Febuxostat msn

Package leaflet: Information for the patient

Febuxostat MSN, 80 mg, coated tablets
Febuxostat MSN, 120 mg, coated tablets
Febuxostatum
Please read carefully all the information in this leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Febuxostat MSN is and what it is 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 pack and other information

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

This medicine contains the active substance febuxostat and is used in the treatment of gout, a disease associated with 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 may become too high for the compound to remain dissolved. In such cases, urate crystals may form inside and around joints and in the kidneys. These crystals can cause sudden, severe pain, redness, warmth, and swelling of a 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 the concentration of uric acid. Maintaining a low uric acid level by taking Febuxostat MSN once daily prevents further crystal deposition 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 tablets, is also used to treat and prevent high levels of uric acid in the blood that may occur when starting chemotherapy for blood cancer. During chemotherapy, cancer cells are destroyed, leading to a rise in uric acid levels in the blood unless uric acid formation is prevented.
Febuxostat MSN is intended for use in adults.

2. Important information before taking Febuxostat MSN

When not to use Febuxostat MSN

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

Warnings and precautions
Before starting Febuxostat MSN, consult your doctor:

• if you have or have had heart failure or 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 abnormal liver function test results;
• if you are being treated for high uric acid levels due to Lesch-Nyhan syndrome (a rare inherited disorder with excessive uric acid in the blood);
• if you have a thyroid disorder.

If you experience an allergic reaction to Febuxostat MSN, stop taking the medicine immediately (see section 4).
Possible symptoms of an allergic reaction include:

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

Rare cases of potentially life-threatening skin rashes (Stevens-Johnson syndrome) have been reported during treatment with Febuxostat MSN, initially presenting as reddish, concentric or circular spots, often with blisters, typically on the trunk. Symptoms may also include ulceration of the mouth, throat, nose, genital organs, and conjunctivitis (redness and swelling around the eyes). The rash may progress to blistering and cause peeling and detachment of the outer layer of skin.
If Stevens-Johnson syndrome occurs during treatment with Febuxostat MSN, febuxostat must never be restarted. If you develop a rash or any of the mentioned skin symptoms, contact your doctor immediately and inform them that you are taking this medicine.
If you are experiencing a gout attack (sudden onset of severe pain, tenderness, redness, warmth, and swelling of a joint), wait until the attack subsides before starting treatment with Febuxostat MSN.
In some people, gout attacks may worsen when starting treatment with certain medicines that control uric acid levels. Flares do not occur in everyone, but they may occur even while taking Febuxostat MSN, especially during the first weeks or months of treatment. It is important to continue taking Febuxostat MSN even if you experience a flare, as Febuxostat MSN continues to reduce uric acid levels. Over time, gout attacks will become less frequent and less painful if Febuxostat MSN is taken daily.
Your doctor may prescribe additional medicines, if necessary, to help prevent or treat flare symptoms (such as joint pain and swelling).
In patients with very high uric acid levels (e.g. those undergoing chemotherapy), treatment with uric acid-lowering medicines may lead to xanthine accumulation in the urinary tract, possibly resulting in stone formation, despite this not having been observed in patients treated with Febuxostat MSN due to tumor lysis syndrome.
Your doctor may order blood tests to check whether liver function is normal.

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

Febuxostat MSN and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription, as well as any you plan to take.
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 MSN, and your doctor may consider taking necessary measures:

• mercaptopurine (used in cancer treatment),
• azathioprine (used to suppress the immune response),
• theophylline (used in the treatment of asthma).

Pregnancy and breastfeeding
It is not known whether Febuxostat MSN may harm the unborn child. Febuxostat MSN should not be used during pregnancy. It is not known whether Febuxostat MSN passes into breast milk. Do not use Febuxostat MSN if you are breastfeeding or planning to breastfeed.
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before using this medicine.

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

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

3. How to take Febuxostat MSN
Always take this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

• The usual dose is one tablet per day. The days of the week are printed on the back of the blister pack to help you keep track of daily dosing.
• Tablets should be taken orally; the medicine can be taken with or without food.

Gout
Febuxostat MSN is available as 80 mg and 120 mg tablets. Your doctor will prescribe the most appropriate dose for you.
Febuxostat MSN should be taken daily, even if there is no flare-up or gout attack.

Prevention and treatment of high uric acid levels in patients undergoing chemotherapy due to cancer
Febuxostat MSN is available as 120 mg tablets.
Treatment with Febuxostat MSN should be started two days before chemotherapy and continued as directed by your doctor. Treatment is usually short-term.

Taking more Febuxostat MSN than prescribed
If you accidentally take too much, consult your doctor or go to the nearest hospital emergency department immediately.

Missing a dose of Febuxostat MSN
If you miss a dose of Febuxostat MSN, 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 dose at the usual time. Do not take a double dose to make up for a missed dose.

Stopping 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 within joints and in the kidneys.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must stop taking the medicine and contact your doctor immediately or go to
the nearest emergency department if any of the following rare (occurring in 1 in 1,000
patients) adverse reactions occur, 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 body surfaces such as the mouth and genital organs, painful mouth ulcers and (or) genital area ulcers associated with fever, sore throat and fatigue (Stevens-Johnson syndrome, toxic epidermal necrolysis), or swollen lymph nodes, enlarged liver, liver inflammation (leading to liver failure), increased white blood cell count (drug reaction with eosinophilia and systemic symptoms - DRESS) (see section 2);
• generalized skin rashes.

Common adverse reactions (may occur in 1 in 10 people):

• abnormal liver function test results,
• diarrhoea,
• headache,
• rash (including various types of rashes, see below under "not very common" and "rare"),
• nausea,
• worsening of gout symptoms,
• localized swelling due to fluid accumulation in tissues (oedema),
• dizziness,
• shortness of breath,
• itching,
• limb pain, muscle or joint pain,
• fatigue.

