Febuxostat Laboratorios Liconsa

1. What is Febuxostat Laboratorios Liconsa and what is it used for

Febuxostat Laboratorios Liconsa tablets contain the active substance febuxostat and are used to treat gout, which is associated with an excess of a chemical compound called uric acid (urate) in the body. In some people, the amount of uric acid in the blood increases and can become too high to remain dissolved. In this case, urate crystals can form inside and around the joints and kidneys. These crystals can cause sudden, severe pain, redness, warmth, and swelling of the joint (gout attack). If the disease is not treated, larger deposits called tophi can form inside and around the joints. Tophi can cause joint and bone damage. Febuxostat Laboratorios Liconsa works by reducing uric acid levels. Maintaining low uric acid levels by taking Febuxostat Laboratorios Liconsa once a day prevents the formation of crystals and over time reduces symptoms. Maintaining sufficiently low uric acid levels for a long enough period can also lead to a reduction in tophi. Febuxostat Laboratorios Liconsa, 120 mg, tablets are also used to treat and prevent high uric acid levels in the blood that can occur when starting chemotherapy for blood cancer. When chemotherapy is used, cancer cells are destroyed, and uric acid levels in the blood increase accordingly, unless uric acid formation is prevented. Febuxostat Laboratorios Liconsa is used in adults. NL-H-4167_Febuxostat 80, 120 mg orig 30.01.2022

2. Important information before taking Febuxostat Laboratorios Liconsa

When not to take Febuxostat Laboratorios Liconsa:

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

Warnings and precautions

Before starting treatment with Febuxostat Laboratorios Liconsa, you should consult a doctor:

• if the patient has or has had heart failure or heart disease; heart problems or stroke
• if the patient currently has or has had kidney disease and (or) severe allergic reactions to allopurinol (a medicine used to treat gout)
• if the patient currently has or has had liver disease or abnormal liver function test results;
• if the patient is 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 the patient has thyroid disease.

In case of an allergic reaction to Febuxostat Laboratorios Liconsa, you should stop taking this medicine immediately (see also section 4). Possible symptoms of an allergic reaction are:

• rash (including severe forms of rash, such as blistering, nodules, itching, flaking rash), itching
• swelling of limbs or face
• difficulty breathing
• fever and lymph node enlargement
• severe, life-threatening allergic reactions with cardiac arrest and circulatory failure. The doctor may decide to permanently discontinue treatment with Febuxostat Laboratorios Liconsa.

There have been reports of rare, potentially life-threatening skin rashes (Stevens-Johnson syndrome) during treatment with Febuxostat Laboratorios Liconsa, initially presenting as red, concentric patches or circular patches often with blisters on the trunk. Symptoms may also include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (redness and swelling around the eyes). The rash may spread and cause peeling and separation of the skin. In case of Stevens-Johnson syndrome during treatment with Febuxostat Laboratorios Liconsa, treatment with febuxostat should not be restarted. In case of rash or the mentioned skin symptoms, you should immediately contact a doctor and inform them about taking febuxostat. If the patient experiences a gout attack (sudden onset of severe pain, tenderness, redness, warmth, and swelling of the joint): before starting treatment with Febuxostat Laboratorios Liconsa, you should wait until the attack subsides. In some people, gout attacks may worsen when starting treatment with certain medicines that control uric acid levels. Worsening does not occur in everyone, but worsening may occur, even if the patient is taking Febuxostat Laboratorios Liconsa, especially during the first few weeks or months of treatment. It is essential to continue taking Febuxostat Laboratorios Liconsa even if the patient experiences worsening, as Febuxostat Laboratorios Liconsa still reduces uric acid levels. Over time, gout attacks will become less frequent and less painful if Febuxostat Laboratorios Liconsa is taken daily. The doctor often prescribes other medicines if necessary to help prevent or treat worsening symptoms (such as pain and joint swelling). Patients who have very high uric acid levels (e.g., those undergoing chemotherapy) may experience the accumulation of xanthine in the urinary tract, with the possibility of stone formation, although this has not been observed in patients treated with Febuxostat Laboratorios Liconsa due to tumor lysis syndrome. The doctor may recommend blood tests to check if liver function is normal.

Children and adolescents

Febuxostat Laboratorios Liconsa should not be used in children under 18 years of age, as the safety and efficacy of febuxostat in this age group have not been established.

Febuxostat Laboratorios Liconsa and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription. It is particularly important to inform your doctor or pharmacist if you are taking medicines containing any of the following substances, as they may interact with Febuxostat Laboratorios Liconsa, and your doctor may need to take necessary measures:

• mercaptopurine (used to treat cancer),
• azathioprine (used to reduce the immune system response),
• theophylline (used to treat asthma).

Pregnancy and breastfeeding

It is not known whether Febuxostat Laboratorios Liconsa can harm an unborn child. Febuxostat Laboratorios Liconsa should not be used during pregnancy. It is not known whether Febuxostat Laboratorios Liconsa passes into breast milk. Febuxostat Laboratorios Liconsa should not be used if the patient is breastfeeding or plans to breastfeed. If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.

