Febuxostat Viatri

Package leaflet: Information for the patient

Febuxostat Viatris 80 mg film-coated tablets, 120 mg film-coated tablets

febuxostat
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Never give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Febuxostat Viatris tablets contain the active substance febuxostat and are used to treat
gout, a condition associated with excess uric acid (urate) in the body. In some people,
the amount of uric acid accumulating in the blood may become so high that it can no longer remain
in solution. In such cases, urate crystals may form within and around joints and in the kidneys.
These crystals can cause sudden, severe pain, redness, warmth, and swelling in a joint (a gout attack).
If left untreated, larger deposits called tophi may form within and around the joints.
Tophi can damage joints and bones.
Febuxostat Viatris works by lowering uric acid levels. Maintaining low uric acid levels through daily
administration of Febuxostat Viatris prevents the accumulation of crystals and, over time, reduces symptoms.
If uric acid levels are kept low for a sufficiently long period, existing tophi may even gradually resolve.
Febuxostat Viatris 120 mg tablets are also used for the treatment and prevention of elevated blood levels of
uric acid that may occur during chemotherapy for blood cancers.
During chemotherapy, cancer cells are destroyed, leading to increased levels of uric acid in the blood,
unless the formation of this acid is prevented.
Febuxostat Viatris is for use in adults.

2. What you need to know before taking Febuxostat Viatris

Do not take Febuxostat Viatris:

• 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 taking Febuxostat Viatris:

• 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 abnormal liver function tests
• If you have high levels of uric acid due to Lesch-Nyhan syndrome (a rare inherited condition in which there is too much uric acid in the blood)
• If you have any thyroid problems.

If allergic reactions to Febuxostat Viatris occur, stop treatment with this
medicine (see also section 4).
Possible symptoms of allergic reactions may include:

• Skin rash, including severe forms (e.g. blisters, nodules, itchy rash, exfoliative skin rash), itching
• Swelling of limbs or face
• Difficulty breathing
• Fever with swollen lymph nodes
• Or even severe, life-threatening allergic conditions with cardiac and circulatory arrest.
• Your doctor may decide to permanently discontinue treatment with Febuxostat Viatris.

Rare, life-threatening skin rashes (Stevens-Johnson syndrome) have been reported with the use of febuxostat,
initially appearing on the trunk as reddish spots or circular lesions, often with central blisters. These may also
include mouth, throat, nose, genital ulcers, and conjunctivitis (red, swollen eyes). The rash may progress to
widespread blistering or skin peeling.
If you have developed Stevens-Johnson syndrome while taking febuxostat, treatment with Febuxostat
Viatris must not be restarted. If you develop a skin rash or these skin symptoms, consult your
doctor immediately and inform them that you are being treated with this medicine.
If you currently have a gout attack (sudden onset of severe pain, tenderness, redness, warmth, and swelling in a joint), wait until the gout attack has resolved before starting treatment with Febuxostat Viatris.
In some people, gout attacks may flare up at the beginning of certain treatments used to control uric acid levels. Not everyone experiences flares, but you may experience one even while taking Febuxostat Viatris, especially during the first weeks or months of treatment. It is important that you continue taking Febuxostat Viatris even during a flare-up, as Febuxostat Viatris continues to work to lower your uric acid levels. If you continue taking Febuxostat Viatris daily, over time, flare-ups will occur less frequently and become less painful.
Often, your doctor will prescribe additional medicines, if needed, to help prevent or treat symptoms of flare-ups (such as pain and joint swelling).
In patients with very high urate levels (e.g. patients undergoing chemotherapy), treatment with medicines that lower uric acid levels might lead to xanthine accumulation in the urinary tract, potentially causing kidney stones, although this has not been observed in patients treated with febuxostat for Tumor Lysis Syndrome.
Your doctor may prescribe blood tests to monitor your liver function.
Children and adolescents
Do not administer this medicine to children under 18 years of age, as safety and efficacy have not been established.
Other medicines and Febuxostat Viatris
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
It is very important that you inform your doctor or pharmacist if you are taking a medicine containing any of the following substances, as they may interact with Febuxostat Viatris and your doctor may need to take appropriate measures:

• Mercaptopurine (used to treat cancer)
• Azathioprine (used to reduce immune response)
• Theophylline (used to treat asthma)

Pregnancy and breastfeeding
It is not known whether febuxostat may harm the unborn baby. Febuxostat Viatris must not be used
during pregnancy. It is not known whether febuxostat passes into breast milk. You must not take Febuxostat
Viatris if you are breastfeeding or planning to breastfeed.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
Driving and use of machines
Be aware that you may experience dizziness, drowsiness, blurred vision, numbness, or tingling during treatment; if so, you must not drive or operate machinery.
Febuxostat Viatris contains lactose
Febuxostat Viatris tablets contain lactose (a type of sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
Febuxostat Viatris contains sodium
Febuxostat Viatris contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially “sodium-free”.

