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PATIENT INFORMATION LEAFLET

MELOXICAM 7.5mg AND 15mg 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 further questions, please ask your doctor or your pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms 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

The name of your medicine is Meloxicam Tablets.

Meloxicam Tablets belong to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to reduce inflammation and pain in the joints and muscles. Meloxicam Tablets are for the short-term treatment of acute attacks of osteoarthritis and for the long-term treatment of pain and stiffness in joints (rheumatoid arthritis) or backbone (ankylosing spondylitis).

Do not take Meloxicam Tablets:

•    if you are allergic to meloxicam or to any of the other ingredients listed in section 6, Contents of the pack and other information.

•    if you are allergic (hypersensitive) to aspirin or other non-steroidal anti-inflammatory medicines (NSAIDs)

•    if you have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation

•    if you suffer from severe heart problems

•    if you have severe liver problems

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

•    if you have suffered gastrointestinal bleeding (bleeding in the stomach or gut) after taking NSAIDs

•    if you have suffered cerebrovascular bleeding (bleeding in the brain) or any other bleeding disorder

•    if you are in the last trimester of pregnancy

•    if you are under 16 years of age

Before you use Meloxicam Tablets tell your doctor:

•    if you use other non-steroidal anti-inflammatory medicines (NSAIDs)

•    if you use any medication which may increase the risk of bleeding or ulcers in the stomach, e.g. warfarin, anti-platelet medicines

•    if you have a history of gastrointestinal disease e.g. inflammation of the stomach (gastritis) or gullet (oesophagitis), ulcer, ulcerative colitis,

Crohn’s disease - combination therapy with a protective medicine (e.g. proton pump inhibitor or misoprostol) may be suitable for you

•    if you are elderly

•    if you have high blood pressure or heart problems

•    if you have any liver or kidney problems

•    if you have or have had bronchial asthma

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

•    if you suffer from lupus (an auto-immune disorder)

•    if you have hypovolaemia (reduced blood volume) which may occur after serious blood loss or low fluid intake

•    if you have ever been diagnosed with high potassium levels in the blood -can happen with diabetes and can be caused by certain medicines

•    if you have been told by your doctor that you have an intolerance to some sugars as this product contains lactose

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 or duration of treatment.

Talk to your doctor or pharmacist before taking Meloxicam 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).

Taking other medicines

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

•    Other non-steroidal anti-inflammatory drugs (NSAIDs) e.g. aspirin, ibuprofen or naproxen

•    Medicines which prevent blood clotting such as warfarin and streptokinase

•    Corticosteroids (e.g. hydrocortisone, used to treat psoriasis)

•    Certain medicines used to treat depression (SSRIs e.g. citalopram)

•    Medicines used to treat high blood pressure and heart problems, e.g. digoxin, ramipril, losartan, oxprenolol, furosemide

•    Calcineurin inhibitors (e.g. Ciclosporin and Tacrolimus) used to treat some types of cancer, psoriasis or prevent organ rejection after transplant or for severe skin conditions, rheumatoid arthritis or nephrotic syndrome

•    Intra-uterine contraceptive device (IUD), commonly called the coil

•    Lithium, used to treat depression

•    Methrotrexate, used to treat some types of cancer, or psoriasis or rheumatoid arthritis

•    Cholestyramine, used to reduce cholesterol

•    Tacrolimus, used to prevent organ rejection after transplant

Tell your doctor about any other medicines you are taking even those obtained without a prescription.

Pregnancy and breast-feeding

This product should not be used during pregnancy. If you are planning to become pregnant or if you think/know you are pregnant, you should talk to your doctor for advice.

Meloxicam may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Meloxicam should not be given to breast-feeding mothers.

Driving and using machines

These tablets may make you feel dizzy or drowsy and may cause blurred vision. If they affect you in this way, DO NOT drive or operate machinery.

Important information about some of the ingredients of your medicine

These tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

For oral administration, to be taken with or after food. Follow your doctor’s instructions about when and how to take your medicine and always read the label.

The tablets should be swallowed with water or another liquid, during a meal. If you need to take two tablets they must be taken together as a single dose.

Adults and adolescents (over the age of 16)

Acute attacks of osteoarthritis

The usual dose is 7.5mg a day. Your doctor may increase your dose to 15mg a day if necessary.

Pain and stiffness in joints (rheumatoid arthritis) or backbone (ankylosing spondylitis)

The usual dose is 15mg a day. Your doctor may reduce your dose to 7.5mg a day if necessary.

Elderly patients

Elderly patients are at an increased risk of side effects.

The lowest effective dose should be used for the shortest possible time.

The recommended dose for long-term treatment of pain or stiffness in joints and backbone in the elderly is 7.5mg a day.

Patients with kidney impairment

Meloxicam Tablets are not recommended for use in patients with severe kidney problems who are not receiving dialysis.

The maximum recommended dose for treatment in dialysis patients with severe kidney failure is 7.5mg a day.

Patients with mild to moderate kidney problems should use the normal dose.

Patients with liver impairment

Meloxicam Tablets are not recommended for use in patients with severe liver problems.

The maximum recommended dose for treatment in patients with less severe liver problems is 7.5mg a day.

Patients with mild to moderate liver problems should use the normal dose.

