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Package Leaflet: Information for the patient

Nabumetone 500 mg Film-coated 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 Nabumetone is and what it is used for

2.    What you need to know before you take Nabumetone

3.    How to take Nabumetone

4.    Possible side effects

5.    How to store Nabumetone

6.    Contents of the pack and other information.

1.    What Nabumetone is and what it is used for

Nabumetone belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Nabumetone works by reducing inflammation and relieving pain, swelling and stiffness in the joints and muscles. It is used to treat pain and inflammation in rheumatoid arthritis and osteoarthritis.

2.    What you need to know before you take Nabumetone

Do not take Nabumetone:

•    if you are allergic to nabumetone or any of the other ingredients of this medicine (listed in section 6).

•    if you 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

•    if you have or have had a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach or have had two or more episodes of peptic ulcers or if you have had a bleed or perforation (tear) in the stomach or gut after taking any NSAID medicine.

•    if you have severe heart failure, causing shortness of breath and swelling of the feet or legs due to fluid build up, or you have bleeding in the brain or other body site

•    if you have severe liver or kidney problems (including failure).

•    if you are in the last three months of pregnancy or breast-feeding (see also 'Pregnancy, breastfeeding and fertility' later in the leaflet).

Warnings and precautions

Talk to your doctor or pharmacist before taking Nabumetone:

•    if you suffer from or have a history of asthma

•    if you have any problems with your stomach or bowel e.g. ulcerative colitis, Crohn's disease (as your symptoms may become worse)

•    if you have had bleeding problems, bleeding in the brain or problems with your blood not clotting

•    if you have other problems with your liver, or kidneys, or are taking a diuretic (water tablet); your doctor will monitor your kidney function regularly

•    if you have high blood pressure or mild to _ moderate heart failure

•    if you have a condition called systemic lupus erythematosus (SLE or Lupus for short) or any other autoimmune disease

•    if you are an older person, as you have a higher risk of getting side effects, especially in your stomach or gut.

•    if you are taking any other NSAIDs (non-steroidal anti-inflammatory drugs) (medicines used to control pain and inflammation, e.g. aspirin, naproxen, ibuprofen and, diclofenac (including COX-2 selective inhibitors e.g. celecoxib).

•    if you have an infection, as nabumetone (or other NSAIDs) may mask symptoms of infections such as fever and inflammation

•    if you are trying to become pregnant or are a woman undergoing an investigation for infertility (see 'Pregnancy, breast-feeding and fertility' later in the leaflet)

Tell your doctor if any of the above applies to you.

Risk of heart attack or stroke:

Medicines such as nabumetone 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.

Discuss your treatment with the doctor before taking Nabumetone:

•    if you have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries), or any kind of stroke (including 'mini-stroke' or transient ischaemic attack "TIA")

•    if you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.

Your doctor will want to ensure that you take the lowest necessary dose of Nabumetone for the shortest period necessary.

Other medicines and Nabumetone

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, in particular, any of the following:

•    another NSAID including aspirin (acetylsalicylic acid)

•    medicines to lower your blood pressure or to treat a heart condition e.g. cilazapril, captopril, losartan, valsartan and digoxin

•    any diuretic medicine ("water tablets" which make you pass more water) especially potassium sparing diuretics e.g. spironolactone, amiloride which may cause high levels of potassium in your blood which could affect your heartbeat

•    medicines to treat or prevent convulsions (fits) e.g. phenytoin

•    anticoagulants (used to thin your blood and prevent blood clots) such as warfarin or heparin

•    lithium (used e.g. to treat mood swings and some types of depressions)

•    antidepressants known as SSRIs, used to treat depression, such as fluoxetine, citalopram, escitalopram, sertraline, paroxetine

•    methotrexate (used to treat some types of cancer, Crohn's disease, psoriasis or rheumatoid arthritis)

•    probenecid, for gout, as the dose of nabumetone you will need will be lower than usual

•    antibiotics to treat infection e.g. quinolone such as ciprofloxacin, aminoglycosides such as gentamicin or medicines known as sulfonamides e.g. co-trimoxazole

•    corticosteroids (used to treat a variety of conditions such as allergies, inflammation and hormone imbalances e.g. prednisolone

•    ciclosporin, or tacrolimus, immunosuppressant (medicines used to prevent rejection in organ transplants)

•    mifepristone (used for termination of pregnancy), nabumetone should not be taken within 8 - 12 days of taking mifepristone as the effects of mifepristone may be reduced

•    anti-diabetic medicines known as sulfonylureas e.g. gliclazide, glibenclamide, as your dose may need adjusting

•    Zidovudine (used to treat HIV)

•    Bisphosphonates (used to treat bone problems such as weakening of the bone (osteoporosis)

•    Oxypentifylline (pentoxifylline) (used to treat problems affecting the circulation, especially in the legs)

•    Sulfinpyrazone (used to treat gout)

If any of these apply to you tell your doctor immediately.

