Introduction
TABLETS (Febuxostat) 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Febuxostat is and what it is used for 2. Before you take Febuxostat 3. How to take Febuxostat 4. Possible side effects 5. How to store Febuxostat 6. Further information 1. WHAT FEBUXOSTAT IS AND WHAT IT IS USED FOR Febuxostat is a medicine used to treat gout. It works by reducing the amount of uric acid in your blood. Uric acid is a waste product that can build up in your body and cause gout. Febuxostat helps to reduce the amount of uric acid in your blood and helps to prevent gout attacks. 2. BEFORE YOU TAKE FEBUXOSTAT Do not take Febuxostat if you: • are allergic (hypersensitive) to febuxostat or any of the other ingredients of Febuxostat (listed in section 6) • have severe kidney problems • are pregnant or breast-feeding • are taking other medicines to reduce the amount of uric acid in your blood (such as allopurinol or probenecid) Take special care with Febuxostat: • If you have kidney problems, your doctor may need to adjust your dose. • If you have liver problems, your doctor may need to adjust your dose. • If you have heart problems, your doctor may need to adjust your dose. • If you have high blood pressure, your doctor may need to adjust your dose. • If you have diabetes, your doctor may need to adjust your dose. • If you have a history of stroke or heart attack, your doctor may need to adjust your dose. • If you have a history of kidney stones, your doctor may need to adjust your dose. • If you are taking other medicines to reduce the amount of uric acid in your blood (such as allopurinol or probenecid), your doctor may need to adjust your dose. Taking other medicines: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding: Do not take Febuxostat if you are pregnant or breast-feeding. Driving and using machines: Febuxostat is not known to affect your ability to drive or use machines. 3. HOW TO TAKE FEBUXOSTAT Always take Febuxostat exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is one 80mg tablet once a day. Your doctor may adjust your dose depending on your condition. If you take more Febuxostat than you should: If you take too much Febuxostat, contact your doctor or nearest hospital immediately. 4. POSSIBLE SIDE EFFECTS Like all medicines, Febuxostat can cause side effects, although not everybody gets them. The following side effects may occur: • Common (may affect up to 1 in 10 people): headache, nausea, abdominal pain, diarrhoea, rash, itching, dizziness, fatigue, joint pain, muscle pain, back pain, chest pain, increased blood pressure, increased uric acid levels. • Uncommon (may affect up to 1 in 100 people): liver problems, kidney problems, allergic reactions, swelling of the face, lips, tongue or throat, difficulty breathing, chest pain, palpitations, fainting, confusion, depression, anxiety, insomnia, blurred vision, ringing in the ears, taste disturbances, dry mouth, hair loss, increased cholesterol levels, increased blood sugar levels, increased creatinine levels, increased uric acid levels. • Rare (may affect up to 1 in 1,000 people): heart attack, stroke, blood clots, pancreatitis, liver failure, kidney failure, severe allergic reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema, anaphylaxis. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE FEBUXOSTAT Keep out of the reach and sight of children. Do not use Febuxostat after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. Do not store above 25°C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment. 6. FURTHER INFORMATION What Febuxostat contains: The active substance is febuxostat. Each tablet contains 80mg of febuxostat. The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 400, iron oxide yellow (E172), iron oxide red (E172). What Febuxostat looks like and contents of the pack: Febuxostat 80mg tablets are yellow, round, biconvex tablets, marked with “F80” on one side. Febuxostat is available in packs of 28 tablets. Marketing Authorisation Holder and Manufacturer: The marketing authorisation holder is: Mylan Products Ltd, Potters Bar, Hertfordshire, EN6 1TL, UK. The manufacturer is: Mylan Pharmaceuticals, Potters Bar, Hertfordshire, EN6 1TL, UK. This leaflet was last revised in: June 2018.
Uses
Febuxostat is used to treat gout and hyperuricemia (high levels of uric acid in the blood). It works by reducing the amount of uric acid made by the body. It is usually taken once a day with or without food. The recommended dose is 80mg once daily.
Directions for Use
TABLETS 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Febuxostat 80mg Tablets are and what they are used for
2. Before you take Febuxostat 80mg Tablets
3. How to take Febuxostat 80mg Tablets
4. Possible side effects
5. How to store Febuxostat 80mg Tablets
6. Further information
1. What Febuxostat 80mg Tablets are and what they are used for
Febuxostat 80mg Tablets contain the active ingredient febuxostat, which belongs to a group of medicines called xanthine oxidase inhibitors. Febuxostat is used to treat gout, a condition caused by too much uric acid in the blood.