DO NOT exceed the recommended maximum dose of 15mg daily.

If after several days taking meloxicam you feel no improvement talk to your doctor.

Infants and children

Meloxicam tablets should NOT be used in children under the age of 16.

If you take more Meloxicam than you should

If you take more tablets than you should, tell your doctor immediately or go to the nearest hospital. Bring this leaflet or the carton pack with you.

Symptoms of overdose include lack of energy, drowsiness, nausea, vomiting and stomach pain.

If you forget to take Meloxicam

Take your tablets as soon as you remember. If it is almost time for your next dose, wait until that time and continue as normal. Do not take a double dose to make up for the forgotten dose.

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

If you suffer from any of the following at any time during your treatment STOP TAKING the medicine immediately and seek urgent medical advice.

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

•    Fainting, shortness of breath, skin reactions, itching (pruritus) and asthma attacks

•    Severe blistering or peeling of the skin (SJS (Stevens-Johnson Syndrome) and TENs (Toxic Epidermal Necrolysis)), soft tissue lesions or erythma multiforme (serious allergic reaction causing red or purple welts, blistered areas, spots). It can also affect the mouth, eyes, and other moist surfaces on the body.

•    Swelling around the eyes, lips, mouth, throat and face

•    Swollen legs or ankles

•    Liver inflammation (hepatitis). Symptoms include yellowing of the skin or eyeballs (jaundice), pain in the abdomen, loss of appetite.

Any side effects of the digestive tract

•    Passing blood in your faeces

•    Vomiting any blood or dark particles that look like coffee grounds •Abdominal pain

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

If you experience any of these other following side effects, tell your doctor.

Very Common: may affect more than 1 in 10 people

•    Indigestion

•    Nausea and vomiting

•    Constipation

•    Flatulence (wind)

•    Diarrhoea

Common: may affect up to 1 in 10 people

•    Fleadache

Uncommon: may affect up to 1 in 100 people

•    Black tarry stools, stomach/intestinal ulcers

•    Dizziness

•    Spinning (vertigo)

•    Drowsiness

•    Anaemia (symptoms may include tiredness and shortness of breath)

•    Hypertension (an increase in blood pressure)

•    Temporary redness of the face and neck (flushing)

•    Water or sodium retention

•    Increased potassium levels (hyperkalaemia). This can lead to symptoms such as changes to heartbeat, palpitations & muscle weakness

•    Stomatitis (inflammation of the mouth)

•    Gastritis (inflammation of the stomach)

•    Belching

•    Disturbance of liver function tests or laboratory tests to measure kidney function

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

•    Mood disorders

•    Nightmares

•Abnormal blood count including abnormal differential blood count, deceased number of white blood cells (leucocytopenia), and decreased number of blood platelets (thrombocytopenia). These side effects may lead to an increased risk of infection and symptoms such as bruising or nose bleeds.

•    Colitis (inflammation of the large bowel) and Crohn’s disease

•    Blurred vision

•    Oesophagitis (inflammation of the gullet)

•    Conjunctivitis

•    Urticaria, Severe cutaneous adverse reactions (SCARs)

•    Ringing in the ears (tinnitus)

•    Palpitations and cardiac failure have been reported in association with NSAID treatment

Very rare: may affect up to 1 in 10,000 people

•    Complete loss of specific types of white blood cells (agranulocytosis). Symptoms can include: sudden fever, sore throat & infections.

•Acute failure of the kidneys (may be noticed by problems passing urine or blood in the urine)

•    Pancreatitis (may be manifested by severe sudden upper abdominal pain)

Not Known: frequency cannot be estimated from the available data

•    Anaphylactic/anaphylactoid reactions - shortness of breath and skin reactions

•    Rashes caused by exposure to sunlight (photosensitivity reactions)

•    Confusion

•    Disorientation

•    Heart failure

Side effects caused by non-steroidal anti-inflammatory medicines (NSAID’s), but not yet seen after taking Meloxicam tablets.

Changes to the kidney structure resulting in acute kidney failure:

•    Protein in the urine

•    Very rare cases of kidney inflammation

•    Death of some of the cells within the kidney

If any side effects get serious, or if you notice any side effects not listed in the 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.

KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not use this medicine after the expiry date which is stated on the packaging.

Store in the original package below 25°C. Do not refrigerate or freeze.

What Meloxicam Tablets contain

-    The active substance is meloxicam

-    The other ingredients are sodium citrate dihydrate, lactose monohydrate, microcrystalline cellulose, povidone, crospovidone, colloidal anhydrous silica and magnesium stearate.

What Meloxicam Tablets looks like and contents of the pack

Meloxicam Tablets are light yellow, round, flat tablets, scored on one side. Each Meloxicam 7.5mg Tablet contains 7.5mg meloxicam as the active ingredient. Each Meloxicam 15mg Tablet contains 15mg meloxicam as the active ingredient.

Meloxicam Tablets are supplied in packs of 30 tablets.

Marketing Authorisation Holder

Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland. Company responsible for Batch release

Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent, TN24 0GR, U.K.

Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K. Distributor

Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.

PL 30464/0103 and PL 30464/0104

This leaflet was last revised in October 2015.

CP.MEL.JNT.T.SH.V1P1