NABUMETONE TABLETS 500MG

Active substance: NABUMETONE

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Nabumetone 500mg tablets
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• 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.

In this leaflet:
1 What Nabumetone tablets are and
what they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information


1 What Nabumetone tablets are and
what they are used for

Nabumetone belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), which are used
to reduce inflammation and pain in joints and muscles.
Nabumetone tablets are for diseases of the joints such as
rheumatoid arthritis or osteoarthritis.

2 Before you take

Do not take Nabumetone tablets if you:

• are in the last three months of pregnancy or breastfeeding.
• are allergic (hypersensitive) to nabumetone or any of the other
ingredients in Nabumetone tablets (see section 6). Carmoisine aluminium
lake (E122) may cause allergic reactions.
• are allergic to aspirin or other non-steroidal anti-inflammatory
medicines (NSAIDs), or have had difficulty breathing due to narrowing
of the airways, swelling of the face, lips, throat or tongue, runny nose
or a skin rash which has pale or red irregular raised patches with severe
itching, when taking these medicines.
• have or have had a peptic ulcer (ulcer in your stomach or duodenum) or
bleeding in your stomach (2 or more episodes).
• have had bleeding or ulceration of the upper gastrointestinal tract
related to NSAID therapy.
• have severely impaired liver or kidney function.
• have severe heart failure or severely impaired heart function.
• are taking any other non-steroidal anti-inflammatory medicines
(NSAIDs), COX II inhibitors or aspirin.
• have an uncorrected blood clotting disorder.
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 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 high blood pressure, diabetes
or high cholesterol or are a smoker) you should discuss your treatment with
your doctor or pharmacist.

Check with your doctor before taking Nabumetone, if you
have:
• low blood pressure or water retention
• had high blood pressure or heart failure.
• or have had asthma.
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• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
• or have a history of gastrointestinal disease such as ulcerative colitis or
Crohn’s disease.
• had stomach or intestinal problems.
• impaired kidney or liver function.
• an infection. Nabumetone may mask symptoms of infections such as
fever and inflammation.
• systemic lupus erythematosus (SLE) or other connective tissue
disorders.
• your thyroid hormone levels or thyroid function monitored.
Nabumetone can lower blood levels of thyroid hormone and can affect
thyroid function test results.
if you are:
• a woman trying to become pregnant or undergoing investigation for
infertility (see ‘Pregnancy and breast-feeding’ section).
• elderly. If you are elderly, you have a higher risk of getting side effects.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken,
any other medicines, including medicines obtained without a prescription.
Especially:
• medicines which thin the blood or which prevent blood clotting, such as
phenindione, heparins, warfarin and acenocoumarol
• any diuretic medicine (“water tablets”) e.g. bendroflumethiazide
• drugs used to treat high blood pressure such as:
- ACE inhibitors e.g. captopril
- angiotensin II receptor antagonists e.g. candesartan or losartan
- clonidine
- vasodilators such as hydralazine, minoxidil, nitroprusside
- methyldopa
- calcium channel blockers e.g. amlodipine
- beta blockers e.g. atenolol
• cardiac glycosides such as digoxin (used to treat some heart conditions)
• lithium (used for depression)
• zidovudine or ritonavir (antiviral drugs)
• ciclosporin or tacrolimus (used to suppress the immune system)
• mifepristone (used for termination of pregnancy), Nabumetone tablets
should not be taken within 8-12 days of taking mifepristone
• other non-steroidal anti-inflammatory drugs (NSAIDs) including aspirin
• corticosteroids e.g. prednisolone
• antibiotics such as quinolones or aminoglycosides (used to treat
infections)
• selective serotonin re-uptake inhibitors (e.g. paroxetine), venlafaxine or
moclobemide (used for depression)
• phenytoin (used for epilepsy)
• sulphonylureas (e.g. gliclazide) or rosiglitazone (used in diabetes)
• bisphosphonates e.g. alendronic acid (used in bone disorders)
• methotrexate (used to treat some types of cancer, Crohn’s disease,
psoriasis or rheumatoid arthritis)
• baclofen (a muscle relaxant)
• clopidrogel (an anti-platelet drug)
• pentoxifylline (used to treat blood vessel disease)
• drospirenone (progestogen hormone treatment)
• sibutramine (an appetite suppressant)
• adrenergic neurone blockers e.g. guanethidine (used to control blood
pressure)
• nitrates e.g. glyceryl trinitrate (used for angina).
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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

Nabumetone may make you feel drowsy, dizzy, confused, affect your vision or cause
headaches. Make sure you are not affected before you drive or operate machinery.

Tests

If you have impaired liver or kidney function or a history of high blood pressure or
congestive heart failure, your doctor may want to monitor you by carrying out tests.

3 How to take

Always take Nabumetone tablets exactly as your doctor has told you. If you are not
sure, check with your doctor or pharmacist.
Speak to your doctor before drinking alcohol with Nabumetone tablets, as there
may be an increased risk of getting certain side effects.
Swallow tablets with water with or after food, this will reduce the risk of side
effects on the stomach and intestines.