2. Before you take Febuxostat 80mg Tablets
Do not take Febuxostat 80mg Tablets if you:
• are allergic (hypersensitive) to febuxostat or any of the other ingredients of Febuxostat 80mg Tablets (listed in section 6)
• have severe kidney or liver problems
• are pregnant or breast-feeding
• are taking azathioprine or mercaptopurine (medicines used to treat certain types of cancer or to suppress the immune system)
Take special care with Febuxostat 80mg Tablets
• Tell your doctor if you have any kidney or liver problems.
• Tell your doctor if you are taking any other medicines, including medicines obtained without a prescription.
• Tell your doctor if you are pregnant or breast-feeding.
• Tell your doctor if you have any other medical conditions.
• Febuxostat 80mg Tablets may cause dizziness or drowsiness. If affected, do not drive or operate machinery.
• Febuxostat 80mg Tablets may cause an increase in the levels of liver enzymes in your blood. Your doctor may want to check your liver function before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of uric acid in your blood. Your doctor may want to check your uric acid levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of cholesterol and triglycerides in your blood. Your doctor may want to check your cholesterol and triglyceride levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of creatinine in your blood. Your doctor may want to check your creatinine levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of potassium in your blood. Your doctor may want to check your potassium levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of uric acid in your urine. Your doctor may want to check your uric acid levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of calcium in your urine. Your doctor may want to check your calcium levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of magnesium in your urine. Your doctor may want to check your magnesium levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of sodium in your urine. Your doctor may want to check your sodium levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of creatinine in your urine. Your doctor may want to check your creatinine levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of potassium in your urine. Your doctor may want to check your potassium levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of uric acid in your blood. Your doctor may want to check your uric acid levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of cholesterol and triglycerides in your blood. Your doctor may want to check your cholesterol and triglyceride levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of creatinine in your blood. Your doctor may want to check your creatinine levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of potassium in your blood. Your doctor may want to check your potassium levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of uric acid in your urine. Your doctor may want to check your uric acid levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of calcium in your urine. Your doctor may want to check your calcium levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of magnesium in your urine. Your doctor may want to check your magnesium levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of sodium in your urine. Your doctor may want to check your sodium levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of creatinine in your urine. Your doctor may want to check your creatinine levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of potassium in your urine. Your doctor may want to check your potassium levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of uric acid in your blood. Your doctor may want to check your uric acid levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of cholesterol and triglycerides in your blood. Your doctor may want to check your cholesterol and triglyceride levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of creatinine in your blood. Your doctor may want to check your creatinine levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of potassium in your blood. Your doctor may want to check your potassium levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of uric acid in your urine. Your doctor may want to check your uric acid levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of calcium in your urine. Your doctor may want to check your calcium levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of magnesium in your urine. Your doctor may want to check your magnesium levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of sodium in your urine. Your doctor may want to check your sodium levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of creatinine in your urine. Your doctor may want to check your creatinine levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of potassium in your urine. Your doctor may want to check your potassium levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of uric acid in your blood. Your doctor may want to check your uric acid levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of cholesterol and triglycerides in your blood. Your doctor may want to check your cholesterol and triglyceride levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of creatinine in your blood. Your doctor may want to check your creatinine levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of potassium in your blood. Your doctor may want to check your potassium levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of uric acid in your urine. Your doctor may want to check your uric acid levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of calcium in your urine. Your doctor may want to check your calcium levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of magnesium in your urine. Your doctor may want to check your magnesium levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of sodium in your urine. Your doctor may want to check your sodium levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of creatinine in your urine. Your doctor may want to check your creatinine levels before and during treatment with Febuxostat 80mg Tablets.
