Package leaflet: Information for the patient

DYMAURIC 80 mg film-coated tablets, 120 mg film-coated tablets

febuxostat
Equivalent medicine
Please 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 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 adverse reaction, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What DYMAURIC is and what it is used for
What you need to know before taking DYMAURIC
How to take DYMAURIC
Possible side effects
How to store DYMAURIC
Contents of the pack and other information

1. What DYMAURIC is and what it is used for

DYMAURIC contains the active substance febuxostat and is used to treat gout, a condition
associated with an excess of a chemical substance called 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 dissolved. In such cases, urate crystals may form within and around
joints and in the kidneys. These crystals can cause sudden, intense pain, redness, warmth,
and swelling in a joint (gout attack). If left untreated, larger deposits called tophi may form
within and around the joints. Tophi can damage joints and bones.
DYMAURIC works by reducing uric acid levels. Maintaining low uric acid levels through daily
administration of DYMAURIC 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
be reabsorbed.
DYMAURIC 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 and uric acid levels in the blood rise, unless
the formation of this acid is prevented.
DYMAURIC is for use in adults.

2. What you should know before taking DYMAURIC

Do not take DYMAURIC:

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 DYMAURIC:

If you have or have had heart failure or heart problems
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 abnormalities in 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 DYMAURIC occur, stop treatment with
the 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 eruption), itching
Swelling of limbs or face
Difficulty breathing
Fever with swollen lymph nodes
As well as severe, life-threatening allergic conditions with cardiac and circulatory arrest. Your doctor may decide to permanently discontinue treatment with DYMAURIC.

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 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 taking febuxostat, treatment with DYMAURIC must not be restarted. If you develop a rash or these skin symptoms, consult your doctor immediately and inform them that you are being treated with this medicine.
If you are currently experiencing a gout attack (sudden onset of intense pain, tenderness, redness, warmth, and swelling in a joint), wait until the gout attack has resolved before starting treatment with febuxostat.
In some people, gout attacks may recur at the beginning of certain treatments used to control uric acid levels. Not everyone experiences recurrences, but you may have flare-ups even while taking febuxostat, especially during the first weeks or months of treatment. It is important that you continue taking febuxostat even during a flare-up, as febuxostat continues to work to lower your uric acid levels. If you continue taking febuxostat daily, over time, flare-ups will occur less frequently and become less painful.
Often, your doctor may prescribe additional medicines, if needed, to help prevent or treat symptoms of flare-ups (such as pain and swelling in a joint).
In patients with very high urate levels (e.g., patients undergoing chemotherapy), treatment with medicines that lower uric acid levels may lead to xanthine accumulation in the urinary tract, potentially causing stone formation, although this has not been observed in patients treated with febuxostat for Tumor Lysis Syndrome.
Your doctor may order 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 DYMAURIC
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 DYMAURIC and your doctor may need to consider appropriate measures:

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

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
It is not known whether febuxostat may harm the fetus. Febuxostat must not be used during pregnancy. It is not known whether febuxostat passes into breast milk. You must not take febuxostat if you are breastfeeding or planning to breastfeed.
Driving and using machines
Be aware that you may experience dizziness, drowsiness, blurred vision, numbness, or tingling during treatment, and if you experience these symptoms, you must not drive or operate machinery.
DYMAURIC contains lactose
DYMAURIC contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take DYMAURIC

Always take this medicine exactly as instructed by your doctor. If you have any
doubts, you must consult your doctor or pharmacist.
Gout
DYMAURIC is available as 80 mg or 120 mg film-coated tablets. Your doctor will prescribe the dosage most suitable for you.
The usual dose is one tablet per day.
Continue taking DYMAURIC every day, even in the absence of flare-ups or gout attacks.
Prevention and treatment of high uric acid levels in patients undergoing
chemotherapy
The usual dose is one 120 mg tablet per day.
Start taking DYMAURIC two days before chemotherapy and continue taking it as advised by your doctor. Treatment is usually of short duration.
Method of administration
DYMAURIC is for oral use.
The tablets can be taken with or without food.
If you take more DYMAURIC than you should
In case of accidental overdose, contact your doctor or go to the nearest emergency department immediately.
If you forget to take DYMAURIC
If you forget to take a dose of DYMAURIC, 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 missed dose.
If you stop taking DYMAURIC
Do not stop treatment with DYMAURIC without consulting your doctor, even if you feel better. If you stop treatment with DYMAURIC, your uric acid levels may start to rise again and your symptoms may worsen due to the formation of new urate crystals within and around your joints and kidneys.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 side effects (may affect up to 1 in 1,000 people), as these could be signs of a severe allergic reaction:

