Patient Medication Information: uses, side effects, how to take - Mylan-Nabumetone
ABOUT THIS MEDICATION
What the medication is used for:
MYLAN-NABUMETONE is a nonsteroidal anti-inflammatoiy drug (NSAID). It has been prescribed for you by your doctor to treat arthritic symptoms such as swelling, stiffness and joint pain.
What it does:
NSAIDs do not cure arthritis, but they promote suppression of the inflammation and the tissue damaging effects resulting from this inflammation. This medicine will help you only as long as you continue to take it.
When it should not be used:
Do not take MYLAN-NABUMETONE if you are allergic to nabumetone or to any non-medicinal ingredients of MYLAN-NABUMETONE.
What the medicinal ingredient is: Your tablets contain the active ingredient nabumetone.
What the non-medicinal ingredients are: MYLAN-NABUMETONE contains the following non-medicinal ingredients: microcrystalline cellulose, sodium lauryl sulphate, saccharin sodium, hydroxypropyl methylcellulose, sodium starch glycollate, magnesium stearate, titanium dioxide, polyethylene glycol, and talc.
What dosage forms it comes in: The 500 mg tablets are white, film-coated, capsule-shaped tablets with “G” on one side and “NB 500" on the other side.
Check with your doctor or pharmacist if the identifying markings or colour of your tablets appear different.
WARNINGS AND PRECAUTIONS
BEFORE you use MYLAN-NABUMETONE it is important that you tell your doctor or pharmacist about any of the following items so that your doctor may determine if MYLAN-NABUMETONE is suitable for you:
- Allergy (including rash, asthma, hives, sinusitis or anaphylaxis [sudden collapse]) when previously taking MYLAN-NABUMETONE or related anti-inflammatory medicines (e.g. ASA [acetylsalicylic acid], diclofenac, diflunisal, fenoprofen, flurbiprofen, ibuprofen, indomethacin, ketoprofen, mefenamic acid, naproxen, piroxicam, tenoxicam, tiaprofenic acid and tolmetin).
- Family member with asthma, nasal polyps, chronic sinusitis or chronic urticaria (hives).
- Past history of (or current) stomach upset, ulcer, or liver, kidney or heart disease.
- Blood or urine abnormalities.
- High blood pressure.
- Diabetes.
- Special diet, such as low sodium or low sugar diet.
Pregnancy or intention to become pregnant while using MYLAN-NABUMETONE.
- Infant breast feeding.
- Other medical conditions such as alcohol abuse, bleeding problems etc.
While taking this medication:
- tell any other doctor, pharmacist or dentist you see, that you are taking MYLAN-NABUMETONE.
- contact your doctor if you are not getting any relief of your arthritis or if you develop any unusual discomfort.
- report any untoward reactions to your doctor. This is very important as it will aid in the early detection and prevention of potential complications.
- regular medical checkups are essential.
- you should not take MYLAN-NABUMETONE when pregnant or breast feeding unless your doctor tells you to.
- do not take ASA (acetylsalicylic acid) or other drugs to relieve your arthritis unless directed by your doctor.
- not recommended for use in children since safety and effectiveness have not been established.
- do not give MYLAN-NABUMETONE to others because it may not be suitable for them.
INTERACTIONS WITH THIS MEDICATION
Tell your doctor if you are taking any other medication (either prescription or non-prescription) such as other NSAIDs, high blood pressure medication, blood thinners, corticosteroids, methotrexate, cyclosporin, lithium, phenytoin. It is important to tell your doctor, dentist and pharmacist if you are taking other medication, as combining drugs can sometimes result in a change from the expected drug effects, or cause harmful effects.
PROPER USE OF THIS MEDICATION
Usual Dose:
You should take MYLAN-NABUMETONE only as directed by your doctor. Do not take more of it, do not take it more often and do not take it for a longer period of time than your doctor ordered. Taking too much of any of these medicines may increase the chance of unwanted effects, especially if you are an elderly patient.