Driving and using machines

You should be aware that during treatment, dizziness, drowsiness, blurred vision, and numbness or tingling may occur. If such symptoms occur, you should not drive or operate machinery.

Febuxostat Laboratorios Liconsa contains lactose

Febuxostat Laboratorios Liconsa tablets contain lactose (a type of sugar). If the patient has been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.

Febuxostat Laboratorios Liconsa contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 80 mg/120 mg coated tablet, which is essentially "sodium-free".

3. How to take Febuxostat Laboratorios Liconsa

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should consult a doctor or pharmacist.

• The usual dose is one tablet per day. The back of the blister pack has a day-of-the-week notation to help you check if you have taken your daily dose.
• Tablets should be taken orally; the medicine can be taken with or without food.
• The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and should not be used to divide the tablet into equal doses.

Gout
Febuxostat Laboratorios Liconsa is available as 80 mg and 120 mg coated tablets. The doctor will prescribe the most suitable dose for the patient. Febuxostat Laboratorios Liconsa should be taken daily, even if there is no worsening or gout attack. Prevention and treatment of high uric acid levels in patients undergoing chemotherapy for cancer.Febuxostat Laboratorios Liconsa is available as 120 mg tablets. Taking Febuxostat Laboratorios Liconsa should be started 2 days before chemotherapy and continued as prescribed by the doctor. Treatment is usually short-term.

Overdose of Febuxostat Laboratorios Liconsa

In case of accidental overdose, you should ask your doctor for advice or contact the nearest hospital emergency department.

Missed dose of Febuxostat Laboratorios Liconsa

If a dose of Febuxostat Laboratorios Liconsa is missed, it should be taken as soon as the patient remembers, unless it is close to the time for the next dose, in which case the missed dose should be skipped and the next dose taken at the usual time. A double dose should not be taken to make up for a missed dose.

Stopping treatment with Febuxostat Laboratorios Liconsa

You should not stop taking Febuxostat Laboratorios Liconsa without consulting a doctor, even if you feel better. Stopping treatment with Febuxostat Laboratorios Liconsa may cause uric acid levels to increase again, and symptoms may worsen due to the formation of new urate crystals around the joints or in the joints and kidneys. NL-H-4167_Febuxostat 80, 120 mg orig 30.01.2022 If you have any further doubts about taking this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. You should stop taking the medicine and contact a doctor or go to the nearest emergency department immediately if you experience the following rare (occurring in 1 in 1000 patients) side effects, as they can lead to serious allergic reactions:

• anaphylactic reactions, hypersensitivity to the medicine (see also section 2 "Warnings and precautions").
• potentially life-threatening skin rashes characterized by blistering and peeling of the skin and mucous membranes, such as the mouth, throat, and genitals, painful ulcers in the mouth and (or) genitals, with fever, sore throat, and fatigue (Stevens-Johnson syndrome/toxic epidermal necrolysis) or lymph node enlargement, liver enlargement, hepatitis (to liver failure), elevated white blood cell count (drug reaction with eosinophilia and systemic symptoms - DRESS) (see section 2).
• widespread skin rashes.

Frequent side effects(may occur in 1 in 10 patients):

• abnormal liver function tests;
• diarrhea;
• headache;
• rash (including various types of rash, see below "uncommon" and "rare"), nausea;
• worsening of gout symptoms;
• localized swelling due to fluid accumulation in tissues (edema);
• dizziness;
• shortness of breath;
• itching;
• limb pain, muscle/ joint pain or swelling;
• fatigue.

Other side effects not listed above are listed below.
Uncommon side effects(may occur in 1 in 100 patients):

• decreased appetite, changes in blood sugar levels (diabetes), which may cause excessive thirst, increased fat levels in the blood, weight gain;
• decreased sex drive;
• sleep disorders, drowsiness;
• numbness, tingling, weakness, or changes in touch sensation (hypoesthesia, paresis, or paresthesia), taste disorders, decreased sense of smell (hyposmia);

