Product Information for the User

Febuxostat Pharma Combix 80 mg Film-Coated Tablets EFG

Read this entire product information carefully before starting to take this medication, as it contains important information for you.

-Keep this product information, as you may need to refer to it again.

-If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

1. What isFebuxostat Pharma Combixand for what it is used

2. What you need to know before starting to takeFebuxostat Pharma Combix

3. How to takeFebuxostat Pharma Combix

4. Possible adverse effects

5. Storage ofFebuxostat Pharma Combix

6. Contents of the package and additional information

Febuxostat Pharma Combix contains the active ingredient febuxostat and is used to treat gout, which is associated with an excess of a chemical compound called uric acid (urate) in the body. 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 (known as 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 acts by reducing the concentration of uric acid. Maintaining a low concentration of uric acid by taking febuxostat once a day slows the formation of crystals and, over time, reduces symptoms. If the concentration of uric acid is kept low for a sufficient period, the size of the tophi also decreases.

Febuxostat is for adults.

Do not take Febuxostat:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take febuxostat:

• if you have or have had heart failure, other heart problems, or stroke
• if you have or have had kidney disease and/or severe allergic reactions to allopurinol (a medication 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 allergic reactions to febuxostat, stop taking this medication (see also section 4).

Possible symptoms of allergic reactions may include:

• skin 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.

Rare cases of life-threatening skin eruptions (Stevens-Johnson syndrome) have been reported with the use of febuxostat, initially appearing on the trunk as red spots in the shape of a bull's-eye 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 your skin, go immediately to your doctor and tell them that you are taking this medication.

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

Some people may experience a gout attack when starting certain medications that control uric acid levels. Not everyone experiences these attacks, but they can occur even while taking febuxostat, especially during the first weeks or months of treatment. It is essential to continue taking febuxostat daily, as this medication continues to act to reduce uric acid levels. If you continue to take febuxostat, gout attacks will become less frequent and less painful.

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

In patients with very high uric acid levels (e.g. those undergoing chemotherapy for cancer), treatment with medications to reduce uric acid levels may lead to the accumulation of xanthine in the urinary tract, potentially forming stones, although this has not been observed in patients treated with febuxostat 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 medication to children under 18 years of age, as the safety and efficacy have not been established.

Other medications and febuxostat

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

It is especially important to inform your doctor or pharmacist if you are taking medications containing any of the following substances, as they may interact with febuxostat, and your doctor may need to take special measures:

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

Pregnancy and breastfeeding

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

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

Driving and operating machinery

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

Febuxostat Pharma Combixcontains lactose and sodium

Febuxostat Pharma Combix tablets contain lactose (a type of sugar). If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for 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 tablets are taken orally, with or without food.

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

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

If you take more Febuxostat than you should

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

If you forget to take Febuxostat

If you forget a dose of febuxostat, 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 compensate for the missed doses.

If you interrupt treatment with Febuxostat

Although you may be feeling better, do not stop taking febuxostat unless your doctor tells you to. If you stop taking febuxostat, your uric acid concentration may increase 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 (may affect up to 1 in 1,000 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, for example 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, hepatitis (including liver insufficiency), increased white blood cell count (hypersensitivity to medications with eosinophilia and systemic symptoms-syndrome of DRESS) (see section 2)
• generalized skin eruptions.

Frequent side effects(may affect up to 1 in 10 people):

• abnormal liver test results
• diarrhea
• headache
• eruption (including various types of eruption, see below the sections “infrequent” and “rare”)
• nausea
• increased symptoms of gout
• localized swelling due to fluid retention in tissues (edema)
• dizziness
• breathing difficulties
• itching
• limb pain, muscle/joint pain
• fatigue.

Other side effects not mentioned above are included below.