Nabumetone with alcohol

Alcohol should be avoided whilst taking this medicine as it may increase the risk of the gut side effects and the risk of bleeding or ulceration. See section 3.

Pregnancy and breast-feeding

•    If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

•    Nabumetone may make it more difficult to become pregnant and also increase the risk of miscarriage in early pregnancy. Tell your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

•    Nabumetone may cause birth defects especially of the heart.

•    Nabumetone should only be taken in the first six months of pregnancy if decided by your doctor and under their close supervision

•    Nabumetone must not be taken in the last three months of pregnancy as it may affect your unborn baby, especially their heart, lungs and kidneys and also affect your labour, e.g. by causing a longer labour and an increased tendency to bleed in both you and your baby.

•    It is not recommended to breast-feed your baby while taking Nabumetone, as it is not known whether it can pass into breast milk which could affect your baby.

Driving and using machines

Nabumetone may make you feel dizzy, drowsy, tired, confused or affect your vision.

If you experience any of these reactions, do not drive or operate machines.

Nabumetone contains sunset yellow (E110) and ponceau 4R (E124)

Sunset yellow (E110) and ponceau 4R (E124) may cause allergic reactions. Do not take these tablets if you are allergic to those colourants.

3. How to take Nabumetone

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

It is important that you take the lowest dose that controls your pain and you should not take nabumetone for longer than necessary to control your symptoms. If your symptoms do not improve, go back to your doctor.

Adults

The recommended dose is two 500 mg tablets (1 g) taken at bedtime. Your doctor may increase your dose up to four 500 mg tablets (2 g) daily. If your dose is increased, normally you should take two 500 mg tablets (1 g) at bedtime and a further one or two tablets (500 mg to 1 g) in the morning.

Older people

If you are older you maybe more likely to suffer from side effects. Your doctor will give you the lowest dose that is effective. The usual dose is one 500 mg tablet daily. The maximum daily dose is two 500 mg tablets (1 g) a day. It should not be exceeded.

Kidney problems

Your doctor might lower your dose if you suffer from moderate kidney problems.

Use in children and adolescents

Nabumetone should not be given to children under the age of 18.

Swallow the tablets with a glass of water, with or after food.

If you take more Nabumetone than you should

If you take more Nabumetone than you should, contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you. Symptoms of overdose include headache, feeling or being sick, heartburn, indigestion and stomach pain, bleeding from your gut or intestines, rarely diarrhoea, disorientation, excitation, drowsiness, dizziness, low blood pressure, ringing in the ears, fainting, coma, and occasionally fits. In cases of significant poisoning, kidney and liver damage are possible.

If you forget to take Nabumetone

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects are more likely in elderly patients.

If any of the following happen, stop taking Nabumetone and tell your doctor immediately or go to your nearest hospital emergency department:

Uncommon (may affect up to 1 in 100 people)

•    if you have severe stomach pain, indigestion or heartburn, any other stomach problems, or notice black tarry stools or fresh blood in your stools (poo) or if you are sick and you notice blood or particles that look like coffee grounds - these may be signs of an ulcer in the gut (stomach or duodenum) or a bleed in the gut.