NL-H-4167_Febuxostat 80, 120 mg orig 30.01.2022

• abnormalities in the ECG recording, irregular or rapid heartbeat, palpitations;
• hot flashes or skin redness (e.g., facial or neck redness), elevated blood pressure, bleeding (hemorrhage, observed only in patients undergoing chemotherapy for blood diseases);
• cough, discomfort or chest pain, nasal and (or) throat inflammation (upper respiratory tract infection), bronchitis, lower respiratory tract infection;
• dry mouth, abdominal pain or discomfort, gas, upper abdominal pain, heartburn or indigestion, constipation, frequent bowel movements, vomiting, stomach discomfort;
• itching, rash, hives, skin inflammation, skin discoloration, small, red or purple spots on the skin, small, flat red spots on the skin, flat, red areas on the skin covered with small bumps, rash, localized redness and spots on the skin, increased sweating, night sweats, hair loss, skin redness (erythema), psoriasis, other skin disorders;
• muscle spasms, muscle weakness, bursitis or tendonitis (arthritis, usually accompanied by pain, swelling, and (or) stiffness), back pain, muscle cramps, muscle or joint pain or swelling, stiffness;
• blood in urine, abnormal frequent urination, abnormal urine test results (elevated protein levels in urine), decreased kidney function, urinary tract infection;
• chest pain, discomfort in the chest;
• gallstones or bile duct stones (cholelithiasis);
• increased TSH levels;
• changes in blood chemistry or blood cell count (abnormal blood test results);
• kidney stones;
• erectile dysfunction;
• decreased thyroid function, blurred vision, changes in vision;
• ringing in the ears;
• runny nose;
• mouth ulcers;
• pancreatitis: common symptoms are abdominal pain, nausea, and vomiting;
• sudden need to urinate;
• pain;
• weakness;
• increased INR;
• bruising;
• lip swelling.

Rare side effects(may occur in 1 in 1000 patients):

• muscle damage, a condition that can be severe in isolated cases. Muscle disorders may occur, with associated poor general health or high fever, caused by muscle damage. You should contact a doctor immediately if you experience muscle pain, tenderness, or weakness;
• severe swelling of the deep layers of the skin, particularly around the eyes, genitals, hands, feet, or tongue, with possible sudden breathing difficulties;

NL-H-4167_Febuxostat 80, 120 mg orig 30.01.2022

• high fever with a rash, lymph node enlargement, liver enlargement, hepatitis (to liver failure), elevated white blood cell count (leukocytosis with or without eosinophilia);
• rashes of various types (e.g., with white spots, blisters, pus-filled blisters, peeling skin, rash-like erythema), widespread redness, necrosis, blisters on the skin and mucous membranes causing peeling and the possibility of sepsis (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• nervousness;
• feeling thirsty;
• weight loss, increased appetite, uncontrolled loss of appetite (anorexia);
• abnormal low blood cell count (white or red blood cells or platelets);
• changes in urine or decreased urine output related to kidney inflammation (interstitial nephritis);
• hepatitis;
• jaundice;
• urinary tract infection; liver damage;
• increased creatine phosphokinase activity in the blood (a marker of muscle damage);
• sudden cardiac death;
• low red blood cell count (anemia);
• depression;
• sleep disorders;
• loss of taste;
• burning sensation;
• dizziness;
• circulatory failure;
• lung infection (pneumonia);
• mouth ulcers; mouth inflammation;
• perforation of the digestive tract;
• rotator cuff syndrome;
• polymyalgia rheumatica;
• feeling hot;
• sudden loss of vision due to blockage of an artery in the eye.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected]. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Febuxostat Laboratorios Liconsa

• Keep out of the sight and reach of children.

NL-H-4167_Febuxostat 80, 120 mg orig 30.01.2022

• Do not use this medicine after the expiry date stated on the carton and on the blister pack after "EXP". The expiry date refers to the last day of the month stated.
• There are no special storage precautions for this medicine.

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

6. Contents of the pack and other information

What Febuxostat Laboratorios Liconsa contains

• The active substance is febuxostat. Each coated tablet contains 80 mg or 120 mg of febuxostat (as febuxostat hemihydrate).
• The other ingredients are: Tablet core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hydroxypropylcellulose, poloxamer 407, colloidal silicon dioxide, magnesium stearate. Tablet coating (Opadry II Yellow): polyvinyl alcohol, titanium dioxide (E 171), macrogol 4000, talc, yellow iron oxide (E 172)

What Febuxostat Laboratorios Liconsa looks like and contents of the pack

Febuxostat Laboratorios Liconsa, 80 mg, coated tablets are light yellow, approximately 17.5 mm x 7.9 mm in size, with a score line. Febuxostat Laboratorios Liconsa, 120 mg, coated tablets are light yellow, approximately 19 mm x 8 mm in size, with the symbol "120" embossed on one side. Febuxostat Laboratorios Liconsa 80 mg and 120 mg are packaged in transparent PVC/PVDC/Aluminum blisters. Febuxostat Laboratorios Liconsa 80 mg and 120 mg are available in packs containing 14, 28, 42, 56, 84, and 98 coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder: Laboratorios Liconsa, S.A. C/Dulcinea S/N, 28805 Alcalá de Henares, Madrid, Spain Manufacturer: Laboratorios Liconsa S.A. Avda. Miralcampo, N 7 Polígono Industrial Miralcampo, 19200 Azuqueca de Henares (Guadalajara) Spain NL-H-4167_Febuxostat 80, 120 mg orig 30.01.2022 For more detailed information, you should contact the local representative of the marketing authorization holder.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands, Romania, Poland, Hungary Febuxostat Universal Farma Bulgaria, Czech Republic, Lithuania, Latvia, Estonia Febuxostat Zentiva Slovenia Febuksostat Universal Farma

Date of last revision of the leaflet: 21 July 2022