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NABUMETONE 500MG FILM-COATED TABLETS

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,
­pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
• In this leaflet, Nabumetone 500 mg Film-coated
­Tablets will be called Nabumetone.
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 (known as NSAIDs).
It works by reducing the production of some natural
chemicals found in the body. These chemicals
­(prostaglandins) cause the symptoms of inflammation
such as pain and swelling.
Nabumetone is used to treat the pain, stiffness and
swelling of joints which are affected by osteoarthritis or
rheumatoid arthritis.
2. What you need to know before you take
­Nabumetone

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Do not take Nabumetone if:
• You are allergic to nabumetone
• You are allergic to any of the other ingredients of
Nabumetone (see section 6)
• You have ever had an allergic reaction like a rash,
itchy, runny or bleeding nose, or become short of
breath when you have taken aspirin (acetylsalicylic
acid) or other NSAID medicines. Such medicines
include ibuprofen, diclofenac or naproxen. Some
people who have had previous a­ llergic reactions to
NSAID medicines have very ­serious, sometimes fatal
reactions if they take this kind of medicine again
• You have, or have ever had a stomach (peptic) ulcer
or any perforation or bleeding (haemorrhage) in your
digestive system or if you have or have ever had
­peptic disease
• You have serious problems with your heart (severe
heart failure)
• You are currently receiving treatment for a stroke or
other internal bleed
• You have serious problems with your liver (liver cirrhosis)
• You have serious problems with your kidneys (kidney
failure)
• You are in the last three months of pregnancy.
• You are breast feeding
If any of the above applies to you, talk to your doctor or
pharmacist.
Warnings and Precautions
Children and Adolescents
Do not give Nabumetone to children.
Check with your doctor before taking Nabumetone if:
• You have, or have ever had asthma
• You have, or have ever had stomach problems.
This includes Crohn’s disease or ulcerative colitis
• You have kidney problems
• You have liver problems
• You have heart problems
• you have or have ever had high blood pressure
(hypertension)
• You have ever had a stroke
• You have any signs of water building up in your body,
such as swollen ankles
• You have a condition called systemic lupus
­erythematosus (SLE or Lupus for short) or any other
autoimmune disease
• You are in the first six months of pregnancy
• You are trying to, or planning to become pregnant
• You have diabetes
• You have high cholesterol
• You are a smoker
• You are over 65 years of age.
• You have an infection. NSAID medicines such as
naubmetone may hide the symptoms of infections
such as fever an inflammation.

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3. How to take Nabumetone
Important:
• Only take the amount of this medicine your
doctor has prescribed
• Only take this medicine for the treatment
time your doctor has prescribed.
This will stop you getting so many side-­
effects. This will reduce any chance of you
having a stroke or heart attack.
Important:
Your doctor will choose the dose that is right
for you. Your dose will be shown clearly on
the label that your pharmacist puts on your
medicine. If it does not, or you are not sure,
ask your doctor or pharmacist.
Remember: Always take this medicine with or after a
meal. Swallow the tablets whole with water. Do not
chew the tablets.
Some patients may need to take another medicine at
the same time as taking Nabumetone. Your doctor will
prescribe this if you need it.
Adults
• The recommended dose is two tablets (1 g) taken
once a day at bedtime.
• If you need to take more, your doctor will explain how
much to take and when to take it.

