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PACKAGE LEAFLET: INFORMATION FOR THE USER

Nabumetone 500mg film-coated tablets

Nabumetone

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 Nabumetone tablets are and what they are used for

2.    What you need to know before you take Nabumetone tablets

3.    How to take Nabumetone tablets

4.    Possible side effects

5.    How to store Nabumetone tablets

6.    Contents of the pack and other information

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

Each Nabumetone tablet contains 500 mg of the active ingredient nabumetone.

Nabumetone belongs to a group of drugs called non-steroidal anti-inflammatory drugs (also known as NSAIDs), which relieve pain and reduce inflammation. Nabumetone is used to treat pain and inflammation caused by osteoarthritis or rheumatoid arthritis.

2.    What you need to know before you take Nabumetone tablets

Do not take Nabumetone tablets If you:

-    are allergic (hypersensitive) to nabumetone or any of the other Ingredients of this medicine (listed in section 6). An allergic reaction may include skin rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.

-    have taken an NSAID in the past e.g. ibuprofen, acetylsalicylic acid (aspirin), and suffered an allergic reaction or asthma (difficulty breathing, wheezing), urticaria (hives, sudden itchy skin rash), rhinitis (inflamed nasal lining, runny nose) or sudden swelling of the mouth, tongue or throat.

-    have, or have ever had a stomach (peptic) ulcer or any perforation or bleeding (hemorrhage) in your digestive system or if you have or have ever had peptic disease.

-    have a severe liver disorder, (e.g. cirrhosis)

-    have had severe heart failure

-    are currently receiving treatment for a stroke or other internal bleed

-    have serious problems with your kidneys (kidney failure)

-    are in the last three months of pregnancy.

-    are breast-feeding

Warnings and precautions

Talk to your doctor or pharmacist before taking Nabumetone tablets, if you:

-    suffer from asthma or have ever had asthma

-    have had a disease of the digestive tract

-    suffer from fluid retention

-    have had hypertension (high blood pressure) or heart failure

-    have heart disease

-    have peripheral arterial disease (a disease of the blood vessels)

-    have cerebrovascular disease (a disease of the blood vessels in the brain)

-    are at risk of heart disease because you have high blood pressure, high lipid levels, diabetes, or you smoke

-    have a kidney or liver disorder.

-    have, or have ever had stomach problem. this includes Crohn's disease or ulcerative colitis

-    have a condition called systemic lupus erythematosus (SLE or Lupus for short) or any other autoimmune disease.

-    have an infection. NSAID medicines such as nabumetone may hide the symptoms of infections such as fever and inflammation.

-    are elderly, as you have a higher risk of getting side effects, especially in your digestive tract.

-    are taking any other NSAIDs including COX-2 selective inhibitors.

Medicines such as nabumetone may be associated with a small increased risk of heart attack (myocardial infraction) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.

Children

Do not give this medicine to children.

Other medicines and Nabumetone tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,

-    other painkillers (including aspirin)

-    corticosteroids (drugs that reduce inflammation, such as hydrocortisone)

-    anti-coagulants (blood thinners)

-    anti-platelet agents (reduce the risk of blood clots)

-    anticonvulsants (treatment for epilepsy)

-    protein bound drugs such as sulphonamides, sulphonylureas or hydantoin (used in medicines to treat bacterial infection, diabetes, oedema, hypertension and gout)

-    cardiac glycosides or ACE Inhibitors (treatment for heart conditions , such as digoxin)

-    lithium (treatment for mental illness)

-    methotrexate (treatment for rheumatoid arthritis and cancer)

-    diuretics (water tablets)

-    antihypertensives such as ACE inhibitors or angiotensin receptor agonists (to control high blood pressure)

-    mifepristone (a drug used for abortion)

-    quinolones (a type of antibiotic)

-    zidovudine (to treat HIV)

-    ciclosporin and tacrolimus (to prevent transplanted organs being rejected)

-    antidepressants such as selective serotonin reuptake inhibitors (SSRI's) (to treat depression)

Nabumetone tablets with food and drink

Nabumetone tablets should be taken with or after food.

Pregnancy and breast-feeding

You should not take Nabumetone tablets if you are pregnant, especially in the last 3 months, plan to become pregnant or are breast-feeding. Ask your doctor for advice before taking any medicine. Nabumetone may make it more difficult to become pregnant, speak to your doctor if you are having problems.

Driving and using machines

If you feel dizzy, tired, drowsy, confused, have problems with your vision after taking Nabumetone, you should not drive or operate machinery.

3.    How to take Nabumetone tablets

Dosage

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

-    The usual dose for adults is two tablets (1 g) taken as a single dose at bedtime.

-    For severe or long-lasting symptoms, or for sudden flare-ups, an extra one or two tablets (500 mg -1 g) may be given as a morning dose.

