Febuxostat Cinfamed 120 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Febuxostat cinfamed 120 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

2. What you need to know before taking Febuxostat cinfamed

3. How to take Febuxostat cinfamed

4. Possible side effects

5. How to store Febuxostat cinfamed

6. Contents of the pack and other information

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

This medicine contains the active substance 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 can no longer dissolve. When this occurs, urate crystals form both within and around the joints and kidneys. These crystals can cause sudden, severe pain, redness, warmth, and swelling in the joints (known as gout attacks). If left untreated, large deposits called tophi may form around and within the joints. Tophi can damage joints and bones.

This medicine works by reducing the concentration of uric acid. Keeping uric acid levels low by taking Febuxostat cinfamed once daily helps prevent the formation of crystals and, over time, reduces symptoms. If uric acid levels are kept low for a sufficient period, the size of tophi also decreases.

Febuxostat cinfamed 120 mg tablets are also used to treat and prevent high levels of uric acid in the blood that may occur when starting chemotherapy for blood cell cancers.

When chemotherapy is administered, cancer cells are destroyed, which can lead to increased levels of uric acid in the blood unless its formation is prevented.

This medicine is for use in adults.

2. What you need to know before starting to take Febuxostat cinfamed

Do not take Febuxostat cinfamed:

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

Warnings and precautions

Talk to 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 medicine used to treat gout)
• if you have or have had liver disease or impaired liver function
• if you are being treated for high uric acid levels due to Lesch-Nyhan syndrome (a rare inherited condition 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 medicine (see also section 4). Possible symptoms of allergic reactions may include:

• rash including severe forms (e.g. blisters, nodules, exfoliative rashes causing itching), itching
• swelling of the limbs or face
• difficulty breathing
• fever with swollen lymph nodes
• also severe allergic reactions which may be life-threatening, associated with cardio-circulatory arrest.

Rare cases of life-threatening skin rashes (Stevens-Johnson syndrome) have been reported with the use of febuxostat, initially appearing on the trunk as reddish target-shaped spots or circular lesions, often with a blister in the center. It may also include mouth ulcers, throat, nose, genitals, and conjunctivitis (red and swollen eyes). The rash may progress to widespread blisters or skin peeling.

If you have developed Stevens-Johnson syndrome while using febuxostat, you must never restart treatment with febuxostat. If you develop a rash or these skin symptoms, seek immediate medical advice and tell the doctor that you are taking this medicine.

If you suffer a gout attack (sudden severe pain accompanied by tenderness, redness, warmth, and swelling in a joint), wait until the attack subsides before starting treatment with febuxostat.

Some people may experience a gout attack when starting certain medicines that control uric acid levels. Not everyone experiences these attacks, but they may occur even while taking febuxostat, especially during the first weeks or months of treatment. It is important to continue taking febuxostat even if you have a gout attack, as this medicine continues to work to reduce uric acid. With daily use of febuxostat, gout attacks will become less frequent and less painful over time.

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

In patients with very high urate levels (e.g., those undergoing chemotherapy for cancer), treatment with medicines to lower uric acid may lead to xanthine accumulation in the urinary tract, potentially causing 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 properly.

Children and adolescents

Do not give this medicine to children under 18 years of age, as safety and efficacy have not been established.

Other medicines and Febuxostat cinfamed

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to 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 containing any of the following active 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 whether this medicine may harm the fetus. Febuxostat should not be used during pregnancy. It is not known whether febuxostat passes into breast milk. Do not use this medicine if you are breastfeeding or planning to breastfeed.

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

Driving and use of machines

Please note that you may experience dizziness, drowsiness, blurred vision, numbness, or tingling sensations during treatment. If this occurs, you should not drive or operate machinery.

Febuxostat cinfamed contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is essentially “sodium-free”.

3. How to take Febuxostat cinfamed

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• The recommended dose is one tablet per day.
• The tablets are taken orally, with or without food.

Gout

This medicine is available in 80 mg and 120 mg tablets. Your doctor will prescribe the most appropriate dose for you.

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

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

Start taking febuxostat two days before chemotherapy and continue using it as directed by your doctor. In general, treatment is of short duration.

If you take more Febuxostat cinfamed than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine 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 for your next dose. In that case, skip the missed dose and take the next one at the usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Febuxostat cinfamed

Even if you feel better, do not stop taking febuxostat unless instructed by your doctor. If you stop taking febuxostat, uric acid levels may rise 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 adverse effects

Like all medicines, this medicine can cause adverse 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 adverse effects (may affect up to 1 in 1,000 people), as you may be about to experience a severe allergic reaction:

• anaphylactic reactions, hypersensitivity to the medicine (see also section 2 “Warnings and precautions”)
• skin rashes that may be life-threatening, characterized by blistering and peeling of the skin and mucous membranes (e.g. mouth and genitals), painful sores 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, enlarged liver, hepatitis (including liver failure), increased number of white blood cells (leukocytes) in the blood (drug reaction with eosinophilia and systemic symptoms, DRESS syndrome) (see section 2)
• generalized skin rashes

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

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

Other adverse effects not mentioned above are listed below.

