Febuxostat Normon 80 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Febuxostat Normon 80 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 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 adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions 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, a condition 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 in the 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 helps prevent 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 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 swollen lymph nodes.
• Also severe allergic reactions that may be life-threatening, associated with cardio-circulatory 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 reddish target-like spots or circular lesions often with a blister in the center. It may also include mouth ulcers, throat, nose, genitals, and conjunctivitis (red and swollen eyes). The rash may progress to widespread blisters or skin peeling.

If you have developed Stevens-Johnson syndrome while taking febuxostat, you must never restart this 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 experience a gout attack (sudden, intense 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 gout attacks when starting certain medicines that control uric acid levels. Not everyone experiences these attacks, 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 during a gout attack, as the medicine continues to work to reduce uric acid. With daily use of febuxostat, gout attacks will become less frequent and less painful over time.

If needed, your doctor may 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. 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 that you inform your doctor or pharmacist if you are taking medicines containing any of the following active 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 must 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 use of machines

Please note that you may experience dizziness, drowsiness, blurred vision, numbness, or tingling sensations during treatment. If you experience any of these symptoms, you must 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/her 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 taking your dose every day.
• 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 attack or flare-up of gout.

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

Febuxostat is available as 120 mg tablets.

Start taking febuxostat two days before chemotherapy and continue using 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 immediately at telephone number: 91 562 04 20, stating 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 the 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 your doctor tells you to. 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 can cause adverse 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 adverse effects (may affect up to 1 in 1,000 people), as you may be experiencing a severe allergic reaction:

• Anaphylactic reactions, hypersensitivity to the medicine (see also section 2 “Warnings and precautions”).
• Life-threatening skin rashes characterized by blistering and peeling of the skin and mucous membranes, for example in 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 swollen lymph nodes, enlarged liver, hepatitis (including liver failure), increased number of white blood cells (leukocytes) in the blood (drug reaction with eosinophilia and systemic symptoms—DRESS syndrome) (see section 2).
• Generalized skin rashes.

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

• 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 listed above are included below.

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

• Decreased appetite, changes 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).
• Abnormal ECG (electrocardiogram), irregular or rapid heartbeat, awareness of heartbeats (palpitations).
• Hot flushes or flushing (redness of the face or neck), increased blood pressure, bleeding (hemorrhage, observed only in patients receiving chemotherapy for blood disorders).
• Cough, chest discomfort or pain, inflammation of the 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, increased sweating, night sweats, alopecia, skin redness (erythema), psoriasis, eczema, skin rashes with small interconnected bumps, rash, bumps and spots on the skin, other skin changes.
• 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 bile duct stones (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 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.
• Malaise.
• Increased INR.
• Bruising.
• Swelling of the lips.

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

• Muscle damage, which in rare cases may be severe. This 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 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 measles-like rash, swollen lymph nodes, enlarged liver (including liver failure), increased number of white blood cells in blood (leukocytosis, with or without eosinophilia).
• Erythema, different types of rashes (e.g., with white spots, with blisters, with pus-filled blisters, with skin peeling, measles-like rash), generalized erythema, necrosis, blistering and 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 volume due to kidney inflammation (tubulointerstitial nephritis).
• Inflammation of the liver (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; inflammation of the mouth.
• Gastrointestinal perforation.
• Rotator cuff syndrome.
• Polymyalgia rheumatica.
• Feeling 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 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 containers and unused medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. 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 80 mg film-coated tablets EFG: Each tablet contains 80 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 80 mg film-coated tablets EFG: biconvex, pale yellow to yellow, oblong film-coated tablets, embossed with "80" on one side and smooth on the other.

Febuxostat Normon 80 mg film-coated tablets EFG: packed in PVC/PCTFE/Aluminum or PVC/PE/PVDC/Aluminum blisters.

Febuxostat Normon 80 mg film-coated tablets EFG: available in packs of 14, 28, 42, 56, 84 and 98 film-coated tablets.

Only certain 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 revision of this leaflet: February 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/