FEBUXOSTAT MABO 80 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for theuser

Febuxostat MABO 80 mg film-coated tablets EFG.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

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

5 Conservation of Febuxostat MABO

1. Contents of the pack and further information

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

Febuxostat MABO tablets contain the active substance febuxostat and are 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 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 (this is 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.

Febuxostat MABO works by reducing the concentration of uric acid. Keeping uric acid levels low by taking Febuxostat MABO once a day prevents the formation of crystals and, over time, reduces symptoms. If uric acid levels are kept low for long enough, the size of the tophi also decreases.

2. What you need to know before you take Febuxostat MABO

Do not take Febuxostat MABO

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

Warnings and precautions

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

• if you have or have had heart failure or other heart problems
• 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 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 Febuxostat MABO, stop taking this medicine (see also section 4). Possible symptoms of allergic reactions could be:

• rash including severe forms (e.g. blisters, nodules, exfoliative rashes that cause itching), itching
• swelling of limbs or face
• difficulty breathing
• fever with enlarged lymph nodes
• also severe allergic reactions that can put your life at risk, associated with cardio-circulatory arrest.

Your doctor may decide to permanently discontinue treatment with Febuxostat MABO.

Rare cases of skin rashes that can put your life at risk (Stevens-Johnson Syndrome) have been reported with the use of febuxostat, initially appearing on the trunk as reddish spots in the shape of a target 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 medicine.

If you suffer a gout attack (severe pain that starts suddenly accompanied by sensitivity, redness, heat, and swelling of a joint), wait for the attack to subside before starting treatment with Febuxostat MABO.

Some people may suffer a gout attack when starting certain medications that control uric acid levels. Not everyone suffers these attacks, but they can occur even while taking Febuxostat MABO, especially during the first weeks or months of treatment. It is essential to continue taking Febuxostat MABO even if you suffer a gout attack, as this medicine continues to work to reduce uric acid. If you continue to take Febuxostat MABO 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 decrease uric acid could 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 febuxostat for Tumor Lysis Syndrome.

Your doctor may perform blood tests to check that your liver is working normally.

Children and adolescents

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

Using Febuxostat MABO with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

It is especially important that you inform your doctor or pharmacist if you are using medicines that contain any of the following substances, as they may interact with Febuxostat MABO, 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 MABO can harm the fetus. Febuxostat MABO should not be used during pregnancy. It is not known if Febuxostat MABO passes into breast milk. Do not use Febuxostat MABO 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 medicine.

Driving and using machines

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

Febuxostat MABO contains lactose

Febuxostat MABO tablets contain lactose (a type of sugar). If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Febuxostat MABO contains sodium

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

3. How to take Febuxostat MABO

Follow the instructions for administration of this medicine exactly 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.
• Tablets are taken orally, with or without food.

Febuxostat MABO is available in 80 mg tablets. Your doctor will prescribe the most suitable dose.

Continue taking Febuxostat MABO every day, even if you no longer have gout attacks.

If you take more Febuxostat MABO than you should

In case of accidental overdose, consult your doctor or go to the nearest emergency center.

If you forget to take Febuxostat MABO

If you forget a dose of Febuxostat MABO, 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 Febuxostat MABO

Even if you feel better, do not stop taking Febuxostat MABO unless your doctor tells you to. If you stop taking Febuxostat MABO, 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 1000 people), as you may experience a severe allergic reaction:

• anaphylactic reactions, hypersensitivity to the medicine (see also section 2 "Warnings and precautions")
• skin rashes that can put your life at risk, characterized by the formation of blisters 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 enlarged lymph nodes, liver enlargement, hepatitis (including liver failure), increased white blood cell count in blood (hypersensitivity to medicines with eosinophilia and systemic symptoms - DRESS syndrome) (see section 2)
• generalized skin rashes

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

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)

Other side effects not mentioned above are included below.

