Patient Medication Information: uses, side effects, how to take - M-Febuxostat
What the medication is used for:
M-FEBUXOSTAT is used to lower uric acid levels in adult patients with gout. It is used when allopurinol has not worked well enough or when allopurinol is not right for you.
What it does:
M-FEBUXOSTAT contains febuxostat which is a xanthine oxidase (XO) inhibitor. M-FEBUXOSTAT works to lower the uric acid in the blood by selectively inhibiting XO involved in uric acid formation. The normal uric acid level should be lower than 360 µmol/L (6.0 mg/dL).
When it should not be used:
Do not take M-FEBUXOSTAT if you are allergic to febuxostat or any other ingredients in M-FEBUXOSTAT.
Do not take M-FEBUXOSTAT if you take:
- azathioprine
- mercaptopurine
What the medicinal ingredient is:
Febuxostat as (febuxostat hemihydrate).
What the important nonmedicinal ingredients are:
Lactose monohydrate, microcrystalline cellulose, Pregelatinized starch, sodium croscarmellose, colloidal silicon dioxide and magnesium stearate. M-FEBUXOSTAT tablets are coated with Opadry II green (which contains polyvinyl alcohol, talc, PEG 4000, titanium dioxide, FD&C Yellow No.5 tartrazine aluminium lake, FD&C Blue No.1, and FD&C Blue No.2).
What dosage forms it comes in:
Tablets. Each tablet contains 80 mg febuxostat (as febuxostat hemihydrate).
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
A higher number of deaths was seen in a study of gout patients with heart problems who were treated with Febuxostat. This was compared to patients treated with allopurinol.
|
|---|
M-FEBUXOSTAT treatment should only be started when the acute attack of gout has subsided.
Whenever you start medicines that can lower uric acid levels, like M-FEBUXOSTAT, gout may flare up. This is due to the body’s efforts to get rid of uric acid crystals from the joints.
However, over time, reducing your uric acid level can decrease your gout flares. Your healthcare professional may add other medicines to help prevent or manage flares while taking M-FEBUXOSTAT.
Heart attacks, strokes and heart- related deaths have been reported. You should not use M-FEBUXOSTAT if you have heart problems, such as heart failure or have had a stroke or heart attack.
Mild increases in liver function tests were reported in some patients taking M-FEBUXOSTAT. Your healthcare professional may do blood tests to check your liver function.
Some serious skin and allergic reactions such as rash, skin reddening, pain, swelling or blistering of lips, eyes or mouth, skin peeling and flu-like symptoms have been reported in patients taking M-FEBUXOSTAT. If you get these symptoms, your doctor may stop your treatment until your skin condition improves. Patients who had previous reactions to allopurinol are at greater risk for these skin conditions.
BEFORE you use M-FEBUXOSTAT talk to your doctor or pharmacist if you:
- have taken allopurinol. Tell your doctor what happened to you while you were taking it.
- have a history of liver or kidney problems.
- have heart disease, heart problems or had a stroke.
are pregnant, breastfeeding or plan to become pregnant, or plan to breast-feed. It is not known if M-FEBUXOSTAT will harm your unborn baby. It is also unknown if M-FEBUXOSTAT passes into your breast milk.
Have one of the following hereditary diseases:
- Galactose intolerance
- Lapp lactase deficiency
- Glucose-galactose malabsorption
This is because M-FEBUXOSTAT contains lactose.
It is not known if M-FEBUXOSTAT is safe and effective in children under 18 years of age.
INTERACTIONS WITH THIS MEDICATION
| Do not take M-FEBUXOSTAT if you take: |
|---|
- azathioprine
- mercaptopurine
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. M-FEBUXOSTAT may affect the way other medicines work, and other medicines may affect how M-FEBUXOSTAT works.
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
PROPER USE OF THIS MEDICATION
Usual adult dose:
The recommended dose of M-FEBUXOSTAT is one 80 mg tablet once daily.
- Take M-FEBUXOSTAT exactly as your healthcare provider tells you to take it.
M-FEBUXOSTAT can be taken with or without food.
- M-FEBUXOSTAT can be taken with antacids.
- It is important not to stop taking your M-FEBUXOSTAT without first consulting with your healthcare provider even if you have a flare.
- Your healthcare provider may do certain tests while you take M-FEBUXOSTAT.
Overdose:
| If you think you have taken too much M-FEBUXOSTAT, contact your healthcare professional (e.g. doctor), hospital emergency department or the regional Poison Control Centre, immediately even if there are no symptoms. |
|---|
Missed Dose: If you miss a dose of M-FEBUXOSTAT, take your M-FEBUXOSTAT as soon as you remember. If it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
The most common side effects of M-FEBUXOSTAT include:
- liver problems
- diarrhea
- rash
nausea
- dizziness
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and get immediate medical help | ||
| Only if severe | In all cases | |||
| Uncommon | Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, Difficulty swallowing or breathing | √ | ||
| Serious Skin Reaction (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, DRESS [drug rash with eosinophilia and systemic symptoms]): any combination of red itchy rash with blisters and peeling of the skin and /or of the lips, eyes, mouth, nasal passages or genitals. It often goes with fever, chills, headache, cough, body aches or joint pain. You may have less or dark urine, yellow skin or eyes. | √ | |||
| Stroke: loss of feeling or movement on one side of the body, slurring of speech, sudden blurry vision, or severe headache. | √ | |||
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and get immediate medical help | |||
| Only if severe | In all cases | ||||
| Heart problems: chest pain, shortness of breath, dizziness, fainting or feeling light-headed, rapid or irregular heart beat. | √ | ||||
This is not a complete list of side effects. For any unexpected
effects while taking M-FEBUXOSTAT, contact your doctor or pharmacist.
HOW TO STORE IT
M-FEBUXOSTAT should be protected from light.
Store M-FEBUXOSTAT between 15°C - 30°C.
Keep M-FEBUXOSTAT and all medicines out of the reach of children.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
|---|
MORE INFORMATION
For more information, please contact your healthcare professionals or pharmacist first, or Mantra Pharma Inc. at medinfo@mantrapharma.ca or at 1-833-248-7326.
Mantra Pharma Inc.
1000 rue Du Lux, Suite 201
Brossard, Quebec
J4Y 0E3