Patient Medication Information: uses, side effects, how to take - Uloric
What the medication is used for:
ULORIC® 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:
ULORIC® contains febuxostat which is a xanthine oxidase (XO) inhibitor. ULORIC® 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 ULORIC® if you are allergic to febuxostat or any other ingredients in ULORIC®.
Do not take ULORIC® if you take:
- azathioprine
- mercaptopurine
What the medicinal ingredient is:
febuxostat
What the important nonmedicinal ingredients are:
Lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, sodium croscarmellose, silicon dioxide, magnesium stearate, and Opadry II green (which contains polyvinyl alcohol, talc, PEG 3000, titanium dioxide, D&C Yellow No.10 aluminum 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.
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 ULORIC®. This was compared to patients treated with allopurinol.
Your doctor will consider the side effects and benefits of ULORIC® before and during your treatment. ULORIC® should only be used when allopurinol has not worked well enough or when allopurinol is not right for you.
ULORIC® treatment should only be started when the acute attack of gout has subsided.
Whenever you start medicines that can lower uric acid levels, like ULORIC®, 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 ULORIC®.
Heart attacks, strokes and heart-related deaths have been reported. You should not use ULORIC® 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 ULORIC®. 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 ULORIC®. 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 ULORIC® 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 ULORIC® will harm your unborn baby. It is also unknown if ULORIC® passes into your breast milk.
Have ones of the following hereditary diseases:
- Galactose intolerance
- Lapp lactase deficiency
- Glucose-galactose malabsorption
This is because ULORIC® contains lactose.
It is not known if ULORIC® is safe and effective in children under 18 years of age.
INTERACTIONS WITH THIS MEDICATION
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. ULORIC® may affect the way other medicines work, and other medicines may affect how ULORIC® works.
Know the medicines you take. Keep a list of them and show it to
Do not take ULORIC® if you take:
- azathioprine
- mercaptopurine
your healthcare provider and pharmacist when you get a new medicine.
PROPER USE OF THIS MEDICATION
Usual adult dose:
The recommended dose of ULORIC® is one 80 mg tablet once daily.
- Take ULORIC® exactly as your healthcare provider tells you to take it.
ULORIC® can be taken with or without food.
- ULORIC® can be taken with antacids.
- It is important not to stop taking your ULORIC® without first consulting with your healthcare provider even if you have a flare.
- Your healthcare provider may do certain tests while you take ULORIC®.
Overdose:
In case of drug overdose, contact a healthcare practitioner (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 ULORIC®, take your ULORIC® 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 ULORIC® 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 call your doctor or pharmacist | ||
| 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 call your doctor or pharmacist |
|---|
| 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 ULORIC®, contact your doctor or pharmacist.
HOW TO STORE IT
ULORIC® should be protected from light.
Store ULORIC® between 15°C - 30°C.
Keep ULORIC® and all medicines out of the reach of children.
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:
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
For more information, please contact your healthcare professionals or pharmacist first, or Takeda Canada Inc. at 1-866-295-4636 or visit the website at www.takeda.com/en-ca.
ULORIC® is a registered trademark of Teijin Limited and used under licence by Takeda Canada Inc.