NABUMETONE 500 MG TABLETS

Active substance: NABUMETONE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

NABUMETONE 500 MG TABLETS
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

1. WHAT NABUMETONE TABLETS ARE AND WHAT THEY ARE USED FOR
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
Do not take Nabumetone if you:
- 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.
- have had attacks of asthma, urticaria (nettle rash) or rhinitis (inflammation of the lining of the nose) when you have
taken aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs)
- have, or suffer from, stomach ulcers
- have a severe liver disorder, (e.g. cirrhosis)
- have had severe heart failure
Take special care with Nabumetone (and talk to your doctor) 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
- 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 at risk of heart disease because you have high blood pressure, high lipid levels, diabetes, or you smoke
- have a kidney or liver disorder.
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.
- other painkillers (including aspirin)
- corticosteroids (drugs that reduce inflammation, such as hydrocortisone)
- anti-coagulants (blood thinners)
- anticonvulsants (treatment for epilepsy)
- sulphonylurea hypoglycaemics (chlorpropamide, glibenclamide - treatment for diabetes)
- cardiac glycosides or ACE Inhibitors (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)
It may still be all right for you to be given Nabumetone and your doctor will be able to decide what is suitable for you.
Taking Nabumetone with food and drink
Nabumetone tablets should be taken with or after food.
Pregnancy and breast-feeding
If you are thinking about taking Nabumetone, tell your doctor if you are pregnant or wish to become pregnant. Also tell
your doctor before breast-feeding your baby. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
If you feel dizzy, tired, have problems with your vision or have headaches after taking Nabumetone, you should not drive
or operate machinery.

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.
- 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.
Nabumetone tablets are not recommended for children.
If you take more Nabumetone than you should
If you have accidentally taken too many tablets you must contact your doctor or local casualty department, as soon as possible.
If you forgot to take Nabumetone
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 straight
away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching
(especially affecting your whole body).
The following side effects have been reported:
Dry mouth, diarrhoea, indigestion, nausea (feeling sick), constipation, abdominal (tummy) pain, vomiting, mouth ulcers,
stomach ulcers, inflammation of the stomach, flatulence (wind).
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.

Other side effects:
Headache, dizziness, tiredness, confusion, sleepiness, depression, insomnia, tinnitus (ringing in the ears), abnormal
vision, oedema (swelling due to water retention), menorrhagia (heavy periods in women), paraesthesia (a pins and
needles feeling), hallucinations, vertigo (spinning sensation), malaise (feeling ill), allergic reactions (some severe) have
also been reported. Skin reactions including rash, pruritus (ichiness), urticaria (nettle rash), alopecia (hair loss) and
light sensitivity reactions may occur.
Very rarely:
Altered liver function tests, jaundice (yellow skin and eyes), liver failure, severe skin eruptions (blistering or peeling of
the skin) and blood disorders (symptoms include unusual bruising, abnormal bleeding, fever or sore throat)
There have been rare reports of kidney problems including kidney failure.
Medicines such as nabumetone may be linked to a small increased risk of heart attack or stroke.
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
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 and Manufacturer:
The Product Licence holder is Cipla (EU) Ltd., Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW.
The manufacturer responsible for batch release is Fannin (UK) Ltd., 57 High Street, Odiham, Hants, RG29 1LF.
This leaflet was approved in
This leaflet was last revised in August 2012.

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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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