Prospect: information for the user

ADENURIC 80mg film-coated tablets.

ADENURIC 120mg film-coated tablets.

febuxostat

Read this prospect carefully before starting to take the medicine because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is ADENURIC and for what it is used

2.What you need to know before starting to take ADENURIC

3.How to take ADENURIC

4.Possible adverse effects

5.Storage of ADENURIC

6.Contents of the package and additional information

ADENURIC tablets contain the active ingredient febuxostat and are used to treat gout, which is associated with an excess of a chemical compound called uric acid (urate) in the body. In some people, uric acid accumulates in the blood to the point where it cannot be dissolved. When this occurs, urate crystals form both inside and around the joints and kidneys. These crystals can cause sudden and intense pain, redness, heat, and swelling in the joints (this is called gout attacks). If left untreated, large deposits called tophi can form around the joints and inside them. Tophi can damage the joints and bones.

ADENURIC works by reducing the concentration of uric acid. Keeping uric acid levels low by taking ADENURIC once a day slows the formation of crystals and, over time, reduces symptoms. If uric acid levels are kept low for a sufficient amount of time, the size of tophi also decreases.

ADENURIC 120 mg tablets are also used in the treatment and prevention of high levels of uric acid in the blood, which can occur when chemotherapy is started to treat blood cancer.

When chemotherapy is administered, cancer cells are destroyed, and as a result, uric acid levels in the blood increase, unless their formation is prevented.

ADENURIC is for adults.

Do not take ADENURIC

• if you are allergic to febuxostat or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take ADENURIC:

• 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 liver function abnormalities
• if you are being treated for high uric acid levels due to Lesch-Nyhan syndrome (a rare genetic disorder in which there is too much uric acid in the blood)
• if you have thyroid problems.

If you experience allergic reactions to ADENURIC, stop taking this medicine (see also section 4).

Possible symptoms of allergic reactions may be:

• skin rash including severe forms (e.g. blisters, nodules, exfoliative rashes that cause itching), itching
• swelling of the limbs or face
• difficulty breathing
• fever with enlarged lymph nodes
• also severe allergic reactions that can put your life at risk, associated with cardiac arrest.

Your doctor may decide to permanently discontinue treatment with ADENURIC.

Rare cases of life-threatening skin eruptions (Stevens-Johnson syndrome) have been reported with the use of ADENURIC, initially appearing on the trunk as red spots in the shape of a target or circular spots 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 generalized blisters or skin peeling.

If you have developed Stevens-Johnson syndrome with the use of febuxostat, do not restart treatment at any time. If you develop a rash or these symptoms on your skin, go to your doctor immediately and tell them that you are taking this medicine.

If you experience a gout attack (a sudden, intense pain accompanied by sensitivity, redness, heat, and swelling of a joint), wait for the attack to subside before starting treatment with ADENURIC.

Some people may experience a gout attack when starting certain medicines that control uric acid levels. Not everyone experiences these attacks, but they can occur even while taking ADENURIC, especially during the first weeks or months of treatment. It is essential to continue taking ADENURIC daily, as this medicine continues to act to reduce uric acid levels. If you continue to take ADENURIC, gout attacks will become less frequent and less painful.

If necessary, your doctor will prescribe other medicines to prevent or treat symptoms of gout attacks (such as joint pain and swelling).

In patients with very high uric acid levels (e.g. those undergoing chemotherapy for cancer), treatment with medicines to reduce uric acid levels may lead to the accumulation of xanthine in the urinary tract, with possible stone formation, although this has not been observed in patients treated with ADENURIC for Tumor Lysis Syndrome.

Your doctor may perform blood tests to check that your liver is functioning normally.

Children and adolescents

Do not administer this medicine to children under 18 years of age, as the safety and efficacy have not been established.

Use of ADENURIC with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine, including those purchased without a prescription.

It is especially important to inform your doctor or pharmacist if you are using medicines that contain any of the following substances, as they may interact with ADENURIC, 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

It is not known if ADENURIC can harm the fetus. ADENURIC should not be used during pregnancy. It is not known if ADENURIC passes into breast milk. Do not use ADENURIC if you are breastfeeding or planning to breastfeed.

