FEBUXOSTAT 80 mg Film-Coated Tablets

Зміст інструкції

1. Febuxostat Viatris 80 mg film-coated tablets, 120 mg film-coated tablets
   1. What is Febuxostat Viatris and what is it 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. Package contents and other information

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

febuxostat

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those 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 you take 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 is Febuxostat Viatris and what is it used for

Febuxostat Viatris tablets contain the active ingredient febuxostat and are used to treat
gout, a disease associated with an excess of uric acid (urate) in the body. In some people,
the amount of uric acid that accumulates in the blood can become too high to remain in
solution. In this case, urate crystals can form inside and around the joints and
kidneys. These crystals can cause intense and sudden pain, redness, a sensation
of heat and swelling in a joint (gout attack). If left untreated, larger deposits, called tophi, can form
inside and around the joints. Tophi can damage the
joints and bones.
Febuxostat Viatris works by reducing uric acid levels. Maintaining low levels of uric
acid by taking Febuxostat Viatris once a day prevents the accumulation of
crystals, and over time reduces symptoms. If uric acid levels are kept low for a
sufficiently long time, tophi can also be reabsorbed.
Febuxostat Viatris 120 mg tablets is also used for the treatment and prevention of high
blood uric acid levels that can occur during chemotherapy for blood cancers.
During chemotherapeutic treatment, cancer cells are destroyed and uric acid levels
in the blood increase, unless the formation of this acid can be prevented.
Febuxostat Viatris is for adults.

2. What you need to know before taking Febuxostat Viatris

Do not take Febuxostat Viatris:

• If you are allergic to febuxostat or 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 suffer from or have suffered from 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 problems with your thyroid.

If you experience allergic reactions to Febuxostat Viatris, stop taking the medicine (see also section 4).
Possible symptoms of allergic reactions may be:

• skin rash including severe forms (e.g. blisters, nodules, itchy rash, exfoliating rash), itching
• swelling of the limbs or face
• difficulty breathing
• fever with swollen lymph nodes
• but also severe life-threatening allergic conditions with cardiac and circulatory arrest.
• Your doctor may decide to permanently stop treatment with Febuxostat Viatris.

Rare skin rashes (Stevens-Johnson syndrome) that
have put the patient's life in danger have been reported with the use of febuxostat, which appeared on the trunk initially as reddish spots or circular spots often with central blisters. They may also include ulcers in the
mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). The rash may progress
to widespread blisters or skin peeling.
If you develop Stevens-Johnson syndrome with the use of febuxostat, treatment with Febuxostat
Viatris should no longer be resumed. If you develop a skin rash or these skin symptoms, consult
your doctor immediately and tell them that you are taking this medicine.
If you currently have a gout attack (sudden onset of severe pain, tenderness,
redness, heat and swelling in a joint), wait for the end of the gout attack
before starting therapy with Febuxostat Viatris.
In some people, gout attacks may worsen at the beginning of certain therapies used for
controlling uric acid levels. Not all people experience exacerbations, but you may
experience an exacerbation even when taking Febuxostat Viatris, especially during the first
weeks or months of therapy. It is important that you continue to take Febuxostat Viatris even
in the presence of an exacerbation, as Febuxostat Viatris continues to work to lower the level of
your uric acid. If you continue to take Febuxostat Viatris every day, over time, the
exacerbations will occur less frequently and will be less painful.
The doctor will often prescribe other medicines, if necessary, to help prevent or treat
the symptoms of exacerbations (such as pain and swelling in a joint).
In patients with very high uric acid levels (e.g. patients undergoing chemotherapy), treatment with
drugs that lower uric acid levels may cause xanthine to accumulate in the urinary tract
with possible formation of stones, although this has not been observed in patients treated with
febuxostat for Tumor Lysis Syndrome.
The doctor may prescribe blood tests to check that your liver is functioning
normally.

Children and adolescents
Do not give this medicine to children under 18 years of age because safety and efficacy
have not been established.

