Febuxostat Msn

Leaflet accompanying the packaging: patient information

Febuxostat MSN, 80 mg, film-coated tablets

Febuxostat MSN, 120 mg, film-coated tablets

Febuxostat

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Febuxostat MSN and what is it used for
• 2. Important information before taking Febuxostat MSN
• 3. How to take Febuxostat MSN
• 4. Possible side effects
• 5. How to store Febuxostat MSN
• 6. Contents of the packaging and other information

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

This medicine contains the active substance febuxostat and is used to treat gout, a disease related to an excess of a chemical compound called uric acid (urate) in the body. In some people, the amount of uric acid in the blood increases and can become too high for the compound to dissolve. In such cases, urate crystals may form inside and around the joints and kidneys. The resulting crystals can cause sudden, severe pain, redness, warmth, and swelling of the joint (known as a gout attack). If the disease is left untreated, larger deposits called tophi may form inside and around the joints. Tophi can cause joint and bone damage.
Febuxostat MSN works by reducing uric acid levels. Maintaining low uric acid levels by taking Febuxostat MSN once a day prevents the formation of crystals and, over time, reduces symptoms. Maintaining sufficiently low uric acid levels for a long enough period may also lead to a reduction in tophi.
Febuxostat MSN, 120 mg, film-coated tablets are also used to treat and prevent high uric acid levels in the blood that may occur when starting chemotherapy for blood cancer.
When chemotherapy is administered, cancer cells are destroyed, and uric acid levels in the blood increase accordingly, unless uric acid formation is prevented.
Febuxostat MSN is intended for use in adults.

2. Important information before taking Febuxostat MSN

When not to take Febuxostat MSN

• if the patient is allergic to febuxostat or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Febuxostat MSN, consult your doctor:

• if the patient has or has had heart failure or heart problems or a stroke;
• if the patient has or has had kidney disease and (or) severe allergic reactions to allopurinol (a medicine used to treat gout);
• if the patient has or has had liver disease or abnormal liver function test results;
• if the patient is 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 the patient has thyroid disease.

In case of an allergic reaction to Febuxostat MSN, stop taking the medicine immediately (see section 4).
Possible symptoms of an allergic reaction are:

• rash, including severe forms of rash (e.g., blisters, nodules, itching, flaking rash), itching;
• swelling of limbs or face;
• breathing difficulties;
• fever and swollen lymph nodes;
• severe, life-threatening allergic reactions with cardiac arrest and circulatory collapse. The doctor may decide to permanently discontinue treatment with Febuxostat MSN.

There have been rare reports of potentially life-threatening skin rashes (Stevens-Johnson syndrome) during treatment with Febuxostat MSN, initially presenting as red, concentric patches or circular patches often with blisters on the trunk. Symptoms may also include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (redness and swelling around the eyes). The rash may progress, becoming blisters and causing peeling and separation of the skin.
In case of Stevens-Johnson syndrome during treatment with Febuxostat MSN, treatment with febuxostat should never be restarted. In case of rash or the mentioned skin symptoms, immediately contact a doctor and inform them about taking this medicine.
If the patient experiences a gout attack (sudden onset of severe pain, tenderness, redness, warmth, and swelling of the joint), wait until the attack has subsided before starting treatment with Febuxostat MSN.
In some people, gout attacks may worsen when starting treatment with certain uric acid-lowering medicines. Worsening may not occur in everyone, but it may occur, even if the patient is taking Febuxostat MSN, especially during the first few weeks or months of treatment. It is essential to continue taking Febuxostat MSN, even if the patient experiences worsening, as Febuxostat MSN still reduces uric acid levels. Over time, gout attacks will become less frequent and less painful if Febuxostat MSN is taken daily.
The doctor often prescribes other medicines if necessary to help prevent or treat symptoms of worsening (such as joint pain and swelling).
In patients with very high uric acid levels (e.g., those undergoing chemotherapy for blood diseases), treatment with uric acid-lowering medicines may lead to the accumulation of xanthine in the urinary tract, with the possibility of stone formation, although this has not been observed in patients treated with Febuxostat MSN due to tumor lysis syndrome.
The doctor may order blood tests to check if liver function is normal.

Children and adolescents

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

Febuxostat MSN and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
It is particularly important to inform your doctor or pharmacist if you are taking medicines containing any of the following substances, as they may interact with Febuxostat MSN, and your doctor may need to take necessary measures:

• mercaptopurine (used to treat cancer),
• azathioprine (used to reduce the immune system response),
• theophylline (used to treat asthma).

