Patient leaflet - Nabumetone 500 mg film-coated tablets
1. What Nabumetone Tablets are and what they are used for
Nabumetone Tablets belong to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
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 when you have
taken NSAID medicines. An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips throat or tongue.
if you have or have had a peptic ulcer (ulcer in your
stomach or duodenum) or bleeding in your stomach (2 or more episodes).
if you have had bleeding or ulceration of the upper
gastrointestinal tract related to NSAID therapy.
- if you have severe heart failure.
- if you have severely impaired liver or kidney functions.
if you are in the last three months of pregnancy (third
trimester).
- if you are breast-feeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking Nabumetone Tablets if you:
have a history of gastrointestinal disease such as Crohn’s
disease or ulcerative colitis
- had stomach ulcers or inflammatory bowel disease
- have a serious heart condition called congestive heart failure
- have or have ever had high blood pressure (hypertension)
have peripheral arterial disease (circulation problems in the
limbs, usually in the legs)
are a woman trying to become pregnant or undergoing
investigation for infertility (see ‘Pregnancy and breast-feeding’ section)
- have diabetes
- have high cholesterol (hyperlipidaemia)
- have ever had a stroke
- have had bleeding in the brain or other bleeding problems
- are a smoker
are over 65 years of age as you have a higher risk of
getting side effects
If you are going to be treated for a long time you should have regular medical tests for side effects and kidney function.
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.
You should take the lowest dose for the shortest time necessary to relieve your symptoms.
Children
Do not give Nabumetone Tablets to children.
Other medicines and Nabumetone Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.This includes herbal medicines.
Other medicines which may interact with Nabumetone Tablets:
Anticoagulants such as warfarin or heparin (to thin your
blood)
Selective Serotonin Reuptake Inhibitors (SSRI’s) (to treat
depression)
Oral antidiabetics such as chlorpropamide and metformin
(to control blood sugar levels)
Anti-hypertensives such as ACE inhibitors or angiotensin
receptor agonists (to reduce high blood pressure)
Cardiac glycosides such as digoxin (to manage certain
heart conditions)
Ciclosporin and tacrolimus (to prevent transplanted organs
being rejected)
- Corticosteroids (to reduce inflammation)
- Diuretics (water tablets to make you pass more urine)
- Lithium (to treat mental illness)
- Methotrexate (to treat arthritis)
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs or
COX-2), including ibuprofen, aspirin (acetylsalicylic acid), diclofenac, naproxen, clopidogrel
- Quinolone, aminoglycosides (antibiotics)
- Probenecid (used to treat gout)
- Zidovudine (to treat HIV/AIDS)
Highly protein-bound drugs such as sulphonamides,
sulphonylureas, probenecid, sulfinpyrazone or hydantoin
Nabumetone Tablets with food, drink and alcohol
Do not drink alcohol during treatment with Nabumetone Tablets as there is an increased risk of stomach ulcers or bleeding.
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.
Do not take Nabumetone Tablets if you are in the last 3 months of pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and cause labour to be later or longer than expected. You should not take Nabumetone Tablets during the first 6 months of pregnancy or while breastfeeding unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, Nabumetone Tablets can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.
Nabumetone Tablets may make it more difficult to become pregnant. Speak to your doctor if you are having problems.
Driving and using machines
Dizziness and confusion have been reported after taking Nabumetone Tablets. If these symptoms occur, do not drive or operate machinery.
Nabumetone 500mg film-coated Tablets contain sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
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.
Adults
- The recommended dose is 1 g (2 x 500 mg tablets).taken as a single night time dose with or without food
- For severe or persistent symptoms, or during flare ups, an extra 500 mg (1 x 500 mg tablet) to 1 g (2 x 500 mg tablets) may be given as a morning dose
- For short-term conditions, 1 g (2 x 500 mg tablets) may be given to start with
- The total dosage should not be more than 2 g (4 x 500 mg tablets) a day
Elderly (65 years and over)
- The recommended starting dose is 500 mg (1 x 500 mg tablet) taken as a single night time dose with or without food
The total daily dosage should not be more than 1 g (2 x
500 mg tablets)
Children
Nabumetone Tablets are not recommended for use in children.
If you take more Nabumetone Tablets than you should
If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you.
Symptoms of overdose may include: feeling or being sick, stomach pain, diarrhoea, disorientation, excitation, coma, drowsiness, dizziness or fits (convulsions). Kidney failure and liver damage are also possible.
If you forget to take Nabumetone Tablets
Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.
