Febuxostat laboratorios liconsa

NL-H-4167_Febuxostat 80, 120 mg orig 30.01.2022
Febuxostat Laboratorios Liconsa, 80 mg, film-coated tablets
Febuxostat Laboratorios Liconsa, 120 mg, film-coated tablets
Febuxostatum
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet :

1. What is Febuxostat Laboratorios Liconsa and what is it used for
2. Important information before taking Febuxostat Laboratorios Liconsa
3. How to take Febuxostat Laboratorios Liconsa
4. Possible side effects
5. How to store Febuxostat Laboratorios Liconsa
6. Contents of the pack and other information

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

Febuxostat Laboratorios Liconsa tablets contain the active substance febuxostat and are used in
the treatment of gout, a condition associated with an excess of a chemical compound called uric acid (urate) in the body. In some individuals, the amount of uric acid in the blood increases and may become so high that the compound can no longer remain dissolved. In such cases, urate crystals may form within and around joints and in the kidneys.
These crystals may cause sudden, severe pain, redness, warmth, and swelling of a joint (known as a gout attack). If left untreated, larger deposits called tophi may form inside and around the joints. Tophi may lead to joint and bone damage.
Febuxostat Laboratorios Liconsa works by lowering the concentration of uric acid.
Maintaining a low uric acid level by taking Febuxostat Laboratorios Liconsa once daily prevents the formation of new crystals and over time reduces symptoms. Sustaining sufficiently low uric acid levels for an adequate duration may also lead to a reduction in gout tophi.
Febuxostat Laboratorios Liconsa 120 mg tablets are also used to treat and prevent high uric acid levels in the blood that may occur when initiating chemotherapy for blood cancer. During chemotherapy, tumor cells are destroyed, leading to a corresponding increase in uric acid levels in the blood unless uric acid formation is prevented.
Febuxostat Laboratorios Liconsa is intended for use in adults.
NL-H-4167_Febuxostat 80, 120 mg orig 30.01.2022

2. Important information before using Febuxostat Laboratorios Liconsa

When not to use Febuxostat Laboratorios Liconsa:

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

Warnings and precautions
Before starting treatment with Febuxostat Laboratorios Liconsa, 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 previously had kidney disease and/or severe allergic reactions to allopurinol (a medicine used in the treatment of gout)
• if the patient currently has or has previously had liver disease or abnormal liver function test results
• if the patient is being treated for high levels of uric acid due to Lesch-Nyhan syndrome (a rare inherited disorder in which there is too much uric acid in the blood)
• if the patient has a thyroid disorder.

If an allergic reaction to Febuxostat Laboratorios Liconsa occurs, treatment with this medicine must be stopped immediately (see also section 4).
Possible symptoms of an allergic reaction include:

• rash, including severe forms of rash (e.g. blisters, nodules, itchy, peeling rash), itching
• swelling of limbs or face
• difficulty breathing
• fever and swollen lymph nodes
• severe, life-threatening allergic reactions with cardiac arrest and circulatory collapse. The doctor may decide to permanently discontinue treatment with Febuxostat Laboratorios Liconsa.

Rare cases of potentially life-threatening skin rashes (Stevens-Johnson syndrome) have been reported during treatment with Febuxostat Laboratorios Liconsa, initially presenting as reddish, concentric spots or circular lesions, often with blisters, on the trunk.
Symptoms may also include ulceration of the mouth, throat, nose, genitals, and conjunctivitis (redness and swelling around the eyes).
The rash may spread and lead to peeling and detachment of the epidermis.
If Stevens-Johnson syndrome occurs during treatment with Febuxostat Laboratorios Liconsa, treatment with febuxostat must not be restarted.
If a rash or any of the mentioned skin symptoms occur, contact a doctor immediately and inform them about taking febuxostat.
If the patient experiences a gout attack (sudden onset of severe pain, tenderness, redness, warmth, and swelling in a joint): wait until the gout attack subsides before starting treatment with Febuxostat Laboratorios Liconsa for the first time.
In some people, gout attacks may worsen when starting treatment with certain medicines that control uric acid levels. Flares do not occur in everyone, but a flare may occur even if the patient is taking Febuxostat Laboratorios Liconsa, especially during the first weeks or months of treatment. It is important to continue taking Febuxostat Laboratorios Liconsa even if a flare occurs, because
NL-H-4167_Febuxostat 80, 120 mg orig 30.01.2022
Febuxostat Laboratorios Liconsa continues to reduce uric acid levels. Over time, gout attacks will become less frequent and less painful if Febuxostat
Laboratorios Liconsa is taken daily.
The doctor may often prescribe other medicines, if necessary, to help prevent or treat flare symptoms (such as joint pain and swelling).
In patients who have very high levels of uric acid (e.g. those undergoing chemotherapy), treatment with medicines that lower uric acid levels may lead to xanthine accumulation in the urinary tract with a risk 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 whether liver function is normal.
Children and adolescents
This medicine should not be used in children under 18 years of age, as the efficacy and safety have not been established.
Febuxostat Laboratorios Liconsa and other medicines
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 especially 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 the doctor may consider taking necessary measures:

