Nabumetone 500mg Tablets Bp
NABUMETONE 500 mg TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 get 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 is and what it is used for
2. Before you take Nabumetone
3. How to take Nabumetone
4. Possible side effects
5. How to store Nabumetone
6. Further information
1. WHAT NABUMETHONE IS AND WHAT IT IS USED FOR
Nabumetone belongs to a group of medicines called non steroidal anti-inflammatory drugs (NSAIDs).
Nabumetone is used to relieve pain, stiffness and swelling of the joints affected by osteoarthritis or rheumatoid arthritis.
2. BEFORE YOU TAKE NABUMETHONE
DO NOT take Nabumetone and talk to your doctor if you:
• are allergic to nabumetone or any of the other ingredients of this medicine (see section 6),
• 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,
• ever had an allergic reaction like rash, runny nose, swelling, or become short of breath when you have taken aspirin, ibuprofen or other non-steroidal anti-inflammatory drugs,
• have ever had any serious problems with your kidneys (kidney failure), liver (liver cirrhosis) or heart (heart failure),
• have ever had a stroke,
• are in the last three months of pregnancy or are breastfeeding,
• have or had any bleeding caused by taking NSAIDs.
Take special care with Nabumetone
Tell your doctor before you start to take this medicine if you:
• are in early pregnancy or may become pregnant,
• have got swollen ankles, high blood pressure or heart disease,
• suffer from or have suffered from asthma, or difficulty in breathing or wheezing,
• suffer from or have suffered from peptic ulcer,
• suffer from Stevens-Johnson syndrome or toxic epidermal necrolysis,
• have kidney problems,
• have liver problems,
• have, or ever had stomach problems. This includes Crohn’s disease or ulcerative colitis (abdominal pain, diarrhoea, vomiting or weight loss).
• are elderly (65 years or older) ,
• have uncontrolled high blood pressure,
• have fluid retention,
• are being started on a longer-term treatment and have high levels of fats in your blood, diabetes, or if you are a smoker,
• have a problems with prostaglandins in your body,
• suffer from lupus (SLE),
• are female and having fertility problems,
• have previously suffered from asthma or ever had an allergic reaction like rash, runny nose, when you have taken aspirin or other non-steroidal anti-inflammatory drugs.
Medicines such as Nabumetone may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.
Taking other medicines
Talk to your doctor if you are taking any of the following:
• medicines to thin your blood (warfarin),
• aspirin or any other NSAID medicines,
• if you are taking any protein binding medicines for your blood, as your dose may need to be changed,
• medicines for particular heart conditions (congestive heart failure or an irregular heartbeats),
• if you are taking diuretics (water tablets) your dose may need to be changed,
• medicines to control high blood pressure e.g. antihypertensives, as nabumetone can reduce the way the antihypertensive effect,
• lithium (used to treat depression),
• methotrexate (used to treat some types of tumours, psoriasis or rheumatoid arthritis),
• corticosteroids, as there is a risk of getting an ulcer or internal bleeding,
• mifepristone (steroids), NSAIDs should not be given for 8-12 days after the mifepristone,
• anti-platelet agents and selective serotonin -re-uptake inhibitors (SSRIs) used to treat depression, as there is a risk of bleeding,
• tacrolimus or ciclosporin (used to stop organ transplants being rejected), when given with NSAIDs increases the risk of kidney problems,
• zidovudine (used to treat HIV and AIDS) as there is a risk of blood problems,
• sulphonamides (antibacterial agent),
• sulphonylureas (anti-diabetics),
• hydantoins (to prevent fits),
• if you are also taking Quinolone antibiotics there is a risk of having fits.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
Important information about some of the ingredients of Nabumetone
• Patients who are intolerant to lactose should note that Nabumetone tablets contain a small amount of lactose. If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking this medicine.
Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant or are breast-feeding, ask your doctor for advice before taking this medicine. Your doctor will decide if you can take it.
Driving and using machines
Nabumetone may cause dizziness, drowsiness, fatigue, or visual disturbances. If you are affected, DO NOT drive or operate machinery.
3. HOW TO TAKE NABUMETONE
For Oral use: Swallow the tablets whole with water preferably with or after food.
