GOTARIC 80 mg FILM-COATED TABLETS

Introduction

Leaflet: information for the user

Gotaric 80 mg film-coated tablets EFG

Read the entire leaflet carefully before starting to take this medication, 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 medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Gotaric and what is it used for
2. What you need to know before taking Gotaric
3. How to take Gotaric
4. Possible side effects

1. Storage of Gotaric
   1. Package contents and additional information

1. What is Gotaric and what is it used for

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 builds up in the blood to the point where it cannot be dissolved. When this happens, 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 (called 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. Keeping the uric acid concentration low by taking febuxostat once a day prevents the formation of crystals and, over time, reduces the symptoms. If the uric acid concentration is kept low for a long enough time, the size of the tophi is also reduced.

Gotaric is for adults.

2. What you need to know before taking Gotaric

Do not take Gotaric:

• if you are allergic to febuxostat or any of the other components of this medication (listed in section 6)

Warnings and precautions

Consult your doctor or pharmacist before 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 medication used to treat gout)
• if you have or have had liver disease or liver function disorders
• if you are being treated for high uric acid levels due to Lesch-Nyhan syndrome (a rare inherited disease 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 medication (see also section 4).

Possible symptoms of allergic reactions may include:

• rash, including severe forms (e.g., blisters, nodules, exfoliative rashes that cause itching), itching
• swelling of the limbs or face
• difficulty breathing
• fever with swollen 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 rashes (Stevens-Johnson syndrome) have been reported with the use of Gotaric, initially appearing on the trunk as reddish spots in a target shape or circular spots that often have a blister in the center. It can also include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes). The rash can evolve into generalized blisters or skin peeling.

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

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

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

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

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

Children and adolescents

Do not give this medication to children under 18 years of age, as safety and efficacy have not been established.

Taking Gotaric with other medications

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

It is especially important that you inform your doctor or pharmacist if you are taking medications that contain 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 the 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

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

Gotaric contains lactose and sodium

Gotaric film-coated tablets contain lactose (a type of sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

3. How to take Gotaric

Follow your doctor's instructions for taking this medication exactly.

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 are taking your dose every day.
• Tablets are taken orally, with or without food.

Gout

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

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 using it as directed by your doctor. In general, treatment is short-term.

If you take more Gotaric than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology 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 for your next dose; in this case, skip the missed dose and take the next one at the usual time. Do not take a double dose to make up for missed doses.

If you stop taking Gotaric

Even if you feel 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 using this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Stop taking this medication 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 medication (see also section 2 "Warnings and precautions")
• skin rashes that can be life-threatening, characterized by the formation of blisters and peeling of the skin and mucous membranes, such as the 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 in the blood (hypersensitivity to medications with eosinophilia and systemic symptoms - DRESS) (see section 2)
• generalized skin rashes

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

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

Other side effects not mentioned above are listed below.

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

• decreased appetite, change in blood sugar levels (diabetes) whose symptom may be excessive thirst, increased blood fats, weight gain
• decreased sex drive
• difficulty sleeping, drowsiness
• numbness, tingling, decreased or altered sensation (hypoesthesia, hemiparesis, or paresthesia), altered sense of taste, decreased sense of smell (hyposmia)
• abnormalities in the ECG (electrocardiogram), irregular or rapid heartbeat, perception of heartbeats (palpitations)
• hot flashes or flushing (redness 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, pain in the upper abdominal area, heartburn or indigestion, constipation, more frequent bowel movements, vomiting, stomach discomfort
• itchy rash, hives, skin inflammation or discoloration, small red or purple spots on the skin, small bumps on the skin, skin rash with small interconnected bumps, rash, hives, and spots on the skin, increased sweating, night sweats, hair loss, skin redness (erythema), psoriasis, eczema, other skin disorders

• muscle cramps, muscle weakness, bursitis or arthritis (joint inflammation, usually accompanied by pain, swelling, or stiffness), back pain, muscle spasms, muscle and/or joint stiffness

• blood in urine, abnormally frequent urination, abnormal urine tests (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 the blood
• changes or decreases in urine volume due to kidney inflammation (tubulointerstitial nephritis)

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

• muscle damage, which can be severe in rare cases. It can cause muscle problems, and particularly if you are also feeling unwell or have a high fever, it can be due to abnormal muscle destruction. Contact your doctor immediately if you experience muscle pain, sensitivity, or weakness
• severe swelling of the deep layers of the skin, especially around the eyes, genitals, hands, feet, or tongue, which can cause sudden difficulty breathing
• high fever accompanied by a rash similar to measles, swollen lymph nodes, liver enlargement, hepatitis (including liver failure), increased white blood cell count in the blood (leukocytosis, with or without eosinophilia)
• various types of rash (e.g., with white spots, with blisters, with pus-filled blisters, with skin peeling, measles-like rash), generalized redness, necrosis, blistering and peeling of the skin and mucous membranes, leading to exfoliation and possible sepsis (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• nervousness
• feeling of thirst
• weight loss, increased appetite, uncontrolled loss of appetite (anorexia)
• muscle and/or joint stiffness
• abnormal blood cell count (white blood cells, red blood cells, or platelets)
• changes in blood biochemistry or blood cell count
• kidney stones
• difficulty getting an erection
• decreased thyroid gland activity
• blurred vision, changes in vision
• ringing in the ears
• runny nose
• mouth ulcers
• pancreatitis: common symptoms are abdominal pain, nausea, and vomiting
• urgent need to urinate
• pain
• discomfort
• increased INR
• bruising
• swelling of the lips

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Gotaric

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date shown on the carton and blister pack after EXP. 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 wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Packaging Content and Additional Information

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, sodium croscarmellose, hydroxypropylcellulose, hydrated colloidal silica, magnesium stearate
• Tablet coating:polyvinyl alcohol, titanium dioxide (E171), macrogols 3350, talc, yellow iron oxide (E172).

Appearance of the Product and Packaging Content

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

Gotaric 80 mg is packaged in a transparent Aclar/PVC/Aluminum blister pack.

Gotaric 80 mg is available in packs containing 14, 28, 42, 56, 84, and 98 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Centrum Pharmaceutical Specialties, S.A.

C/ Sagitario, 14

03006 Alicante (Spain)

Asacpharma Group

Manufacturer

WESSLING Hungary Kft.

Anonymus utca 6.

Budapest, 1045

Hungary

Or

Pharmadox Healthcare Ltd,

KW20A Kordin Industrial Park,

Paola, PLA3000

Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

The Netherlands Febuxostat Vivanta 80 mg film-coated tablets

Germany Febuxostat Vivanta 80 mg Filmtabletten

Spain Gotaric 80 mg film-coated tablets EFG

Date of the last revision of this leaflet: July 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)