• mercaptopurine (used in cancer treatment),
• azathioprine (used to suppress the immune system response),
• theophylline (used in the treatment of asthma).

Pregnancy and breastfeeding
It is not known whether Febuxostat Laboratorios Liconsa may harm the 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 planning to breastfeed.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Be aware that during treatment dizziness, drowsiness, blurred vision, or numbness or tingling may occur. If such symptoms occur, do not drive or operate machinery.
Febuxostat Laboratorios Liconsa contains lactose
NL-H-4167_Febuxostat 80, 120 mg orig 30.01.2022
Febuxostat Laboratorios Liconsa tablets contain lactose (a type of sugar). If the patient has been diagnosed with an intolerance to certain sugars, consult a doctor before taking this medicine.
Febuxostat Laboratorios Liconsa contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per 80 mg / 120 mg coated tablet, i.e. essentially "sodium-free".

3. How to take Febuxostat Laboratorios Liconsa

This medicine should always be taken exactly as your doctor has told you. If you are not sure, please consult your doctor or pharmacist.

• The usual dose is one tablet daily. On the back of the blister pack there is a marking indicating the days of the week, which helps you check whether you have taken the dose each day.
• The tablets should be taken orally. The medicine can be taken with or without food.
• The break line on the tablet is only intended to facilitate tablet splitting for easier swallowing, not for dividing the tablet into equal doses.

Gout
Febuxostat Laboratorios Liconsa is available as 80 mg coated tablets and 120 mg coated tablets. Your doctor will prescribe the most appropriate dose for you.
Febuxostat Laboratorios Liconsa should be taken every day, even if there is no flare-up or acute attack of gout.

Prevention and treatment of high uric acid levels in patients undergoing chemotherapy due to cancer
Febuxostat Laboratorios Liconsa is available as 120 mg tablets.
Treatment with Febuxostat Laboratorios Liconsa should be started two days before chemotherapy and continued as directed by your doctor. Treatment is usually short-term.

Taking more Febuxostat Laboratorios Liconsa than prescribed
If you accidentally take too much medicine, consult your doctor immediately or contact the nearest hospital emergency department.

If you forget to take Febuxostat Laboratorios Liconsa
If you miss a dose of Febuxostat Laboratorios Liconsa, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and take the next dose at your regular time. Do not take a double dose to make up for a missed dose.

Stopping Febuxostat Laboratorios Liconsa
Do not stop taking Febuxostat Laboratorios Liconsa without consulting your doctor, even if you feel better. Stopping treatment with Febuxostat Laboratorios Liconsa may cause uric acid levels to rise again, and symptoms may worsen due to the formation of new urate crystals around or within the joints and in the kidneys.

NL-H-4167_Febuxostat 80, 120 mg orig 30.01.2022
If you have any further questions about the use of this medicine, please consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should stop taking the medicine and contact your doctor immediately or go to
the nearest emergency department if any of the following rare (occurring in 1 out of 1000
patients) adverse reactions occur, as they may 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 internal mucosal surfaces, e.g. mouth and genital organs, painful mouth ulcers and (or) genital area ulcers accompanied by fever, sore throat and fatigue (Stevens-Johnson syndrome/toxic epidermal necrolysis) or swollen lymph nodes, enlarged liver, hepatitis (leading to liver failure), increased white blood cell count (drug reaction with eosinophilia and systemic symptoms - DRESS) (see section 2).
• generalized skin rashes.

Common adverse reactions (may occur in 1 out of 10 patients):

• abnormal liver function test results;
• diarrhoea;
• headache;
• rash (including various types of rashes, see below under "uncommon" and "rare");
• nausea;
• exacerbation of gout symptoms;
• localized swelling due to fluid accumulation in tissues (oedema);
• dizziness;
• shortness of breath;
• itching;
• limb pain, muscle/joint pain or swelling;
• fatigue.

