Prospect: information for the user

Febuxostat Normon 120 mg film-coated tablets EFG

febuxostat

Read this prospect carefully before starting to take this medicine, as 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 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

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

3. How to take Febuxostat Normon

4. Possible adverse effects

5. Storage of Febuxostat Normon

6. Contents of the pack and additional information

Febuxostat 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 a 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.

Febuxostat acts 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 tophi also decreases.

Febuxostat 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.

Febuxostat is for adults..

Do not take Febuxostat:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Febuxostat Normon:

• 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 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 an allergic reaction to febuxostat, stop taking this medication (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 febuxostat.

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 mouth ulcers, throat, nose, genital, 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 medication.

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 febuxostat, especially during the first weeks or months of treatment. It is essential to continue taking febuxostat daily, as this medication continues to act to reduce uric acid levels. If you continue to take febuxostat, gout attacks will become less frequent and less painful.

If necessary, your doctor will prescribe other medications 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 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 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 medication to children under 18 years of age, as the safety and efficacy have not been established.

Use of Febuxostat Normon with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use 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 febuxostat, 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 febuxostat can harm the fetus. Febuxostat should not be used during pregnancy. It is not known if febuxostat passes into breast milk. Do not use febuxostat 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 medication.

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.

Febuxostat Normon contains lactose

Febuxostat Normon 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 medication.

Febuxostat Normon contains sodium

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

Follow exactly the administration instructions of 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

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

Continue taking Febuxostat every day, even if you no longer have a flare-up or an attack of gout.

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

Febuxostat is available in 120 mg tablets.

Start taking febuxostat two days before chemotherapy and continue using it as indicated by your doctor. In general, the treatment is of short duration.

If you take more Febuxostat 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 Febuxostat

If you forget a dose of febuxostat, 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

Although you may be feeling better, do not stop taking febuxostat, unless your doctor tells you to. If you stop taking febuxostat, your uric acid levels 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 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 insufficiency), 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
• Rash (including various types of rash, see below the 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.

Theinfrequent side effects(may affect up to 1 in 100 people) are as follows:

• 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, drowsiness
• Dizziness, 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 (flushing of the face or neck), increased tension, 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, or gas, heartburn or indigestion, constipation, frequent bowel movements, vomiting, abdominal discomfort
• 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, rash, rashes, and spots on the skin, other skin alterations
• Muscle cramps, muscle weakness, muscle pain, and joint pain, bursitis or arthritis (inflammation of the joints, usually accompanied by pain, swelling, or stiffness), limb pain, 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 biochemistry or blood cell count abnormalities (anomalous results in blood analysis)
• Stones in the kidney
• Erectile dysfunction

Therare side effects(may affect up to 1 in 1,000 people) are as follows:

• Muscle damage, which in rare cases can be severe. It may cause muscle problems and particularly, if you are unwell or have 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 lips, eyes, genitals, hands, feet, or tongue, which may cause sudden difficulty breathing
• High fever accompanied by rash similar to measles, swollen lymph nodes, enlarged liver, hepatitis (including liver insufficiency), increased white blood cell count (leucocytosis, with or without eosinophilia)
• Redness of the skin (erythema), different types of rash (e.g. itching, with white spots, with blisters, with pus-filled blisters, with peeling 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
• Mouth ulcers
• Pancreatitis: common symptoms include 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)
• Sudden cardiac death

Reporting of side effects

If you experience any type of side effect, consult your doctoror 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.

Keepthis medicationout 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 SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Febuxostat Normon

The active ingredient is febuxostat.

Febuxostat Normon 120 mg film-coated tablets EFG: Each tablet contains 120 mg of febuxostat.

The other components are:

Tablet core:Lactose monohydrate, microcrystalline cellulose, magnesium stearate, hydroxypropyl cellulose, croscarmellose sodium, anhydrous lactose, anhydrous colloidal silica, sodium lauryl sulfate.

Tablet coating:poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide (E172)

Appearance of the product and content of the container

Febuxostat Normon 120 mg film-coated tablets EFG: film-coated biconvex tablets, pale yellow to yellow, oblong, embossed with "120" on one side and smooth on the other.

Febuxostat Normon 120 mg film-coated tablets EFG: packaged in blisters of PVC / PCTFE / Aluminum or PVC / PE / PVDC / Aluminum.

Febuxostat Normon 120 mg film-coated tablets EFG: marketed in containers of 14, 28, 42, 56, 84 and 98 film-coated tablets.

Only some container sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6. 28760 Tres Cantos, Madrid (Spain)

Responsible for manufacturing:

Genepharm S.A

18 km Marathonos Avenue,

153 51 Pallini Attiki

Greece

Ó

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6. 28760 Tres Cantos, Madrid(Spain)

Last review date of this leaflet:February 2022

Other sources of information

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/