Nabumetone 500 mg film-coated Tablets

• 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.

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

• 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.

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.

Do not give Nabumetone Tablets to children.

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

Do not drink alcohol during treatment with Nabumetone Tablets as there is an increased risk of stomach ulcers or bleeding.

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.

Dizziness and confusion have been reported after taking Nabumetone Tablets. If these symptoms occur, do not drive or operate machinery.

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

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.

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.

It is important that you keep taking this medicine for as long as your doctor has told you to.

• 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)
• 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

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.

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.

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.