Be sure to take MYLAN-NABUMETONE regularly as prescribed. Try to take your tablets at the same time each day. The effect of MYLAN-NABUMETONE is evident early in treatment, however, in some types of arthritis, up to 1 week may pass before you feel the full relief from this medicine. It is important to keep taking MYLAN-NABUMETONE even after you start to feel better.
Generally, patients are instructed to take 1000 mg once a day. During treatment, your doctor may decide to increase the dosage up to 2000 mg each day, according to your response to the medication. In that case it may be divided in two doses per day.
Stomach upset is one of the common problems with NSAIDs. To lessen stomach upset, take this medicine immediately after a meal or with food or milk. You should swallow the tablets whole, with water or milk. Do not chew them. You should remain standing or sitting upright (i.e., do not lie down) for about 15 to 30 minutes after taking the medicine. This helps to prevent irritation that may lead to trouble swallowing. If stomach upset (indigestion, nausea, vomiting, stomach pain or diarrhea) occurs and continues, contact your doctor.
If you are prescribed this medication for use over a long period of time, your doctor will check your health during regular visits to assess your progress and to ensure that this medicine is not causing unwanted effects.
Important: Your doctor may give you different instructions better suited to your specific needs. If you need more information on how to take MYLAN-NABUMETONE properly, double check with your doctor or pharmacist.
Overdose:
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose:
If you forget to take a tablet, leave out that dose completely. Take your next dose at the normal time it is due.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Any medication can cause side effects. Most people tolerate the medicine well. Elderly, frail or debilitated patients often seem to experience more frequent or more serious side effects. The most common adverse effects associated with MYLAN-NABUMETONE are gastrointestinal, such as diarrhea, indigestion, abdominal pain, nausea, constipation and flatulence (i.e., large amounts of gas in the intestines). Stomach problems may be more likely to occur if you drink alcoholic beverages. Therefore, do not drink alcoholic beverages while taking this medication.
Other side effects such as headaches, tiredness, dizziness, sleepiness, insomnia (i.e., not able to sleep) have also been
observed. If dizziness occurs after taking MYLAN-NABUMETONE, do not drive or operate machinery.
Consult your doctor if these symptoms become troublesome.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND | ||
| WHAT TO DO ABOUT THEM |
Consult your doctor if the following occur:
- shortness of breath, wheezing, troubled breathing or tightness in chest
- blurred vision or any visual disturbance, ringing in the ears or hearing problems
- skin rash, hives, swelling or itching
- swelling of face, feet or lower legs
- vomiting or persistent indigestion, nausea, stomach pain or diarrhea
- yellow discoloration of the skin or eyes
- any change in the amount of, or colour of your urine (dark red or brown)
- any pain or difficulty experienced while urinating
- malaise, fatigue, loss of appetite
- mental confusion, depression, dizziness, lightheadedness
If you develop a skin rash or asthma while you are taking MYLAN-NABUMETONE, do not take any more tablets and contact your doctor at once.
Check with your doctor immediately if you experience unexpected weakness while taking this medication, or if you vomit any blood or have dark or bloody stools.
Some people may become more sensitive to sunlight than they are normally. Exposure to sunlight or sunlamps, even for brief periods of time, may cause sunburn, blisters on the skin, skin rash, redness, itching or discoloration; or vision changes. If you have a reaction from the sun, check with your doctor.
Check with your doctor immediately if chills, fever, muscle aches or pains, or other flu like symptoms occur, especially if they occur shortly before, or together with, a skin rash.
Very rarely, these effects may be the first signs of a serious reaction to this medication.
This is not a complete list of side effects. For any unexpected effects while taking MYLAN-NABUMETONE, contact your doctor or pharmacist.
HOW TO STORE IT
Store your tablets in a dry place at room temperature in the original container provided by the pharmacy. Keep this medication out of reach of children. Do not keep outdated medicine or medicine no longer needed.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- 1. Report online at www.healthcanada.gc.ca/medeffect
- 2. Call toll-free at 1-866-234-2345
- 3.
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701D
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at
www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.mylan.ca
or by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379