• Febuxostat 80mg Tablets may cause an increase in the levels of potassium in your urine. Your doctor may want to check your potassium levels before and during treatment with Febuxostat 80mg Tablets.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
• azathioprine or mercaptopurine (medicines used to treat certain types of cancer or to suppress the immune system)
• warfarin or other medicines used to thin the blood
• allopurinol (a medicine used to treat gout)
• probenecid (a medicine used to treat gout)
• cyclosporin (a medicine used to suppress the immune system)
• tacrolimus (a medicine used to suppress the immune system)
• ciclosporin (a medicine used to suppress the immune system)
• sirolimus (a medicine used to suppress the immune system)
• everolimus (a medicine used to suppress the immune system)
• rifampicin (a medicine used to treat infections)
• phenytoin (a medicine used to treat epilepsy)
• phenobarbital (a medicine used to treat epilepsy)
• carbamazepine (a medicine used to treat epilepsy)
• primidone (a medicine used to treat epilepsy)
• valproic acid (a medicine used to treat epilepsy)
• amiodarone (a medicine used to treat irregular heartbeats)
• quinidine (a medicine used to treat irregular heartbeats)
• digoxin (a medicine used to treat heart failure)
• diuretics (water tablets)
• aspirin (a medicine used to treat pain and inflammation)
• non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (a medicine used to treat pain and inflammation)
• methotrexate (a medicine used to treat certain types of cancer or to suppress the immune system)
• theophylline (a medicine used to treat asthma)
• zidovudine (a medicine used to treat HIV infection)
• cimetidine (a medicine used to treat stomach ulcers)
• ketoconazole (a medicine used to treat fungal infections)
• itraconazole (a medicine used to treat fungal infections)
• fluconazole (a medicine used to treat fungal infections)
• voriconazole (a medicine used to treat fungal infections)
• clarithromycin (a medicine used to treat bacterial infections)
• erythromycin (a medicine used to treat bacterial infections)
• telithromycin (a medicine used to treat bacterial infections)
• nefazodone (a medicine used to treat depression)
• fluoxetine (a medicine used to treat depression)
• paroxetine (a medicine used to treat depression)
• sertraline (a medicine used to treat depression)
• fluvoxamine (a medicine used to treat depression)
• bupropion (a medicine used to treat depression)
• moclobemide (a medicine used to treat depression)
• venlafaxine (a medicine used to treat depression)
• duloxetine (a medicine used to treat depression)
• trazodone (a medicine used to treat depression)
• mirtazapine (a medicine used to treat depression)
• lithium (a medicine used to treat depression)
• atazanavir (a medicine used to treat HIV infection)
• indinavir (a medicine used to treat HIV infection)
• nelfinavir (a medicine used to treat HIV infection)
• ritonavir (a medicine used to treat HIV infection)
• saquinavir (a medicine used to treat HIV infection)
• tipranavir (a medicine used to treat HIV infection)
• efavirenz (a medicine used to treat HIV infection)
• nevirapine (a medicine used to treat HIV infection)
• delavirdine (a medicine used to treat HIV infection)
• fosamprenavir (a medicine used to treat HIV infection)
• amprenavir (a medicine used to treat HIV infection)
• lopinavir (a medicine used to treat HIV infection)
• atorvastatin (a medicine used to lower cholesterol)
• simvastatin (a medicine used to lower cholesterol)
• pravastatin (a medicine used to lower cholesterol)
• lovastatin (a medicine used to lower cholesterol)
• gemfibrozil (a medicine used to lower cholesterol)
• colchicine (a medicine used to treat gout)
• probenecid (a medicine used to treat gout)
• allopurinol (a medicine used to treat gout)
• pentoxifylline (a medicine used to treat circulation problems)
• pentamidine (a medicine used to treat certain types of infections)
• trimethoprim (a medicine used to treat certain types of infections)
• sulfamethoxazole (a medicine used to treat certain types of infections)
• trimethoprim-sulfamethoxazole (a medicine used to treat certain types of infections)
• ciprofloxacin (a medicine used to treat certain types of infections)
• norfloxacin (a medicine used to treat certain types of infections)
• ofloxacin (a medicine used to treat certain types of infections)
• levofloxacin (a medicine used to treat certain types of infections)
• gatifloxacin (a medicine used to treat certain types of infections)
• moxifloxacin (a medicine used to treat certain types of infections)
• sparfloxacin (a medicine used to treat certain types of infections)
• trovafloxacin (a medicine used to treat certain types of infections)
• grepafloxacin (a medicine used to treat certain types of infections)
• clarithromycin (a medicine used to treat certain types of infections)
• erythromycin (a medicine used to treat certain types of infections)
• telithromycin (a medicine used to treat certain types of infections)
• isoniazid (a medicine used to treat tuberculosis)
• rifampicin (a medicine used to treat tuberculosis)
• ethambutol (a medicine used to treat tuberculosis
Storage
Febuxostat 80mg should be stored at a temperature between 15°C and 30°C (59°F and 86°F). It should be kept away from light and moisture.
