FEBUXOSTAT BLUEPHARMA 80 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Febuxostat Bluepharma 80 mg film-coated tablets EFG.

Febuxostat (as Febuxostat hemihydrate)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Febuxostat Bluepharma and what is it used for
2. What you need to know before you take Febuxostat Bluepharma
3. How to take Febuxostat Bluepharma
4. Possible side effects
5. Storing Febuxostat Bluepharma
6. Contents of the pack and other information

1. What is Febuxostat Bluepharma and what is it used for

Febuxostat Bluepharma tablets contain the active substance febuxostat and are used to treat gout, which is associated with an excess in the body of a chemical compound called uric acid (urate). In some people, uric acid builds up in the blood to the point where it cannot be dissolved. When this happens, urate crystals form both inside and around the joints and kidneys. These crystals can cause sudden and severe pain, redness, heat, and swelling in the joints (this is called a gout attack). If left untreated, large deposits called tophi can form around the joints and inside them. Tophi can damage the joints and bones.

Febuxostat Bluepharma works by reducing the concentration of uric acid. Keeping uric acid levels low by taking Febuxostat Bluepharma once a day prevents the formation of crystals and, over time, reduces symptoms. If uric acid levels are kept low for a long enough time, the size of tophi is also reduced.

Febuxostat Bluepharma is for adults.

2. What you need to know before you take Febuxostat Bluepharma

Do not take Febuxostat Bluepharma

• if you are allergic to febuxostat or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Febuxostat Bluepharma:

• if you have or have had heart failure or other heart problems
• if you have or have had kidney disease and/or severe allergic reactions to allopurinol (a medicine used to treat gout)
• if you have or have had liver disease or liver function disorders
• if you are being treated for high uric acid levels due to Lesch-Nyhan syndrome (a rare inherited disease in which there is too much uric acid in the blood)
• if you have thyroid problems.

If you experience allergic reactions to Febuxostat Bluepharma, stop taking this medicine (see also section 4).

Possible symptoms of allergic reactions could be:

• rash including severe forms (e.g. blisters, nodules, exfoliative rash), itching
• swelling of limbs or face
• difficulty breathing
• fever with swollen lymph nodes
• also life-threatening allergic reactions associated with cardiac arrest.

Your doctor may decide to permanently discontinue treatment with Febuxostat Bluepharma.

Rare cases of skin rash that can be life-threatening (Stevens-Johnson syndrome) have been reported with the use of Febuxostat Bluepharma, initially appearing on the trunk as reddish target-like spots or circular patches that often have a blister in the center. It can also include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes). The rash can evolve into generalized blisters or skin peeling.

If you have developed Stevens-Johnson syndrome with the use of febuxostat, you should not restart treatment at any time. If you develop a rash or these skin symptoms, go immediately to your doctor and tell them that you are taking this medicine.

If you suffer a gout attack (a sudden and severe pain accompanied by sensitivity, redness, heat, and swelling of a joint), wait for the attack to subside before starting treatment with Febuxostat Bluepharma.

Some people may suffer a gout attack when starting to take certain medicines that control uric acid levels. Not everyone suffers these attacks, but they can occur even while taking Febuxostat Bluepharma, especially during the first weeks or months of treatment. It is essential to continue taking Febuxostat Bluepharma even if you suffer a gout attack, as this medicine continues to work to reduce uric acid. If you continue to take Febuxostat Bluepharma daily, gout attacks will become less frequent and less painful.

If necessary, your doctor will prescribe other medicines to prevent or treat the symptoms of attacks (such as pain and joint swelling).

In patients with very high urate levels (e.g., those undergoing chemotherapy for cancer), treatment with medicines to decrease uric acid could produce the accumulation of xanthine in the urinary tract, with the possible formation of stones, although this has not been observed in patients treated with Febuxostat Bluepharma for Tumor Lysis Syndrome.

Your doctor may perform blood tests to check that your liver is working normally.

Children and adolescents

Do not give this medicine to children under 18 years of age as the safety and efficacy have not been established.

Other medicines and Febuxostat Bluepharma

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

It is especially important that you inform your doctor or pharmacist if you are taking medicines that contain any of the following substances, as they may interact with Febuxostat Bluepharma, and your doctor may need to take special precautions:

• Mercaptopurine (used to treat cancer)
• Azathioprine (used to reduce the immune response)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is not known if Febuxostat Bluepharma can harm the fetus. Febuxostat Bluepharma should not be used during pregnancy. It is not known if Febuxostat Bluepharma passes into breast milk. Do not use Febuxostat Bluepharma if you are breastfeeding or planning to breastfeed.

Driving and using machines

Be aware that you may experience dizziness, drowsiness, blurred vision, and numbness or tingling during treatment, so if this happens, do not drive or operate machinery.

Febuxostat Bluepharma contains lactose

This medicine contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Febuxostat Bluepharma

Follow exactly the instructions of administration of this medicine given to you by your doctor. In case of doubt, consult your doctor or pharmacist again.

• The recommended dose is one tablet per day. The blister pack has the days of the week printed on the back to help you check that you take your dose every day.
• The tablets are taken orally, with or without food.

Febuxostat Bluepharma is available in film-coated tablets of 80 mg and 120 mg. Your doctor will prescribe the most suitable dose for you.

Continue to take Febuxostat Bluepharma every day, even if you no longer have gout attacks.

