Febuxostat STADA 120 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Febuxostat STADA 120 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine because 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

Febuxostat Stada tablets contain the active substance febuxostat and are 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 happens, urate crystals form both within and around the joints and kidneys. These crystals can cause sudden, intense pain, redness, warmth, and swelling in the joints (this is known as gout attacks). If left untreated, large deposits called tophi may form 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 120 mg tablets are also used for the treatment and prevention of 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, leading to an increase in uric acid levels in the blood, unless its formation is prevented.

Febuxostat is for use in adults.

2. What you need to know before taking Febuxostat Stada

Do NOT take Febuxostat Stada

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

Warnings and precautions

Talk to your doctor or pharmacist before taking febuxostat:

• 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 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 limbs or face
• difficulty breathing
• fever with swollen 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.

Stevens-Johnson syndrome

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

If you have developed Stevens-Johnson syndrome while taking febuxostat, you must never restart treatment with febuxostat. 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 are experiencing a gout attack (sudden, intense 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 beginning treatment with 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. If you take febuxostat daily, gout attacks will become less frequent and less painful over time.

If needed, your doctor may 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 that lower uric acid may lead to xanthine accumulation in the urinary tract, potentially causing kidney stones. However, this has not been observed in patients treated with febuxostat for Tumor Lysis Syndrome.

Your doctor may perform blood tests to monitor normal liver function.

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 Stada

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

It is especially important to 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

It is unknown whether febuxostat may harm the fetus. Febuxostat must not be used during pregnancy. It is also unknown whether febuxostat passes into breast milk. Do not use febuxostat 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 using machines

Be aware that you may experience dizziness, drowsiness, blurred vision, or numbness and tingling sensations during treatment. If you experience any of these symptoms, you must not drive or operate machinery.

Febuxostat Stada contains sodium

This medicine contains 1.8 mg of sodium (less than 1 mmol of sodium (23 mg)) per tablet; therefore, it is essentially “sodium-free”.

3. How to take Febuxostat Stada

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Dosage

The recommended dose is one tablet per day.

Gout

Febuxostat is available in 80 mg tablets or 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 chemotherapy for cancer

Febuxostat is available in 120 mg tablets.

Begin taking febuxostat two days before chemotherapy and continue using it as directed by your doctor.

In general, treatment is of short duration.

Method of administration

The tablets should be swallowed whole and may be taken with or without food.

If you take more Febuxostat Stada than you should

In case of accidental overdose, consult your doctor or go to the nearest emergency department.

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, stating the medicine and the amount ingested. It is recommended to bring the medicine package and leaflet to the healthcare professional.

If you forget to take Febuxostat Stada

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 Stada

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 experiences 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, liver enlargement, hepatitis (including liver failure), increased number of white blood cells (leukocytes) in 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 results in liver function tests

? diarrhea

? headache

? rash (including various types of rash; see the “uncommon” and “rare” sections 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 mentioned above are listed below.

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 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 interconnected small 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 concentration of protein in urine), reduced kidney function, urinary tract infection
• fatigue, 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
• prolonged coagulation time (increased INR)
• bruising (contusion)
• 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 high fever, may be due to abnormal muscle breakdown. Contact your doctor immediately if you experience muscle pain, tenderness, or weakness
• severe swelling of deeper layers of the skin, especially around the lips, eyes, genitals, hands, feet, or tongue, possibly causing sudden breathing difficulties
• high fever accompanied by measles-like rash, swollen lymph nodes, enlarged liver (including liver failure), increased number of white blood cells in blood (leukocytosis, with or without eosinophilia)
• various types of rash (e.g. itchy, 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)
• 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
• sensation of dizziness or spinning (vertigo)
• circulatory failure
• lung infection (pneumonia)
• mouth sores; mouth inflammation
• gastrointestinal perforation
• rotator cuff syndrome
• polymyalgia rheumatica
• sensation of warmth
• sudden loss of vision due to blockage of an eye artery

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Stada

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 on the blister after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Febuxostat Stada

The active substance is febuxostat.

Each tablet contains 120 mg of febuxostat (as hemihydrate).

The other components are:

Tablet core: microcrystalline cellulose, sodium starch glycolate (derived from potato), colloidal anhydrous silica, magnesium stearate, copovidone.

Tablet coating: Opadry II Yellow 85F42129 containing: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172).

Appearance of the product and contents of the pack

Yellow, oblong, biconvex, film-coated tablets, 18 mm x 8 mm.

Febuxostat Stada 120 mg is available in PVC/PVDC/Al blisters containing 14, 28, 84 and 98 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

or

STADA M&D SRL

Str. Trascaului, nr 10

RO-401135, Turda

Romania

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

Date of the last revision of this leaflet: April 2024

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