Other adverse reactions not listed above are listed below.
Uncommon adverse reactions (may occur in 1 out of 100 patients):

• decreased appetite, change in blood sugar levels (diabetes), which may present as excessive thirst, increased blood lipid levels, weight gain;
• loss of libido;
• sleep disorders, drowsiness;
• numbness, tingling, weakness or altered sense of touch (hypoesthesia, paresis or paraesthesia), taste disturbances, reduced sense of smell (hyposmia);

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

• abnormalities in ECG findings, irregular or rapid heartbeat, palpitations;
• hot flushes or skin redness (e.g. redness of face or neck), elevated blood pressure, bleeding (haemorrhage, observed only in patients undergoing chemotherapy for blood disorders);
• cough, chest discomfort or pain, inflammation of nose and (or) throat (upper respiratory tract infection), bronchitis, lower respiratory tract infection;
• dry mouth, abdominal pain or discomfort or flatulence, upper abdominal pain, heartburn or indigestion, constipation, more frequent bowel movements, vomiting, stomach discomfort;
• itching, rash, urticaria, skin inflammation, skin discoloration, small red or purple spots on the skin, small flat red spots on the skin, flat red areas covered with small bumps, rash, local redness and skin spots, increased sweating, night sweats, hair loss, skin redness (flushing), psoriasis, eczema, other types of skin disorders;
• muscle cramps, muscle weakness, tenosynovitis or joint inflammation (arthritis, usually associated with pain, swelling and (or) stiffness), back pain, muscle cramps, muscle or joint pain, stiffness;
• blood in urine, abnormal frequent urination, abnormal urine test results (increased protein in urine), reduced kidney function, urinary tract infection;
• chest pain, chest discomfort;
• gallstones in the gallbladder or bile ducts (cholelithiasis);
• increased TSH levels;
• changes in blood chemical composition or blood cell or platelet count (abnormal blood test results);
• nephrolithiasis;
• erectile dysfunction;
• reduced thyroid activity, blurred vision, changes in vision;
• tinnitus;
• rhinitis;
• mouth ulceration;
• pancreatitis: common symptoms include abdominal pain, nausea and vomiting;
• sudden urge to urinate;
• pain;
• weakness;
• increased INR;
• contusion;
• lip swelling.

Rare adverse reactions (may occur in 1 out of 1000 patients):

• muscle injury, a condition which in isolated cases may be severe. Muscle disorders may occur, accompanied by malaise or high fever, caused by muscle damage. You should contact your doctor immediately if muscle pain, tenderness or weakness occurs;
• severe swelling of deep skin layers, particularly around the eyes, genital organs, hands, feet or tongue, possibly with sudden breathing difficulties;

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

• high fever with rash resembling measles, swollen lymph nodes, enlarged liver, hepatitis (leading to liver failure), increased white blood cell count (leukocytosis with or without eosinophilia);
• various types of rashes (e.g. with white spots, blisters, pustular blisters, skin peeling, measles-like rash), diffuse erythema, necrosis, blisters on skin and mucous membranes leading to separation and risk 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 reduced urine output associated with kidney inflammation (tubulointerstitial nephritis);
• hepatitis;
• yellowing of the skin (jaundice);
• bladder infection; liver damage;
• increased blood creatine phosphokinase activity (a marker of muscle damage);
• sudden death due to cardiovascular causes;
• low red blood cell count (anaemia);
• depression;
• sleep disorders;
• loss of taste sensation;
• burning sensation;
• dizziness;
• circulatory failure;
• lung infection (pneumonia);
• mouth ulcers; inflammation of the mouth;
• gastrointestinal perforation;
• rotator cuff syndrome (injury);
• polymyalgia rheumatica;
• feeling of heat;
• sudden loss of vision due to blockage of an artery in the eye.

Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, you should inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration 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]
Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Febuxostat Laboratorios Liconsa

• Keep the medicine 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 outer carton and on the blister foil after the words "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
• There are no special requirements for storage.

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

6. Contents of the package 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: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, hydroxypropylcellulose, poloxamer 407, hydrated colloidal silica, 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 pale yellow coated tablets, approximately 17.5 mm x 7.9 mm in size, with a break line.
Febuxostat Laboratorios Liconsa 120 mg, coated tablets are pale yellow coated tablets, approximately 19 mm x 8 mm in size, with the mark "120" embossed on one side.
Febuxostat Laboratorios Liconsa 80 mg and 120 mg is packed in transparent blisters made of PVC/PVDC/Aluminium.
Febuxostat Laboratorios Liconsa 80 mg and 120 mg is available in packs containing 14, 28, 42, 56, 84 and 98 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 further information, please contact the local representative of the Marketing Authorisation Holder.

This medicinal product is authorised 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: Febuxostat Universal Farma