3. How to take Febuxostat Viatris

Always take this medicine exactly as directed by your doctor. If you have any doubts, you must
consult your doctor or pharmacist.

• The usual dose is one tablet per day. The back of the calendar blister pack is marked with the days of the week to help you check that you have taken a dose each day.
• The tablets should be taken by mouth. They can be taken with or without food.

Gout
Febuxostat Viatris is available as 80 mg or 120 mg tablets. Your doctor will have prescribed the most suitable dosage for you.
Continue taking Febuxostat Viatris every day, even if you do not currently have a flare-up or gout attack.

Prevention and treatment of high uric acid levels in patients undergoing chemotherapy
Febuxostat Viatris is available as 120 mg tablets.
Start taking Febuxostat Viatris two days before beginning chemotherapy and continue taking it as directed by your doctor. Treatment is usually of short duration.

If you take more Febuxostat Viatris than you should
In case of accidental overdose, contact your doctor or go to the nearest emergency department immediately.

If you forget to take Febuxostat Viatris
If you forget to take a dose of Febuxostat Viatris, 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 dose at the scheduled time. Do not take a double dose to make up for the forgotten dose.

If you stop taking Febuxostat Viatris
Do not stop treatment with Febuxostat Viatris without consulting your doctor, even if you feel better. If you stop taking Febuxostat Viatris, your uric acid levels may start to rise again, and your symptoms may worsen due to the formation of new urate crystals in and around your joints and kidneys.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Stop taking the medicine and contact your doctor immediately or go to the nearest emergency room if you experience any of the following rare adverse reactions (may affect up to 1 in 1,000 people), as they may lead to a severe allergic reaction:

• anaphylactic reactions, hypersensitivity to the drug (see also section 2 "Warnings and Precautions")
• skin rashes that can be life-threatening, characterized by blistering and peeling of the skin and internal body surfaces, 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 (up to liver failure), increased white blood cell count (drug reaction with eosinophilia and systemic symptoms - DRESS) (see section 2)
• generalized skin rash

Other adverse reactions not listed above are listed below.
Common adverse reactions (may affect up to 1 in 10 people) are:

• abnormalities in liver function tests
• diarrhea
• headache
• skin rash (including various types of rashes, see below under "uncommon" and "rare")
• nausea
• worsening of gout symptoms
• localized swelling due to fluid retention in tissues (edema)
• dizziness
• shortness of breath
• itching
• limb pain, muscle or joint pain
• fatigue

Uncommon adverse reactions (may affect up to 1 in 100 people) are:

• decreased appetite, changes in blood glucose levels (diabetes), one symptom of which may be excessive thirst, increased blood lipid levels, weight gain
• loss of libido (sexual desire)
• difficulty sleeping, drowsiness
• numbness, tingling, reduced or altered sense of touch (hypoesthesia, hemiparesis or paresthesia), altered taste, reduced sense of smell (hyposmia)
• abnormalities in ECG tracings, irregular or rapid heartbeat, awareness of heartbeat (palpitations)
• hot flushes or flushing (e.g. redness of face or neck), increased blood pressure, bleeding (hemorrhage, observed only in patients undergoing chemotherapy for blood disorders)
• cough, chest pain, inflammation of nasal passage and/or throat (respiratory tract infection), bronchitis, lower respiratory tract infection
• dry mouth, abdominal pain or discomfort, excessive intestinal gas, upper abdominal pain, heartburn/indigestion, constipation, more frequent bowel movements, vomiting, gastric discomfort
• itchy skin rash, urticaria, skin inflammation, change in skin color, small red or purple spots on the skin, small flat red spots on the skin, red area of skin covered with small confluent bumps, skin rashes, areas of redness 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 and/or stiffness), back pain, muscle spasms, muscle and/or joint stiffness
• blood in urine, increased frequency of urination, abnormalities in urine test results (increased protein levels in urine), reduced kidney function, urinary tract infections
• chest pain, chest discomfort
• gallstones or bile duct stones (cholelithiasis)
• increased blood levels of thyroid-stimulating hormone (TSH)
• changes in blood biochemical test values or red blood cell or platelet counts (abnormal blood test results)
• kidney stones
• difficulty achieving erection
• reduced thyroid gland activity, blurred vision, changes in vision
• ringing in the ears
• runny nose
• oral ulceration
• pancreatitis: common symptoms are abdominal pain, nausea and vomiting
• urgency to urinate
• pain
• malaise
• increased INR (index of blood coagulability)
• bruising
• swelling of the lips