The adverse reactions listed below were not mentioned above.
Not very common adverse reactions (may occur in 1 in 100 people):

• decreased appetite, change in blood sugar levels (diabetes), which may present as excessive thirst, increased blood lipid levels, weight gain;
• reduced libido;
• sleep disturbances, drowsiness;
• numbness, tingling, weakness, or altered sense of touch (hypoesthesia, paresis, or paraesthesia), taste disturbances, reduced sense of smell (hyposmia);
• abnormalities in ECG recording, irregular or rapid heartbeat, sensation of heart palpitations;
• hot flushes or skin redness (e.g. redness of the face or neck), increased blood pressure, bleeding (haemorrhage, observed only in patients undergoing chemotherapy for blood disorders);
• cough, discomfort or pain in the chest, inflammation of the nasal and (or) throat mucosa (upper respiratory tract infection), bronchitis, lower respiratory tract infection;
• dry mouth, abdominal pain or discomfort or flatulence, upper abdominal pain, heartburn or indigestion, constipation, more frequent bowel movements, vomiting, stomach discomfort;
• itchy rash, urticaria, 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 covered with small bumps, rash, local redness and spots on the skin, excessive sweating, night sweats, hair loss, skin redness (erythema), psoriasis, rash, other types of skin disorders;
• muscle cramps, muscle weakness, tenosynovitis or joint inflammation (arthritis, usually associated with pain, swelling and (or) stiffness), back pain, muscle cramps, stiffness of muscles and (or) joints;
• blood in urine, abnormal frequent urination, abnormal urine test results (increased protein in urine), kidney function disorders, urinary tract infection;
• chest pain, discomfort in the chest;
• gallstones in the gallbladder or bile ducts (cholelithiasis);
• increased activity of thyroid-stimulating hormone (TSH);
• changes in blood chemistry or number of blood cells or platelets (abnormal blood test results);
• kidney stones;
• erectile dysfunction;
• hypothyroidism;
• blurred vision, change in vision;
• tinnitus;
• nasal congestion;
• mouth ulceration;
• pancreatitis: common symptoms include abdominal pain, nausea and vomiting;
• sudden urge to urinate;
• pain;
• malaise;
• increased INR;
• injury;
• swelling of the lips.

Rare adverse reactions (may occur in 1 in 1,000 people):

• muscle damage, a condition which in isolated cases may be severe. Muscle disorders may occur, associated with malaise or high fever, caused by muscle injury. You should contact your doctor immediately if you experience muscle pain, tenderness or weakness;
• severe swelling of the deep layers of skin, particularly around the eyes, genitals, hands, feet or tongue, possibly with sudden breathing difficulties;
• high fever with rash resembling measles, swollen lymph nodes, enlarged liver, liver inflammation (leading to liver failure), elevated white blood cell count (leukocytosis with or without eosinophilia);
• rashes of various types (e.g. with white spots, blisters, pustular blisters, skin peeling, measles-like rash), widespread erythema, necrosis, blisters on the skin and mucous membranes leading to their separation and risk of sepsis (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• nervousness;
• feeling of thirst;
• weight loss, increased appetite, uncontrolled loss of appetite (anorexia);
• abnormal low number of blood cells (white or red blood cells or platelets);
• changes in urine or reduced urine output related to kidney inflammation (tubulointerstitial nephritis);
• hepatitis;
• yellowing of the skin (jaundice);
• urinary bladder infection;
• liver damage;
• increased blood creatine phosphokinase activity (a marker of muscle damage);
• sudden death due to cardiovascular causes;
• low red blood cell count (anaemia);
• depression;
• sleep disturbances;
• loss of smell;
• burning sensation;
• vertigo of labyrinthine origin;
• circulatory collapse;
• lung infection (pneumonia);
• mouth ulceration; inflammation of the mouth;
• gastrointestinal tract perforation;
• rotator cuff syndrome;
• polymyalgia;
• feeling of heat;
• sudden loss of vision due to blockage of an artery in the eye.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website:
https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity. By reporting
adverse reactions, additional information on the safety of the medicine's use can be collected.

5. How to store Febuxostat MSN

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

6. Contents of the pack and other information

What Febuxostat MSN contains
The active substance is febuxostat.
Each coated tablet contains 80 mg or 120 mg of febuxostat (as febuxostat hemihydrate).
The other ingredients are:
Tablet core: microcrystalline cellulose (PH 101), monohydrate lactose, sodium croscarmellose, hydroxypropylcellulose, colloidal anhydrous silica, magnesium stearate.
Tablet coating (Opadry II Yellow 85F42129): polyvinyl alcohol partially hydrolysed, titanium dioxide (E 171), polyethylene glycol 3350, talc, yellow iron oxide (E 172).

What Febuxostat MSN looks like and contents of the pack
Febuxostat MSN, 80 mg, coated tablets
Yellow, capsule-shaped (approximately 17 mm long and 6 mm wide), biconvex (approximately 5 mm thick) coated tablets, embossed with the number "80" on one side and smooth on the other.

Febuxostat MSN, 120 mg, coated tablets
Yellow, capsule-shaped (approximately 19 mm long and 8 mm wide), biconvex (approximately 6 mm thick) coated tablets, embossed with the number "120" on one side and smooth on the other.

Febuxostat MSN 80 mg and 120 mg tablets are packed in transparent Aclar/PVC/Aluminium blisters, packed into cardboard boxes.
Febuxostat MSN 80 mg and 120 mg are available in pack sizes containing 14, 28, 42, 56, 84, and 98 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised 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