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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.

• 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.

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
non-steroidal 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.

• or have a history of gastrointestinal disease such as ulcerative

colitis or Crohn’s disease.
• had stomach and intestinal problems.
• impaired kidney 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.
If you experience any skin reactions or rash when you first start
taking Nabumetone please stop using it and talk to your doctor.

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 warfarin
• drugs used to treat high blood pressure such as:

- ACE inhibitors e.g. captopril
- angiotensin II receptor antagonists e.g. candesartan or losartan
• cardiac glycosides such as digoxin (used to treat some heart

conditions)
• lithium (used for depression)

• ciclosporin (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 (used to treat infections)

• selective serotonin re-uptake inhibitors (e.g. paroxetine), venlafaxine

or moclobemide (used for depression)
• sulphonylureas (e.g. gliclazide) (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)
• clopidrogel (an anti-platelet drug)

• pentoxifylline (used to treat blood vessel disease)

• probenecid or sulfinpyrazone(used to treat gout)


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.
Continued top of next column

Continued over page

148x210 Leaflet Reel Fed Profile (BST)
colours/plates:

Nabumetone 500mg 56 Tablets PIL - UK

1. Black

item no: AAAH7250

dimensions: 148 x 210 Reel Fed

print proof no: 3

pharmacode:

origination date: 11.03.15

min pt size: 7

2.
3.
4.
5.
6.

approved for print/date

revision date: 11.06.15

Technical Approval
date sent: 11.03.15

supplier: Actavis UK

technically app. date:

Non Printing Colours
1. Text Safe Area
2.
3.

Nabumetone Tablets
500mg x 56’s (UK)
JDE No.:

50847672

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 4015
Date Sent:
26/02/15
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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 dizzy and confused. 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 Nabumetone tablets 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.
Severe rash involving reddening, peeling and swelling of the skin that
resembles severe burns (toxic epidermal necrolysis), Severe form of skin
rash with flushing, fever, blisters or ulcers (Stevens Johnsons syndrome)
or Widespread skin rash – circular, irregular red patches on the skin of the
hands and arms (erythema multiforme)
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.

Continued top of next column
50847672 AAAH7250

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).
Psychiatric: confusion, hallucinations, difficulty sleeping, nervousness.
Nervous system: headache, dizziness, sedation, tiredness, ‘pins and
needles’ or tingling, 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.
Eye: abnormal vision, problems with your sight or with your eyes.
Ear: ringing or buzzing in the ears, problems with your hearing or your ears.
Heart: high blood pressure.
Airways: nosebleeds, breathing difficulties, inflammation of the lungs
causing coughing or wheezing.
Stomach and intestines: diarrhoea, indigestion, 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, stomach problems,
inflammation of the mouth.
Liver: liver failure, disease of the liver causing yellowing of the skin or whites
of the eyes (jaundice).
Skin: hair loss, rash, itching, sensitivity to sunlight or artificial light (e.g. sun
beds), itchy skin rash caused by allergic reaction- pale or red irregular raised
patches with severe itching (hives), swollen face, lips, throat or tongue,
sweating.
Muscles: weakness.
Kidneys: kidney failure, protein in your urine, urinary tract problems.
Reproductive system: impaired female fertility, heavy periods.
General disorders: water retention (causing swelling in a specific area of
the body), weakness or loss of strength, tiredness
Investigations: abnormal liver enzymes as seen in a blood tests

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

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 June 2015.
Actavis, Barnstaple, EX32 8NS, UK

148x210 Leaflet Reel Fed Profile (BST)
colours/plates:

Nabumetone 500mg 56 Tablets PIL - UK

1. Black

item no: AAAH7250

dimensions: 148 x 210 Reel Fed

print proof no: 3

pharmacode:

origination date: 11.03.15

min pt size: 7

2.
3.
4.
5.
6.

approved for print/date

revision date: 11.06.15

Technical Approval
date sent: 11.03.15

supplier: Actavis UK

technically app. date:

Non Printing Colours
1. Text Safe Area
2.
3.

Nabumetone Tablets
500mg x 56’s (UK)
JDE No.:

50847672

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 4015
Date Sent:
26/02/15
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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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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