Febuxostat Pharma Combix 80 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Febuxostat Pharma Combix 80 mg film-coated tablets EFG

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

• Keep this leaflet, as 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, and you should 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.

Leaflet contents

1. What Febuxostat Pharma Combix is and what it is used for
2. What you need to know before taking Febuxostat Pharma Combix
3. How to take Febuxostat Pharma Combix
4. Possible adverse effects
5. How to store Febuxostat Pharma Combix
6. Contents of the pack and other information

1. What Febuxostat Pharma Combix is and what it is used for

Febuxostat Pharma Combix contains the active substance febuxostat and is used to treat gout, a condition associated with 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 a gout attack). If left untreated, large deposits called tophi may develop around and within the joints. Tophi can damage joints and bones.

Febuxostat works by reducing the concentration of uric acid. Keeping uric acid levels low by taking febuxostat 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 is for use in adults.

2. What you need to know before starting to take Febuxostat Pharma Combix

Do not take Febuxostat:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take febuxostat:

• if you have or have had heart failure, other 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 levels of uric acid 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, 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 enlarged lymph nodes
• also severe allergic reactions that may be life-threatening, associated with circulatory arrest.

Your doctor may decide to permanently discontinue treatment with febuxostat.

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 taking febuxostat, you must never restart treatment. If you develop a rash or these skin symptoms, seek immediate medical attention and inform your doctor that you are taking this medicine.

If you experience 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 gout attacks 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 during a gout attack, as this medicine continues to work to reduce uric acid. If you continue taking febuxostat daily, gout attacks will become less frequent and less painful over time.

If necessary, your doctor will prescribe additional medicines to prevent or treat symptoms of gout attacks (such as joint pain and 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 kidney stones, 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

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 suppress the immune response)
• Theophylline (used to treat asthma)

Pregnancy and breastfeeding

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

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

Driving and using machines

Be aware 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 Pharma Combix contains lactose and sodium

Febuxostat Pharma Combix tablets contain lactose (a type of sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor 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 Pharma Combix

Follow exactly the instructions for use of this medicine as given by your doctor. 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.

Febuxostat is available as 80 mg and 120 mg film-coated tablets. Your doctor will prescribe the most appropriate dose for you.

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

If you take more Febuxostat than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Febuxostat

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 forgotten doses.

If you stop taking Febuxostat

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 serious allergic reaction:

• anaphylactic reactions, hypersensitivity to the medicine (see also section 2 “Warnings and precautions”)
• life-threatening skin rashes characterized by blistering and peeling of the skin and mucous membranes, for example in the mouth and genital areas, painful sores in the mouth and/or genital areas, accompanied by fever, sore throat, and fatigue (Stevens-Johnson syndrome/toxic epidermal necrolysis), or enlarged lymph nodes, liver enlargement, 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):

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

Other adverse effects not listed above are included below.

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

• decreased appetite, change 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, decreased or altered sensitivity (hypoesthesia, hemiparesis, or paresthesia), altered sense of taste, reduced sense of smell (hyposmia)
• ECG (electrocardiogram) abnormalities, irregular or rapid heartbeat, awareness of heartbeats (palpitations)
• hot flushes or flushing (redness of the face or neck), increased blood pressure, bleeding (hemorrhage, observed only in patients receiving chemotherapy for blood disorders)
• cough, chest discomfort or pain, nasal and/or throat inflammation (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 bumps, skin bumps covered with small interconnected lumps, rash, bumps, and spots on the skin, 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 bile duct stones (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 activity of the thyroid gland
• 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.

The 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 measles-like rash, enlarged lymph nodes, liver enlargement (including liver failure), increased number of white blood cells in blood (leukocytosis, with or without eosinophilia)
• various types of rash (e.g., with white spots and blisters, with pus-filled blisters, with skin peeling, measles-like rash), generalized erythema, necrosis, blistering detachment of 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)
• muscle and/or joint stiffness
• abnormal blood cell count (white blood cells, red blood 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; mouth inflammation
• 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Febuxostat Pharma Combix

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

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Febuxostat Pharma Combix 80 mg

The active substance is febuxostat. Each film-coated tablet contains 80 mg of febuxostat.

• Other components (excipients) are:
• Tablet core: microcrystalline cellulose, monohydrate lactose, sodium croscarmellose, hydroxypropylcellulose, sodium lauryl sulfate, anhydrous lactose, colloidal anhydrous silica, and magnesium stearate.
• Tablet coating: poly(vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc, and yellow iron oxide (E172).

Appearance of the product and contents of the pack

Light yellow or yellow, film-coated, oblong, biconvex tablets with approximate dimensions of 17.2 mm in length, 6.2 mm in width, and 5.2 mm in thickness, imprinted with "80" on one side and smooth on the other.

Febuxostat Pharma Combix 80 mg is available in PVC/PE/PVDC-Al and PVC/PCTFE-Al blisters, in packs of 28 tablets.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Genepharm S.A.

18th km, Marathonos Ave,

Pallini Attiki, 15351

Greece

Date of the most recent revision of this leaflet: June 2023

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