Febuxostat Normon 120 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Febuxostat Normon 120 mg film-coated tablets EFG

febuxostat

Read the entire leaflet carefully before you start taking this medicine, because 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 must not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Febuxostat Normon is and what it is used for
2. What you need to know before taking Febuxostat Normon
3. How to take Febuxostat Normon
4. Possible side effects
5. How to store Febuxostat Normon
6. Contents of the pack and other information

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

Febuxostat 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, warmth, and swelling in the joints (this is known as gout attacks). If left untreated, large deposits called tophi may form around and within the joints. Tophi can damage joints and bones.

Febuxostat 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.

Febuxostat 120 mg tablets are also used for the treatment and prevention of high levels of uric acid in the blood that may occur when starting chemotherapy for the treatment of blood cell cancers.

When chemotherapy is administered, cancer cells are destroyed, leading to an increase in blood uric acid levels unless its formation is prevented.

Febuxostat is for use in adults.

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

Do not take Febuxostat:

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

Warnings and precautions

Talk to 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 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 febuxostat, 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 enlarged lymph nodes.
• Also severe allergic reactions which may be life-threatening, associated with cardiac arrest.

Your doctor may decide to permanently discontinue treatment with febuxostat.

Rare cases of life-threatening skin rashes (Stevens-Johnson Syndrome) have been reported with the use of febuxostat, initially appearing on the trunk as red target-like spots or circular patches, often with a blister in the center. It may also include mouth, throat, nose, or genital ulcers and conjunctivitis (red, swollen eyes). The rash may progress to widespread blistering or skin peeling.

If you have developed Stevens-Johnson Syndrome while taking 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 are experiencing a gout flare (sudden, intense pain accompanied by tenderness, redness, warmth, and swelling in a joint), wait until the flare subsides before starting treatment with febuxostat.

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

If needed, your doctor may prescribe other medicines to prevent or treat flare symptoms (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. However, 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 properly.

Children and adolescents

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

Use of Febuxostat Normon 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 substances, as they may interact with febuxostat, 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 febuxostat may harm the fetus. Febuxostat should not be used during pregnancy. It is not known whether febuxostat passes into breast milk. Do not use febuxostat 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, or numbness or tingling sensations during treatment. If this occurs, you should not drive or operate machinery.

Febuxostat Normon contains lactose

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

Febuxostat Normon contains sodium

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

3. How to take Febuxostat Normon

Follow exactly the instructions for use of this medicine as given by your doctor. If in 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 keep track of whether you have taken your daily dose.
• The tablets are taken orally, with or without food.

Gout

Febuxostat is available as film-coated tablets of 80 mg and 120 mg. Your doctor will prescribe the most appropriate dose for you.

Continue taking Febuxostat every day, even if you are no longer experiencing an acute gout attack.

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

Febuxostat is available as 120 mg tablets.

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

If you take more Febuxostat than you should

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

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

If you stop taking Febuxostat

Even if you feel better, do not stop taking febuxostat unless instructed by your doctor. If you stop taking febuxostat, 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 may 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 about to experience a severe allergic reaction:

• Anaphylactic reactions, hypersensitivity to the medicine (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 (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, enlarged liver, hepatitis (including liver failure), increased number of white blood cells (leukocytes) in blood (drug reaction with eosinophilia and systemic symptoms—DRESS syndrome) (see section 2).
• Widespread skin rashes.

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

• Abnormal results in liver function tests.
• 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 listed above are included below.

The uncommon adverse effects (may affect up to 1 in 100 people) are the following:

• 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 abnormalities (electrocardiogram), irregular or rapid heartbeat, awareness of heartbeat (palpitations).
• Hot flushes or flushing (reddening of face or neck), increased blood pressure, bleeding (hemorrhage, observed only in patients receiving chemotherapy for blood disorders).
• Cough, chest discomfort or pain, inflammation of nasal passages and/or throat (upper respiratory tract infection), bronchitis, lower respiratory tract infection.
• Dry mouth, abdominal pain or discomfort or gas, upper abdominal pain, 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 skin bumps, skin rashes with interconnected small bumps, rash, hives, and skin spots, 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 protein in urine), reduced kidney function, urinary tract infection.
• Chest pain, chest discomfort.
• Gallstones or stones in 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, 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.
• Malaise.
• Increased INR.
• Bruising.
• Swelling of the lips.

The rare adverse effects (may affect up to 1 in 1,000 people) are the following:

• 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 difficulty breathing.
• High fever accompanied by measles-like rash, swollen lymph nodes, enlarged liver (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 peeling of the skin and mucous membranes, leading to exfoliation and possible sepsis (Stevens-Johnson syndrome/toxic epidermal necrolysis).
• Restlessness.
• Feeling 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 output due to kidney inflammation (tubulointerstitial 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.
• Feeling of warmth.
• Sudden loss of vision due to blockage of an eye artery.

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 may 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 Febuxostat Normon

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 refers to 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 unused medicines and their packaging at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Febuxostat Normon

The active substance 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, hydroxypropylcellulose, sodium croscarmellose, anhydrous lactose, colloidal anhydrous 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 contents of the pack

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

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

LABORATORIOS NORMON, S.A.

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

Manufacturer:

Genepharm S.A

18 km Marathonos Avenue,

153 51 Pallini Attiki

Greece

Or

LABORATORIOS NORMON, S.A.

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

Date of the most recent review of this summary: January 2025

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