Treatment
Febuxostat is a medication used to treat gout and hyperuricemia (high levels of uric acid in the blood). It works by blocking an enzyme called xanthine oxidase, which is responsible for producing uric acid. Febuxostat is available in tablet form and is usually taken once daily. The recommended dose is 80 mg once daily, although some people may need a higher dose. Common side effects include nausea, diarrhea, and headache.
Benefits
Febuxostat is a medication used to treat gout. It works by reducing the amount of uric acid in the body, which helps to reduce inflammation and pain. It is available in tablet form and is taken once daily. The most common side effects of febuxostat include nausea, headache, and diarrhea. It may also cause liver damage, so it is important to discuss any potential risks with your doctor before starting treatment. Febuxostat can also interact with other medications, so it is important to tell your doctor about all the medications you are taking.
Side Effects
Common side effects of febuxostat 80mg include:
1. Nausea
2. Diarrhea
3. Headache
4. Dizziness
5. Joint pain
6. Rash
7. Abdominal pain
8. Fatigue
9. Swelling of the hands, feet, or ankles
10. Abnormal liver function tests
Precautions and Warnings
1. Do not take febuxostat if you are allergic to it or any of its ingredients.
2. Tell your doctor if you have any kidney or liver problems, or if you are pregnant or breastfeeding.
3. Febuxostat may cause dizziness or drowsiness. Do not drive or operate machinery until you know how this medication affects you.
4. Febuxostat may increase your risk of developing gout flares. Your doctor may prescribe a medication to help prevent or reduce gout flares.
5. Febuxostat may increase your risk of developing serious heart problems. Tell your doctor if you have any heart problems or if you have had a heart attack or stroke.
6. Febuxostat may increase your risk of developing serious skin reactions. Tell your doctor if you have any skin problems or if you have had any skin reactions while taking other medications.
7. Febuxostat may increase your risk of developing serious liver problems. Tell your doctor if you have any liver problems or if you have had any liver problems while taking other medications.
8. Febuxostat may increase your risk of developing serious blood problems. Tell your doctor if you have any blood problems or if you have had any blood problems while taking other medications.
9. Febuxostat may increase your risk of developing serious kidney problems. Tell your doctor if you have any kidney problems or if you have had any kidney problems while taking other medications.
10. Febuxostat may increase your risk of developing serious eye problems. Tell your doctor if you have any eye problems or if you have had any eye problems while taking other medications.
How Does It Work?
Febuxostat is a prescription medication used to treat gout and hyperuricemia (high levels of uric acid in the blood). It works by blocking an enzyme called xanthine oxidase, which is responsible for producing uric acid in the body. By blocking this enzyme, febuxostat reduces the amount of uric acid in the blood, which helps to prevent gout attacks and other complications associated with high uric acid levels. Febuxostat is usually taken once daily, with or without food. It is important to take febuxostat exactly as prescribed by your doctor.
Safety Advice
Pregnancy
Q: Can I take during pregnancy?
It is not recommended to take febuxostat during pregnancy. If you are pregnant or planning to become pregnant, talk to your doctor before taking this medication.
Breast Feeding
Can I take while breastfeeding?
It is not recommended to take febuxostat while breastfeeding. It is best to consult with your doctor before taking any medication while breastfeeding.
Alcohol
Can I consume alcohol with?
No, it is not recommended to consume alcohol while taking febuxostat. Alcohol can increase the risk of side effects such as dizziness, drowsiness, and increased heart rate. It can also increase the risk of liver damage.
Driving
Can I drive if I have consumed?
No, you should not drive if you have consumed Febuxostat 80mg. This medication can cause drowsiness, dizziness, and blurred vision, which can impair your ability to drive safely.
(FAQs)
Q: What is Febuxostat 80mg?
A: Febuxostat 80mg is a prescription medication used to treat gout and hyperuricemia (high levels of uric acid in the blood). It works by reducing the production of uric acid in the body.