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

• decreased appetite, change in blood sugar levels (diabetes) whose symptom may be excessive thirst, increased blood fats, weight gain
• decreased sexual desire
• difficulty sleeping, drowsiness
• dizziness, numbness, tingling, decreased or altered sensitivity (hypoesthesia, hemiparesis, or paresthesia), altered or decreased sense of taste (hypogeusia)
• 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, breathing difficulties, discomfort or pain in the chest, inflammation of the nasal passages and/or throat (upper respiratory tract infection), bronchitis
• dry mouth, abdominal pain or discomfort, gas, heartburn or indigestion, constipation, more frequent bowel movements, vomiting, stomach upset
• itching, hives, skin inflammation or discoloration, small red or purple spots on the skin, small bumps on the skin, skin rash covered with small interconnected bumps, rash, hives, and spots on the skin, other skin disorders
• muscle cramps, muscle weakness, muscle and joint pain, bursitis or arthritis (joint inflammation, usually accompanied by pain, swelling, or stiffness), pain in the limbs, back pain, muscle spasms
• blood in urine, abnormally frequent urination, abnormal urine tests (increased protein concentration in urine), reduced kidney function
• fatigue, chest pain, chest discomfort
• gallstones or bile duct stones (cholelithiasis)
• increased levels of thyroid-stimulating hormone (TSH) in blood
• changes in blood biochemistry or blood cell count or platelets (abnormal blood test results)
• kidney stones
• difficulty getting an erection

Rare side effects(may affect up to 1 in 1000 people) are:

• muscle damage, which can rarely be severe. It can cause muscle problems and, in particular, if you also feel unwell or have a high fever, it can be due to abnormal muscle breakdown. Contact your doctor immediately if you experience muscle pain, sensitivity, or weakness
• severe swelling of the deep layers of the skin, especially the skin around the lips, eyes, genitals, hands, feet, or tongue, which can cause sudden difficulty breathing
• high fever accompanied by a rash similar to measles, enlarged lymph nodes, liver enlargement (including liver failure), increased white blood cell count in blood (leukocytosis, 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 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)
• nervousness
• feeling of thirst
• ringing in the ears
• blurred vision, changes in vision
• hair loss
• mouth ulcers
• pancreatitis: common symptoms are abdominal pain, nausea, and vomiting
• increased sweating
• weight loss, increased appetite, uncontrolled loss of appetite (anorexia)
• muscle and joint stiffness
• abnormal blood cell count (white blood cells, red blood cells, or platelets)
• urgent need to urinate
• changes or decrease in urine volume due to kidney inflammation (interstitial nephritis)
• liver inflammation (hepatitis)
• yellowish skin (jaundice)
• liver damage
• increase in creatine phosphokinase levels in blood (an indicator of muscle damage)

If you experience any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system included in Annex V.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Febuxostat MABO

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.
• This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Febuxostat MABO

The active substance is febuxostat.

Each tablet contains 80 mg of febuxostat, equivalent to 82.28 mg of febuxostat hemihydrate.

The other ingredients are:

Tablet core:lactose monohydrate, microcrystalline cellulose (E460), magnesium stearate (E470b), hydroxypropylcellulose (E463), croscarmellose sodium, anhydrous colloidal silica (E551).

Tablet coating:polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350, talc (E553b), yellow iron oxide (E172), methacrylic acid - ethyl acrylate copolymer (1:1) (type A), sodium hydrogen carbonate (E500(ii)).

Appearance of the product and pack contents

Light yellow or yellow, film-coated tablets, capsule-shaped, with the number "80" engraved on one face and smooth on the other, with dimensions 16.5 mm x 7.0 mm ± 5%.

Febuxostat MABO 80 mg is available in Aluminio-OPA/Alu/PVC or Aluminio-PVC/PE/PVDC blisters.

Febuxostat MABO 80 mg is available in packs of 14, 28, 45, 56, 84, and 98 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

MABO-FARMA S.A.

Calle Rejas 2. Planta 1.

28821 Coslada (Madrid)

Spain

Manufacturer:

Rontis Hellas Medical and Pharmaceutical Products S.A

P.O. Box 3012 Larisa

41004, Greece

or

PharOS MT Ltd

HF 62X, Hal-Far Industrial Estate,

Birzebbugia BBG 3000,

Malta

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

Spain:Febuxostat MABO 80mg film-coated tablets EFG

Malta:Febuxostat PharOS 80mg film-coated tablets

Date of last revision of this leaflet: November 2021