Febuxostat Teva-Ratiopharm 80 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Febuxostat Teva-ratiopharm 80 mg film-coated tablets EFG

Please read this entire leaflet carefully before you start taking this medicine, as 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. Do not give it to others, 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 not listed in this leaflet. See section 4.

Leaflet Contents

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 excess of a chemical compound in the body called uric acid (urate). In some people, uric acid accumulates in the blood to the point where it cannot dissolve. When this occurs, urate crystals form both within and around the joints and in the kidneys. These crystals can cause sudden, intense pain, redness, warmth and swelling in the joints (this is known as 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 crystal formation 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 is for use in adults.

2. What you need to know before taking 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

Talk to 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-ratiopharm, 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 swollen lymph nodes
• also severe allergic reactions which 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 reactions (Stevens-Johnson Syndrome) have been reported with the use of febuxostat, initially appearing on the trunk as red, target-shaped 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 are experiencing 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 beginning certain medications 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 take febuxostat daily, gout flares will become less frequent and less painful over time.

If needed, 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 to 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 to 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 reduce 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

Please note that you may experience dizziness, drowsiness, blurred vision, or numbness and tingling sensations during treatment. If this occurs, you should not drive or operate machinery.

Febuxostat Teva-ratiopharm contains lactose

If your doctor has informed you that you have 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 for use of this medicine as given by your doctor. 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 per day.

Continue taking 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 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 telephone number: 91 562 04 20, indicating the medicine and the amount taken.

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 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 a missed dose.

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 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 will experience 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 subsequently experience a severe allergic reaction:

• anaphylactic reactions, drug hypersensitivity (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 genital areas, painful ulcers in the mouth and/or genital areas, accompanied by fever, sore throat and fatigue (Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis), or enlarged lymph nodes, liver enlargement, hepatitis (including liver failure), increased number of white blood cells in the 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, 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 the 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, skin bumps covered with small interconnected 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
• chest pain, chest discomfort
• gallstones or stones in the bile ducts (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 are 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 a 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, possibly causing sudden difficulty breathing
• high fever accompanied by a measles-like rash, enlarged 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, with blisters, with pus-filled blisters, with skin peeling, 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 blood cells, red blood 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 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 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 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 unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Pack contents and other information

Composition of Febuxostat Teva-ratiopharm

• The active substance 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 of the product and contents of the pack

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.

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

The 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)

Manufacturer responsible

Actavis Ltd.

BLB015-016 Bulebel Industrial Estate

ZTN 3000 Zejtun

Malta

or

Teva Gyógyszerkészítő 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 tabletes
Latvia Febuxostat Teva 80 mg apvalkotas tabletes
The Netherlands Febuxostat Teva 80 mg, filmomhulde tabletten
Slovakia Febuxostat Teva 80 mg

Date of the most recent revision of this summary: July 2022

Detailed information on this medicinal product 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 medicinal product by scanning with your mobile phone (smartphone) the QR code included on the packaging. You can also access this information at the following web address: https://cima.aemps.es/cima/dochtml/p/83254/P_83254.html

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