised liver enzymes like transaminases or an increase of the bile pigment bilirubin). Your doctor can detect these using a blood test

•    Disturbance of laboratory tests investigating kidney (renal) function (e.g. raised creatinine or urea).

Rare (may affect up to 1 in 1,000 people):

•    mood disorders

•    nightmares

•    abnormal blood count, including:

•    abnormal differential blood count

•    decreased number of white blood cells (leucocytopenia)

•    decreased number of blood platelets (thrombocytopenia)

These effects may lead to increased risk of infection and symptoms such as bruising or nosebleeds.

•    ringing in the ears (tinnitus)