Prospect: information for theuser

Febuxostat MABO 80 mg film-coated tablets EFG.

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 otherpeople, even if they have the same symptoms as you, as it mayharm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they arenot listed in this prospect. See section 4.

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

2.What you need to know before starting to take Febuxostat MABO

3.How to take Febuxostat MABO

4.Possible adverse effects

5Storage of Febuxostat MABO

6.Contents of the package and additional information

Febuxostat MABO 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.

Febuxostat MABO acts by reducing the concentration of uric acid. Maintaining low uric acid levels by taking Febuxostat MABO once a day slows the formation of crystals and, over time, reduces symptoms. If uric acid levels are kept low for a sufficient period, the size of tophi also decreases.

Do not take Febuxostat MABO

• 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 Febuxostat MABO:

• if you have or have had heart failure or other 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 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 Febuxostat MABO, 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 Febuxostat MABO.

Rare cases of life-threatening skin eruptions (Stevens-Johnson syndrome) have been reported with the use of febuxostat, 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 onset of intense pain accompanied by sensitivity, redness, heat, and swelling of a joint), wait for the attack to subside before starting treatment with Febuxostat MABO.

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 Febuxostat MABO, especially during the first weeks or months of treatment. It is essential to continue taking Febuxostat MABO daily, as this medicine continues to act to reduce uric acid levels. If you continue to take Febuxostat MABO, 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 the possible formation of stones, 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 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 Febuxostat MABO 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 Febuxostat MABO, and your doctor may need to take special 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 if Febuxostat MABO can harm the fetus. Febuxostat MABO should not be used during pregnancy. It is not known if Febuxostat MABO passes into breast milk. Do not use Febuxostat MABO 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.

Febuxostat MABO contains lactose

Febuxostat MABO tablets contain lactose (a type of sugar). If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

Febuxostat MABO contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this 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 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.

Febuxostat MABO is marketed in 80 mg tablets. Your doctor will prescribe the most suitable dose for you.

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

If you take more Febuxostat MABO than you should

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

If you forget to take Febuxostat MABO

If you forget a dose of Febuxostat MABO, take it as soon as you remember, unless it is almost time to take the next one; 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 the missed doses.

If you interrupt treatment with Febuxostat MABO

Although you may be feeling better, do not stop taking Febuxostat MABO unless your doctor tells you to. If you stop taking Febuxostat MABO, your uric acid concentration may increase 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 medication (see also section 2 "Warnings and precautions")
• Skin eruptions that can be life-threatening, characterized by the formation of blisters and peeling of the skin and mucous membranes (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 failure), increased white blood cell count (hypersensitivity to medications with eosinophilia and systemic symptoms - DRESS syndrome) (see section 2)
• Generalized skin eruptions

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

?Abnormal results from liver tests

?Diarrhea

?Headache

?Rash (including various types of rash, see the following sections "infrequent" and "rare")

?Nausea

?Increased symptoms of gout

?Localized swelling due to fluid retention in tissues (edema)

Other side effects not mentioned above are included below.

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

• Decreased appetite, change in blood sugar levels (diabetes) whose symptom may be excessive thirst, increased blood fats, weight gain
• Loss of sexual appetite
• Difficulty sleeping, somnolence
• Dizziness, numbness, tingling, decreased or altered sensitivity (hypoaesthesia, hemiparesis, or paresthesia), altered or decreased sense of taste (hypogeusia)electrocardiogram (ECG) abnormalities, irregular or rapid heartbeat, perception of heartbeats (palpitations)
• Headaches or flushing (redness of the face or neck), increased blood pressure, bleeding (haemorrhage, observed only in patients receiving chemotherapy for blood diseases)
• Cough, respiratory difficulties, chest discomfort, inflammation of the nasal passages and/or throat (upper respiratory tract infection), bronchitis
• Dry mouth, abdominal pain or discomfort, gas, heartburn, indigestion, constipation, frequent bowel movements, vomiting, stomach discomfort
• Itching, urticaria, skin inflammation or discoloration, small red or purple spots on the skin, small skin rashes, skin rashes covered with small, interconnected bumps, rash, rashes, and skin spots, other skin changes
• Muscle cramps, muscle weakness, muscle pain, and joint pain, bursitis or arthritis (inflammation of the joints, usually accompanied by pain, swelling, or stiffness), pain in the limbs, back pain, muscle spasms
• Blood in urine, frequent urination, abnormal urine tests (increased protein concentration in urine), reduced kidney function
• Fatigue, chest pain, chest discomfort
• Stones in the gallbladder or bile ducts (cholelithiasis)
• Increased levels of thyroid-stimulating hormone (TSH) in the blood
• Blood chemistry or blood cell count abnormalities (anomalous results in blood tests)
• Stones in the kidney
• Erectile dysfunction

Rare 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 deepest layers of the skin, especially around the lips, 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 failure), increased white blood cell count (leucocytosis, with or without eosinophilia)
• Redness of the skin (erythema), different types of rash (e.g. itching, with white patches with blisters, with blisters containing pus, with peeling of the skin, 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
• Tinnitus (ringing in the ears)
• Blurred vision, changes in vision
• Hair loss
• Oral ulcers
• Pancreatitis: common symptoms are abdominal pain, nausea, and vomiting
• Increased sweating
• 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)
• Urgent need to urinate
• Changes or decreased urine volume due to kidney inflammation (tubulointerstitial nephritis)
• Liver inflammation (hepatitis)
• Yellow skin (jaundice)
• Liver damage
• Increased levels of creatine phosphokinase in the blood (a marker of muscle damage)

If you experience any side effect, report it to your doctor or pharmacist. This includes any side effect not mentioned in this leaflet.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet.You can alsoreport them directly through the national notification system included in Annex 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 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 Febuxostat MABO

The active ingredient is febuxostat.

Each tablet contains 80 mg of febuxostatequivalent to 82.28mg of hemihydrate of febuxostat.

The other components are:

Tablet core:lactose monohydrate, microcrystalline cellulose (E460), magnesium stearate (E470b), hydroxypropylcellulose (E463), croscarmellose sodium, anhydrous colloidal silica (E551).

Tablet coating:polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350, talc (E 553b), yellow iron oxide (E172),copolymers of methacrylic acid - ethyl acrylate (1: 1) (type A),sodium hydrogen carbonate (E500 (ii)).

Appearance of the product and contents of the packaging

Yellowish or yellow tablets, coated with a film, in the form of a capsule, with the number “80” engraved on one face andsmooth on the other, with dimensions 16.5 mm x 7.0 mm ± 5%.

Febuxostat MABO 80 mg is presented in blistersAluminum-OPA / Alu / PVC or Aluminum-

PVC / PE / PVDC.

Febuxostat MABO 80 mg is available in packaging of 14, 28, 45, 56, 84 and 98film-coated tablets.

Only some packaging sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

MABO-FARMA S.A.

Calle Rejas 2. Planta 1.

28821 Coslada (Madrid)

Spain

Responsible manufacturer:

Rontis Hellas Medical and Pharmaceutical Products S.A

P.O. Box 3012 Larisa

41004, Greece

or

PharOS MT Ltd

HF 62X, Hal-Far Industrial Estate,

Birzebbugia BBG 3000,

Malta

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain: Febuxostat MABO 80mgfilm-coated tablets EFG

Malta:Febuxostat PharOS 80mgfilm-coated tablets

Date of the last review of this leaflet: November 2021