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

Be aware that you may experience dizziness, drowsiness, blurred vision, numbness, or tingling during treatment, so if this happens, do not drive or operate machinery.

ADENURIC contains lactose

ADENURIC tablets contain lactose (a type of sugar). If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.

ADENURIC contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

• The recommended dose is one tablet per day. The blister pack has the days of the week printed on the back to help you check that you take your dose every day.
• The tablets are taken orally, with or without food.

Gout

ADENURIC is available in tablets of 80 mg and 120 mg. Your doctor will prescribe the most suitable dose.

Continue taking ADENURIC every day, even if you no longer have gout attacks.

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

ADENURIC is available in tablets of 120 mg.

Start taking ADENURIC two days before chemotherapy and continue as directed by your doctor. The treatment is generally of short duration.

The groove in the 80 mg tablet is only for breaking the tablet if it is difficult to swallow whole.

If you take more ADENURIC than you should

In case of accidental overdose, consult your doctor or go to the nearest emergency center.

If you forget to take ADENURIC

If you forget a dose of ADENURIC, take it as soon as you remember, unless it is almost time to take the next dose; in that case, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with ADENURIC

Although you may be feeling better, do not stop taking ADENURIC unless your doctor tells you to. If you stop taking ADENURIC, 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 other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side 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 side effects (may affect up to 1 in 1000 people), as you may experience a severe allergic reaction:

• Anaphylactic reactions, hypersensitivity to the medicine (see also section 2 “Warnings and precautions”)
• Skin eruptions that can be life-threatening, characterized by the formation of blisters and skin and mucous membrane peeling (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 by swollen lymph nodes, liver enlargement, hepatitis (including liver insufficiency), increased white blood cell count in the blood (hypersensitivity to medications with eosinophilia and systemic symptoms-Syndrome of DRESS) (see section 2)
• Generalized skin eruptions

Thefrequent side effects(may affect up to 1 in 10 people) are the following:

• Abnormal liver test results
• Diarrhea
• Headache
• Rash (including various types of rash, see below the sections “infrequent” and “rare”)
• Nausea
• Increased gout symptoms
• Localized swelling due to fluid retention in tissues (edema)
• Dizziness
• Respiratory difficulties
• Itching
• Pain in the limbs, muscle and joint pain
• Fatigue

Other side effects not mentioned above are listed below.

Theinfrequent side effects(may affect up to 1 in 100 people) are the following:

• Decreased appetite, change in blood sugar level (diabetes) whose symptom may be excessive thirst, increased blood fats, weight gain
• Loss of sexual desire
• Difficulty sleeping, somnolence
• Numbness, tingling sensation, decreased or altered sensitivity (hypoaesthesia, hemiparesis or paresthesia), altered sense of taste, decreased sense of smell (hyposmia)
• ECG (electrocardiogram) abnormalities, irregular or rapid heartbeat, perception of heartbeats (palpitations)
• Flushes or redness (enrojecimiento of the face or neck), increased blood pressure, bleeding (haemorrhage, observed only in patients receiving chemotherapy for blood diseases)
• Cough, discomfort or pain in the chest, inflammation of the nasal passages and/or throat (upper respiratory tract infection), bronchitis, lower respiratory tract infection
• Dry mouth, stomach pain or discomfort, gas, stomach pain, indigestion, constipation, frequent bowel movements, vomiting, stomach discomfort
• Rash with itching, urticaria, skin inflammation or discoloration, small red or purple spots on the skin, small skin rashes, skin rashes with small interconnected bumps, rash, rashes, and spots on the skin, increased sweating, nocturnal sweating, alopecia, skin redness (erythema), psoriasis, eczema, other skin changes
• Muscle cramps, muscle weakness, bursitis or arthritis (inflammation of the joints, usually accompanied by pain, swelling, or stiffness), back pain, muscle spasms, muscle and/or joint stiffness
• Blood in urine, frequent urination, abnormal urine tests (increased protein concentration in urine), reduced kidney function, urinary tract infection
• Chest pain, chest discomfort
• Stones in the gallbladder or bile ducts (cholelithiasis)
• Increased levels of thyroid-stimulating hormone (TSH) in the blood
• Blood chemistry changes or changes in the number of blood cells or platelets (abnormal blood test results)
• Stones in the kidney
• Difficulty achieving an erection
• Decreased thyroid gland activity
• Blurred vision, changes in vision
• Tinnitus
• Nasal discharge
• Mouth ulcers
• Pancreatitis: common symptoms are abdominal pain, nausea, and vomiting
• Urgent need to urinate
• Pain
• Discomfort
• Increased INR
• Contusion
• Lip swelling

