Product Information for the User

Febuxostat STADA 120 mg Film-Coated Tablets EFG

Read this entire product information carefully before starting to take the medicine because it contains important information for you.

-Keep this product information, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

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

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

3.How to take Febuxostat Stada

4.Possible side effects

5Storage of Febuxostat Stada

6.Contents of the package and additional information

Febuxostat Stada tablets contain the active ingredient febuxostat and are 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 accumulates in the blood to the point where it cannot be dissolved. When this occurs, 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 (this is 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.

Febuxostat acts by reducing the concentration of uric acid. Maintaining low uric acid levels by taking febuxostat once a day slows 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 in the treatment and prevention of high levels of uric acid in the blood, which can occur when chemotherapy is started to treat blood cancer.

When chemotherapy is administered, cancer cells are destroyed, and as a result, uric acid levels in the blood increase, unless their formation is prevented.

Febuxostat is for adults.

Do not take Febuxostat Stada

?if you are allergic to febuxostat or any of the other ingredients 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, 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 liver function abnormalities
• if you are being treated for high uric acid levels due to Lesch-Nyhan syndrome (a rare inherited disease where 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 be:

• eruption including severe forms (e.g. blisters, nodules, exfoliative eruptions that cause itching), itching
• swelling of the limbs or face
• difficulty breathing
• fever with enlarged lymph nodes
• also severe allergic reactions that can put your life at risk, associated with cardio-circulatory arrest.

Your doctor may decide to permanently discontinue treatment with febuxostat.

Stevens-Johnson syndrome

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

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

If you experience a gout attack (a sudden onset of 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 certain medicines 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 daily, as this medicine continues to act to reduce uric acid levels. If you continue to take febuxostat, gout attacks will become less frequent and less painful.

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

In patients with very high uric acid levels (e.g. those undergoing chemotherapy for cancer), treatment with medicines to reduce uric acid levels may cause the accumulation of xanthine in the urinary tract, with the possible formation of 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 normally.

Children and adolescents

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

Other medicines and Febuxostat Stada

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

It is especially important to inform your doctor or pharmacist if you are using medicines 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 and breastfeeding

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

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

Driving and operating machinery

Be aware that you may experience dizziness, drowsiness, blurred vision and numbness or tingling during treatment, so if this happens, do 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; this is, essentially “sodium-free”.

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

Dose

The recommended dose is one tablet per day.

Gout

Febuxostat is available in 80 mg tablets or in 120 mg tablets. Your doctor will prescribe the most suitable 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.

Start taking febuxostat two days before chemotherapy and continue as indicated by your doctor.

Generally, the treatment is of short duration.

Administration Form

The tablets should be swallowed and can 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 center.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Febuxostat Stada

If you forget a dose of febuxostat, take it as soon as you remember, unless it is almost time to take the next one; in that case, skip the missed dose and take the next one at the usual time. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Febuxostat Stada

Although you may be feeling better, do not stop taking febuxostat, unless your doctor tells you to. If you stop taking febuxostat, your 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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking this medicine and contact your doctor immediately or go to the nearest hospitalif 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 medicine (see also section 2 “Warnings and precautions”)
• skin eruptions that can be life-threatening, characterized by the formation of blisters 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 swollen lymph nodes, liver enlargement, hepatitis (including liver failure), increased white blood cell count (hypersensitivity to medications with eosinophilia and systemic symptoms - DRESS syndrome) (see section 2)
• generalized skin eruptions

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

?abnormal liver test results

?diarrhea

?headache

?eruption (including various types of eruption, see the following sections “infrequent” and “rare”)

?nausea

?increased symptoms of gout

?localized swelling due to fluid retention in tissues (edema)

• dizziness
• respiratory difficulties
• itching
• pain in the limbs, muscle/joint pain
• fatigue

Other side effects not mentioned above are included below.

