Package Leaflet: Information for the User

Febuxostat Bluepharma 120 mg Film-Coated Tablets.

Febuxostat (as Febuxostat hemihydrate)

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

2. What you need to know before you start taking Febuxostat Bluepharma

3. How to take Febuxostat Bluepharma

4. Possible side effects

5. Storage of Febuxostat Bluepharma

6. Contents of the pack and additional information

Febuxostat Bluepharma tablets contain the active ingredient febuxostat and is 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 accumulates in the blood to the point where it cannot be dissolved. When this occurs, urate crystals form both inside and around the joints and kidneys. These crystals can cause a sudden and intense pain, redness, heat, and swelling in the joints (this is called gout attacks). If left untreated, large deposits called tophi can form around the joints and inside them. Tophi can damage the joints and bones.

Febuxostat Bluepharma acts by reducing the concentration of uric acid. Keeping uric acid levels low by taking Febuxostat Bluepharma once a day slows the formation of crystals and, over time, reduces symptoms. If uric acid levels are kept low for a sufficient amount of time, the size of the tophi also decreases.

Febuxostat Bluepharma 120 mg tablets is also used in the treatment and prevention of high levels of uric acid in the blood, which can occur when chemotherapy is started to treat blood cancer.

When chemotherapy is administered, cancer cells are destroyed, and as a result, uric acid levels in the blood increase, unless its formation is prevented.

Febuxostat Bluepharma is for adults.

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

Consult 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 abnormalities

• if you are being treated for high uric acid levels due to Lesch-Nyhan syndrome (a rare genetic disorder in which there is too much uric acid in the blood)

• if you have thyroid problems.

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

Possible symptoms of allergic reactions may include:

- rash including severe forms (e.g. blisters, nodules, exfoliative rashes that cause itching), itching

- swelling of the limbs or face

- difficulty breathing

- fever with enlarged lymph nodes

- also severe allergic reactions that can be life-threatening, associated with cardiac arrest.

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

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

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

If you experience a gout attack (a sudden onset of intense 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 experience a gout attack when starting certain medicines that control uric acid levels. Not everyone experiences 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 daily, as this medicine continues to act to reduce uric acid levels. If you continue to take Febuxostat Bluepharma, gout attacks will become less frequent and less painful.

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

In patients with very high uric acid levels (e.g. those undergoing chemotherapy for cancer), treatment with medicines to reduce uric acid levels may lead to the accumulation of xanthine in the urinary tract, with possible stone formation, 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 functioning normally.

Children and adolescents

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

Other medicines and Febuxostat Bluepharma

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including those purchased without a prescription.

It is especially important to 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 measures:

• Mercaptopurine (used to treat cancer)

• Azathioprine (used to reduce immune response)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

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 operating machines

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

Febuxostat Bluepharma contains lactose

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

Follow exactly the administration instructions of this medication as indicated 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.

Gout:

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

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

Prevention and treatment of high uric acid levels in patients undergoing chemotherapy for cancer:

Febuxostat Bluepharmais availablein 120 mg tablets.

Start taking Febuxostat Bluepharma two days before chemotherapy and continue as directed by your doctor. The treatment is generally of short duration.

If you take more Febuxostat Bluepharma than you should

In case of accidental overdose, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Febuxostat Bluepharma

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

If you interrupt treatment with Febuxostat Bluepharma

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 (which may affect up to 1 in 1000 people), as you may be experiencing a severe allergic reaction:

- anaphylactic reactions, hypersensitivity to the medicine (see also section 2 “Warnings and precautions”)

- skin eruptions that can be life-threatening, characterized by the formation of blisters 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, enlarged liver, hepatitis (including liver failure), increased white blood cell count (hypersensitivity to medications with eosinophilia and systemic symptoms-syndrome of DRESS) (see section 2)

- generalized skin eruptions

Thefrequent side effects(which may affect up to 1 in 10 people) are as follows:

• abnormal liver test results

• diarrhea

• headache

• rash (including various types of rash, see below the sections “infrequent” and “rare”)

• nausea

• localized swelling due to fluid retention in tissues (edema)

Other side effects not mentioned above are listed below.

