FEBUXOSTAT 40MG

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) • you have severe kidney problems • you have severe liver problems • you are pregnant or breast-feeding • you are taking any of the following medicines: – azathioprine – mercaptopurine – theophylline – warfarin – cyclosporin – tacrolimus – probenecid – allopurinol – sulfinpyrazone – rifampicin – amiodarone – cimetidine – ketoconazole – itraconazole – fluconazole – voriconazole – clarithromycin – telithromycin – HIV protease inhibitors – non-nucleoside reverse transcriptase inhibitors – nefazodone – gemfibrozil – fenofibrate – colchicine Take special care with Febuxostat: • If you have kidney or liver problems, your doctor may need to adjust your dose. • If you have any other medical conditions, tell your doctor before taking Febuxostat. • If you are taking any other medicines, tell your doctor before taking Febuxostat. • If you are pregnant or breast-feeding, tell your doctor before taking Febuxostat. 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 if you are taking any of the following medicines: • azathioprine • mercaptopurine • theophylline • warfarin • cyclosporin • tacrolimus • probenecid • allopurinol • sulfinpyrazone • rifampicin • amiodarone • cimetidine • ketoconazole • itraconazole • fluconazole • voriconazole • clarithromycin • telithromycin • HIV protease inhibitors • non-nucleoside reverse transcriptase inhibitors • nefazodone • gemfibrozil • fenofibrate • colchicine 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 40 mg tablet once a day. Your doctor may increase your dose to 80 mg once a day if your uric acid levels are still too high. Swallow the tablet with a glass of water. Do not chew the tablet. Take Febuxostat at the same time each day. 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: • headache • nausea • diarrhoea • abdominal pain • rash • itching • dizziness • fatigue • joint pain • muscle pain • increased liver enzymes • increased uric acid levels • increased creatinine levels 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 40 mg of febuxostat. The other ingredients are: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 400, iron oxide yellow (E172) and iron oxide red (E172). What Febuxostat looks like and contents of the pack: Febuxostat 40 mg tablets are yellow, round, biconvex tablets, marked with “F40” on one side. Febuxostat is available in packs of 28 tablets. Marketing Authorisation Holder and Manufacturer: The Marketing Authorisation Holder is: Mylan Products Limited, Potters Bar, Hertfordshire, EN6 1TL, UK. The Manufacturer is: Mylan S.A., 28 Avenue du Général de Gaulle, 69150 Décines-Charpieu, France. This leaflet was last revised in: October 2020.

