Febuxostat Teva-Ratiopharm 120 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Febuxostat Teva-ratiopharm 120 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, 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 others, 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.

Contents of this leaflet

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

1. What Febuxostat Teva-ratiopharm is and what it is 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 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 (this is called a gout attack). If left untreated, large deposits called tophi may form around and within the joints. Tophi can damage 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 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 Teva-ratiopharm 120 mg is also used for the treatment and prevention of high levels of uric acid in the blood that may occur when starting chemotherapy for the treatment of 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 Teva-ratiopharm is for use in adults.

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

Do not take Febuxostat Teva-ratiopharm

• if you are allergic to febuxostat or to 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 impaired liver function
• if you are being treated for high levels of uric acid due to Lesch-Nyhan syndrome (a rare inherited 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, 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 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 reddish target-like spots or circular lesions 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 progress to widespread blistering or skin peeling.

If you have developed Stevens-Johnson Syndrome while using 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 flare (sudden, intense pain accompanied by tenderness, redness, warmth, and swelling in a joint), wait until the flare subsides before starting treatment with febuxostat.

Some people may experience gout flares when starting certain medicines that control uric acid levels. Not everyone experiences these flares, 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 flare, as this medicine continues to work to reduce uric acid. If you keep taking febuxostat daily, gout flares will become less frequent and less painful over time.

If necessary, your doctor will prescribe other medicines to prevent or treat flare symptoms (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, possibly resulting in stone formation, 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.

Taking Febuxostat Teva-ratiopharm with other medicines

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 Teva-ratiopharm, 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, or numbness or tingling during treatment. If this occurs, you should not drive or operate machinery.

Febuxostat Teva-ratiopharm contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

Febuxostat Teva-ratiopharm contains sodium

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

3. How to take Febuxostat Teva-ratiopharm

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

Gout

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

The recommended dose is 1 tablet daily.

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

Prevention and treatment of high uric acid levels in patients undergoing chemotherapy for cancer

The usual dose is one 120 mg tablet daily.

Start taking Febuxostat Teva-ratiopharm two days before chemotherapy and continue using it as directed by your doctor. Generally, treatment is of short duration.

Method of administration

Febuxostat Teva-ratiopharm is for oral use.

The tablets may 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 department.

If you have taken more febuxostat than you should, contact your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount taken.

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 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 Teva-ratiopharm

Even if you feel better, do not stop taking Febuxostat Teva-ratiopharm unless instructed by your doctor. If you stop taking Febuxostat Teva-ratiopharm, 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 experiencing 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, for example in the 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 number of white blood cells in blood (drug hypersensitivity 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 "uncommon" and "rare" sections below)
• nausea
• worsening of gout symptoms
• localized swelling due to fluid retention in tissues (edema)
• dizziness
• difficulty breathing
• 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):

• decreased appetite, changes 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, reduced or altered sensitivity (hypoesthesia, hemiparesis, or paresthesia), altered sense of taste, reduced sense of smell (hyposmia)
• ECG abnormalities (electrocardiogram), 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 inflammation or discoloration, small red or purple spots on the skin, small skin bumps, interconnected bumps on the skin, 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
• 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 thyroid gland activity, blurred vision, vision changes
• ringing in the ears
• runny nose
• mouth ulcers
• pancreatitis: common symptoms include abdominal pain, nausea, and vomiting
• urgent need to urinate
• pain
• malaise
• increased INR
• bruising
• swelling of the lips

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

• muscle damage, which may occasionally be severe. This 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 eyes, genitals, hands, feet, or tongue, which may cause sudden difficulty breathing
• high fever accompanied by measles-like rash, swollen lymph nodes, enlarged liver, hepatitis (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, blisters, pus-filled blisters, peeling skin, measles-like rash), generalized erythema, necrosis, blistering detachment of the skin and mucous membranes, leading to exfoliation and possible sepsis (Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis)
• restlessness
• 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)
• gallbladder inflammation
• 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 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 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. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly 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 Teva-ratiopharm

• The active substance is febuxostat.

Each film-coated tablet contains 120 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 of the product and contents of the pack

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

The 120 mg film-coated tablets are marked with “120” on one side and “A265” on the other. The tablet dimensions are 19 mm x 8.2 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 certain pack sizes may be marketed.

Marketing Authorization Holder

Teva B.V.
Swensweg 5,
2031GA Haarlem
The Netherlands

For more information about this medicine, 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)

Manufacturer

Actavis Ltd.
BLB015-016 Bulebel Industrial Estate
ZTN 3000 Zejtun
Malta

or

Teva Gyógyszerkereskedelmi 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Germany Febuxostat-ratiopharm 120 mg Filmtabletten
Denmark Febuxostat Teva
Estonia Febuxostat Teva
Spain Febuxostat Teva-ratiopharm 120 mg film-coated tablets EFG
Luxembourg Febuxostat-ratiopharm 120 mg Filmtabletten
Lithuania Febuxostat Teva 120 mg plevele dengtos tabletes
Latvia Febuxostat Teva 120 mg apvalkotas tabletes
The Netherlands Febuxostat Teva 120 mg, filmomhulde tabletten
Slovakia Febuxostat Teva 120 mg

Date of the most recent review of this leaflet: July 2022

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included on the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/83255/P_83255.html

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