Therare side effects(may affect up to 1 in 1000 people) are the following:

• Muscle damage, which in rare cases can be severe. It may cause muscle problems and particularly, if you are unwell or have a high fever, it may be due to abnormal muscle destruction. Contact your doctor immediately if you experience muscle pain, sensitivity, or weakness
• Severe swelling of the deeper layers of the skin, especially around the eyes, genitals, hands, feet, or tongue, which may cause sudden difficulty breathing
• High fever accompanied by a rash similar to measles, swollen lymph nodes, liver enlargement (including liver insufficiency), increased white blood cell count in the blood (leucocytosis, with or without eosinophilia)
• Different types of rashes (e.g. with white spots and blisters, with pus-filled blisters, with skin peeling, rash similar to measles), generalized erythema, necrosis, blistering of the skin and mucous membranes, leading to exfoliation and possible sepsis (Stevens-Johnson syndrome/Toxic epidermal necrolysis)
• Anxiety
• Thirst
• Weight loss, increased appetite, uncontrolled loss of appetite (anorexia)
• Muscle stiffness and/or joint stiffness
• 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)
• Yellow skin (jaundice)
• Urinary tract infection
• Liver damage
• Increased levels of creatine phosphokinase in the blood (a marker of muscle damage)
• Sudden cardiac death
• Anemia (low red blood cell count)
• Depression
• Sleep disorder
• Loss of taste
• Burning sensation
• Dizziness
• Circulatory insufficiency
• Pulmonary infection (pneumonia)
• Mouth sores; inflammation of the mouth
• Gastrointestinal perforation
• Rotator cuff syndrome
• Polymyalgia rheumatica
• Sensation of heat
• Sudden loss of vision due to obstruction of an eye artery

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the carton box and on the blister pack after CAD/EXP. The expiration date is the last day of the month indicated.
• This medication does not require special storage conditions.

Do not dispose of the medication through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. In this way, you will help protect the environment.

Composition of ADENURIC

The active ingredient is febuxostat.

Each tablet contains 80mg or 120mg of febuxostat.

The other components are:

Core of the tablet:lactose monohydrate, microcrystalline cellulose, magnesium stearate, hydroxypropyl cellulose, croscarmellose sodium, hydrated colloidal silica.

Coating of the tablet:Opadry II yellow 85F42129, which contains: polyvinyl alcohol, titanium dioxide (E171), macrogl 3350, talc, yellow iron oxide (E172).

Appearance of the product and contents of the package

ADENURIC film-coated tablets are yellow or light yellow tablets in capsule shape.

The 80mg film-coated tablets have the imprint “80”on one side and a notch on the other side. The 120mg film-coated tablets have the imprint “120”on one side.

ADENURIC 80 mg and 120 mg are presented in transparent blisters (Aclar/PVC/Aluminum or PVC/PE/PVDC/ALUMINIO) of 14 tablets.

ADENURIC 80 mg and 120 mg is available in packaging of 14, 28, 42, 56, 84 and 98 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Menarini International Operations Luxembourg S.A.

1, Avenue de la Gare, L-1611 Luxembourg

Luxembourg

Manufacturer:

Patheon France

40 boulevard de Champaret

38300 Bourgoin Jallieu

France

or

Menarini - Von Heyden GmbH

Leipziger Strasse 7-13

01097 Dresden

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder.

Last revision date of this leaflet:

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency:Hhttp://www.ema.europa.eu