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NABUMETONE 500MG FILM-COATED TABLET

Active substance(s): NABUMETONE

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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

tbc
111222

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.

Date: 29 Apr 2015
Description Nabumetone 500 mg 56
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 581042

SAP No. N/A

Superceded Affiliate Item Code 565438
TrackWise PR No. 581042
MA No. 04569/0441

Vendor Job No. 247192
Proof No. 4
Client Market UK

No. of colours
Colours

1

Time: 12:52
Page Count

1/2

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Non-Print
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Equate CMYK
with

Packing Site/Printer N/A

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111222

Package Leaflet: Information for the patient

Myriad Pro
170 x 480 mm

Body Text Size 9 pt
Min Text Size used 7 pt

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.

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)

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.

• reduction in blood platelets, which increases
risk of bleeding or bruising (thrombocytopenia)
• hair loss
• unusually heavy and prolonged menstrual
period at regular intervals (menorrhagia)

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

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

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:

• 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.

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

This leaflet was last revised in 05/2015

Date: 29 Apr 2015
Description Nabumetone 500 mg 56
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 581042

SAP No. N/A

Superceded Affiliate Item Code 565438
TrackWise PR No. 581042
MA No. 04569/0441

Vendor Job No. 247192
Proof No. 4
Client Market UK

No. of colours
Colours

Time: 12:52
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Main Font

Supplier Code N/A

Barcode Info N/A

Dimensions

Sign-offs

1

581042

Myriad Pro
170 x 480 mm

Body Text Size 9 pt
Min Text Size used 7 pt

Expand view ⇕

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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