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

• muscle damage, a condition that may rarely be serious. Muscle problems may develop, and particularly if you also feel unwell or have a high fever, this could be due to abnormal breakdown of muscle cells. Contact your doctor immediately if you experience muscle pain, tenderness or weakness
• marked swelling of deeper layers of the skin, especially around the eyes, genitals, hands, feet or tongue, possibly with sudden difficulty breathing
• high fever associated with measles-like rash, swollen lymph nodes, enlarged liver, hepatitis (up to liver failure), increased white blood cell count (leukocytosis, with or without eosinophilia)
• various types of skin rashes (e.g. with white spots, blisters, pustule-containing blisters, skin peeling, measles-like rash), diffuse erythema, necrosis and blistering detachment of the epidermis and mucous membranes, leading to exfoliation and possible sepsis (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• nervousness
• thirst
• weight loss, increased appetite, uncontrolled loss of appetite (anorexia)
• abnormally low levels of blood cells (white blood cells or red blood cells or platelets)
• changes or reduced amount of urine due to kidney inflammation (tubulo-interstitial nephritis)
• liver inflammation (hepatitis)
• yellowing of the skin (jaundice)
• bladder infection
• liver damage
• increased blood levels of creatine phosphokinase (a marker of muscle damage)
• sudden cardiac death
• low red blood cell count (anemia)
• depression
• sleep disorders
• loss of taste
• burning sensation
• dizziness
• circulatory failure
• lung infection (pneumonia)
• mouth ulcers; inflammation of the mouth
• gastrointestinal perforation
• rotator cuff syndrome
• polymyalgia rheumatica
• sensation of warmth
• sudden loss of vision due to blockage of an artery in the eye

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system listed in Annex V. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Febuxostat Viatris

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 packaging after Exp. The expiry
date refers to the last day of the month.
For bottles, after first opening, use within 180 days.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer require. This will help protect the environment.

6. Package contents and other information

What Febuxostat Viatris contains
The active substance is febuxostat. Each tablet contains 80 mg or 120 mg of febuxostat.
The excipients are:
Tablet core: lactose (see section 2, “Lactose and sodium content”), microcrystalline cellulose, magnesium stearate, hydroxypropylcellulose, sodium croscarmellose, colloidal hydrated silica, and colloidal anhydrous silica.
Tablet coating: hypromellose, titanium dioxide (E171), ethylcellulose, yellow iron oxide (E172), triacetin, and black iron oxide (E172).

What Febuxostat Viatris looks like and contents of the pack
Febuxostat Viatris film-coated tablets are yellow, capsule-shaped, biconvex tablets. The 80 mg tablets are marked with "M" on one side and "FX3" on the other side. The 120 mg tablets are marked with "M" on one side and "FX4" on the other side.
Febuxostat Viatris 80 mg and 120 mg film-coated tablets are available in blisters of 14, 28, and 84 tablets, calendar blisters of 28 and 84 tablets, and perforated single-dose blisters of 28 × 1 tablets, as well as multipack cartons containing 84 tablets, comprising two packs each containing 42 film-coated tablets.
Febuxostat Viatris 80 mg and 120 mg film-coated tablets are also available in plastic bottles containing 28 and 84 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Viatris Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland

Manufacturer
Mylan Hungary Kft
Mylan utca 1
H2900 Komárom
Hungary
McDermott Laboratories Limited, trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland
Mylan Germany GmbH
Branch office Bad Homburg v. d. Hoehe, Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352,
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Viatris bvba/sprl Viatris UAB
Tél/Tel: + 32 (0)2 658 61 00 Tel: +370 5 205 1288

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: +359 2 44 55 400 Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: +420 222 004 400 Tel.: + 36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: +45 28 11 69 32 Tel: + 356 21 22 01 74

Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: +49 800 0700 800 Tel: +31 (0)20 426 3300

Eesti Norge
Viatris OÜ Viatris AS
Tel: + 372 6363 052 Tlf: + 47 66 75 33 00

Ελλάδα Österreich
Viatris Hellas Ltd Arcana Arzneimittel GmbH
Τηλ: +30 2100 100 002 Tel: +43 1 416 2418

España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z o.o.
Tel: + 34 900 102 712 Tel.: + 48 22 546 64 00

France Portugal
Viatris Santé Mylan, Lda.
Tél: +33 4 37 25 75 00 Tel: + 351 214 127 200

Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000

Ireland Slovenija
Mylan Ireland Limited Viatris d.o.o
Tel: +353 1 8711600 Tel: + 386 1 23 63 180

Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100

Italia Suomi/Finland
Viatris Italia S.r.l. Viatris Oy
Tel: + 39 (0) 2 612 46921 Puh/Tel: +358 20 720 9555

Κύπρος Sverige
GPA Pharmaceuticals Ltd Τηλ: +357 22863100 Viatris AB
Tel: +46 (0)8 630 19 00

Latvija United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: +371 676 055 80 Tel: +353 18711600

This Patient Information Leaflet was last revised on

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu