Package Insert:Information for the Patient

FebuxostatTeva-ratiopharm80 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication,because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult yourdoctororpharmacist.

-This medication has been prescribedonlyto you, and you should not give it to others even if they have the same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,evenif they are not listed in this package insert. See section 4.

1.What is Febuxostat Teva-ratiopharm and what is it used for

2.What you need to know before starting to take Febuxostat Teva-ratiopharm

3.How to take Febuxostat Teva-ratiopharm

4.Possible adverse effects

5.Storage of Febuxostat Teva-ratiopharm

6.Contents of the package and additional information

FebuxostatTeva-ratiopharmcontains the active ingredient 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 cannot be dissolved. When this occurs, urate crystals form both inside and around the joints and kidneys. These crystals can cause a sudden and intense pain, redness, heat, and swelling in the joints (this is called a gout attack). If left untreated, large deposits called tophi can form around the joints and inside them. Tophi can damage the joints and bones.

FebuxostatTeva-ratiopharmacts by reducing the concentration of uric acid. Maintaining a low concentration of uric acid by taking FebuxostatTeva-ratiopharmonce a day slows the formation of crystals and, over time, reduces symptoms. If the concentration of uric acid is kept low for a sufficient period, the size of the tophi also decreases.

FebuxostatTeva-ratiopharmis for adults.

Do not take Febuxostat Teva-ratiopharm

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

Warnings and precautions

Consult your doctor before starting to take Febuxostat Teva-ratiopharm:

• if you have or have had heart failure, heart problems, or a 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 abnormalities
• if you are being treated for high uric acid levels due to Lesch-Nyhan syndrome (a rare genetic disorder in which there is too much uric acid in the blood)
• if you have thyroid problems.

If you experience allergic reactions to Febuxostat Teva-ratiopharm, stop taking this medication (see also section 4).

Possible symptoms of allergic reactions may include:

• skin 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 life-threatening allergic reactions associated with cardiac arrest.

Your doctor may decide to permanently discontinue treatment with Febuxostat Teva-ratiopharm.

Rare cases of life-threatening skin rashes (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 mouth ulcers, throat, nose, genital, and conjunctivitis (red and swollen eyes). The rash may progress to generalized blisters or skin peeling.

If you have developed Stevens-Johnson syndrome with the use of febuxostat, do not restart treatment 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 medication.

If you experience a gout attack (a sudden, 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 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 daily, as this medication 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 medications 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 medications to reduce uric acid levels may lead to the accumulation of xanthine in the urinary tract, potentially forming 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 medication to children under 18 years of age, as the safety and efficacy have not been established.

Taking Febuxostat Teva-ratiopharm with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

It is especially important to inform your doctor or pharmacist if you are taking medications containing any of the following substances, as they may interact with Febuxostat Teva-ratiopharm, 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 and lactation

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

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

Driving and operating machinery

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

Febuxostat Teva-ratiopharm contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Febuxostat Teva-ratiopharm contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per coated tablet; it is essentially "sodium-free".

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

Dose

Febuxostat Teva-ratiopharm is marketed in film-coated tablets of 80 mg and 120 mg. Your doctor will prescribe the most suitable dose.

The recommended dose is 1 tablet per day.

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

Administration Form

Febuxostat Teva-ratiopharm is for oral use.

The tablets can be taken with or without food.

If you take more Febuxostat Teva-ratiopharm than you should

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

If you have taken more febuxostat than you should, consult your doctor immediately, your pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to take Febuxostat Teva-ratiopharm

If you forget a dose of Febuxostat Teva-ratiopharm, 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 treatment with Febuxostat Teva-ratiopharm

Although you may be feeling better, do not stop taking Febuxostat Teva-ratiopharm unless your doctor tells you to. If you stop taking Febuxostat Teva-ratiopharm, 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 visit the nearest hospital if you experience any of the following rare side effects (which may affect up to 1 in 1,000 people), as you may be experiencing 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, for example, 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, enlarged liver, hepatitis (including liver failure), increased white blood cell count (hypersensitivity to medications with eosinophilia and systemic symptoms-Syndrome of DRESS) (see section 2)
• Generalized skin eruptions

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

• Abnormal liver test results
• Diarrhea
• Headache
• Rash (including various types of rash, see below the sections “infrequent” and “rare”)
• Nausea
• Increased symptoms of gout
• Localized swelling due to fluid retention in tissues (edema)
• Dizziness
• Difficulty breathing
• Itching
• Pain in the limbs, muscle or joint pain
• Fatigue

Other side effects not mentioned above are included below.

