FEBUXOSTAT BLUEPHARMA 120 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Febuxostat Bluepharma 120 mg film-coated tablets EFG.

Febuxostat (as Febuxostat hemihydrate)

Read the entire package leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this package leaflet, as 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Febuxostat Bluepharma and what is it used for
2. What you need to know before taking Febuxostat Bluepharma
3. How to take Febuxostat Bluepharma
4. Possible side effects
5. Storage of Febuxostat Bluepharma
6. Contents of the pack and further 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 intense 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 the uric acid concentration low by taking Febuxostat Bluepharma once a day slows down the formation of crystals and, over time, reduces the symptoms. If the uric acid concentration is kept low for a long enough time, the size of the tophi is also reduced.

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

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

Febuxostat Bluepharma is for adults.

2. What you need to know before taking 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 rashes that itch), itching
• swelling of the limbs or face
• difficulty breathing
• fever with swollen lymph nodes
• also severe allergic reactions that can put your life at risk, associated with cardiac arrest.

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

Rare cases of skin rashes that can put your life at risk (Stevens-Johnson Syndrome) have been reported with the use of Febuxostat Bluepharma, initially appearing on the trunk as reddish spots in a target shape or circular spots 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 to the doctor immediately and tell them that you are taking this medicine.

If you experience a gout attack (a sudden and 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 to take certain medications 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 even if you experience 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 medications 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 medications to decrease uric acid may 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 the liver is functioning 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 whether Febuxostat Bluepharma can harm the fetus. Febuxostat Bluepharma should not be used during pregnancy. It is not known whether 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 them before taking this medicine.

3. How to take Febuxostat Bluepharma

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, 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 80 mg and 120 mg film-coated tablets. 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 Bluepharma is available in 120 mg tablets.

Start taking Febuxostat Bluepharma two days before chemotherapy and continue using it as indicated by your doctor. In general, treatment is 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

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 for the 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 the missed 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 about 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 put your life at risk, characterized by the formation of blisters and skin peeling 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 in the blood (hypersensitivity to medicines with eosinophilia and systemic symptoms - DRESS syndrome) (see section 2)
• generalized skin rashes

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 the 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 sexual desire
• difficulty sleeping, drowsiness
• dizziness, numbness, tingling, decreased or altered sensation (hypoesthesia, hemiparesis, or paresthesia), altered or decreased sense of taste (hypogeusia)
• abnormalities in the ECG (electrocardiogram), irregular or rapid heartbeat, perception of heartbeats (palpitations)
• flushing or reddening (redness of the face or neck), increased blood pressure, bleeding (hemorrhage, observed only in patients receiving chemotherapy for blood diseases)
• cough, difficulty breathing, discomfort or pain in the chest, 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 discomfort
• itching, hives, skin inflammation or discoloration, small red or purple spots on the skin, small bumps on the skin, skin rash and bumps, other skin disorders
• muscle cramps, muscle weakness, muscle and joint pain, bursitis or arthritis (joint inflammation, usually accompanied by pain, swelling, or stiffness), pain in the limbs, 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 thyroid-stimulating hormone (TSH) levels in the 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 may be due to abnormal muscle destruction. Contact your doctor immediately if you experience muscle pain, sensitivity, or weakness
• severe swelling of the deep layers of the skin, especially the one surrounding 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 in the blood (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 decreased urine volume due to kidney inflammation (tubulointerstitial nephritis)
• liver inflammation (hepatitis)
• yellowish skin (jaundice)
• liver damage
• increased creatine phosphokinase levels in the blood (an indicator of muscle damage)

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

Reporting of 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 package leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: www.notificaRam.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Febuxostat Bluepharma

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

Do not use this medicine after the expiry date stated on the carton and on the blister pack after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Febuxostat Bluepharma

The active ingredient is febuxostat (as febuxostat hemihydrate).

Each tablet contains 120 mg of febuxostat.

The other components are:

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

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

Appearance of the Product and Packaging Content

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 packs of 28 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Bluepharma - Indústria Farmacêutica, S.A.

São Martinho do Bispo

3045-016 Coimbra

Portugal

You can request more information about this medication by contacting the local representative of the marketing authorization holder.

Date of the Last Revision of this Prospectus: June 2018

Other Sources of Information

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