Details for: JAMP FEBUXOSTAT
Company: JAMP PHARMA CORPORATION
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02490870 | JAMP FEBUXOSTAT | FEBUXOSTAT | 80 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
JAMP 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
JAMP FEBUXOSTAT contains febuxostat which is a xanthine oxidase (XO) inhibitor. JAMP 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 JAMP FEBUXOSTAT if you are allergic to febuxostat or any other ingredients in JAMP FEBUXOSTAT.
Do not take JAMP FEBUXOSTAT if you take:
What the medicinal ingredient is
febuxostat
What the non-medicinal ingredients are
Lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, sodium croscarmellose, silicon dioxide, sodium lauryl sulphate and magnesium stearate. The tablets are coated and the coating contains: polyvinyl alcohol, Polyethylene glycol 3350, talc, titanium dioxide and yellow iron oxide.
What dosage form it comes in
Tablets. Each tablet contains 80 mg febuxostat (as febuxostat hemihydrate).
Warnings and precautions
Serious Warnings and Precaution
- 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.
- Your doctor will consider the side effects and benefits of JAMP FEBUXOSTAT before and during your treatment. JAMP FEBUXOSTAT should only be used when allopurinol has not worked well enough or when allopurinol is not right for you.
JAMP 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 JAMP 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 JAMP FEBUXOSTAT.
Heart attacks, strokes and heart- related deaths have been reported. You should not use JAMP 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 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 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 JAMP 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 JAMP FEBUXOSTAT will harm your unborn baby. It is also unknown if JAMP FEBUXOSTAT passes into your breast milk.
- Have ones of the following hereditary diseases:
- Galactose intolerance
- Lapp lactase deficiency
- Glucose-galactose malabsorption
This is because JAMP FEBUXOSTAT contains lactose. It is not known if JAMP FEBUXOSTAT is safe and effective in children under 18 years of age.
Interactions with this medication
Do not take JAMP 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. JAMP FEBUXOSTAT may affect the way other medicines work, and other medicines may affect how JAMP 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 JAMP FEBUXOSTAT is one 80 mg tablet once daily.
- Take JAMP FEBUXOSTAT exactly as your healthcare provider tells you to take it.
- JAMP FEBUXOSTAT can be taken with or without food.
- JAMP FEBUXOSTAT can be taken with antacids.
- It is important not to stop taking your JAMP FEBUXOSTAT without first consulting with your healthcare provider even if you have a flare.
Your healthcare provider may do certain tests while you take JAMP FEBUXOSTAT.
Overdose:
Missed Dose:
If you miss a dose of JAMP FEBUXOSTAT, take your JAMP 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 JAMP 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.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Uncommon | |||
| Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | ✔ | ||
| Serious Skin Reaction (StevensJohnson 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. | ✔ | ||
| Heart problems: chest pain, shortness of breath, dizziness, fainting or feeling lightheaded, rapid or irregular heartbeat. | ✔ | ||
This is not a complete list of side effects .For any unexpected effects while taking JAMP-FEBUXOSTAT, contact your doctor or pharmacist.
How to store
Store JAMP FEBUXOSTAT between 15°C - 30°C.
Keep JAMP FEBUXOSTAT and all medicines out of the reach and sight of children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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
If you want more information about JAMP FEBUXOSTAT:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://health-products.canada.ca/dpdbdpp/index-eng.jsp;) the manufacturer’s website (www.jamppharma.com), or by calling JAMP Pharma Corporation at 1-866-399-9091
This leaflet was prepared by
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Québec
J4B 5H3
Revision Date: March 24, 2020