Prospecto:information for the user

Febuxostat cinfamed 120 mg film-coated tablets

Read this prospectus carefully before starting to take this medicine,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.

If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribedonlyto you, and you must not give it to other people evenifthey havethe same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist, evenifthey are not listed in this prospectus. See section 4.

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

2.What you need to knowbeforestarting totake Febuxostat cinfamed

3.How to take Febuxostat cinfamed

4.Possible adverse effects

5Storage of Febuxostat cinfamed

6.Contents of the package and additional information

This medicationcontains 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 sudden and intense pain, redness, heat, and swelling in the joints (known as gout attacks). If left untreated, large deposits called tophi can form around the joints and inside them. Tophi can damage the joints and bones.

This medicationacts by reducing the concentration of uric acid. Maintaining low uric acid levels by takingFebuxostat cinfamedonce a day slows the formation of crystals and, over time, reduces symptoms. If uric acid levels are kept low for a sufficient period, the size of the tophi also decreases.

Febuxostat cinfamed120 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 to treat blood cancer.

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

This medicationis for adults.

Do not takeFebuxostat cinfamed:

• 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 cinfamed:

• if you have or have had heart failure, 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 cinfamed, stop taking this medication (see also section 4). Possible symptoms of allergic reactions may be:

• 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 put your life at risk, associated with cardio-circulatory arrest.

Your doctor may decide to permanently discontinue febuxostat treatment.

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 mouth ulcers, throat, nose, genital, and conjunctivitis (red and swollen eyes). The rash may evolve into generalized blisters or skin peeling.

If you have developed Stevens-Johnson syndrome with the use of febuxostat, do not restart febuxostat 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 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 febuxostat treatment.

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, with possible stone formation, 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 cinfamed

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

It is especially important to inform your doctor or pharmacist if you are using 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, breastfeeding, and fertility

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

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

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 cinfamed contains lactose and sodium

This medication contains lactose. 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 of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• The recommended dose is one tablet per day. The blister 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

This medication is marketed in 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 a gout attack.

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

Start taking febuxostat two days before chemotherapy and continue using it as indicated by your doctor. Generally, the treatment is of short duration.

If you take more Febuxostat cinfamed than you should

In case of overdose or accidental ingestion, 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 cinfamed

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 the treatment with Febuxostat cinfamed

Although you may be feeling better, do not stop taking febuxostat, unless your doctor tells you to. If you stop taking febuxostat, the 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 immediatelyor 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 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, liver enlargement, hepatitis (including liver failure), increased white blood cell count (hypersensitivity to medications with eosinophilia and systemic symptoms of DRESS syndrome) (see section 2)

• generalized skin eruptions

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

• 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
• respiratory 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:

• 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, decreased or altered sensitivity (hypoaesthesia, hemiparesis, or paresthesia),altered sense of taste, decreased sense of smell (hyposmia)
• ECG (electrocardiogram) anomalies, irregular or rapid heartbeat, perception of heartbeats (palpitations)
• flushes or redness (e.g. face or neck redness), 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
• mouth dryness,abdominal pain or discomfort, gas, stomach pain, indigestion, constipation, frequent bowel movements, vomiting, stomach discomfort
• eruption with itching, urticaria, skin inflammation or discoloration, small red or purple spots on the skin, small skin rashes, skin rashes with small interconnected bumps, skin eruption, rashes, and spots, increased sweating, nocturnal sweating, alopecia, skin 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 tests (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
• blood biochemistry changes or changes in the number of blood cells or platelets (abnormal blood test results)
• 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
• lip swelling

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

• 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 deepest 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 failure), increased white blood cell count (leucocytosis, with or without eosinophilia)
• different types of eruptions (e.g. with white spots with blisters, with pus-filled blisters, with skin peeling, measles-like rash), 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)
• abnormal blood cell count (white blood cells, red blood cells, or platelets)
• kidney inflammation (tubulointerstitial nephritis) due to changes or decreased urine volume
• 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
• feeling 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 throughthe Spanish System for Pharmacovigilance 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.

Do not store at a temperature above 30°C.

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

Composition of Febuxostat cinfamed

• The active ingredient is febuxostat.

Each Febuxostat cinfamed tablet contains 120 mg of febuxostat.

• The other components are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hydroxypropyl cellulose, sodium lauryl sulfate, anhydrous colloidal silica, magnesium stearate forming the core of the tablet and poly(vinyl alcohol) (E1203), macrogol 3350 (E1521), talc (E553b), titanium dioxide (E171) and yellow iron oxide (E172) forming the coating of the tablet. See section 2 “Febuxostat cinfamed contains lactose”.

Appearance of Febuxostat cinfamed and contents of the package

Yellow-coated, biconvex, capsule-shaped tablets with “F 20” engraved on one face and smooth on the other.

The box contains PVC/PE/PVdC blisters and an aluminum sheet.

It is available in packages of 28 and 84 coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10 Industrial Estate Areta

31620 Huarte (Navarra) – Spain.

Responsible for manufacturing

Macleods Pharma UK Limited

Wynyard Park House,

Wynyard Avenue,

Wynyard, Billingham,

TS22 5TB

United Kingdom

or

Synoptis Industrial Sp. z o.o.

ul. Rabowicka 15,

62-020Swarzedz, Poland

or

Heumann Pharma GmbH & Co. Generica KG,

Südwestpark 50, 90449 Nürnberg,

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

United Kingdom - Febuxostat 120 mg film-coated tablets

Germany - Febuxostat Heumann 120 mg Filmtabletten

Last review date of this prospectus:September 2022

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

You can access detailed and updated information on this medicine by scanning the QR code included in the prospectus and packaging with your smartphone. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/83403/P_83403.html

QR code to:https://cima.aemps.es/cima/dochtml/p/83403/P_83403.html