-    For elderly patients, the maximum dose is 2 tablets (1 g) per day.

Side effects may be minimised by taking the lowest effective dose for the shortest duration necessary to control symptoms.

Nabumetone tablets are not recommended for children.

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If you take more Nabumetone tablets than you should

If you have accidentally taken too many tablets you must contact your doctor or local casualty department, as soon as possible.

If you forgot to take Nabumetone tablets

If you have forgotten to take your medicine, do not make up for this by taking an extra tablet. Continue with your usual routine and take the next tablet at the next prescribed time.

Do not take a double dose to make up for a forgotten dose.

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

4.    Possible side effects

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

Stop taking this medicine and seek immediate medical help if you have any of the following symptoms:

-    you have difficulty breathing

-    severe skin eruptions where the skin reddens, peels and swells and looks severely burnt, or a severe skin rash with flushing, fever, blisters and ulcers or a wide-spread skin rash with circular irregular red patches on the hands and feet.

-    your face or throat swells

-    you have chest pains or sudden numbness and confusion

-    you have blood in your stools. They may look black and tarry.

-    you vomit blood or dark particles that look like coffee granules.

-    aseptic meningitis (stiff neck, headache, feeling or being sick, fever, disorientation) especially in patients who already have an autoimmune disorder such as systemic lupus erythematosus or mixed connective tissue disorder,

Stop taking this medicine and tell your doctor if you have any of the following symptoms:

This is especially important if you are elderly.

-    you have indigestion or heart burn

-    you have severe pains in your stomach

-    you have any other abnormal stomach symptoms.

-    depression, hallucinations

-    Inflammation of the pancreas, which causes severe pain in the abdomen and back

-    blood disorders which can include lower levels of red blood cells, white blood cells and platelets (changes in the numbers and types of blood cells. You may get ill more often with a sore throat, fever, chills, anaemia or abnormal bruising or bleeding known as blood dyscrasias)

-    a problem with the kidneys known as interstitial nephritis. The symptoms include fever, rash, enlarged kidneys, lower back pain, problem when passing water,

-    yellowing of your skin and the whites of your eyes (jaundice), liver failure.

The following are known side effects of using Nabumetone Common (may affect up to 1 in 10 people):

-    ringing in your ears or problem with the ears,

-    increase in blood pressure (you may feel dizzy and have a headache),

-    diarrhoea, constipation, feeling sick, inflammation of the stomach lining, stomach ache, wind,

-    rash, itchy skin,

-    fluid retention which cause swelling e. g. swollen ankles.

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

-    confusion, nervousness, problems sleeping,

-    tiredness, dizziness, headache, "pins and needles" or tingling feelings, anxiety,

-    problems with your sight or with your eyes,

-    breathing difficulties, nose bleeds,

-    upset stomach, being sick,

-    mouth ulcers, dry mouth,

-    increased skin sensitivity to sunlight or artificial light, red, raised patches on the skin, sweating,

-    problems with your muscles,

-    problems with your urinary tract,

-    loss of strength or energy, fatigue.

-    abnormal liver enzymes, shown by blood test results.

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

-    low numbers of blood platelets,

-    inflammation of the lungs causing shortness of breath and dry cough,

-    skin hives, loss of hair,

-    a disorder called pseudoporphyria which causes skin blisters, stomach pains and nervous system problems,

-    kidney problems such as blood in the urine, kidney failure,

-    heavy or unusually prolonged periods.

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

-    vertigo, drowsiness,

-    inflammation of the optic nerve,

-    asthma or worsening of existing asthma,

-    red or purple skin patches,

-    a general feeling of being unwell or "out of sorts",

-    worsening of existing stomach conditions such as Croh'n disease or ulcerative colitis.

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 any 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 Nabumetone tablets

Keep this medicine out of the sight and reach of children.

Do not store above 25°C. Store in the original package.

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of the that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information

What Nabumetone tablets contain:

The active substance is Nabumetone hydrochloride.

The other ingredients are maize starch, sodium starch glycollate (Type A), povidone , sodium lauryl sulphate, colloidal silicon dioxide and magnesium stearate, hypromellose, titanium dioxide, talc, red iron oxide and glycerol triacetate

What Nabumetone tablets look like and contents of the pack

Nabumetone 500mg Tablets are Capsule shaped, brown coloured, biconvex film coated tablets plain on both sides. Blister packs containing 8, 56, or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom.

Manufacturer:

Cipla (EU) Limited, 20 Balderton Street, London W1K 6TL,United Kingdom Cipla Europe NV, Uitbreidingstraat 80, 2600 Antwerp, Belgium This leaflet was last revised in 10/2015

Cipla

PACKAGING DEVELOPMENT

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