FEBUXOSTAT TEVA-RATIOPHARM 80 mg FILM-COATED TABLETS

Introduction

Package Leaflet:information for the patient

FebuxostatTeva-ratiopharm80 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Febuxostat Teva-ratiopharm contains the active substance 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 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 severe 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.

Febuxostat Teva-ratiopharm works by reducing the concentration of uric acid. Keeping uric acid levels low by taking Febuxostat Teva-ratiopharm once a day prevents the formation of crystals and, over time, reduces symptoms. If uric acid levels are kept low for long enough, the size of tophi is also reduced.

Febuxostat Teva-ratiopharm is for adults.

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

Do not take Febuxostat Teva-ratiopharm

• 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 before starting to take Febuxostat Teva-ratiopharm:

• 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 disorders
• 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 Teva-ratiopharm, stop taking this medicine (see also section 4).

Possible symptoms of allergic reactions could be:

• rash including severe forms (e.g., blisters, nodules, exfoliative rash that itches), itching
• swelling of limbs or face
• difficulty breathing
• fever with swollen 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 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 at any time. If you develop a rash or these skin symptoms, go immediately to the doctor and tell them that you are taking this medicine.

If you are experiencing a gout attack (severe pain that starts suddenly 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 few weeks or months of treatment. It is essential to continue taking febuxostat even if you experience a gout attack, as this medicine 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 will prescribe other medications to prevent or treat the symptoms of attacks (such as pain and joint swelling).

In patients with very high levels of urates (e.g., those undergoing chemotherapy for cancer), treatment with medications to decrease uric acid may produce 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 working normally.

Children and adolescents

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

Taking Febuxostat Teva-ratiopharm with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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 that contain 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 the immune response)
• Theophylline (used to treat asthma)

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is not known if febuxostat can 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 breast-feeding or planning to breast-feed.

Driving and using machines

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 Teva-ratiopharm contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Febuxostat Teva-ratiopharm contains sodium

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

3. How to take Febuxostat Teva-ratiopharm

Follow exactly the instructions of administration of this medicine indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Gout

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

The recommended dose is one tablet per day.

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

Method of administration

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, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

If you forget to take Febuxostat Teva-ratiopharm

If you miss a dose of Febuxostat Teva-ratiopharm, take it as soon as you remember, unless it is almost time to take the next one; 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 forgotten doses.

If you stop taking Febuxostat Teva-ratiopharm

Even if you feel 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 further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking this medicine and contact your doctor immediately or go to the nearest hospital if you experience any of the following rare side effects (may affect up to 1 in 1,000 people), as you may experience a severe 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, 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 swollen lymph nodes, liver enlargement, hepatitis (including liver failure), increased white blood cell count (hypersensitivity to drugs with eosinophilia and systemic symptoms - DRESS) (see section 2)
• widespread skin rash

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

• 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
• limb pain, muscle and/or joint pain
• fatigue

Other side effects not mentioned above are listed below.

Uncommon side effects(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
• decreased sex drive
• difficulty sleeping, drowsiness
• numbness, tingling, decreased or altered sensitivity (hypoesthesia, hemiparesis, or paresthesia), altered sense of taste, decreased sense of smell (hyposmia)
• abnormalities in the ECG (electrocardiogram), irregular or rapid heartbeat, perception of heartbeats (palpitations)
• hot flashes 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 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, rash on the skin covered with small interconnected bumps, rash, hives, 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 thyroid-stimulating hormone (TSH) levels in blood
• changes or decrease in urine volume due to kidney inflammation (tubulointerstitial nephritis)
• liver inflammation (hepatitis)
• yellowish skin (jaundice)
• gallbladder inflammation
• liver damage
• increased creatine phosphokinase levels in blood (an indicator of muscle damage)
• sudden cardiac death
• low red blood cell count (anemia)
• depression
• sleep disorder
• loss of taste
• burning sensation
• vertigo
• 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

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

• muscle damage, which can rarely be severe. It can cause muscle problems and, in particular, if you are also feeling unwell or have a high fever, it may be due to abnormal muscle breakdown. Contact your doctor immediately if you experience muscle pain, sensitivity, or 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, swollen lymph nodes, liver enlargement, hepatitis (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, measles-like rash), generalized redness, 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)
• gallbladder inflammation
• liver damage
• increased creatine phosphokinase levels in blood (an indicator of muscle damage)
• sudden cardiac death
• low red blood cell count (anemia)
• depression
• sleep disorder
• loss of taste
• burning sensation
• vertigo
• 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 of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects 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 medicine.

5. Storage of Febuxostat Teva-ratiopharm

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

Do not use this medicine after the expiry date which is stated on the carton, bottle, and blister after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Composition of FebuxostatTeva-ratiopharm

• The active ingredient is febuxostat.

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

• The other ingredients are:

Tablet core:microcrystalline cellulose, lactose monohydrate, hydroxypropylcellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.

Tablet coating:polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).

Appearance and Packaging of the Product

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 "A275" on the other. The tablet dimensions are 16 mm x 7 mm.

Package 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.

Not all 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, 1ª planta

28108 Alcobendas, Madrid (Spain)

Manufacturer

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 Febuxostat Teva

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

Luxembourg Febuxostat-ratiopharm 80 mg Filmtabletten

Lithuania Febuxostat Teva 80 mg plevele dengtos tabletės

Latvia Febuxostat Teva 80 mg apvalkotas tabletes

Netherlands Febuxostat Teva 80 mg, filmomhulde tabletten

Slovakia Febuxostat Teva 80 mg

Date of the last revision of thisleaflet:July 2022

Detailed 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 packaging with your mobile phone (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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