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NABUMETONE 500 MG FILM-COATED TABLETS

Active substance(s): NABUMETONE / NABUMETONE

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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 or nurse.
- 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 or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.

SAPCODE

Nabumetone
500 mg Tablets
XXXXXXXX

32 mm

What is in this leaflet
1 What Nabumetone Tablets are and what they
are used for
2 What you need to know before you take
Nabumetone Tablets
3 How to take Nabumetone Tablets
4 Possible side effects
5 How to store Nabumetone Tablets
6 Contents of the pack and other information
1 What Nabumetone Tablets are and what they

are used for

32 mm

XXXXXXXXX

Nabumetone
500 mg Tablets

Pharma
Code
SAPCODE

Nabumetone Tablets belong to a group of medicines called
non-steroidal anti-inflammatory drugs (known as NSAIDs).
They work 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 Tablets are 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
Tablets
Do not take Nabumetone Tablets:
- if you are allergic to nabumetone or any of the other
ingredients of this medicine (listed in section 6).
- if 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 or other NSAID medicines. Such
medicines include ibuprofen, acetylsalicylic acid,
diclofenac or naproxen. Some people who have had
previous allergic reactions to NSAID medicines have very
serious, sometimes fatal, reactions if they take this kind of
medicine again.
- if 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.
- if you have serious problems with your heart (severe
heart failure).
- if you are currently receiving treatment for a stroke or
other internal bleed.
- if you have serious problems with your liver (liver
cirrhosis).
- if you have serious problems with your kidneys (kidney
failure).
- if you are in the last three months of pregnancy.
- if you are breast-feeding.
If any of the above applies to you, talk to your doctor or
pharmacist.

Warnings and precautions
Check with your doctor before taking Nabumetone Tablets if
you:
- have, or have ever had asthma
- have, or have ever had stomach problems. This includes
Crohn's disease or ulcerative colitis
- have kidney problems
- have liver problems
- have heart problems
- have or have ever had high blood pressure
(hypertension)
- have ever had a stroke
- have any signs of water building up in your body, such as
swollen ankles
- have a condition called systemic lupus erythematosus
(SLE or Lupus for short) or any other autoimmune disease
- are in the first six months of pregnancy or planning to
become pregnant
- have diabetes
- have high cholesterol
- are a smoker
- are over 65 years of age
- have an infection. NSAID medicines such as Nabumetone
Tablets may hide the symptoms of infections such as
fever and inflammation.
Medicines such as Nabumetone Tablets 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.
Other medicines and Nabumetone Tablets
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other 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 (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 Tablets.
- Non steroidal anti-inflammatory drugs (NSAIDs or COX2). 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,
sulphonylureas, probenecid, sulfinpyrazone or
hydantoin (used in medicines to treat bacterial infections,
diabetes, oedema, hypertension and 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
Nabumetone Tablets with food, drink and alcohol
Take this medicine with or after a meal.
Do not drink alcohol during treatment with Nabumetone
Tablets.

Pregnancy, breast-feeding and fertility
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.
You should not take Nabumetone Tablets during the last 3
months of pregnancy.
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 Tablets you may feel dizzy, tired,
drowsy, confused or notice problems with your eyesight. 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.
3 How to take Nabumetone Tablets
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
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 also
reduce any chance of you having a stroke or heart attack.
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 Tablets. Your doctor will
prescribe this if you need it.

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Package leaflet: Information for the patient
Nabumetone 500 mg film-coated Tablets
Nabumetone

Adults
Ÿ The recommended dose is 1 g taken once a day at
bedtime (as two 500 mg tablets).
Ÿ The label your pharmacist puts on your medicine will tell
you exactly how many tablets to take.
Ÿ If you need to take more, your doctor will explain how
much to take and when to take it.
Elderly (65 years and over)
Ÿ The recommended starting dose is 500 mg taken once a
day at bedtime (as one 500 mg tablet).
Ÿ The label your pharmacist puts on your medicine will tell
you exactly how many tablets to take.
Ÿ If you need to take more, your doctor will explain how
much to take and when to take it.
Ÿ Never take more than 1 g of Nabumetone Tablets each
day (two 500 mg tablets).
Always take this medicine exactly as described in this leaflet
or as your doctor, or pharmacist or nurse has told you. Check
with your doctor or pharmacist or nurse if you are not sure.
Children
Nabumetone Tablets are not recommended for children.
Medical check-ups
When you are taking this medicine, your doctor may ask
you to come for check-ups which may include:
Ÿ Checking your kidneys to make sure they are working
properly. Your doctor may want to do some tests before
you start taking Nabumetone Tablets and then re-check
your kidney function once you have been taking the
medicine for a few weeks.
Ÿ Checking your liver is working properly.
Ÿ Checking you are not getting any problems with swelling
of any part of your body. Your doctor may want to give
you some medicine to help with these symptoms.
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Ÿ If you are elderly you will need to go for check-ups during
the first four weeks of taking the medicine. This is 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 Tablets than you should
Do not take more Nabumetone Tablets 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 many Nabumetone Tablets may make you feel or
be sick, be dizzy or faint, develop a headache or have fits
(convulsions).
If you forget to take Nabumetone Tablets
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 on the use of this medicine,
ask your doctor or pharmacist.