Pregnancy and breastfeeding

It is not known if Febuxostat MSN can harm an unborn baby. Febuxostat MSN should not be used during pregnancy. It is not known if Febuxostat MSN can pass into breast milk. Do not use Febuxostat MSN if you are breastfeeding or plan to breastfeed.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Be aware that dizziness, drowsiness, blurred vision, and numbness or tingling may occur during treatment. If you experience these symptoms, do not drive or operate machinery.

Febuxostat MSN contains lactose and sodium

Febuxostat MSN contains lactose. If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Febuxostat MSN

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

• The usual 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 your daily dose.
• Take the tablets orally; you can take the medicine with or without food.

Gout
Febuxostat MSN is available as 80 mg and 120 mg tablets. Your doctor will prescribe the most suitable dose for you.
Take Febuxostat MSN every day, even if you do not experience a gout attack or worsening.
Prevention and treatment of high uric acid levels in patients undergoing chemotherapy for cancer
Febuxostat MSN is available as 120 mg tablets.
Start taking Febuxostat MSN two days before chemotherapy and continue as directed by your doctor. Treatment is usually short-term.

Taking a higher dose of Febuxostat MSN than recommended

In case of accidental overdose, ask your doctor for advice or contact the nearest hospital emergency department.

Missing a dose of Febuxostat MSN

If you miss a dose of Febuxostat MSN, take it as soon as you remember, unless it is close to the time for your next dose, in which 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 dose.

Stopping treatment with Febuxostat MSN

Do not stop taking Febuxostat MSN without consulting your doctor, even if you feel better. Stopping treatment with Febuxostat MSN may cause uric acid levels to rise again, and symptoms may worsen due to the formation of new urate crystals around or in the joints and kidneys.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking the medicine and contact your doctor or go to the nearest emergency department immediately if you experience the following rare (occurring in 1 in 1,000 patients) side effects, as they may lead to severe allergic reactions:

• anaphylactic reactions, hypersensitivity to the medicine (see also section 2 "Warnings and precautions");
• potentially life-threatening skin rashes characterized by blistering and peeling of the skin and internal surfaces, such as the mouth and genitals, painful ulcers in the mouth and (or) genitals with fever, sore throat, and fatigue (Stevens-Johnson syndrome, toxic epidermal necrolysis) or swollen lymph nodes, liver enlargement, hepatitis (leading to liver failure), increased white blood cell count (drug reaction with eosinophilia and systemic symptoms, DRESS) (see section 2);
• generalized skin rashes.

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

• abnormal liver test results,
• diarrhea,
• headache,
• rash (including various types of rash, see below "uncommon" and "rare"),
• nausea,
• worsening of gout symptoms,
• localized swelling due to fluid accumulation in tissues (edema),
• dizziness,
• shortness of breath,
• itching,
• limb pain, muscle pain, or joint pain,
• fatigue.

The following are other side effects not listed above.
Uncommon side effects(may affect up to 1 in 100 people):

• decreased appetite, changed blood sugar levels (diabetes), which may cause excessive thirst, increased blood fat levels, weight gain;
• decreased libido;
• sleep disturbances, drowsiness;
• numbness, tingling, weakness, or altered sensation (hypoesthesia, paresis, or paresthesia), taste disturbances, decreased sense of smell (hyposmia);
• abnormal ECG, irregular or rapid heartbeat, palpitations;
• hot flashes or flushing of the skin (e.g., facial flushing), increased blood pressure, bleeding (hemorrhage, observed only in patients undergoing chemotherapy for blood diseases);
• cough, discomfort or pain in the chest, nasal congestion or throat infection (upper respiratory tract infection), bronchitis, lower respiratory tract infection;
• dry mouth, abdominal pain or discomfort, gas, upper abdominal pain, heartburn or indigestion, constipation, frequent bowel movements, vomiting, abdominal discomfort;
• itchy rash, hives, skin inflammation, skin discoloration, small, red or purple spots on the skin, small, flat red spots on the skin, flat, red areas on the skin with small bumps, rash, localized redness and spots on the skin, excessive sweating, night sweats, hair loss, skin redness (erythema), psoriasis, eczema, other skin disorders;
• muscle spasms, muscle weakness, bursitis or tendonitis (arthritis, usually accompanied by pain, swelling, and (or) stiffness), back pain, muscle cramps, muscle stiffness and (or) joint stiffness;
• blood in urine, abnormal frequent urination, abnormal urine test results (increased protein in urine), kidney function disorders, urinary tract infections;
• chest pain, discomfort in the chest;
• gallstones or bile duct stones (cholelithiasis);
• increased thyroid-stimulating hormone (TSH) levels;
• changes in blood chemistry or blood cell count (abnormal blood test results);
• kidney stones;
• erectile dysfunction;
• hypothyroidism;
• blurred vision, changed vision;
• ringing in the ears;
• runny nose;
• mouth ulcers;
• pancreatitis: common symptoms include abdominal pain, nausea, and vomiting;
• sudden urge to urinate;
• pain;
• malaise;
• increased INR;
• injury;
• lip swelling.