If you stop taking Nabumetone Tablets
It is important that you keep taking this medicine for as long as your doctor has told you to. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking this medicine and and contact your doctor immediately if you notice any of the following symptoms:
Allergic reactions: sudden wheeziness, difficulty in breathing
(anaphylaxis), swelling of the eyelids, face or lips, rash or itching
- 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, abdominal pains (pains in your stomach), indigestion or heartburn. Peptic ulcers (ulcer in your stomach or duodenum), or stomach or intestinal bleeding, sometimes fatal, particularly in the elderly may occur
- Peeling of the skin over large areas of the body (exfoliative dermatitis)
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Nabumetone 500 mg
Film-coated Tablets
Nabumetone 500 mg Tablets
Package leaflet (POM)
L. 286 x H. 311 mm
510522057GB03 Refer to remark UK
All
NA
1502
9 points (Reg text)
510522057GB02
CC 271543 (SPC Update)
L. 32 x H. 32 mm
Severe blistering of the skin, mouth, eyes and genitals
(Stevens Johnson syndrome, toxic epidermal necrolysis)
Frequent wheezing, breathlessness, abdominal pain,
diarrhoea, fever, cough and rashes due to an increase in certain white blood cells (eosinophilia)
Fever, general ill feeling, swollen/enlarged lymph nodes
and skin eruption (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS])
Potentially serious adverse drug reaction (hypersensitivity
syndrome).
The following side effects have been reported:
Common side effects: (may affect up to 1 in 10 people)
- Ringing in your ears (tinnitus) or ear disorders
- Increase in blood pressure
Diarrhoea, constipation, indigestion (dyspepsia), feeling
sick (nausea), inflammation of the stomach lining (gastritis), stomach ache, wind (flatulence)
- Rash, severe itching (pruritus)
- Fluid retention which causes swelling of the body (oedema)
Uncommon side effects: (may affect up to 1 in 100 people)
- Confusion
- Nervousness
- Problems sleeping (insomnia), tiredness (somnolence)
- Dizziness
- Headache
- Tingling or numbness in the hands or feet (paraesthesia)
- Anxiety
- Abnormal vision, eye disorders
- Shortness of breath or difficulty in breathing (dyspnoea)
- Nose bleeds
- Being sick (vomiting)
- Inflammation of the mouth (stomatitis), dry mouth
- Increased skin sensitivity to sunlight
- Skin rashes with the formation of wheals (urticaria)
- Sweating
- Muscle weakness
- Urinary tract disorders
- General weakness (asthenia)
- Tiredness, weakness or lack energy (fatigue)
- Abnormal liver enzymes (detected in a blood test)
Very rare side effects: (may affect up to 1 in 10,000 people)
A reduction in blood platelets, which increases risk of
bleeding or bruising (thrombocytopenia)
- Inflammation of the lungs (interstitial pneumonitis)
Yellowing of the skin or whites of the eyes (jaundice), liver
failure
- Loss of hair (alopecia)
Skin condition that causes blisters and fragile skin on
sun-exposed areas (pseudoporphyria)
- Protein in the urine (nephrotic syndrome), kidney failure
Abnormally heavy and prolonged menstrual periods
(menorrhagia)
- Inflammation of the pancreas (pancreatitis)
Not known (frequency cannot be estimated from the available data)
More prone to infections due to a severe reduction in
number of white blood cells (neutropenia, agranulocytosis, leucopenia)
Severe reduction in blood cells which can cause weakness,
bruising or make infections more likely (aplastic anaemia)
Reduction in red blood cells which can make the skin pale
yellow and cause weakness or breathlessness (haemolytic anaemia)
- Depression
- Hallucinations
Serious inflammation of the linings of the brain (aseptic
meningitis). Symptoms include stiff neck, headache, feeling or being sick, fever, disorientation, especially in patients with an existing autoimmune disorder such as systemic lupus erythematosus or mixed connective tissue disorder
A sensation of whirling and loss of balance, feeling dizzy or
giddy (vertigo)
- Drowsiness
Inflammation of the optic nerve causing blurring, blind
spots, distorted vision, reduced colour vision and pain when moving the eyes. In a small number of cases blindness may occur (optic neuritis)
- Asthma or worsening of existing asthma, difficulty in breathing or wheezing (bronchospasm)
- Skin rash caused by small blood vessels bleeding into the skin (purpura)
- Inflammation of the kidney (interstitial nephritis)
- Generally feeling unwell (malaise)
- Worsening of Crohn’s disease or ulcerative colitis
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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 date which is stated on the carton/label after EXP. The expiry date refers to the last day of that month.
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
Each film-coated tablet contains 500 mg of 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. Nabumetone is available in an HDPE bottle containing 56 tablets.
Marketing Authorisation Holder and Manufacturer
Tillomed Laboratories Ltd
220 Butterfield
Great Marlings Luton
LU2 8DL
United Kingdom
This leaflet was last revised in 08/2026
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To get this information in large print or another format, please email medical.information@tillomed.com or call 0800 970 6115.