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137

Patient Information Leaflet
Important information for the patient

Warnings
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.
Stop taking this medicine and tell your doctor if you
notice any signs of rash or redness, itching or blistering
which may be signs of serious skin reaction.
Tell your doctor if you are taking any of the
­following medicines:
• Anticoagulants such as warfarin (to thin your blood)
• Anticonvulsants such as phenytoin (to prevent fits)
• Antidepressants such as selective serotonin-reuptake
inhibitors (SSRI’s) (to treat depression)
• Antidiabetics such as chlorpropamide and metformin
(taken by mouth to control blood sugar levels)
• Antihypertensives such as ACE inhibitors or angiotensin
receptor agonists (to control high blood pressure)
• Cardiac glycosides such as digoxin (to manage
­certain heart conditions)
• Ciclosporin and tacrolimus (to prevent transplanted
organs being rejected)
• Corticosteroids (to treat skin conditions)
• Diuretics or ‘water tablets’ (to make you pass more
water)
• Lithium (to treat mental problems)
• Methotrexate (to treat arthritis)
• Mifepristone (used by doctors to terminate pregnancies).
If you have taken mifepristone within the last two
weeks you should not take Nabumetone
• Non steroidal anti-inflammatory drugs (NSAIDs or
COX-2). These include ibuprofen, acetylsalicylic acid,
diclofenac, naproxen, clopidogrel or aspirin
• Quinolone antibiotics (to treat infections)
• Zidovudine (to treat HIV)
• Protein bound drugs such as sulphonamides,
­sulphoylureas, probenecid, sulfinpyrazone or
­hydantoin (used in medicines to treat bacterial
­infections, diabetes, oedema, hypertension and gout)
• Probenecid (to treat gout)
• Bisphosphonates (used in medicines to treat
­conditions that effect your bones)
• Oxpentifylline (pentoxyfilline) (used in medicines to
treat the symptoms of intermittent claudication)
• Any other medicine, including medicines obtained
without a prescription.
Taking Nabumetone with food and drink
You must take this medicine with or after a meal. No
alcohol should be consumed during treatment with Relifex
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.
Your doctor will decide if taking this medicine at this
time is right for you and/or your baby.
Remember: Taking this medicine may make it harder for
you to become pregnant. Ask your doctor for advice
Driving and using machines
Whilst taking Nabumetone you may feel dizzy, tired,
drowsy or notice problems with your eye sight. If this
happens, do not drive or operate machinery. Your doctor
may arrange for you to have an eye examination if your
eyesight is affected whilst you are taking this medicine.

4. Possible side effects
Like all medicines Nabumetone can cause side effects,
although not everybody gets them.

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Stop taking this medicine and seek immediate
medical help if you have any of the following
symptoms:
• You have difficulty breathing
• Your face or throat swells
• You have a severe rash that may blister
• 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.
• Low numbers of blood 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
• Inflammation of the lungs causing shortness
of breath and a dry cough
• Yellowing of your skin and the whiteness of
your eyes (jaundice), liver failure
• 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
widespread skin rash with circular irregular
patches on the hands and feet
• A disorder called pseudoporphyria which
causes skin blisters, stomach pains and
nervous system problems
• Kidney problems such as blood in the urine,
kidney failure, problems with the kidneys
known as interstitial nephritis. The symptoms in the urine fever, rash, enlarged
kidneys, lower back pain, ­problems when
passing water
• Inflammation of the optic nerve
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 heartburn
• You have severe pains in your stomach
• You have any other abnormal stomach symptoms.
The following side effects are common and may
affect up to one in 10 people taking Nabumetone:
• Ringing in your ears 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, stomach ache, wind

