FEBUXOSTAT CINFAMED 80 mg FILM-COATED TABLETS

Introduction

Leaflet:information for the user

Febuxostat Cinfamed 80 mg film-coated tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• 1. If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Febuxostat Cinfamed and what is it used for
2. What you need to know before taking Febuxostat Cinfamed
3. How to take Febuxostat Cinfamed
4. Possible side effects
5. Storage of Febuxostat Cinfamed
6. Package contents and additional information

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

This medication 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 builds up in the blood to the point where it cannot be dissolved. When this happens, 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 (called 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 medication works by reducing the concentration of uric acid. Keeping the uric acid concentration low by taking Febuxostat Cinfamed once a day prevents the formation of crystals and, over time, reduces the symptoms. If the uric acid concentration is kept low for a long enough time, the size of the tophi is also reduced.

This medication is for adults.

2. What you need to know before taking Febuxostat Cinfamed

Do not takeFebuxostat Cinfamed:

• if you are allergic to febuxostat or any of the other components 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 alterations
• if you are 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 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 include:

• 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 skin rashes that can be life-threatening (Stevens-Johnson syndrome) have been reported with the use of febuxostat, initially appearing on the trunk as reddish spots in a target shape or circular spots that often have a blister in the center. It can also include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes). The rash can evolve into generalized blisters or skin peeling.

If you have developed Stevens-Johnson syndrome with the use of febuxostat, you should not restart treatment with Febuxostat Cinfamed at any time. If you develop a rash or these skin symptoms, go to the doctor immediately and tell them that you are taking this medication.

If you experience a gout attack (a sudden and 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 to take 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, as this medication continues to work to reduce uric acid. If you continue to take febuxostat daily, gout attacks will become less frequent and less painful.

If necessary, your doctor may prescribe other medications to prevent or treat the symptoms of attacks (such as pain and joint swelling).

Your doctor may perform blood tests to check that the liver is functioning normally.

Children and adolescents

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

Other medications and Febuxostat Cinfamed

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

It is especially important that you inform your doctor or pharmacist if you are using medications that contain 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 the 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 using machines

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

Febuxostat Cinfamed contains lactose andsodium

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

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

3. How to take Febuxostat Cinfamed

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

Gout

This medication is marketed in 80 mg and 120 mg tablets. 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 directed by your doctor. In general, treatment is short-term.

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 Toxicology 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 dose; in this case, skip the missed dose and take the next one at the usual time. Do not take a double dose to make up for missed doses.

If you stop taking Febuxostat Cinfamed

Even if you feel better, do not stop taking febuxostat unless your doctor tells you to. If you stop taking febuxostat, uric acid levels 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.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Stop taking this medication 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 medication (see also section 2 “Warnings and precautions”)
• skin rashes that can be life-threatening, characterized by blistering 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 enlarged lymph nodes, liver enlargement, hepatitis (including liver failure), increased white blood cell count (leukocytosis, with or without eosinophilia) (see section 2)

• generalized skin rashes

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

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

Other side effects not mentioned above are included below.

The uncommon side effects(may affect up to 1 in 100 people) are:

• decreased appetite, change in blood sugar levels (diabetes) whose symptom may be excessive thirst, increased blood fats, weight gain
• decreased sexual appetite
• difficulty sleeping, drowsiness
• numbness, tingling, decreased or altered sensitivity (hypoesthesia, hemiparesis, or paresthesia), altered sense of taste, decreased sense of smell (hyposmia)
• ECG abnormalities (electrocardiogram), irregular or rapid heartbeat, perception of heartbeats (palpitations)
• hot flashes or flushing (e.g., redness of the face or neck), increased blood pressure, bleeding (hemorrhage, observed only in patients receiving chemotherapy for blood diseases)
• cough, discomfort or chest pain, inflammation of the nasal passages and/or throat (upper respiratory tract infection), bronchitis, lower respiratory tract infection
• dry mouth, abdominal pain or discomfort, gas, upper abdominal pain, heartburn or indigestion, constipation, more frequent bowel movements, vomiting, stomach upset
• itchy rash, hives, skin inflammation or discoloration, small red or purple spots on the skin, small bumps on the skin, skin bumps covered with small interconnected bumps, rash, bumps, and spots on the skin, increased sweating, night sweats, hair loss, 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 bile duct stones (cholelithiasis)
• increased TSH levels in blood
• changes or decrease in urine volume due to kidney inflammation (tubulointerstitial nephritis)
• liver inflammation (hepatitis)
• yellowish skin (jaundice)
• bladder infection
• liver damage
• increased creatine phosphokinase levels in blood (a indicator 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; mouth inflammation
• gastrointestinal perforation
• rotator cuff syndrome
• polymyalgia rheumatica
• feeling of heat
• sudden loss of vision due to blockage of an eye artery

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

• muscle damage, which can rarely be severe. It can cause muscle problems, and particularly if you are also feeling unwell or have a high fever, it may be due to abnormal muscle destruction. Contact your doctor immediately if you experience pain, sensitivity, or muscle weakness
• severe swelling of the deep layers of the skin, especially around the eyes, genitals, hands, feet, or tongue, which can cause sudden difficulty breathing
• high fever accompanied by a rash similar to measles, enlarged lymph nodes, liver enlargement (including liver failure), increased white blood cell count (leukocytosis, with or without eosinophilia)
• various types of rash (e.g., with white spots with blisters, with pus-filled blisters, with skin peeling), generalized erythema, necrosis, blistering and peeling of the skin and mucous membranes, leading to exfoliation and possible sepsis (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• nervousness
• feeling of thirst
• weight loss, increased appetite, uncontrolled loss of appetite (anorexia)
• abnormal blood cell count (white blood cells, red blood cells, or platelets)
• changes or decrease in urine volume due to kidney inflammation (tubulointerstitial nephritis)
• liver inflammation (hepatitis)
• yellowish skin (jaundice)
• bladder infection
• liver damage
• increased creatine phosphokinase levels in blood (a indicator 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; mouth inflammation
• gastrointestinal perforation
• rotator cuff syndrome
• polymyalgia rheumatica
• feeling of heat
• sudden loss of vision due to blockage of an eye artery

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Febuxostat Cinfamed

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date shown on the carton and blister pack after EXP. The expiration date is the last day of the month indicated.

Do not store above 30°C

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Container contents and additional information

Composition of Febuxostat cinfamed

• The active ingredient is febuxostat.

Each Febuxostat cinfamed tablet contains 80 mg of febuxostat.

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

Appearance of Febuxostat cinfamed and container contents

Yellow film-coated tablets, biconvex, capsule-shaped, engraved with "F 19" on one side and smooth on the other.

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

It is available in packs of 28 and 84 film-coated tablets.

Only some 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 Nürnberg,

Germany

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

United Kingdom - Febuxostat 80 mg film-coated tablets

Germany - Febuxostat Heumann 80 mg Filmtabletten

Date of the last revision of thisleaflet:April 2025

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

You can access detailed and updated information about this medicinal product by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/83404/P_83404.html

QR code to: https://cima.aemps.es/cima/dochtml/p/83404/P_83404.html