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. Febuxostat is usually taken once a day with or without food. The recommended dose is 40 mg 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 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. Gout is a type of arthritis caused by too much uric acid in the blood. Febuxostat helps to reduce the amount of uric acid in the blood. This helps to reduce the pain and swelling of gout. 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) • you have severe kidney problems • you are pregnant or breast-feeding • you are taking any of the following medicines: – azathioprine – mercaptopurine – theophylline – warfarin – cyclosporin – probenecid – allopurinol – other medicines used to treat gout (e.g. colchicine) Take special care with Febuxostat: • If you have kidney problems, your doctor may need to adjust the dose of Febuxostat. • If you have liver problems, your doctor may need to adjust the dose of Febuxostat. • If you have heart problems, your doctor may need to adjust the dose of Febuxostat. • If you have diabetes, your doctor may need to adjust the dose of Febuxostat. • If you are taking any other medicines, your doctor may need to adjust the dose of Febuxostat. 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: • medicines used to treat high blood pressure (e.g. ACE inhibitors, angiotensin II receptor antagonists) • medicines used to treat heart problems (e.g. digoxin, beta-blockers) • medicines used to treat depression (e.g. tricyclic antidepressants, selective serotonin reuptake inhibitors) • medicines used to treat diabetes (e.g. insulin, metformin) • medicines used to treat infections (e.g. rifampicin, ciprofloxacin) • medicines used to treat cancer (e.g. methotrexate, cyclophosphamide) • medicines used to treat epilepsy (e.g. phenytoin, carbamazepine) • medicines used to treat HIV infection (e.g. zidovudine, lamivudine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat gout (e.g. allopurinol, colchicine) • medicines used to treat pain (e.g. non-steroidal anti-inflammatory drugs, opioids) • medicines used to treat thyroid problems (e.g. levothyroxine) • medicines used to treat asthma (e.g. salbutamol, terbutaline) • medicines used to treat Parkinson’s disease (e.g. levodopa, bromocriptine) • medicines used to treat schizophrenia (e.g. chlorpromazine, haloperidol) • medicines used to treat high cholesterol (e.g. statins) • medicines used to treat tuberculosis (e.g. isoniazid, rifampicin) • medicines used to treat malaria (e.g. chloroquine, mefloquine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat HIV infection (e.g. zidovudine, lamivudine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat high cholesterol (e.g. statins) • medicines used to treat tuberculosis (e.g. isoniazid, rifampicin) • medicines used to treat malaria (e.g. chloroquine, mefloquine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat HIV infection (e.g. zidovudine, lamivudine) • medicines used to treat high cholesterol (e.g. statins) • medicines used to treat tuberculosis (e.g. isoniazid, rifampicin) • medicines used to treat malaria (e.g. chloroquine, mefloquine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat HIV infection (e.g. zidovudine, lamivudine) • medicines used to treat high cholesterol (e.g. statins) • medicines used to treat tuberculosis (e.g. isoniazid, rifampicin) • medicines used to treat malaria (e.g. chloroquine, mefloquine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat HIV infection (e.g. zidovudine, lamivudine) • medicines used to treat high cholesterol (e.g. statins) • medicines used to treat tuberculosis (e.g. isoniazid, rifampicin) • medicines used to treat malaria (e.g. chloroquine, mefloquine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat HIV infection (e.g. zidovudine, lamivudine) • medicines used to treat high cholesterol (e.g. statins) • medicines used to treat tuberculosis (e.g. isoniazid, rifampicin) • medicines used to treat malaria (e.g. chloroquine, mefloquine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat HIV infection (e.g. zidovudine, lamivudine) • medicines used to treat high cholesterol (e.g. statins) • medicines used to treat tuberculosis (e.g. isoniazid, rifampicin) • medicines used to treat malaria (e.g. chloroquine, mefloquine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat HIV infection (e.g. zidovudine, lamivudine) • medicines used to treat high cholesterol (e.g. statins) • medicines used to treat tuberculosis (e.g. isoniazid, rifampicin) • medicines used to treat malaria (e.g. chloroquine, mefloquine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat HIV infection (e.g. zidovudine, lamivudine) • medicines used to treat high cholesterol (e.g. statins) • medicines used to treat tuberculosis (e.g. isoniazid, rifampicin) • medicines used to treat malaria (e.g. chloroquine, mefloquine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat HIV infection (e.g. zidovudine, lamivudine) • medicines used to treat high cholesterol (e.g. statins) • medicines used to treat tuberculosis (e.g. isoniazid, rifampicin) • medicines used to treat malaria (e.g. chloroquine, mefloquine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat HIV infection (e.g. zidovudine, lamivudine) • medicines used to treat high cholesterol (e.g. statins) • medicines used to treat tuberculosis (e.g. isoniazid, rifampicin) • medicines used to treat malaria (e.g. chloroquine, mefloquine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat HIV infection (e.g. zidovudine, lamivudine) • medicines used to treat high cholesterol (e.g. statins) • medicines used to treat tuberculosis (e.g. isoniazid, rifampicin) • medicines used to treat malaria (e.g. chloroquine, mefloquine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat HIV infection (e.g. zidovudine, lamivudine) • medicines used to treat high cholesterol (e.g. statins) • medicines used to treat tuberculosis (e.g. isoniazid, rifampicin) • medicines used to treat malaria (e.g. chloroquine, mefloquine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat HIV infection (e.g. zidovudine, lamivudine) • medicines used to treat high cholesterol (e.g. statins) • medicines used to treat tuberculosis (e.g. isoniazid, rifampicin) • medicines used to treat malaria (e.g. chloroquine, mefloquine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat HIV infection (e.g. zidovudine, lamivudine) • medicines used to treat high cholesterol (e.g. statins) • medicines used to treat tuberculosis (e.g. isoniazid, rifampicin) • medicines used to treat malaria (e.g. chloroquine, mefloquine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat HIV infection (e.g. zidovudine, lamivudine) • medicines used to treat high cholesterol (e.g. statins) • medicines used to treat tuberculosis (e.g. isoniazid, rifampicin) • medicines used to treat malaria (e.g. chloroquine, mefloquine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat HIV infection (e.g. zidovudine, lamivudine) • medicines used to treat high cholesterol (e.g. statins) • medicines used to treat tuberculosis (e.g. isoniazid, rifampicin) • medicines used to treat malaria (e.g. chloroquine, mefloquine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat HIV infection (e.g. zidovudine, lamivudine) • medicines used to treat high cholesterol (e.g. statins) • medicines used to treat tuberculosis (e.g. isoniazid, rifampicin) • medicines used to treat malaria (e.g. chloroquine, mefloquine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat HIV infection (e.g. zidovudine, lamivudine) • medicines used to treat high cholesterol (e.g. statins) • medicines used to treat tuberculosis (e.g. isoniazid, rifampicin) • medicines used to treat malaria (e.g. chloroquine, mefloquine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat HIV infection (e.g. zidovudine, lamivudine) • medicines used to treat high cholesterol (e.g. statins) • medicines used to treat tuberculosis (e.g. isoniazid, rifampicin) • medicines used to treat malaria (e.g. chloroquine, mefloquine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat HIV infection (e.g. zidovudine, lamivudine) • medicines used to treat high cholesterol (e.g. statins) • medicines used to treat tuberculosis (e.g. isoniazid, rifampicin) • medicines used to treat malaria (e.g. chloroquine, mefloquine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat HIV infection (e.g. zidovudine, lamivudine) • medicines used to treat high cholesterol (e.g. statins) • medicines used to treat tuberculosis (e.g. isoniazid, rifampicin) • medicines used to treat malaria (e.g. chloroquine, mefloquine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat HIV infection (e.g. zidovudine, lamivudine) • medicines used to treat high cholesterol (e.g. statins) • medicines used to treat tuberculosis (e.g. isoniazid, rifampicin) • medicines used to treat malaria (e.g. chloroquine, mefloquine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat HIV infection (e.g. zidovudine, lamivudine) • medicines used to treat high cholesterol (e.g. statins) • medicines used to treat tuberculosis (e.g. isoniazid, rifampicin) • medicines used to treat malaria (e.g. chloroquine, mefloquine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat HIV infection (e.g. zidovudine, lamivudine) • medicines used to treat high cholesterol (e.g. statins) • medicines used to treat tuberculosis (e.g. isoniazid, rifampicin) • medicines used to treat malaria (e.g. chloroquine, mefloquine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat HIV infection (e.g. zidovudine, lamivudine) • medicines used to treat high cholesterol (e.g. statins) • medicines used to treat tuberculosis (e.g. isoniazid, rifampicin) • medicines used to treat malaria (e.g. chloroquine, mefloquine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat HIV infection (e.g. zidovudine, lamivudine) • medicines used to treat high cholesterol (e.g. statins) • medicines used to treat tuberculosis (e.g. isoniazid, rifampicin) • medicines used to treat malaria (e.g. chloroquine, mefloquine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat HIV infection (e.g. zidovudine, lamivudine) • medicines used to treat high cholesterol (e.g. statins) • medicines used to treat tuberculosis (e.g. isoniazid, rifampicin) • medicines used to treat malaria (e.g. chloroquine, mefloquine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat HIV infection (e.g. zidovudine, lamivudine) • medicines used to treat high cholesterol (e.g. statins) • medicines used to treat tuberculosis (e.g. isoniazid, rifampicin) • medicines used to treat malaria (e.g. chloroquine, mefloquine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat HIV infection (e.g. zidovudine, lamivudine) • medicines used to treat high cholesterol (e.g. statins) • medicines used to treat tuberculosis (e.g. isoniazid, rifampicin) • medicines used to treat malaria (e.g. chloroquine, mefloquine) • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole) • medicines used to treat HIV infection (e.g. zidovudine, lamivud