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• Rash, itchy skin
• Fluid retention which causes swelling e.g. swollen
ankles.
The following side effects are uncommon and may
affect up to one 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.
The following side effects are very rare and may
affect up to one in 10,000 people:
• Skin hives, loss of hair
• Heavy or unusually prolonged periods.
The following side effects have also been reported
by people taking Nabumetone although it is not
known how many people have these side effects:
• Depression, hallucinations
• 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
• Vertigo, drowsiness
• Asthma or worsening of existing asthma
• Red or purple skin patches
• A general feeling of being unwell or “out of sorts”
• Changes in the numbers and types of blood cells.
• Worsening of existing stomach conditions such as
Crohn’s disease or ulcerative colitis.
Important: Medicines such as Nabumetone may be
associated with a small increased risk of heart attack
(myocardial infarction) or stroke.
Reporting of side effect
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 Nabumetone
Keep out of the reach and sight of children.
Do not use Nabumetone after the expiry date on the
label or carton. The expiry date refers to the last day of
that month.
Keep the tablets in their original bottle. Protect from light.
Medicines should not be disposed of via wastewater or
in household waste. Return any medicine you no longer
need to your pharmacist.
6. Contents of the pack and other information
What Nabumetone contains
• The active substance in Nabumetone is nabumetone.
• Each tablet contains 500 mg nabumetone.
• The other ingredients are sodium starch glycollate,
sodium lauryl sulphate, hydroxylpropyl- methylcellulose, magnesium stearate, microcrystalline cellulose
(E460), red carmine (E120), yellow iron oxide (E172),
titanium dioxide (E171), talc, polyethylene glycol 400,
saccharin sodium, liquid caramel flavour, purified
water and carnauba wax.
What Nabumetone looks like
Nabumetone 500 mg Film-coated Tablets are red and
oblong. The tablets come in plastic bottles containing
56 tablets.
Marketing Authorisation Holder:
Beechmere Pharmaceuticals Ltd
Merlin Place
Milton Road
Cambridge
CB4 0DP
UK
Manufacturer:
Haupt Pharma Wülfing GmbH
Bethelner Landstraße 18
31028 Gronau
Germany
This leaflet was last revised December 2015
If this leaflet is difficult to see or read or you would
like it in a different format, please contact
Beechmere Pharmaceuticals Ltd, Merlin Place,
Milton Road, Cambridge, CB4 0DP, UK

225 8516 5
56UK1784131-01

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137

Elderly (65 years and over)
• The recommended starting dose is one tablet
(500 mg) taken once a day at bedtime.
• If you need to take more, your doctor will explain how
much to take and when to take it.
• Never take more than two tablets (1 g) each day.
Children
• Nabumetone is not recommended for use in children.
Medical check-ups
When you are taking this medicine, your doctor may ask
you to come for check-ups which may include:
• Checking your kidneys to make sure they are working
properly. Your doctor may want to do some tests
before you start taking Nabumetone and then
re-check your kidney function once you have been
taking the medicine for a few weeks.
• Check your liver is working properly
• Checking you are not getting problems with swelling
of any parts of your body. Your doctor may want to
give you some medicine to help with these symptoms
• If you are elderly, you will need to go for check-ups
during the first four weeks of taking the medicine.
These are to make sure that the medicine is working
properly and that the dose you are taking is right for
you.
If you take more Nabumetone than you should
Do not take more Nabumetone than you should.
If you accidentally take too much of your medicine,
immediately tell your doctor or go to the nearest hospital
casualty department.
Taking too much Nabumetone may make you feel or be
sick, be dizzy or faint, develop a headache or have fits
(convulsions).
If you forget to take Nabumetone
Do not take a double dose to make up for a forgotten
dose.
Simply take the next dose as planned.
If you have any further questions about the use of this
medicine, ask your doctor or pharmacist.

Studio Oberländer GmbH · Rubensstr.  33 · 60596 Frankfurt a. M. · Germany
Phone: +49 69 631520-85  ·  Fax: -87  ·  E-Mail: info@studio-oberlaender.de

SPECIFICATION BOX: Leaflet
MANUFACTURER: Meda Pharma GmbH & Co. KG

COLOURS USED:

PRODUCT: Nabumetone 500 mg

Black



Pantone 032

Film-Coated Tablets

MEDA-NO.: 56UK1784131-01
MFS-NO.:
225 8516 5
LAETUS-CODE:

137
COUNTRY:

United Kingdom UK

137

LANGUAGE: English
PACK SIZE:

155 x 300 mm

CORRECTION: 3.

FONT SIZE:

8,0 pt / 8,2 pt

DATE:

0715_GI_Nabumetone_500mg_56UK1784131-01.indd 3

14. 12. 2015

14.12.15 17:37

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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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