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Document: leaflet MAH GENERIC_PL 20417-0054 change

• leaflet MAH GENERIC_PL 00530-0575
• leaflet MAH GENERIC_PL 20417-0054

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PACKAGE LEAFLET : INFORMATION FOR THE USER NABUMETONE 500mg TABLETS

(nabumetone)

The name of this medicine is Nabumetone 500mg Tablets, which will be referred to as Nabumetone Tablets throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine.

-    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    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.

In this leaflet:

1.    What Nabumetone Tablets are and what they are used for

2.    Before you take Nabumetone Tablets

3.    How you take Nabumetone Tablets

4.    Possible side effects

5.    How to store Nabumetone Tablets

6.    Further information

Each Nabumetone Tablet contains 500 mg of the active ingredient nabumetone.

Nabumetone belongs to a group of drugs called non-steroidal anti-inflammatory drugs (also known as NSAIDs), which relieve pain and reduce inflammation. Nabumetone is used to treat pain and inflammation caused by osteoarthritis or rheumatoid arthritis.

2. BEFORE YOU TAKE NABUMETONE TABLETS

Do not take Nabumetone Tablets if you:- have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation.

-    have had GI bleeding or perforation after taking other NSAIDs

-    are allergic (hypersensitive) to nabumetone or any of the other ingredients of Nabumetone Tablets (see list of ingredients in Section 6). An allergic reaction may include skin rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.

-    are taking any other NSAIDs (non-steroidal anti-inflammatory drugs)

-    have had attacks of asthma, urticaria (nettle rash), angioedema (swelling around the mouth, throat and tongue) or rhinitis (inflammation of the lining of the nose) when you have taken ibuprofen, aspirin or other NSAIDs

-    have a severe liver disorder, (e.g. cirrhosis)

-    have severe kidney disease

-    have had severe heart failure

-    are in the last trimester of pregnancy

Take special care with Nabumetone Tablets if you:

-    are or maybe pregnant or breast-feeding

-    suffer from asthma or have ever had asthma

-    have had a disease of the digestive tract such as colitis or Crohn’s disease

-    suffer from fluid retention

-    have had hypertension (high blood pressure) or heart failure

-    have heart disease

-    have peripheral arterial disease (a disease of the blood vessels)

-    have cerebrovascular disease (a disease of the blood vessels in the brain)

-    are elderly, your doctor will give you regular check ups during your treatment with nabumetone

-    are taking other medicines such as steroids, blood thinners (e.g. warfarin) or aspirin

-    are trying to become pregnant, nabumetone is not recommended for women who are trying to become pregnant

-    have a kidney or liver disorder

-    have systemic lupus erythematosus (SLE), or other connective tissue disorders, your doctor will tell you if you have these disorders

-    suffer from blurred vision or any visual disturbance, your doctor may refer you to an optician

If you suffer from any of the following at any time during your treatment STOP TAKING the medicine and seek immediate medical help:

•    Pass blood in your faeces (stools/motions)

•    Pass black tarry stools

•    Vomit any blood or dark particles that look like coffee grounds

STOP TAKING the medicine and tell your doctor if you experience:

•    Indigestion or heartburn

•    Abdominal pain (pains in your stomach) or other abnormal stomach symptoms.

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 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.

Nabumetone Tablets should be discontinued at the first sign of skin reactions.

NSAIDs can hide signs of infections.

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. This is particularly true of the following as they may interact with your Nabumetone Tablets:

-    other NSAIDs (painkillers such as aspirin or ibuprofen)

-    corticosteroids (drugs that reduce inflammation, such as hydrocortisone)

-    anti-coagulants (blood thinners such as warfarin)

-    anticonvulsants (treatment for epilepsy)

- anti-platelet agents (medicines that help prevent the formation of blood clots)

- selective serotonin reuptake inhibitors (SSRIs) - medicines used to treat depression

-    sulphonylurea hypoglycaemics (chlorpropamide, glibenclamide - medicines used to treat diabetes)

-    sulphonamides (anti-bacterial agents)

-    cardiac glycosides (treatment for heart conditions, such as digoxin)

-    lithium (treatment for mental illness)

-    methotrexate (treatment for rheumatoid arthritis and cancer)

-    diuretics (water tablets)

-    antihypertensives (drugs that reduce blood pressure)

-    mifepristone (a drug used for abortion)

-    quinolines (a type of antibiotic)

-    ciclosporin or tacrolimus (medicines used to prevent organ rejection after a transplant), they may increase the risk of kidney damage

-    zidovudine (to treat HIV)

It may still be all right for you to take nabumetone and your doctor will be able to decide what is suitable for you.

Taking Nabumetone Tablets with food and drink

Nabumetone Tablets should be taken with or after food.

Pregnancy and breast-feeding

Do not take Nabumetone Tablets during the last trimester of your pregnancy. You should not take nabumetone if you are pregnant or breast-feeding unless your doctor has advised you to do so. If you are thinking about taking nabumetone, tell your doctor if you are pregnant or wish to become pregnant. Ask your doctor or pharmacist for advice before taking any medicine.

