Leaflet:information for the user

Gotaric 80 mg film-coated tablets

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

5.Storage of Gotaric

1. Contents of the pack and additional information

This medication contains the active ingredient febuxostat and is 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 (known as a gout attack). If left untreated, large deposits called tophi can form around the joints and inside them. Tophi can damage the joints and bones.

Gotaric works by reducing the concentration of uric acid. Maintaining low uric acid levels by taking febuxostat 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 the tophi also decreases.

Gotaric is for adults.

Do not take Gotaric:

• 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 pharmacistbefore starting to take Gotaric:

• 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 Gotaric, stop taking this medicine (see also section 4).

Possible symptoms of allergic reactions may include:

• 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 be life-threatening, associated with cardio-circulatory arrest. Your doctor may decide to permanently discontinue treatment with Gotaric.

Rare cases of life-threatening skin eruptions (Stevens-Johnson syndrome) have been reported with the use of Gotaric, 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 immediately to your doctor 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 febuxostat.

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

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

In patients with very high uric acid levels (e.g. those undergoing chemotherapy for cancer), treatment with medications to reduce uric acid levels may cause the accumulation of xanthine in the urinary tract, potentially leading to stone formation, although this has not been observed in patients treated with Gotaric 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.

Gotaric with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

It is especially important to inform your doctor or pharmacist if you are taking medications containing any of the following substances, as they may interact with Gotaric, 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 Gotaric can harm the fetus. Gotaric should not be used during pregnancy. It is not known if Gotaric passes into breast milk. Do not use Gotaric 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 occurs, do not drive or operate machinery.

Gotaric contains lactose and sodium

Gotaric 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.

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.

If in 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.

Gout

Gotaric is marketed in film-coated tablets of 80 mg and 120 mg. Your doctor will prescribe the most suitable dose.

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

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

Gotaric is available in 120 mg tablets.

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

If you take more Gotaric than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to take Gotaric

If you forget a dose of Gotaric, 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 Gotaric

Although you may be feeling better, do not stop taking Gotaric unless your doctor tells you to. If you stop taking Gotaric, 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 1,000 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 peeling of the skin and mucous membranes, for example, 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, enlarged liver, hepatitis (including liver failure), increased white blood cell count (hypersensitivity to medications with eosinophilia and systemic symptoms-syndrome of DRESS) (see section 2)
• generalized skin eruptions

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

• abnormal liver test results
• diarrhea
• headache
• eruption (including various types of eruption, see below the sections “infrequent” and “rare”)
• nausea
• increased symptoms of gout
• localized swelling due to fluid retention in tissues (edema)
• dizziness
• breathing difficulties
• itching
• limb pain, muscle/joint pain
• fatigue

Other side effects not mentioned above are listed below.

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

• decreased appetite, change in blood sugar level (diabetes) whose symptom may be excessive thirst, increased blood fats, weight gain
• loss of sexual appetite
• difficulty sleeping, somnolence
• numbness, tingling, 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 (hemorrhage, 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, abdominal pain or discomfort, gas, stomach pain, heartburn, indigestion, constipation, frequent bowel movements, vomiting, stomach discomfort
• eruption with itching, urticaria, skin inflammation or discoloration, small red spots or purpura on the skin, small rashes on the skin, rashes on the skin covered with small interconnected bumps, eruption, rashes, and spots on the skin, increased sweating, nocturnal sweating, alopecia, skin redness (erythema), psoriasis, eczema, other skin alterations

• 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 test results (increased protein concentration in urine), reduced kidney function, urinary tract infection
• chest pain, chest discomfort
• gallstones or bile duct stones (cholelithiasis)
• increased levels of thyroid-stimulating hormone (TSH) in blood
• blood chemistry or blood cell count anomalies (abnormal blood test results)
• kidney stones
• erection difficulties
• 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
• bruising
• swelling of the lips

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

• muscle damage, which in rare cases can be severe. It may cause muscle problems and, in particular, 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 breathing difficulties
• high fever accompanied by a rash similar to measles, swollen lymph nodes, enlarged liver, hepatitis (including liver failure), increased white blood cell count (leucocytosis, with or without eosinophilia)
• different types of eruptions (e.g., with white spots, blisters, pus-filled blisters, skin peeling, measles-like rash), 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)
• kidney inflammation (tubulointerstitial nephritis) resulting in decreased or altered urine volume
• liver inflammation (hepatitis)
• yellow skin (jaundice)
• urinary tract infection
• liver damage
• increased levels of creatine phosphokinase in blood (a marker of muscle damage)
• sudden cardiac death
• low red blood cell count (anemia)
• depression
• sleep disorder
• loss of taste
• burning sensation
• dizziness
• circulatory insufficiency
• lung infection (pneumonia)
• mouth sores; inflammation of the mouth
• gastrointestinal perforation
• rotator cuff syndrome
• polymyalgia rheumatica
• sensation of heat
• sudden lossof vision due to obstruction of an eye artery

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. 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 usethis medicationafter the expiration date that appears onthe carton box and on the blister packafter CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need.This will help protect the environment.

Composition ofGotaric

The active ingredient is febuxostat.

Each tablet contains 80 mg of febuxostat (as hemihydrate).

The other components are:

• Tablet core:microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, hydroxypropyl cellulose, hydrated colloidal silica, magnesium stearate
• Tablet coating:polyvinyl alcohol,titania dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).

Appearance of the product and contents of the package

Gotaric80 mg film-coated tablets are yellow, capsule-shaped (approximately 17 mm long and 6 mm wide), film-coated biconvex tablets (approximately 5 mm thick) marked with "80" on one face and smooth on the other face.

Gotaric80 mg is packaged in transparent Aclar/PVC/Aluminum blisters.

Gotaric80 mg is available in packaging containing 14, 28, 42, 56, 84, and 98 film-coated tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Especialidades Farmacéuticas Centrum, S.A.

C/ Sagitario, 14

03006 Alicante (Spain)

Grupo Asacpharma

Responsible for manufacturing

WESSLING Hungary Kft.

Anonymus utca 6.

Budapest, 1045

Hungary

O

Pharmadox Healthcare Ltd,

KW20A Kordin Industrial Park,

Paola, PLA3000

Malta

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

The NetherlandsFebuxostat Vivanta 80 mg filmomhulde tabletten

GermanyFebuxostat Vivanta 80 mg Filmtabletten

SpainGotaric 80 mg comprimidos recubiertos con película EFG

Last review date of this leaflet: July 2022

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)