Other medicines and Febuxostat Viatris
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines, including those available without a prescription.
It is very important that you tell your doctor or pharmacist if you are taking a medicine that contains
any of the following substances, as these may interact with Febuxostat Viatris and your doctor
may want to consider appropriate measures:

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

Pregnancy and breastfeeding
It is not known whether febuxostat can harm the fetus. Febuxostat Viatris should not be used
during pregnancy. It is not known whether febuxostat passes into breast milk. Do not take Febuxostat
Viatris if you are breastfeeding or intend to do so.
If you are pregnant, suspect or are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
Be aware that you may experience dizziness, drowsiness, blurred vision
numbness or tingling during treatment and, in such cases, you should not
drive vehicles or operate machinery.

Febuxostat Viatris contains lactose
The tablets of Febuxostat Viatris contain lactose (a type of sugar). If your doctor has told you
that you have an intolerance to some sugars, talk to 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 your doctor has told you. If you have any doubts, you should
consult your doctor or pharmacist.

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

Gout
Febuxostat Viatris is available in tablet form of 80 mg or 120 mg. Your doctor will have
prescribed you the most suitable dosage.
Continue to take Febuxostat Viatris every day, even in the absence of flare-ups or a gout
attack.

Prevention and treatment of high uric acid levels in patients undergoing chemotherapy
Febuxostat Viatris is available in 120 mg tablets.
Start taking Febuxostat Viatris two days before chemotherapy and continue to take it
as directed by your doctor. Usually the use is short-term.

If you take more Febuxostat Viatris than you should
In case of accidental overdose, contact your doctor to find out what to do or contact the nearest
emergency room.

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 to take your next dose. In that case, skip the missed dose and
take your 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 your doctor's consent, even if you feel
better. If you stop treatment with Febuxostat Viatris, your uric acid levels may
begin to rise and your symptoms may worsen due to the formation of new uric acid
crystals inside and around your joints and kidneys.
If you have any doubts about the use of the medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Stop treatment with the medicine and immediately contact your doctor or go to the nearest emergency
room if you experience the following rare side effects (may affect up to 1 person in 1,000), as a severe
allergic reaction may follow:

• anaphylactic reactions, hypersensitivity to the drug (see also section 2 "Warnings and Precautions")
• skin rashes that may be life-threatening, characterized by the formation of blisters and peeling of the skin and internal surfaces of the body cavities, e.g. mouth and genitals, painful ulcers in the mouth and/or genital area, accompanied by fever, sore throat and fatigue (Stevens-Johnson syndrome/toxic epidermal necrolysis), or enlarged lymph nodes, enlarged liver, hepatitis (up to liver failure), increased white blood cell count in the blood (drug reaction with eosinophilia and systemic symptoms - DRESS) (see section 2).
• generalized skin rash

Other side effects that are not mentioned above are listed below.

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

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

Uncommon side effects(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 levels of fats in the blood, weight gain
• loss of libido (sexual desire)
• difficulty sleeping, drowsiness
• numbness, tingling, reduced or altered sense of touch (hypoesthesia, hemiparesis or paresthesia), altered taste, decreased sense of smell (hyposmia)
• ECG abnormalities, irregular or rapid heartbeat, perception of heartbeat (palpitations)
• hot flashes or redness (e.g. redness of the face or neck), increased blood pressure, bleeding (hemorrhage, observed only in patients undergoing chemotherapy for blood disorders)
• cough, chest pain, inflammation of the nasal passage and/or throat (upper 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, changes in skin color, small red or purple spots on the skin, small flat red spots on the skin, red area on the skin covered with small confluent bumps, 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 (inflammation of the joints 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 levels of protein in the urine) decreased ability of the kidneys to function properly, urinary tract infections
• chest pain, chest discomfort
• gallstones or bile duct stones (cholelithiasis)
• increased levels in the blood of thyroid-stimulating hormone (TSH)
• changes in biochemical blood tests or red blood cell or platelet counts (alteration of blood test results)
• kidney stones
• difficulty achieving an erection
• decreased thyroid gland activity, blurred vision, change in vision
• ringing in the ears
• runny nose
• mouth ulcers
• pancreatitis: common symptoms are abdominal pain, nausea and vomiting
• urgency to urinate
• pain
• malaise
• increased INR (blood clotting index)
• bruising
• swelling of the lips

Rare side effects(may affect up to 1 in 1000 people) are:

• muscle damage, a condition that can rarely be severe. Muscle problems may develop and in particular, if at the same time you do not feel well or have a high fever, this could be a consequence of an abnormal breakdown of muscle cells. Contact your doctor immediately if you experience muscle pain, soreness or weakness
• marked swelling of the deeper layers of the skin, especially around the eyes, genitals, hands, feet or tongue, with possible sudden difficulty breathing
• high fever associated with measles-like rash, enlarged lymph nodes, enlarged liver, hepatitis (up to liver failure), increased white blood cell count (leukocytosis, associated or not with eosinophilia)
• skin rash of various types (e.g. with white spots, with blisters, with blisters containing pus, with peeling of the skin, measles-like rash), widespread erythema, necrosis and blistering detachment of the epidermis and mucous membranes, resulting in 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 decrease in quantity in urine due to inflammation in the kidneys (tubulo-interstitial nephritis)
• liver inflammation (hepatitis)
• jaundice (yellowing of the skin)
• bladder infection
• liver damage
• increased level of creatine phosphokinase in the blood (an indicator of muscle damage)
• sudden cardiac death
• low number of red blood cells (anemia)
• depression
• sleep disorders
• loss of taste
• burning sensation
• vertigo
• circulatory failure
• lung infection (pneumonia)
• mouth ulcers; inflammation of the mouth
• gastrointestinal perforation
• rotator cuff syndrome
• polymyalgia rheumatica
• feeling of warmth
• sudden loss of vision due to blockage of an artery in the eye

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system listed in Annex V. By reporting side effects you can
contribute to providing 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 does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Febuxostat Viatris contains
The active ingredient 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, hydrated colloidal silica
and anhydrous colloidal silica.

Tablet coating:hypromellose, titanium dioxide (E171), ethylcellulose, yellow iron oxide
(E172), triacetin and black iron oxide (E172).

Appearance of Febuxostat Viatris and package contents
Febuxostat Viatris film-coated tablets are yellow in colour, capsule-shaped,
biconvex. The 80 mg tablets have M imprinted on one side and FX3 on the other side. The tablets
of 120 mg have M imprinted 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 unit-dose blisters of
28 × 1 tablets and in multipack packs of 84 tablets comprising 2 packs
each containing 42 film-coated tablets.
Febuxostat Viatris 80 mg and 120 mg film-coated tablets are also available in plastic bottles of
28 and 84 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352,
Germany
For further information on this medicine, please contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Viatris bvba/sprl
Tél/Tel: + 32 (0)2 658 61 00

Lietuva
Viatris UAB
Tel: +370 5 205 1288

България
Майлан ЕООД
Тел.: +359 2 44 55 400

Luxembourg/Luxemburg
Viatris
Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika
Viatris CZs.r.o.
Tel: +420 222 004 400

Magyarország
Viatris Healthcare Kft.
Tel.: + 36 1 465 2100

Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Malta
V.J. Salomone Pharma Ltd
Tel: + 356 21 22 01 74

Deutschland
Viatris Healthcare GmbH
Tel: +49 800 0700 800

Nederland
Mylan BV
Tel: +31 (0)20 426 3300

Eesti
Viatris OÜ
Tel: + 372 6363 052

Norge
Viatris AS
Tlf: + 47 66 75 33 00

Ελλάδα
Viatris Hellas Ltd
Τηλ: +30 2100 100 002

Österreich
Arcana Arzneimittel GmbH
Tel: +43 1 416 2418

España
Viatris Pharmaceuticals, S.L.
Tel: + 34 900 102 712

Polska
Viatris Healthcare Sp. z o.o.
Tel.: + 48 22 546 64 00

France
Viatris Santé
Tél: +33 4 37 25 75 00

Portugal
Mylan, Lda.
Tel: + 351 214 127 200

Hrvatska
Viatris Hrvatska d.o.o.
Tel: +385 1 23 50 599

România
BGP Products SRL
Tel: +40 372 579 000

Ireland
Mylan Ireland Limited
Tel: +353 1 8711600

Slovenija
Viatris d.o.o
Tel: + 386 1 23 63 180

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Italia
Viatris Italia S.r.l.
Tel: + 39 (0) 2 612 46921

Suomi/Finland
Viatris Oy
Puh/Tel: +358 20 720 9555

Κύπρος
GPA Pharmaceuticals LtdΤηλ: +357 22863100

Sverige
Viatris AB
Tel: +46 (0)8 630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

United Kingdom (Northern Ireland)
Mylan IRE Healthcare Limited
Tel: +353 18711600

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