Gotaric 80 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Gotaric 80 mg film-coated tablets EFG

Read this entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Leaflet Contents

1. What Gotaric is and what it is used for

2. What you need to know before taking Gotaric

3. How to take Gotaric

4. Possible side effects

5. How to store Gotaric
   6. Contents of the pack and other information

1. What Gotaric is and what it is used for

This medicine contains the active substance febuxostat and is used to treat gout, which is associated with an excess in the body of a chemical compound called uric acid (urate). In some people, uric acid accumulates in the blood to the point where it can no longer dissolve. When this occurs, urate crystals form both within and around the joints and kidneys. These crystals can cause sudden and severe pain, redness, heat, and swelling in the joints (known as a gout attack). If left untreated, large deposits called tophi may form around and within the joints. Tophi can damage joints and bones.

Gotaric works by reducing the concentration of uric acid. Keeping uric acid levels low by taking febuxostat once daily prevents 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.

Gotaric is for use in adults.

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

Do not take Gotaric:

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

Warnings and precautions

Talk to 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 medicine used to treat gout)
• if you have or have had liver disease or impaired liver function
• if you are being treated for 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 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 causing itching), itching
• swelling of the limbs or face
• difficulty breathing
• fever with swollen lymph nodes
• also severe allergic reactions which may 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 red target-like spots or circular lesions often with a blister in the center. It may also include mouth, throat, nose, genital ulcers, and conjunctivitis (red and swollen eyes). The rash may progress to widespread blistering or skin peeling.

If you have developed Stevens-Johnson syndrome while using febuxostat, you must never restart treatment. If you develop a rash or these skin symptoms, seek immediate medical attention and inform your doctor that you are taking this medicine.

If you suffer a gout attack (sudden severe pain accompanied by tenderness, redness, warmth, and swelling in a joint), wait until the attack subsides before starting treatment with febuxostat.

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

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

In patients with very high urate levels (e.g. those undergoing chemotherapy for cancer), treatment with medicines to lower uric acid may lead to xanthine accumulation in the urinary tract, potentially causing kidney 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 your liver is functioning properly.

Children and adolescents

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

Taking Gotaric with other medicines

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

It is especially important to inform your doctor or pharmacist if you are taking medicines containing any of the following active substances, as they may interact with Gotaric, and your doctor may need to take special measures:

• Mercaptopurine (used to treat cancer)
• Azathioprine (used to suppress the immune response)
• Theophylline (used to treat asthma)

Pregnancy and breastfeeding

It is not known whether Gotaric can harm the fetus. Gotaric must not be used during pregnancy. It is not known whether 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Be aware that you may experience dizziness, drowsiness, blurred vision, and numbness or tingling sensations during treatment. If this occurs, you must not drive or operate machinery.

Gotaric contains lactose and sodium

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

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

3. How to take Gotaric

Follow exactly the instructions for use of this medicine as given by your doctor.

If in doubt, please 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 keep track of taking your dose every day.
• The tablets are taken orally, with or without food.

Gout

Gotaric is marketed as film-coated tablets of 80 mg and 120 mg. Your doctor will prescribe the most appropriate 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 cancer chemotherapy

Gotaric is available in 120 mg tablets.

Start taking Gotaric two days before chemotherapy and continue using it as directed by your doctor. Generally, treatment is of short duration.

If you take more Gotaric than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone: 91 562 04 20, indicating the medicine and the amount taken.

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 that case, skip the missed dose and take the next one at the regular time. Do not take a double dose to make up for a missed dose.

If you stop taking Gotaric

Even if you feel better, do not stop taking Gotaric unless instructed by your doctor. 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Stop taking this medicine and contact your doctor immediately or go to the nearest hospital if you experience any of the following rare adverse effects (may affect up to 1 in 1,000 people), as you may be experiencing 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 mucous membranes, for example in the mouth and genital areas, painful sores 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 number of white blood cells (leukocytes) in the blood (drug hypersensitivity with eosinophilia and systemic symptoms – DRESS syndrome) (see section 2)
• widespread skin rashes

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

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

Other adverse effects not mentioned above are listed below.