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

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

abnormal liver function test results
diarrhoea
headache
rash (including various types of skin eruptions, see below in the “uncommon” and “rare” sections)
nausea
worsening of gout symptoms
localized swelling due to fluid retention in tissues (oedema)

Other side effects not listed above are listed below.
Uncommon side effects (may affect up to 1 in 100 people)

decreased appetite, changes in blood sugar levels (diabetes), one symptom of which may be excessive thirst, increased blood lipid levels, weight gain
loss of sexual desire
difficulty sleeping, drowsiness
dizziness, numbness, tingling, reduced or altered sense of touch (hypoesthesia, hemiparesis or paraesthesia), altered taste, reduced sense of smell (hyposmia)
abnormalities in ECG tracings, irregular or rapid heartbeat, awareness of heartbeat (palpitations)
hot flushes or redness (e.g. of the face or neck), increased blood pressure, bleeding (haemorrhage, observed only in patients undergoing chemotherapy for blood disorders)
cough, shortness of breath, chest pain, inflammation of the nasal passage and/or throat (respiratory tract infection), bronchitis
dry mouth, abdominal pain or discomfort, excessive intestinal gas, heartburn/indigestion, constipation, more frequent bowel movements, vomiting, gastric discomfort
itching, urticaria, skin inflammation, change in skin colour, small red or purple spots on the skin, small flat red spots on the skin, flat red areas on the skin covered with small confluent bumps, skin rashes, areas of redness and spots on the skin, other skin disorders
muscle cramps, muscle weakness, muscle or joint pain, bursitis or arthritis (inflammation of joints usually accompanied by pain, swelling and/or stiffness), limb pain, back pain, muscle spasms
blood in urine, increased frequency of urination, abnormal urine test results (increased protein levels in urine), reduced kidney function
fatigue, 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

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

muscle damage, a condition which 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 lips, eyes, genitals, hands, feet or tongue, possibly causing sudden difficulty in breathing
high fever associated with a measles-like skin rash, swollen lymph nodes, enlarged liver, hepatitis (up to liver failure), increased white blood cell count (leucocytosis, with or without eosinophilia)
skin redness (erythema), skin eruptions of various types (e.g. itching, with white spots, with blisters, with pus-filled blisters, with skin peeling, measles-like rash), widespread 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
ringing in the ears
blurred vision, changes in vision
hair loss
oral ulceration
inflammation of the pancreas: common symptoms are abdominal pain, nausea and vomiting
increased sweating
weight loss, increased appetite, uncontrolled loss of appetite (anorexia)
muscle and/or joint stiffness
abnormally low levels of blood cells (white blood cells or red blood cells or platelets)
urgency to urinate
changes or decreased urine output due to kidney inflammation (tubulo-interstitial nephritis)
liver inflammation (hepatitis)
yellowing of the skin (jaundice)
liver damage
increased blood levels of creatine phosphokinase (a marker of muscle damage)

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store DYMAURIC

Keep this medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the carton and blister after "Exp". The expiry date refers to the last day of the month.
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 use. This will help protect the environment.

6. Package contents and other information

What DYMAURIC contains

The active substance is febuxostat. DYMAURIC 80 mg: Each film-coated tablet contains 80 mg of febuxostat (as febuxostat hemihydrate). DYMAURIC 120 mg: Each film-coated tablet contains 120 mg of febuxostat (as febuxostat hemihydrate).
The other components are: Tablet core: microcrystalline cellulose, lactose monohydrate, hydroxypropylcellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate. Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).
Description of the appearance of DYMAURIC and contents of the pack
DYMAURIC film-coated tablets are yellow, biconvex and oblong.
The 80 mg film-coated tablets are marked with ‘80’ on one side and ‘A275’ on the other. The tablet size is 16 mm x 7 mm.
The 120 mg film-coated tablets are marked with ‘120’ on one side and ‘A265’ on the other. The tablet size is 19 mm x 8.2 mm.
Pack sizes
Blister packs in PVC/PVDC/Al
Blister packs in PVC/PCTFE/PVC/Al
10, 14, 28, 30, 90 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Dymalife Pharmaceutical S.r.l.
Via Bagnulo 95
80063 PIANO DI SORRENTO (NA)
Manufacturer
Teva Pharmaceutical Works Private Limited Company -
Teva Gyógyszergyár Zrt. -
Pallagi ut 13
H-4042 DEBRECEN
This medicinal product is authorised in the European Economic Area countries under the following names:
Germany DYMAURIC 80 mg Filmtabletten
DYMAURIC 120 mg Filmtabletten
Italy DYMAURIC
This leaflet was last revised on