Doses

Your doctor should prescribe the lowest effective dose for the shortest amount of
time. This will reduce any side effects you may have.
• Adults: The usual dose is 1g (two tablets) taken as a single dose at bedtime. If
your pain is severe, persistent or worsens suddenly, your doctor may prescribe
you an extra 500mg-1g (one or two tablets) to be taken in the morning.
• Elderly: If you are elderly, the maximum dose is 1g (two tablets) a day, 500mg
(one tablet) a day may give you enough relief. Your doctor may monitor you for 4
weeks after you start taking Nabumetone tablets.
• Children: Not recommended

If you take more than you should

It is important not to take too many tablets. If you have taken more than you
should, contact your doctor, pharmacist or nearest hospital casualty department
immediately. Symptoms of overdose are headache, feeling or being sick, stomach
pain, bleeding in the stomach or intestines, diarrhoea, disorientation, excitation,
coma, drowsiness, dizziness, ringing or buzzing in the ears, fainting, fits, kidney
failure and liver damage.

If you forget to take the tablets

If you forget to take your tablets, take your next dose as soon as you remember,
unless it is nearly time for your next dose. Do not take a double dose to make up for
one you have missed.

4 Possible side effects

Like all medicines, Nabumetone tablets can cause side effects, although not
everybody gets them.
Do not take if you have or have had a peptic ulcer (ulcer in your stomach or
duodenum) or bleeding in your stomach.
Stop taking Nabumetone tablets and contact your doctor immediately if you
notice signs of stomach or intestinal bleeding, ulceration or perforation, such as:
blood in your faeces (stools/motions), black tarry stools, blood or dark particles that
look like coffee grounds in your vomit, or abdominal pains (pains in your stomach)
or other abnormal stomach symptoms, indigestion or heartburn.
Contact your doctor immediately if you notice signs of an allergic reaction:
itchy skin rash, swelling of the face, lips, throat or tongue, or difficulty breathing or
swallowing.
Tell your doctor if you notice any of the following side effects or notice any other
effects not listed:
Blood: changes in the numbers and types of your blood cells. If you notice
increased bruising, nosebleeds, sore throats, infections, excessive tiredness,
breathlessness on exertion or abnormal paleness of the skin, you should tell your
doctor who may want you to have a blood test.

Immune system: skin reactions including large raised spots on the skin, small
blisters or red, flaky and peeling skin, itching, rash, pale or red irregular raised
patches with severe itching (hives), sensitivity to sunlight or artificial light (e.g. sun
beds) including a disorder causing skin blisters, abdominal pain and nervous system
disorders (pseudoporphyria), severe skin eruptions such as severe form of skin rash
with flushing, fever, blisters or ulcers (Stevens Johnson syndrome), widespread skin
rash with circular, irregular red patches on the skin of the hands and feet (erythema
multiforme), severe rash involving reddening, peeling and swelling of the skin that
resembles severe burns (toxic epidermal necrolysis), dilation or narrowing of blood
vessels causing a runny nose, narrowing of the airways, asthma, difficulty breathing,
inflammation of the lungs (alveolitis), increased white blood cells in the blood of the
lungs (pulmonary eosinophilia), inflammation of the pancreas, aseptic meningitis
(stiff neck, headache, feeling or being sick, fever, disorientation) especially in those
who already have an auto-immune disease such as systemic lupus erythematosus
or mixed connective tissue disease.
Psychiatric: confusion, depression, hallucinations, difficulty sleeping, nervousness.
Nervous system: headache, dizziness, sedation, tiredness, spinning sensation,
drowsiness, a feeling of general weakness, discomfort and illness, difficulty
sleeping, ‘pins and needles’ or tingling.
Eye: abnormal vision, inflammation of the optic nerve, discomfort and irritation of
the eye, swelling of the optical disk.
Ear: ringing or buzzing in the ears.
Heart: heart failure, high blood pressure, fluid retention causing swelling. Medicines
such as nabumetone may be associated with a small increased risk of heart attack
(“myocardial infarction”) or stroke.
Airways: nosebleeds, breathing difficulties, inflammation of the lungs causing
coughing or wheezing.
Stomach and intestines: diarrhoea, dry mouth, feeling or being sick, constipation,
stomach pain, wind, inflammation of the stomach lining, mouth ulcers, colitis,
Crohn’s disease, worsening of existing colitis or Crohn’s disease, inflammation,
perforation or narrowing of the food pipe, ulceration of the food pipe with or
without bleeding.
Liver: abnormal liver enzymes, inflammation of the liver (hepatitis), disease of the
liver causing yellowing of the skin or whites of the eyes (jaundice).
Skin: hair loss, worsening of existing skin problems such as acne and psoriasis,
sweating.
Muscles: weakness.
Kidneys: kidney impairment, inflammation, disease or failure, blood in the urine,
urinary tract problems.
Reproductive system: impaired female fertility, heavy periods.
If you notice any side effects, they get worse, or if you notice any not listed,
please tell your doctor or pharmacist.

5 How to store

Keep out of the reach and sight of children.
Store in the original container.
Do not use Nabumetone tablets after the expiry date which is
stated on the carton. The expiry date refers to the last day of that
month.
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 Further information

What Nabumetone tablets contain

• The active substance (the ingredient that makes the tablets work)
is nabumetone. Each tablet contains 500mg nabumetone.
• The other ingredients are microcrystalline cellulose 101 (E460),
hydroxypropylmethylcellulose (E464), sodium lauryl sulphate,
sodium starch glycollate, colloidal silica, magnesium stearate,
propylene glycol, purified talc (E553), carmoisine aluminium lake
(E122), indigo carmine aluminium lake (E132), titanium dioxide
(E171).

What Nabumetone tablets look like and contents of
the pack
Nabumetone tablets are maroon, oval, biconvex, film-coated
tablets.
Pack size is 56.
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in January 2011.

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Actavis, Barnstaple, EX32 8NS, UK

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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