Always take Nabumetone exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The label will tell you how many to take and how often to take them. The number of tablets you take is called a ‘dose’. The most common dose for adults is 1g (two tablets) to be taken daily at bedtime. Your doctor may increase this dose by one or two tablets a day in some cases. Your doctor will tell you to take this dose in the morning.
Your doctor will give you the lowest effective dose for the shortest time possible.
If you are seeing another doctor or visit a hospital, remember to tell them what medicines you are already taking.
If you are elderly (65 years or over) the daily dose of nabumetone tablets is two tablets once a day. This is also the maximum recommended dose for elderly patients. Your doctor may sometimes prescribe less than this. If you are elderly your doctor will monitor you during the first 4 weeks of treatment with this drug.
Use in Children
Nabumetone tablets are not recommended for children.
If you take more Nabumetone than you should
If you (or someone else) swallow too many Nabumetone tablets, or if you think a child has swallowed any of the Nabumetone tablets, contact your nearest hospital casualty department or your doctor immediately.
Please take this leaflet, any remaining Nabumetone tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
If you forget to take Nabumetone
If you forget to take a dose at the right time, take it as soon as you remember. Do not take two doses together. If it is almost time to take the next dose, wait until then and then carry on as before.
If you stop taking Nabumetone
• You should continue to take your tablets unless your doctor tells you not to. DO NOT stop just because you feel better.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all other medicines Nabumetone can cause side effects, although not everybody gets them.
Stop taking Nabumetone tablets and tell your doctor immediately or go to the casualty department at your nearest hospital if the following happens:
• an allergic reaction causing swelling of the lips, face or neck leading to severe difficulty in breathing, severe skin rash or hives.
This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.
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 pains (pains in your stomach) or other abnormal stomach symptoms.
If taken at high doses for long periods there is an increased risk of heart attaches or strokes.
The following side effects have been reported at the approximate frequencies shown:
Common
ringing in the ears, increase in blood pressure, diarrhoea, constipation, bloating, rash, itching, oedema (fluid retention), indigestion, stomach pain.
Uncommon
confusion, nervousness, sleep disturbances (difficulty in sleeping, sleepiness), dizziness, headache, numbness, abnormal vision, shortness of breath, nose bleed, duodenal ulcer, gastric ulcer, mouth ulcers or dry/ sore mouth, sensitivity to light, vomiting, nettle rash, sweating, pain or weakness in muscles, urinary tract disorders, Lethargy, fatigue, pins and needles, inflammation of the mouth, elevated liver function tests.
Very rare
reduction in blood platelets, which increases risk of bleeding or bruising, serious allergic reaction which causes difficulty in breathing or dizziness, lung abnormalities, problems with your liver e.g. jaundice (yellowing of the skin or eyes), hepatitis, Serious illness with blistering of the skin, mouth, eyes and genitals, hair loss, kidney problems, abnormal heavy or long menstrual periods.
Other side-effects
• blood disorder which may be characterised by fever or chills, sore throat, ulcers in your mouth or throat
• severe reduction in the number of white blood cells which makes infections more likely;
• severe reduction in blood cells which can cause weakness, bruising or make infections more likely.
Medicines such as Nabumetone (NSAIDs) may be associated with a small increased risk of heart attack (myocardial infraction) or stroke.
If you are elderly, the side effects of an adverse reaction may increase. If you feel unwell in any other way, please tell your doctor as soon as you can.
5. HOW TO STORE NABUMETONE
Keep out of the reach and sight of children.
You should keep you tablets in a cool dry place below 25oC
Do not use Nabumetone after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month. Do not use Nabumetone if you notice signs of deterioration.
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:
Each film-coated tablet contains:
• Nabumetone 500 milligrams (mg) (active ingredient),
• Maize starch, sodium starch glycollate, povidone, microcrystalline cellulose, magnesium stearate, hydroxypropylmethylcellulose, lactose monohydrate, PEG 4000, carmoisine lake (E122), titanium dioxide (E171), caramel flavouring, talc, saccharin sodium, FD&C blue #2, indigo carmine lake (E132) (inactive ingredients)
What Nabumetone tablets look like and contents of the pack:
Nabumetone tablets are dark red.
They come in packs of 56.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company responsible for manufacture: Norton Healthcare Limited, T/A IVAX Pharmaceuticals UK, Albert Basin, Royal Docks, London E16 2QJ, United Kingdom.
This leaflet was last revised: November 2010 PL 00530/0575