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

•    if you have an allergic reaction causing difficulty breathing, breathlessness, tightness of the chest, asthma (severe wheezing), swelling of the face, throat or tongue, serious illness with blistering of the skin, mouth, eyes and genitals or severe skin disorders e.g. rashes which may be very itchy or a raised red rash (hives) or

red or purple patches on the skin caused by bleeding under the skin (purpura)

•    inflammation of the lungs which causes breathlessness, cough and raised temperature (interstitial pneumonitis)

•    if you notice sensitivity of the skin to light, red spots or rash on the skin or unusual bruising or bleeding of the skin (pseudophorphyria)

•    if you have yellowing of the skin or whites of the eyes which may be caused by liver problems, including liver failure

•    if you develop a fever, rash, lower back pain and problems when passing urine or blood in the urine these may be signs of kidney problems, including kidney failure

•    if you have severe burning pain in your stomach which also affects your back and feel sick or are sick (pancreatitis)

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

•    if you notice an increase in infections that you get (e.g. sore throat, mouth ulcers ) or fever -these may be signs of a reduction in the white blood cells that help fight infection

•    severe reduction in red blood cells which can make the skin pale and cause weakness or breathlessness (anaemia; haemolytic anaemia)

•    severe reduction in blood cells which can cause weakness, bruising or make infections more likely (aplastic anaemia)

•    if you develop a stiff neck, headache, sensitivity to light with a non- blanching skin rash (rash which does not disappear when a glass is pressed against it), feeling or being sick, fever and feel confused, especially if you already have systemic lupus erythmatosus (SLE) (an allergic condition which causes joint pain, skin rashes and fever) - these may be signs of meningitis

•    if you are short of breath and have swollen ankles - these may be signs of heart failure (a weakness of the heart muscle)

•    if you suffer a loss of vision, which may be partial or complete or pain with movement of your eye (inflammation of the nerve that leads from the eye to the brain- optic neuritis)

•    if you have Crohn's disease and notice a worsening of your symptoms.

Other possible side effects are:

common (may affect up to 1 in 10 people)

•    ringing in the ears (tinnitus); or problems with the ears

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

•    diarrhoea; constipation; feeling sick; inflammation of the stomach lining (gastritis); stomach ache; wind

•    fluid retention which causes swelling e.g. swollen ankles

Uncommon (may affect up to 1 in 100 people)

•    sleep problems, sleeplessness (insomnia)

•    being nervous

•    feeling anxious

•    confusion

•    dizziness

•    headache; feeling of weakness (asthenia); feeling tired

•    sleepiness (somnolence)

•    tingling or numbness in the limbs

•    problems with your sight or with your eyes (you may need to have an eye examination)

•    shortness of breath (dyspnoea)

•    dry mouth; inflammation of the mouth (stomatitis); being sick

•    sweating

•    pain or weakness in muscles (myopathy)

•    problems with urinary tract

•    nosebleeds

•    raised liver enzymes (which may be seen in a blood test result)

•    skin sensitivity to sunlight.

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

•    reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)

•    hair loss

•    unusually heavy and prolonged menstrual period at regular intervals (menorrhagia)

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

•    hallucinations; depression

•    drowsiness

•    a feeling of dizziness or "spinning" (vertigo)

•    high blood pressure (hypertension)

•    general feeling of being unwell

•    asthma, or worsening of symptoms with breathing problems.

•    worsening of symptoms in patients with colitis.

Some anti-inflammatory/pain- relieving medicines (particularly at high doses and in longterm treatment) may be associated with a small increased risk of heart attack or stroke. See 'Risk of heart attack or stroke' in section 2, 'What you need to know before you take Nabumetone'

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, website: 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

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 carton. The expiry date refers to the last day of that month.

Do not store above 25°C. Blister packs: Store in the original package in order to protect from light. Bottle packs: Keep the container tightly closed in order to protect from light.

Do not throw away 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 contains

The active substance is nabumetone 500 mg The other ingredients are microcrystalline cellulose, sodium laurilsulfate, saccharin sodium, hypromellose, sodium starch glycolate and magnesium stearate. The tablet coating contains titanium dioxide (E171), ponceau 4R (E124), sunset yellow (E110), (see section 2 'Nabumetone contains sunset yellow and ponceau 4R), hypromellose and macrogol.

What Nabumetone looks like and contents of the pack

Your medicine comes as a pink/red capsule-shaped film-coated tablet. The tablets are marked 'NB 500' on one side and 'G' on the other.

Nabumetone is available in blister packs or plastic bottles of 10, 14, 20, 28, 30, 50, 56, 60, 100, 112,

168 and 250 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Generics [UK] Ltd, Station Close, Potters Bar, Hertfordshire EN6 1TL, United Kingdom.

Manufacturer:

Generics [UK] Ltd, Station Close, Potters Bar, Hertfordshire EN6 1TL, United Kingdom.

Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

this leaflet was last revised in 05/2015    581042

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Date: 29 APR 2015