If you take more Febuxostat Bluepharma than you should

In case of accidental overdose, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Febuxostat Bluepharma

If you miss a dose of Febuxostat Bluepharma, take it as soon as you remember, unless it is almost time for your next dose; in this case, skip the missed dose and take the next one at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Febuxostat Bluepharma

Even if you feel better, do not stop taking Febuxostat Bluepharma unless your doctor tells you to. If you stop taking Febuxostat Bluepharma, uric acid levels may increase again, and symptoms may worsen due to the formation of new urate crystals in the joints and kidneys.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking this medicine and contact your doctor immediately or go to the nearest hospital if you experience any of the following rare side effects (may affect up to 1 in 1000 people), as you may experience a severe allergic reaction:

• anaphylactic reactions, hypersensitivity to the medicine (see also section 2 “Warnings and precautions”)
• skin rashes that can be life-threatening, characterized by blistering and peeling of the skin and mucous membranes (e.g. mouth and genitals), painful ulcers in the mouth and/or genital areas, accompanied by fever, sore throat, and fatigue (Stevens-Johnson syndrome/toxic epidermal necrolysis), or by swollen lymph nodes, liver enlargement (including liver failure), increased white blood cell count (leukocytosis, with or without eosinophilia) (see section 2)
• widespread skin rash

The common side effects(may affect up to 1 in 10 people) are:

• abnormal liver test results
• diarrhea
• headache
• rash (including various types of rash, see below “uncommon” and “rare” sections)
• nausea
• increased gout symptoms
• localized swelling due to fluid retention in tissues (edema)

Other side effects not mentioned above are included below.

The uncommon side effects(may affect up to 1 in 100 people) are:

• decreased appetite, change in blood sugar levels (diabetes) whose symptom may be excessive thirst, increased blood fats, weight gain
• decreased sex drive
• difficulty sleeping, drowsiness
• dizziness, numbness, tingling, decreased or altered sensitivity (hypoesthesia, hemiparesis, or paresthesia), altered or decreased sense of taste (hypogeusia)
• abnormalities in the ECG (electrocardiogram), irregular or rapid heartbeat, perception of heartbeats (palpitations)
• hot flashes or flushing (redness of the face or neck), increased blood pressure
• cough, breathing difficulties, chest discomfort or pain, inflammation of the nasal passages and/or throat (upper respiratory tract infection), bronchitis
• dry mouth, abdominal pain or discomfort, gas, heartburn or indigestion, constipation, more frequent bowel movements, vomiting, stomach upset
• itching, hives, skin inflammation or discoloration, small red or purple spots on the skin, small bumps on the skin, skin rash, other skin disorders
• muscle cramps, muscle weakness, muscle and joint pain, bursitis or arthritis (joint inflammation, usually accompanied by pain, swelling, or stiffness), limb pain, back pain, muscle spasms
• blood in urine, abnormally frequent urination, abnormal urine tests (increased protein concentration in urine), reduced kidney function
• fatigue, chest pain, chest discomfort
• gallstones or bile duct stones (cholelithiasis)
• increased levels of thyroid-stimulating hormone (TSH) in blood
• changes in blood biochemistry or blood cell or platelet count (abnormal blood test results)
• kidney stones
• difficulty getting an erection

The rare side effects(may affect up to 1 in 1000 people) are:

• muscle damage, which can rarely be severe. It can cause muscle problems and, in particular, if you also feel unwell or have a high fever, it can be due to abnormal muscle breakdown. Contact your doctor immediately if you experience muscle pain, sensitivity, or weakness
• severe swelling of the deep layers of the skin, especially the skin around the lips, eyes, genitals, hands, feet, or tongue, which can cause sudden difficulty breathing
• high fever accompanied by a rash similar to measles, swollen lymph nodes, liver enlargement (including liver failure), increased white blood cell count (leukocytosis, with or without eosinophilia)
• redness of the skin (erythema), different types of rash (e.g. itching, with white spots, with blisters, with pus-filled blisters, with skin peeling), generalized erythema, necrosis, blistering peeling of the skin and mucous membranes, leading to exfoliation and possible sepsis (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• nervousness
• feeling of thirst
• ringing in the ears
• blurred vision, changes in vision
• hair loss
• mouth ulcers
• pancreatitis: common symptoms are abdominal pain, nausea, and vomiting
• increased sweating
• weight loss, increased appetite, uncontrolled loss of appetite (anorexia)
• muscle and joint stiffness
• abnormal blood cell count (white blood cells, red blood cells, or platelets)
• urgent need to urinate
• changes or decrease in urine volume due to kidney inflammation (tubulointerstitial nephritis)
• liver inflammation (hepatitis)
• yellowish skin (jaundice)
• liver damage
• increase in creatine phosphokinase levels in blood (an indicator of muscle damage)

If you experience any side effect, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRam.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Febuxostat Bluepharma

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month shown.
• This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Febuxostat Bluepharma

The active substance is febuxostat (as febuxostat hemihydrate).

Each tablet contains 80 mg of febuxostat.

The other ingredients are:

Tablet core:lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hydroxypropylcellulose, poloxamer 407, colloidal anhydrous silica, magnesium stearate.

Tablet coating:partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 4000, talc, yellow iron oxide (E172).

Appearance and packaging

Yellow, oblong, biconvex tablets, marked with “80” on one side.

Febuxostat Bluepharma 80 mg is available in blister packs (PVC/PCTFE-Aluminum) or (PVC/PVDC-Aluminum) of 14 tablets.

Febuxostat Bluepharma 80 mg is available in packs of 28 film-coated tablets.

Marketing authorization holder and manufacturer

Bluepharma - Indústria Farmacêutica, S.A.

São Martinho do Bispo

3045-016 Coimbra

Portugal

Date of last revision of this leaflet: June 2018

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es