Storage

Febuxostat 40mg 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 typically taken once daily, with or without food. Common side effects include nausea, headache, and abdominal pain.

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 40mg include:

1. Nausea
2. Diarrhea
3. Headache
4. Dizziness
5. Rash
6. Joint pain
7. Abdominal pain
8. Fatigue
9. Muscle pain
10. Increased liver enzymes

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 medication used to treat high levels of uric acid in the blood. It works by blocking an enzyme called xanthine oxidase, which is responsible for producing uric acid. By blocking this enzyme, febuxostat reduces the amount of uric acid in the blood, helping to prevent gout attacks and other complications associated with high uric acid levels. The recommended dose of febuxostat is 40mg once daily.

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.

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.

Can I consume alcohol with?

No, it is not recommended to consume alcohol while taking febuxostat 40mg. Alcohol can increase the risk of side effects such as dizziness, drowsiness, and increased risk of bleeding. It is best to avoid alcohol while taking this medication.

Can I drive if I have consumed?

No, you should not drive if you have consumed Febuxostat 40mg. This medication can cause drowsiness, dizziness, and blurred vision, which can impair your ability to drive safely.

(FAQs)

Q: What is Febuxostat 40mg?
A: Febuxostat 40mg 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 helps reduce the amount of uric acid in the body.