Theinfrequent side effects(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, somnolence
• numbness, tingling sensation, decreased or altered sensitivity (hypoaesthesia, hemiparesis, or paresthesia), altered sense of taste, decreased sense of smell (hyposmia)
• ECG (electrocardiogram) abnormalities, irregular or rapid heartbeat, perception of heartbeats (palpitations)
• flushes or redness (enrojecimiento of the face or neck), increased blood pressure, bleeding (haemorrhage, observed only in patients receiving chemotherapy for blood diseases)
• cough, discomfort or pain in the chest, inflammation of the nasal passages and/or throat (upper respiratory tract infection), bronchitis, lower respiratory tract infection
• dry mouth, abdominal pain or discomfort, or gas, abdominal pain, heartburn, indigestion, constipation, frequent bowel movements, vomiting, stomach discomfort
• eruption with itching, urticaria, inflammation or discoloration of the skin, small red or purple spots on the skin, small rashes on the skin, rashes on the skin covered with small interconnected bumps, eruption, rashes, and spots on the skin,increased sweating, nocturnal sweating, alopecia, facial redness (erythema), psoriasis, eczema,other skin alterations
• muscle cramps, muscle weakness, bursitis or arthritis (inflammation of the joints, usually accompanied by pain, swelling, or stiffness), back pain, muscle spasms, muscle and/or joint stiffness
• blood in urine, frequent urination, abnormal urine test results (increased protein concentration in urine), reduced kidney function, urinary tract infection
• chest pain, chest discomfort
• gallstones in the gallbladder or bile ducts (cholelithiasis)
• increased levels of thyroid-stimulating hormone (TSH) in the blood
• changes in blood biochemistry or the number of blood cells or platelets (abnormal results in blood tests)
• kidney stones
• erection difficulties
• decreased thyroid gland activity
• blurred vision, changes in vision
• tinnitus
• nasal discharge
• mouth ulcers
• pancreatitis: common symptoms are abdominal pain, nausea, and vomiting
• urgent need to urinate
• pain
• discomfort
• increased INR
• bruising
• swelling of the lips.

Therare side effects(may affect up to 1 in 1,000 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 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 deeper layers of the skin, especially around the eyes, genitals, hands, feet, or tongue, which may cause sudden difficulty breathing
• high fever accompanied by a rash similar to measles, swollen lymph nodes, liver enlargement (including liver insufficiency), increased white blood cell count (leucocytosis, with or without eosinophilia)
• different types of eruptions (e.g. with white spots with blisters, with blisters containing pus, with peeling of the skin, rash similar to measles), generalized erythema, necrosis, blistering of the skin and mucous membranes, leading to exfoliation and possible sepsis (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• anxiety
• thirst
• 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)
• changes or decreased urine volume due to kidney inflammation (tubulointerstitial nephritis)
• liver inflammation (hepatitis)
• yellow skin (jaundice)
• urinary tract infection
• liver damage
• increased levels of creatine phosphokinase in the blood (a marker of muscle damage)
• sudden cardiac death
• low red blood cell count (anemia)
• depression
• sleep disorder
• loss of taste
• burning sensation
• dizziness
• circulatory insufficiency
• lung infection (pneumonia)
• mouth sores; inflammation of the mouth
• gastrointestinal perforation
• rotator cuff syndrome
• polymyalgia rheumatica
• sensation of heat
• sudden loss of vision due to obstruction of an eye artery.

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 that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe carton box and on the blister packafter CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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 Pharma Combix 80 mg

The active ingredient is febuxostat. Each film-coated tablet contains 80 mg of febuxostat.

• The other components (excipients) are:
• Tablet core: microcrystalline cellulose , monohydrate lactose, sodium croscarmellose, hydroxypropyl cellulose, sodium lauryl sulfate, anhydrous lactose, anhydrous colloidal silica, and magnesium stearate.
• Tablet coating: poly(vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc, and yellow iron oxide (E172).

Appearance of the product and content of the packaging

Yellowish or yellowish-colored tablets, film-coated, oblong, biconvex, approximately 17.2 mm long, 6.2 mm wide, and 5.2 mm thick, with the engraving "80" on one face and smooth on the other.

Febuxostat Pharma Combix 80 mg is presented in PVC/PE/PVDC-Al blisters and PVC/PCTFE-Al blisters in packs of 28 tablets.

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

Genepharm S.A.

18th km, Marathonos Ave,

Pallini Attiki, 15351

Greece

Last review date of this leaflet: June 2023

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