Side effects infrequent(may affect up to 1 in 100 people) are:

• decreased appetite, change in blood sugar level (diabetes) whose symptom may be excessive thirst, increased blood fats, weight gain
• loss of sexual appetite
• difficulty sleeping, somnolence
• numbness, tingling, decreased or altered sensitivity (hypoesthesia, hemiparesis, or paresthesia), altered sense of taste, decreased sense of smell (hyposmia)
• ECG anomalies, irregular or rapid heartbeat, perception of heartbeats (palpitations)
• headaches or flushing (redness of the face or neck), increased blood pressure, bleeding (hemorrhage, observed only in patients receiving chemotherapy for blood diseases)
• cough, discomfort or pain in the chest, inflammation of the nasal passages and/or throat (upper respiratory tract infection), bronchitis, lower respiratory tract infection
• dry mouth, abdominal pain or discomfort, gas, abdominal pain, heartburn, indigestion, constipation, frequent bowel movements, vomiting, stomach discomfort
• eruption with itching, urticaria, skin inflammation or discoloration, small red or purple spots on the skin, small skin rashes, skin rashes covered with small interconnected bumps, eruption, rashes, and spots on the skin, increased sweating, nocturnal sweating, alopecia, skin redness (erythema), psoriasis, eczema, other skin changes
• muscle cramps, muscle weakness, bursitis or arthritis (inflammation of the joints, usually accompanied by pain, swelling, or stiffness), back pain, muscle spasms, muscle and/or joint stiffness
• blood in urine, frequent urination, abnormal urine tests (increased protein concentration 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 the blood
• blood biochemistry changes or changes in the number of blood cells or platelets (abnormal blood test results)
• kidney stones
• erectile dysfunction
• decreased thyroid gland activity
• blurred vision, changes in vision
• tinnitus
• nasal discharge
• mouth ulcers
• pancreatitis: common symptoms are abdominal pain, nausea, and vomiting
• urgent need to urinate
• pain
• discomfort
• increased bleeding time (increased INR)
• bruising (contusion)
• swelling of the lips

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

• muscle damage, which in rare cases can be severe. It may cause muscle problems and, in particular, if you are unwell or have high fever, it may be due to abnormal muscle destruction. Contact your doctor immediately if you experience muscle pain, sensitivity, or weakness
• severe swelling of the deeper layers of the skin, especially around the lips, eyes, genitals, hands, feet, or tongue, which can cause sudden difficulty breathing
• high fever accompanied by a rash similar to measles, swollen lymph nodes, liver enlargement (including liver failure), increased white blood cell count (leucocytosis, with or without eosinophilia)
• different types of eruptions (e.g. itching, with white patches with blisters, with pus-filled blisters, with skin peeling, measles-like rash), generalized erythema, necrosis, blistering of the skin and mucous membranes, leading to exfoliation and possible sepsis (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• anxiety
• thirst
• weight loss, increased appetite, uncontrolled loss of appetite (anorexia)
• abnormal blood cell count (white blood cells, red blood cells, or platelets)
• kidney inflammation (tubulointerstitial nephritis) due to changes or decreased urine volume
• liver inflammation (hepatitis)
• yellow skin (jaundice)
• urinary tract infection
• liver damage
• increased levels of creatine phosphokinase in the blood (a marker of muscle damage)
• sudden cardiac death
• low red blood cell count (anemia)
• depression
• sleep disorder
• loss of taste
• burning sensation
• dizziness or feeling of spinning (vertigo)
• circulatory insufficiency
• lung infection (pneumonia)
• mouth sores; inflammation of the mouth
• gastrointestinal perforation
• rotator cuff syndrome
• polymyalgia rheumatica
• feeling of heat
• sudden loss of vision due to obstruction of an eye artery

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.You can alsoreport them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the carton box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Febuxostat Stada

The active ingredient is febuxostat.

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

The other components are:

Core of the tablet:microcrystalline cellulose, sodium glycolate starch (from potato), anhydrous colloidal silica, magnesium stearate, copovidone.

Coating of the tablet:Opadry II yellow 85F42129 containing: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172).

Appearance of the product and contents of the package

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

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

or

Clonmel Healthcare Ltd.

Wateford Road

Clonmel, Co. Tipperary

Ireland

or

STADA M&D SRL

Str. Trascaului, nr 10,

RO-401135, Turda,

Romania.

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:April 2024

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/