Theinfrequent side effects(which may affect up to 1 in 100 people) are as follows:

• decreased appetite, change in blood sugar level (diabetes) whose symptom may be excessive thirst, increased blood fats, weight gain

• loss of sexual appetite

• difficulty sleeping, drowsiness

• dizziness, numbness, tingling, decreased or altered sensitivity (hypoaesthesia, 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, bleeding (haemorrhage, observed only in patients receiving chemotherapy for blood diseases)

• cough, respiratory difficulties, chest discomfort, inflammation of the nasal passages and/or throat (upper respiratory tract infection), bronchitis

• dry mouth, abdominal pain or discomfort, heartburn, indigestion, constipation, frequent bowel movements, vomiting, abdominal discomfort

• itching, urticaria, skin inflammation or discoloration, small red spots or purpura on the skin, small rashes on the skin, rashes on the skin covered with small interconnected bumps, rash, rashes, and spots on the skin, other skin alterations

• muscle cramps, muscle weakness, muscle pain, and joint pain, bursitis or arthritis (inflammation of the joints, usually accompanied by pain, swelling, or stiffness), limb pain, back pain, muscle spasms

• blood in urine, 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 the number of blood cells or platelets (abnormal results in blood tests)

• kidney stones

• erectile dysfunction

Therare side effects(which may affect up to 1 in 1000 people) are as follows:

• muscle damage, which in rare cases can be severe. It may cause muscle problems and, particularly if you are unwell or have a high fever, it may be due to abnormal muscle destruction. Contact your doctor immediately if you experience muscle pain, sensitivity, or weakness

• severe swelling of the deepest layers of the skin, especially around the lips, eyes, genitals, hands, feet, or tongue, which may cause sudden difficulty breathing

• high fever accompanied by a rash similar to measles, swollen lymph nodes, enlarged liver (including liver failure), increased white blood cell count (leucocytosis, 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 peeling skin, rash similar to measles), generalized erythema, necrosis, blistering 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 include abdominal pain, nausea, and vomiting

• increased sweating

• weight loss, increased appetite, uncontrolled loss of appetite (anorexia)

• muscle stiffness and/or joint stiffness

• abnormal blood cell count (white blood cells, red blood cells, or platelets)

• urgent need to urinate

• changes or decreased urine volume due to kidney inflammation (tubulointerstitial nephritis)

• liver inflammation (hepatitis)

• yellowish skin (jaundice)

• liver damage

• increased levels of creatine phosphokinase in blood (a marker of muscle damage)

If you experience any side effect, report it to your doctor or pharmacist. This includes any side effect not mentioned in this leaflet.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRam.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Febuxostat Bluepharma

The active ingredient is febuxostat (as febuxostat hemihydrate).

Each tablet contains 120 mg of febuxostat.

The other components are:

Core of the tablet: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hydroxypropyl cellulose, poloxamer 407, anhydrous colloidal silica, magnesium stearate.

Coating of the tablet: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 4000, talc, yellow iron oxide (E172).

Appearance of the product and contents of the packaging

Yellow, oblong, biconvex tablets, marked on one face with “120”.

Febuxostat Bluepharma 120 mg is presented in blisters (PVC/PCTFE-Aluminum) or (PVC/PVDC-Aluminum) of 14 tablets.

Febuxostat Bluepharma 120 mg is available in 28-tablet film-coated packaging.

Holder of the marketing authorization and responsible manufacturer

Bluepharma - Indústria Farmacêutica, S.A.

São Martinho do Bispo

3045-016 Coimbra

Portugal

For more information about this medication, please contact the local representative of the holder of the marketing authorization.

Last review date of this leaflet: June 2018

Other sources of information

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es