Infrequent side effects(which may affect up to 1 in 100 people):

• Decreased appetite, change in blood sugar levels (diabetes) whose symptom may be excessive thirst, increased blood fats, weight gain
• Loss of sexual desire
• Difficulty sleeping, somnolence
• Numbness, tingling, decreased or altered sensitivity (hypoaesthesia, hemiparesis, or paresthesia), altered sense of taste, decreased sense of smell (hyposmia)
• ECG (electrocardiogram) abnormalities, irregular or rapid heartbeat, perception of heartbeats (palpitations)
• Flushes or redness (enrojecimiento of the face or neck), increased blood pressure, bleeding (haemorrhage, 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, stomach pain, indigestion, constipation, frequent bowel movements, vomiting, stomach discomfort
• Rash with itching, urticaria, inflammation, or discoloration of the skin, small red or purple spots on the skin, small rashes on the skin, rashes on the skin covered with small interconnected bumps, rash, rashes, and spots on the skin, increased sweating, nocturnal sweating, alopecia, facial redness (erythema), psoriasis, eczema, other skin alterations
• 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 test results (increased protein concentration in urine), reduced kidney function, urinary tract infection
• Chest pain, chest discomfort
• Stones in the gallbladder or bile ducts (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)
• Stones in the kidney
• Difficulty achieving an erection
• Decreased thyroid gland activity, blurred vision, changes in vision
• Tinnitus
• Nasal discharge
• Mouth ulcers
• Pancreatitis: common symptoms include abdominal pain, nausea, and vomiting
• Urgent need to urinate
• Pain
• Discomfort
• Increased INR
• Contusion
• Lip swelling

Rare side effects(which may affect up to 1 in 1,000 people):

• Muscle damage, which in rare cases can be severe. It may cause muscle problems and, in particular, if you are unwell or have a 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 eyes, genitals, hands, feet, or tongue, which may cause sudden difficulty breathing
• High fever accompanied by a rash similar to measles, swollen lymph nodes, enlarged liver, hepatitis (including liver failure), increased white blood cell count (leucocytosis, with or without eosinophilia)
• Different types of rashes (e.g., with white spots, with blisters, with pus-filled blisters, with skin peeling, rash similar to measles), 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)
• Changes or decreased urine volume due to kidney inflammation (tubulointerstitial nephritis)
• Liver inflammation (hepatitis)
• Yellow skin (jaundice)
• Bile duct inflammation
• Liver damage
• Increased levels of creatine phosphokinase in the blood (a marker of muscle damage)
• Sudden cardiac death
• Anemia (low red blood cell count)
• Depression
• Sleep disorder
• Loss of taste
• Burning sensation
• Dizziness
• Circulatory insufficiency
• Pulmonary infection (pneumonia)
• Mouth sores; inflammation of the mouth
• Gastrointestinal perforation
• Rotator cuff syndrome
• Polymyalgia rheumatica
• Sensation 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 also report them directly through theSistema Español de Farmacovigilancia de medicamentos de Uso Humano:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe box, bottle, and blisterafter CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or trash.Deposit the packaging and unused medications at the SIGRE collection pointat the pharmacy. In case of doubt,please ask your pharmacisthow to dispose ofthepackaging and themedications that you no longerneed.

Febuxostat Composition Teva-ratiopharm

• The active ingredient is febuxostat.

Each film-coated tablet contains 80 mg of febuxostat (as febuxostat hemihydrate).

• The other components are:

Core of the tablet: microcrystalline cellulose, lactose monohydrate, hydroxypropyl cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

Film coating of the tablet: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172).

Appearance of the product and contents of the package

Febuxostat Teva-ratiopharm are yellow, biconvex, capsule-shaped film-coated tablets.

The 80 mg film-coated tablets are marked with “80” on one side and with “A275” on the other. The dimensions of the tablet are 16 mm x 7 mm.

Pack sizes

PVC/PVDC//Al blister

PVC/PCTFE/PVC//Al blister

HDPE bottles.

10, 10 x 1, 14, 14 x 1, 20, 28, 28 x 1, 30 x 1, 42, 42 x 1, 56, 56 x 1, 84, 84 x 1, 98, 98 x 1, 120, 120 x 1 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Teva B.V.

Swensweg 5,

2031GA Haarlem

Netherlands

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid (Spain)

Responsible for manufacturing

Actavis Ltd.

BLB015-016 Bulebel Industrial Estate

ZTN 3000 Zejtun

Malta

or

Teva Gyógyszergergyár Zrt.

Pallagi út 13

4042 Debrecen

Hungary

or

Merckle GmbH

Ludwig-Merckle-Strasse 3,

89143 Blaubeuren

Germany

or

Teva Pharma, S.L.U.

C/C, n. 4, Polígono Industrial Malpica

50016 Zaragoza

Spain

or

PLIVA Croatia Ltd.

Prilaz baruna Filipovica 25

10000 Zagreb

Croatia

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

Germany Febuxostat-ratiopharm 80 mg Filmtabletten

Denmark Febuxostat Teva

Estonia F ebuxostat Teva

Spain Febuxostat Teva-ratiopharm 80 mg film-coated tablets EFG

Luxembourg Febuxostat-ratiopharm 80 mg Filmtabletten

Lithuania Febuxostat Teva 80 mg plevele dengtos tabletes

Latvia Febuxostat Teva 80 mg apvalkotas tabletes

Netherlands Febuxostat Teva 80 mg, filmomhulde tabletten

Slovakia Febuxostat Teva 80 mg

Last date of revision of this summary of product characteristics: july 2022

The detailed 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/ )

You can access detailed and updated information on this medicinal product by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/83254/P_83254.html

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