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

• decreased appetite, change in blood sugar levels (diabetes) which may present as excessive thirst, increased blood fats, weight gain

• loss of sexual appetite

• difficulty sleeping, drowsiness

• numbness, tingling sensation, reduced or altered sensitivity (hypoesthesia, hemiparesis or paresthesia), altered sense of taste, reduced sense of smell (hyposmia)

• ECG (electrocardiogram) abnormalities, irregular or rapid heartbeat, awareness of heartbeats (palpitations)

• hot flushes or flushing (redness of face or neck), increased blood pressure, bleeding (hemorrhage, observed only in patients receiving chemotherapy for blood disorders)

• cough, chest discomfort or pain, nasal and/or throat inflammation (upper respiratory tract infection), bronchitis, lower respiratory tract infection

• dry mouth, abdominal pain or discomfort or gas, upper abdominal pain, heartburn or indigestion, constipation, increased frequency of bowel movements, vomiting, stomach discomfort

• itchy rash, urticaria, skin inflammation or discoloration, small red or purple spots on the skin, small skin bumps, skin bumps covered with small interconnected lumps, rash, bumps and spots on the skin, increased sweating, night sweats, alopecia, 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 concentration of proteins in urine), reduced kidney function, urinary tract infection

• chest pain, chest discomfort

• gallstones or stones in the bile ducts (cholelithiasis)

• increased levels of thyroid-stimulating hormone (TSH) in blood

• changes in blood biochemistry or in the number of blood cells or platelets (abnormal blood test results)

• kidney stones

• erectile dysfunction

• decreased activity of the thyroid gland

• blurred vision, vision changes

• ringing in the ears

• runny nose

• mouth ulcers

• pancreatitis: common symptoms are abdominal pain, nausea and vomiting

• urgent need to urinate

• pain

• malaise

• increased INR

• bruising

• lip swelling

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

• muscle damage, which in rare cases may be severe. It may cause muscle problems and, particularly if you also feel unwell or have a high fever, may be due to abnormal muscle breakdown. Contact your doctor immediately if you experience muscle pain, tenderness or weakness
• severe swelling of deeper layers of the skin, especially around the eyes, genitals, hands, feet or tongue, which may cause sudden breathing difficulties
• high fever accompanied by measles-like rash, swollen lymph nodes, enlarged liver, hepatitis (including liver failure), increased number of white blood cells in blood (leukocytosis, with or without eosinophilia)
• various types of rash (e.g. with white spots, blisters, pus-filled blisters, skin peeling, measles-like rash), generalized erythema, necrosis, blistering detachment of the skin and mucous membranes, leading to exfoliation and possible sepsis (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• restlessness
• sensation of thirst
• weight loss, increased appetite, uncontrolled loss of appetite (anorexia)
• muscle and/or joint stiffness
• abnormal blood cell count (white cells, red cells or platelets)
• changes or decreased urine volume due to kidney inflammation (tubulo-interstitial nephritis)
• liver inflammation (hepatitis)
• yellowing of the skin (jaundice)
• bladder 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 failure
• lung infection (pneumonia)
• mouth sores; mouth inflammation
• gastrointestinal perforation
• rotator cuff syndrome
• polymyalgia rheumatica
• sensation of warmth
• sudden loss of vision due to blockage of an artery in the eye

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gotaric

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

Do not use this medicine after the expiry date stated on the cardboard box and on the blister after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and medicines you no longer need at a pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of unused containers and medicines. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Gotaric

The active substance 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 contents of the pack

Gotaric 80 mg film-coated tablets are yellow, 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 transparent Aclar/PVC/Aluminum blisters.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Especialidades Farmacéuticas Centrum, S.A.

C/ Sagitario, 14

03006 Alicante (Spain)

Grupo Asacpharma

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 European Economic Area member states under the following names:

Netherlands: Febuxostat Vivanta 80 mg filmomhulde tabletten

Germany: Febuxostat Vivanta 80 mg Filmtabletten

Spain: Gotaric 80 mg film-coated tablets EFG

Date of the most recent review 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)