Uncommon adverse effects (may affect up to 1 in 100 people) are:

• decreased appetite, changes in blood sugar levels (diabetes), which may present as excessive thirst, increased blood fats, weight gain
• loss of sexual appetite
• difficulty sleeping, drowsiness
• numbness, tingling sensation, reduced or altered sensitivity (hypoesthesia, hemiparesis or paresthesia), altered sense of taste, reduced sense of smell (hyposmia)
• abnormalities in ECG (electrocardiogram), irregular or rapid heartbeat, awareness of heartbeats (palpitations)
• hot flushes or redness (e.g. reddening of the face or neck), increased blood pressure, bleeding (haemorrhage, observed only in patients receiving chemotherapy for blood disorders)
• cough, chest discomfort or pain, 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, upper abdominal pain, heartburn or indigestion, constipation, more frequent bowel movements, vomiting, stomach discomfort
• itchy rash, hives, skin swelling or discoloration, small red or purple spots on the skin, small skin rashes, rashes with interconnected small bumps, rash, hives and skin spots, increased sweating, night sweats, alopecia, skin redness (erythema), psoriasis, eczema, other skin disorders
• muscle cramps, muscle weakness, bursitis or arthritis (joint inflammation, usually accompanied by pain, swelling or stiffness), back pain, muscle spasms, muscle and/or joint stiffness
• blood in urine, abnormally frequent urination, abnormal urine tests (increased protein concentration in urine), reduced kidney function, urinary tract infection
• chest pain, chest discomfort
• gallstones or stones in the bile ducts (cholelithiasis)
• increased levels of thyroid-stimulating hormone (TSH) in blood
• changes in blood biochemistry or in the number of blood cells or platelets (abnormal blood test results)
• kidney stones
• erectile dysfunction
• decreased thyroid gland activity, blurred vision, vision changes
• ringing in the ears
• runny nose
• mouth ulcers
• pancreatitis: common symptoms are abdominal pain, nausea and vomiting
• urgent need to urinate
• pain
• malaise
• increased INR
• bruising
• swelling of the lips

Rare adverse effects (may affect up to 1 in 1,000 people) are:

• muscle damage, which in rare cases may be severe. It may cause muscle problems and, particularly if you also feel unwell or have a high fever, may be due to abnormal muscle breakdown. Contact your doctor immediately if you experience muscle pain, tenderness or weakness,
• severe swelling of the deeper layers of the skin, especially around the eyes, genitals, hands, feet or tongue, which may cause sudden breathing difficulties,
• high fever accompanied by a measles-like rash, swollen lymph nodes, enlarged liver (including liver failure), increased number of white blood cells in blood (leukocytosis, with or without eosinophilia)
• different types of skin rash (e.g. with white spots and blisters, with pus-filled blisters, with skin peeling, measles-like rash), generalized erythema, necrosis, blistering detachment of the skin and mucous membranes, leading to exfoliation and possible sepsis (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• nervousness
• sensation of thirst
• weight loss, increased appetite, uncontrolled loss of appetite (anorexia)
• abnormal blood cell count (white cells, red cells or platelets)
• changes or decreased urine volume due to kidney inflammation (tubulointerstitial nephritis)
• liver inflammation (hepatitis)
• yellowing of the skin (jaundice)
• bladder infection
• liver damage
• increased levels of creatine phosphokinase in 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 failure
• lung infection (pneumonia)
• mouth sores; inflammation of the mouth
• gastrointestinal perforation
• rotator cuff syndrome
• polymyalgia rheumatica
• sensation of warmth
• sudden vision loss due to blockage of an eye artery

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Febuxostat cinfamed

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the cardboard box and on the blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

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

6. Contents of the pack and other information

Composition of Febuxostat cinfamed

• The active substance is febuxostat.

Each Febuxostat cinfamed tablet contains 120 mg of febuxostat.

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

Appearance of Febuxostat cinfamed and contents of the pack

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

The pack contains PVC/PE/PVdC blisters sealed with an aluminum foil.

Available in pack sizes of 28 and 84 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10 Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

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,

62-020 Swarzedz, Poland

or

Heumann Pharma GmbH & Co. Generica KG,

Südwestpark 50, 90449 Nuremberg,

Germany

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10 Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

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

United Kingdom - Febuxostat 120 mg film-coated tablets

Germany - Febuxostat Heumann 120 mg Filmtabletten

Date of the most recent revision of this package leaflet: April 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) (http://www.aemps.gob.es/)

You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address:

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

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