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4 Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Stop taking this medicine and seek immediate medical
help if you have any of the following symptoms:
Ÿ if you notice signs of an allergic reaction: itchy skin rash,
swelling of the face, lips, throat or tongue, or difficulty
breathing or swallowing.
Ÿ 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).
Ÿ chest pains or sudden numbness and confusion.
Ÿ 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.
The following side effects have been reported:
Ÿ Common side effects: (may affect up to 1 in 10 people)
Ÿ Ringing in your ears or problems with the ears
Ÿ Increase in blood pressure (you may feel dizzy and have a
headache)
Ÿ Diarrhoea, constipation, feeling sick, inflammation of the
stomach lining, stomach ache, wind
Ÿ Rash, itchy skin
Ÿ Fluid retention which causes swelling e.g. swollen ankles
Uncommon side effects: (may affect up to 1 in 100 people)
Ÿ Confusion, nervousness, problems sleeping
Ÿ Tiredness, dizziness, headache, “pins and needles” or
tingling feelings, anxiety
Ÿ Problems with your sight or with your eyes
Ÿ Breathing difficulties, nose bleeds
Ÿ Upset stomach, being sick
Ÿ Mouth ulcers, dry mouth
Ÿ Increased skin sensitivity to sunlight or artificial light, red,
raised patches on the skin, sweating
Ÿ Problems with your muscles
Ÿ Problems with your urinary tract
Ÿ Loss of strength or energy, fatigue
Ÿ Abnormal liver enzymes
Very rare side effects: (may affect up to 1 in 10,000 people)
Ÿ Low numbers of blood platelets
Ÿ Inflammation of the lungs causing shortness of breath
and a dry cough
Ÿ Yellowing of your skin and the whites of your eyes
(jaundice), liver failure

Ÿ 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 red patches on the hands and
feet
Ÿ Skin hives, loss of hair
Ÿ A disorder called pseudoporphyria which causes skin
blisters, stomach pains and nervous system problems
Ÿ Kidney problems such as blood in the urine, kidney failure
Ÿ Heavy or unusually prolonged periods
Ÿ Inflammation of the pancreas (pancreatitis)
Other possible side effects where the frequency is not
known
Ÿ Depression, hallucinations
Ÿ 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
Ÿ Vertigo, drowsiness
Ÿ Inflammation of the optic nerve
Ÿ Asthma or worsening of existing asthma
Ÿ Red or purple skin patches
Ÿ A problem with the kidneys known as interstitial
nephritis. The symptoms include fever, rash, enlarged
kidneys, lower back pain, problems when passing water
Ÿ A general feeling of being unwell or “out of sorts”
Ÿ 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
Ÿ Worsening of existing stomach conditions such as
Crohn's disease or ulcerative colitis
Ÿ Heart (cardiac) failure
Important: Medicines such as Nabumetone Tablets may be
associated with a small increased risk of heart attack
(myocardial infarction) or stroke.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Tillomed Laboratories Ltd
3 Howard Road
Eaton Socon, St Neots
Cambridgeshire, PE19 8ET
United Kingdom
Manufacturer
Tillomed Laboratories Ltd
3 Howard Road
Eaton Socon, St Neots
Cambridgeshire, PE19 8ET
United Kingdom
This medicinal product is authorised in the Member
States of the EEA under the following names:
United Kingdom
Nabumetone 500 mg film-coated
Tablets
Belgium
Nabumetone Tillomed 500 mg
comprimés pelliculés
Nabumetone Tillomed 500 mg
filmomhulde tabletten
Nabumetone Tillomed 500 mg
filmtabletten
Ireland
Nabumetone Tillomed 500 mg
film-coated Tablets
This leaflet was last revised in 05/2017.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist
or nurse. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly via the
national reporting system listed in the Yellow Card Scheme
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 Tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry (EXP) date which is
stated on the label. The expiry (EXP) date refers to the last day
of that month.
This medicinal product does not require any special storage
conditions.
Do not throw away any 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 Tablets contain
The active substance is nabumetone.
Each film-coated tablet contains 500 mg nabumetone.
The other ingredients are: Core: Cellulose microcrystalline,
Sodium starch glycolate (TYPE A), Silica colloidal anhydrous,
Hypromellose, Sodium lauril sulfate and Magnesium
stearate. Coating: Hypromellose, Titanium dioxide (E171)
and Macrogol 6000.
What Nabumetone Tablets look like and contents of the
pack
Nabumetone Tablets are white, modified capsule shaped,
film coated tablets, 17.60 mm x 8.10 mm, debossed with "HP"
on one side and "370" on the other side.
The tablets come in a HDPE bottle containing 56 film-coated
tablets.
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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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