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Driving and using machines

Do not drive or operate machinery if you suffer from any of the side effects and feel dizzy, tired, have problems with your vision or have headaches after taking nabumetone.

3. HOW YOU TAKE NABUMETONE TABLETS

Dosage

Always take nabumetone exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Take the tablets with or after food.

-    The usual dose for adults is two tablets (1 g) taken as a single dose at bedtime.

- For severe or long-lasting symptoms, or for sudden flare-ups, an extra one or two tablets (500 mg - 1 g) may be given as a morning dose.

- For elderly patients, the maximum dose is 2 tablets (1 g) per day. Your doctor will prescribe the lowest dose you need to control your symptoms.

Nabumetone Tablets are not recommended for children.

If you take more Nabumetone Tablets than you should

If you have accidentally taken too many tablets you must contact your doctor or local accident and emergency department, as soon as possible. Take the remaining medicines in the container with you.

Symptoms of an overdose include headaches, feeling sick (nausea), being sick (vomiting), stomach pains, diarrhoea, bleeding from stomach or gut (signs are blood in stools, vomiting blood), feeling excitable or disorientated, drowsiness, fits, ringing in the ears, dizziness, liver and kidney damage, fainting or coma.

If you forgot to take Nabumetone Tablets

If you have forgotten to take your medicine, do not make up for this by taking an extra tablet. Continue with your usual routine and take the next tablet at the next prescribed time.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, nabumetone can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, although serious allergic reactions are very rare.

Tell your doctor or a hospital accident and emergency department straight away if you get any of the following symptoms:

•    Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, skin rash, redness, peeling or itching (especially affecting your whole body).

The following side effects have been reported:

Common side effects (affecting up to 1 in 100 people)

•    tinnitus; ear disorder

•    oedema

•    increase in blood pressure

•    diarrhoea; constipation; indigestion; inflammation of the lining of the stomach (gastritis); feeling sick (nausea); tummy pain; flatulence

•    rash; itching (pruritis)

Uncommon side effects (affecting up to 1 in 1,000 people)

•    confusion

•    nervousness

•    insomnia; sleepiness

•    stomach ulcers; gastrointestinal bleeding; gastrointestinal disorder; black faeces; being sick with blood in it; inflammation of the mucous lining of the mouth; dry mouth

•    dizziness, headache (you may have high blood pressure)

•    tingling or numbness in the hands or feet (paresthsia); pain or weakness of the muscles (myopathy)

•    abnormal vision; eye disorder

•    shortness of breath; respiratory disorder; nosebleed

•    urinary tract disorder

•    feeling of weakness (asthenia); tiredness (fatigue)

•    elevated liver function tests

•    increased sensitivity to light; hives (urticaria); sweating

Very rare side effects (affecting less than 1 in 10,000 people)

•    blood disorders which may increase the risk of bleeding or bruising or which can lead to an increased risk of infection

•    lung disease

•    kidney failure; inflammation of the kidneys

•    liver failure; yellowing of the skin or whites of the eyes caused by liver or blood problems

•    abnormal heavy or prolonged periods in women

•    skin reactions including severe blistering of the skin; Stevens-Johnson syndrome (blistering of the skin, mouth, eyes and genitals); rash; swelling of the skin; skin sensitivity; hair loss (alopecia)

•    inflammation of the pancreas

Other possible side effects

•    inflammation of the eye

•    depression (feeling sad)

•    hallucinations (seeing or hearing things that are not there)

•    generally feeling unwell

Occasionally bleeding of the stomach may occur (signs of this are blood in your vomit or passing black stools), if you notice either of these symptoms, stop taking the tablets and consult your doctor straight away.

There have been reports of aseptic meningitis (bacterial infection), especially in patients with auto-immune diseases such as systemic lupus erythmatosus (SLE) or other connective tissue disorders. Symptoms include a stiff neck, headache, nausea, vomiting, fever or disorientation.

Medicines such as nabumetone may be linked to 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 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.

5. HOW TO STORE NABUMETONE TABLETS

Nabumetone Tablets should be kept out of the reach and sight of children. Do not store above 25 °C. Store in the original package.

Do not take this medicine after the expiry date shown on the label.

If you notice any defects, or if the tablets are broken or chipped, contact your pharmacist for advice before taking them.

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 is nabumetone hydrochloride.

The other ingredients are: Tablet: maize starch, sodium starch glycollate (Type A), povidone, sodium lauryl sulphate, colloidal silicon dioxide and magnesium stearate. Film Coating: hypromellose, titanium dioxide, talc, red iron oxide and glycerol triacetate

What Nabumetone Tablets look like and contents of the pack:

Nabumetone 500mg Tablets are brown, capsule shaped tablets, marked with NEO on one side and NBU500 on the other.

Blister packs containing 8, 56, or 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough, Northamptonshire, NN8 6GT, UK Manufacturer responsible for batch release:

Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent, TN24 0GR, U.K.

Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.

This leaflet was last approved in June 2015.

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