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PACKAGE LEAFLET: INFORMATION FOR THE USER

MELOXICAM 7.5 mg TABLETS MELOXICAM 15 mg TABLETS

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 Tablets are and what they are used for

2.    What you need to know before you take Meloxicam Tablets

3.    How to take Meloxicam Tablets

4.    Possible side effects

5.    How to store Meloxicam Tablets

6.    Contents of the pack and other information

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

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

Meloxicam Tablets have been approved for:

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

•    the long-term symptomatic treatment of pain in connection with rheumatoid arthritis

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

2.    What you need to know before you take Meloxicam Tablets

Do not take Meloxicam Tablets:

•    during the last trimester of pregnancy

•    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). You must not use Meloxicam Tablets if you have previously had symptoms of asthma, nasal polyps, swelling in the skin or mucous membranes (oedema) or hives (urticaria) following treatment with acetylsalicyclic acid or other anti-inflammatory medicines

•    if you have, or have had recurrent stomach or gut ulcers or oesphagitis (inflammation of the gullet), gastritis (inflammation of the stomach)

•    if you have bleeding disorder or have ever suffered from bleeding in the stomach or bowel (gastrointestinal bleeding), or bleeding in the brain (cerebrovascular bleeding)

•    if you have severe liver problems

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

•    if you suffer from severe heart failure.

Take special care with Meloxicam Tablets:

•    if you have previously had inflammation of the oesophagus (oesophagitis); inflammation of the stomach lining (gastritis) and/or stomach ulcers

•    if you have a history of problems with your stomach or gut (such as Crohn's disease or ulcerative colitis)

•    if you are elderly (because of increased side effects)

•    if you have recently undergone major surgery

•    if you have liver, kidney or heart problems

•    if you are suffering from or have a history of asthma

•    if you have an IUD (intra-uterine device e.g. coil) fitted for contraception; the coil may not be as effective

•    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 Tablets

•    if you are trying to become pregnant or undergoing investigations of fertility

•    if you suffer from an infectious disease, this medicinal product may mask symptoms.

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 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 a high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.

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

The following medicines can affect or be affected by Meloxicam Tablets:

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

•    Other non-steroidal anti-inflammatory drugs (NSAIDs) 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 (an immunosuppressant)

•    Diuretics (water tablets)

•    Medicines to treat high blood pressure such as atenolol and enalapril

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

•    Selective serotonin-reuptake inhibitors (for depression)

•    Intrauterine contraceptive devices (contraceptive coils)

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

Meloxicam Tablets with food and drink

Meloxicam Tablets should be swallowed with water during a meal.

Pregnancy, breast-feeding and fertility

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 breast-feeding.

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

Meloxicam Tablets contain 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 pharmacist if you are not sure.

Your doctor will give you the lowest possible dose, for the shortest length of time, to treat your symptoms. If your condition does not get better or you suffer from any side effects, tell your doctor. Your doctor should monitor your condition and treatment.

Dosage

Treatment of osteoarthrosis: The recommended dose is

7.5    mg once daily. This may be increased by your doctor to 15 mg once daily if the effect is too weak.

Treatment of pain from rheumatoid arthritis and ankylosing spondylitis: The recommended dose is 15 mg once daily.

Your doctor may reduce your dose to 7.5 mg a day if your symptoms improve.

Never exceed a dose of 15 mg a day.

Kidney & liver impairment:

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

Patients with kidney or liver problems that are not severe can be given the doses as stated above. Meloxicam Tablets are not recommended for use for patients with severe kidney failure who are not receiving dialysis.

Elderly:

If you are elderly your doctor may recommend a lower dose. The recommended dose for treatment of rheumatoid arthritis and ankylosing spondylitis is

7.5    mg once daily.

Children:

Children under the age of 16 years should not take Meloxicam Tablets.

Method of administration

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

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 increased blood pressure, kidney failure, liver dysfunction, coma, heart problems, lethargy, drowsiness, feeling and being sick and stomach pains.

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 discussion with your doctor.

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

4. Possible side effects

Like all medicines, Meloxicam Tablets can cause side effects, although not everybody gets them.

The following side effects have been reported:

Common side effects (affecting fewer than 1 in 10 people):

•    Anaemia (looking pale and feeling abnormally tired)

•    Dizziness (light-headedness)

•    Headache

•    Indigestion

•    Nausea (feeling sick)

•    Vomiting

•    Stomach pain

•    Constipation

•    Wind

•    Diarrhoea

•    Intense itching

•    Rash

•    Swelling especially of the lower limbs.

Uncommon side effects (affecting fewer than 1 in 100 people):

•    Blood changes

•    Vertigo

•    Ringing in the ears

•    Drowsiness

•    Palpitations

•    Increased blood pressure

•    Feeling flushed

•    Blood in your faeces (stools)

•    Stomach ulcers

•    Inflammation of the oesophagus (food pipe) symptoms include heartburn and a difficulty swallowing

•    Sore mouth or mouth ulcers

•    Changes to kidney or liver function tests

Rare side effects (affecting fewer than 1 in

1.000    people):

•    Severe allergic reaction

•    Mood disorders

•    Difficulty sleeping (insomnia)

•    Nightmares

•    Feeling confused

•    Eyesight problems such as blurred vision

•    Asthma attacks

•    Pain due to tearing of the stomach or gut wall

•    Inflamed stomach or colon

•    Hepatitis (liver problems)

•    Severe skin reactions (such as rash, fever and blistering)

•    Skin sensitivity to light

•    Kidney failure.

•    Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see section 2).

Very rare side effects (affecting fewer than 1 in

10.000    people):

•    Itchy swollen skin

•    Red, itchy spots similar to measles

Not known side effects (frequency cannot be estimated from the available data):

•    Skin sensitivity to light

Stomach ulcers may occur. These may bleed into the gut (causing offensive, tar-coloured stools), rarely these ulcers may perforate causing a hole in the wall of the bowel.

These can occur at any time and are especially important in the elderly and very rarely have been fatal. If any of these symptoms occur you should contact your doctor immediately.

Rarely, serious allergic reactions such as anaphylactic shock can occur. Symptoms include swelling of the face, lips tongue and throat which can result in breathing difficulties. If you think you are having an allergic reaction or you feel unwell stop the treatment and seek medical advice immediately.

In rare cases, Meloxicam Tablets can affect the white blood cells which can weaken your defence against infection. If you contract an infection with symptoms such as fever, with rapid deterioration in general condition, or fever with local infection symptoms such as pain in the neck, throat, mouth or difficulty passing urine, you must contact your doctor immediately for a blood test to rule out a shortage of white blood cells (agranulocytosis).

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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Meloxicam Tablets

Keep out of the sight and reach of children.

Do not use Meloxicam Tablets after the expiry date which is stated on the blister and 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 tablet contains 7.5 mg or 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 looks like and contents of the pack

Meloxicam 7.5 mg Tablets: Pale yellow, round tablets with a score on one side.

Meloxicam 15 mg Tablets: Pale yellow, round tablets with a score on one side.

PVC/PVdC/Al blister 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

Mylan,

Station Close,

Potters Bar Hertfordshire EN6 1TL,

United Kingdom.

Manufacturer

Generics [UK] Ltd Station Close Potters Bar Hertfordshire EN6 1TL

United Kingdom

Gerard Laboratories Baldoyle Industrial Estate,

Grange Road,

Dublin 13 Ireland

Chanelle Medical Limited Loughrea, Co. Galway Ireland

Mylan Hungary Kft H-2900 Komarom Mylan utca 1 Hungary

This leaflet was last revised in January 2015    553531