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

• muscle damage, a condition that can be severe in isolated cases. Muscle disorders may occur, with associated malaise or high fever, caused by muscle damage. Contact your doctor immediately if you experience muscle pain, tenderness, or weakness;
• severe swelling of the deep layers of the skin, particularly around the eyes, genitals, hands, feet, or tongue, with possible sudden breathing difficulties;
• high fever with a rash, swollen lymph nodes, liver enlargement, hepatitis (leading to liver failure), increased white blood cell count (leukocytosis with or without eosinophilia);
• rashes of various types (e.g., with white spots, blisters, pus-filled blisters, peeling skin, rash), generalized redness, necrosis, blisters on the skin and mucous membranes causing them to peel and possibly leading to sepsis (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• nervousness;
• thirst;
• weight loss, increased appetite, uncontrolled loss of appetite (anorexia);
• abnormal blood cell count (low white or red blood cell or platelet count);
• changes in urine or decreased urine output related to kidney inflammation (interstitial nephritis);
• hepatitis;
• jaundice;
• urinary tract infection;
• liver damage;
• increased creatine phosphokinase activity in the blood (a marker of muscle damage);
• sudden cardiac death;
• low red blood cell count (anemia);
• depression;
• sleep disturbances;
• loss of smell;
• burning sensation;
• vertigo of labyrinthine origin;
• circulatory collapse;
• lung infection (pneumonia);
• mouth ulcers; oral inflammation;
• perforation of the digestive tract;
• rotator cuff syndrome;
• polymyalgia rheumatica;
• feeling of heat;
• sudden loss of vision due to blockage of an artery in the eye.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Febuxostat MSN

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Expiry date" or "EXP". The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Febuxostat MSN contains

The active substance is febuxostat.
Each film-coated tablet contains 80 mg or 120 mg of febuxostat (as febuxostat hemihydrate).
The other ingredients are:
Core: microcrystalline cellulose (PH 101), lactose monohydrate, sodium croscarmellose, hydroxypropyl cellulose, colloidal silicon dioxide, magnesium stearate.
Coating (Opadry II Yellow 85F42129): polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172).

What Febuxostat MSN looks like and contents of the pack

Febuxostat MSN, 80 mg, film-coated tablets
Yellow, capsule-shaped (approximately 17 mm long and 6 mm wide), biconvex (approximately 5 mm thick) film-coated tablets with "80" embossed on one side and smooth on the other.
Febuxostat MSN, 120 mg, film-coated tablets
Yellow, capsule-shaped (approximately 19 mm long and 8 mm wide), biconvex (approximately 6 mm thick) film-coated tablets with "120" embossed on one side and smooth on the other.
Febuxostat MSN 80 mg and 120 mg are packaged in transparent blisters (Aclar/PVC/Aluminum) in cardboard boxes.
Febuxostat MSN 80 mg and 120 mg are available in packs of 14, 28, 42, 56, 84, and 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Vivanta Generics s.r.o.
Třtinová 260/1, Čakovice
196 00 Prague 9
Czech Republic

Importer:

WESSLING Hungary Kft.
Anonymus utca 6.
1045 Budapest
Hungary
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA3000
Malta

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

Czech Republic:
Febuxostat MSN
Hungary
Febuxostat MSN
Netherlands
Febuxostat MSN 80 mg/120 mg filmomhulde tabletten
Poland
Febuxostat MSN
Romania
Febuxostat MSN 80 mg comprimate filmate
Febuxostat MSN 120 mg comprimate filmate
Slovakia
Febuxostát MSN 80 mg
Febuxostát MSN 120 mg

Date of last revision of the leaflet: 07/2022