Febuxostat Solinea

Patient Information Leaflet: User Information

Febuxostat Solinea, 80 mg, film-coated tablets

Febuxostat Solinea, 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, you may need to read it again.
• Ask your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

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

Febuxostat Solinea tablets contain the active substance febuxostat and are used to treat gout, which is associated with excessive levels 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 to remain dissolved. In such cases, urate crystals can form inside and around the joints and kidneys. These 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 can form inside and around the joints. Tophi can cause joint and bone damage. Febuxostat Solinea works by reducing uric acid levels. Maintaining low uric acid levels by taking Febuxostat Solinea once daily prevents the formation of crystals and, over time, reduces symptoms. Maintaining sufficiently low uric acid levels for a long enough period can also lead to a reduction in tophi. Febuxostat Solinea 120 mg tablets are also used to treat and prevent high levels of uric acid in the blood that can occur during the initiation of cancer chemotherapy. When chemotherapy is given, cancer cells are destroyed, and uric acid levels in the blood increase, unless measures are taken to prevent this. Febuxostat Solinea is intended for use in adults.

2. Important information before taking Febuxostat Solinea

When not to take Febuxostat Solinea:

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

Warnings and precautions

Before taking Febuxostat Solinea, tell your doctor:

• if you have or have had heart failure or heart disease;
• if you currently have or have had kidney or liver disease, or severe allergic reactions to allopurinol (a medicine used to treat gout);
• if you have or have had liver disease or abnormal liver function tests;
• if you are being treated for high levels of uric acid due to Lesch-Nyhan syndrome (a rare inherited disorder in which there is too much uric acid in the blood);
• if you have thyroid disease. If you experience an allergic reaction to Febuxostat Solinea, stop taking the medicine immediately (see also section 4). Possible symptoms of an allergic reaction are:
• rash, including severe forms of rash (e.g., blisters, nodules, itchy, flaky 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. Your doctor may decide to permanently stop treatment with Febuxostat Solinea.

There have been rare reports of potentially life-threatening skin rashes (Stevens-Johnson syndrome) during treatment with Febuxostat Solinea, initially appearing as red, concentric patches or circular patches often with a central blister 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 spread and cause the skin to peel and separate. If you experience Stevens-Johnson syndrome while taking Febuxostat Solinea, do not start taking febuxostat again. If you experience a rash or any of the skin symptoms mentioned, contact your doctor immediately and inform them that you are taking this medicine.

Children and adolescents

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

Febuxostat Solinea and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, and any that you plan to take, including those obtained 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 Solinea, and your doctor may need to take appropriate 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 whether Febuxostat Solinea can harm an unborn child. Febuxostat Solinea should not be taken during pregnancy. It is not known whether Febuxostat Solinea passes into breast milk. Do not take Febuxostat Solinea if you are breastfeeding or plan to breastfeed. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

Febuxostat Solinea contains lactose and sodium

Febuxostat Solinea tablets contain lactose (a type of sugar). If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine. This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, which is essentially 'sodium-free'.

3. How to take Febuxostat Solinea

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The usual dose is one tablet per day. The tablets should be taken orally, with or without food. GoutFebuxostat Solinea is available as 80 mg and 120 mg tablets. Your doctor will prescribe the most suitable dose for you. You should take Febuxostat Solinea every day, even if you do not have a gout attack. Prevention and treatment of high uric acid levels in patients undergoing cancer chemotherapy.Febuxostat Solinea is available as 120 mg tablets. You should start taking Febuxostat Solinea two days before chemotherapy and continue as directed by your doctor. Treatment is usually short-term.

What to do if you take more Febuxostat Solinea than you should

If you accidentally take too much, ask your doctor for advice or contact the nearest hospital emergency department.

What to do if you forget to take Febuxostat Solinea

If you miss a dose, take it as soon as you remember, unless it is nearly time for your next dose. Do not take a double dose to make up for a forgotten dose.

What to do if you stop taking Febuxostat Solinea

Do not stop taking Febuxostat Solinea without consulting your doctor, even if you feel better. Stopping treatment with Febuxostat Solinea 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 questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Febuxostat Solinea can cause side effects, although not everybody gets them. Stop taking the medicine and contact your doctor immediately or go to the nearest emergency department if you experience any of the following rare (affecting up to 1 in 1,000 people) side effects, as they can 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 of the body, such as the mouth and genitals, painful sores in the mouth and/or genitals with fever, sore throat, and fatigue (Stevens-Johnson syndrome or toxic epidermal necrolysis) or swollen lymph nodes, liver enlargement, liver inflammation (leading to liver failure), increased white blood cell count (drug reaction with eosinophilia and systemic symptoms - DRESS) (see section 2).
• widespread skin rash.

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

• abnormal liver function tests;
• diarrhea;
• headache;
• rash (including various types of rash, see below "uncommon" and "rare");
• nausea;
• exacerbation of gout;
• localized swelling due to fluid accumulation in tissues (edema).

The following are other side effects.

Uncommon side effects(affecting up to 1 in 100 people):

• decreased appetite, changes in blood sugar levels (diabetes), which may cause excessive thirst, increased levels of fats in the blood, weight gain;
• decreased libido;
• sleep disturbances, drowsiness;
• dizziness, numbness, tingling, weakness, or altered sensation

(hypoesthesia, hemiparesis, or paresthesia), taste disturbances or decreased taste (hypogeusia);

• abnormal heart rhythm or rapid heartbeat, palpitations;
• hot flashes or flushing of the skin (e.g., face or neck), high blood pressure, bleeding (hemorrhage, observed only in patients undergoing chemotherapy for blood disorders);
• cough, shortness of breath, discomfort or pain in the chest, sore throat and/or pharyngitis (upper respiratory tract infection), bronchitis;
• dry mouth, abdominal pain or bloating and gas, heartburn or indigestion, constipation, frequent bowel movements, vomiting, discomfort in the stomach;
• itching, 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 covered with small bumps, rash, localized redness and spots on the skin, other skin disorders;
• muscle spasms, muscle weakness, muscle pain or joint pain, tendonitis or bursitis (joint inflammation, usually accompanied by pain, swelling, and/or stiffness), limb pain, back pain, muscle cramps;
• blood in urine, frequent or abnormal urination, abnormal urine test results (increased protein in urine), kidney function disorders;
• excessive fatigue, chest pain, discomfort in the chest;
• gallstones or bile duct stones (cholelithiasis);
• increased thyroid-stimulating hormone (TSH) levels in the blood;
• changes in blood chemistry or blood cell count (abnormal blood test results);
• kidney stones;
• erectile dysfunction.

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

• muscle damage, a condition that can be severe in isolated cases. Muscle disorders can 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 in the lips, eyes, genitals, hands, or feet, with possible sudden breathing difficulties;
• high fever with a rash, swollen lymph nodes, liver enlargement, liver inflammation (leading to liver failure), increased white blood cell count (leukocytosis with or without eosinophilia);
• skin redness (erythema), various types of rash (e.g., itchy, with white spots, with blisters, with pus-filled blisters, with peeling skin, rash-like erythema), widespread erythema, necrosis, blisters on the skin and mucous membranes causing peeling and possible sepsis (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• nervousness;
• excessive thirst;
• ringing in the ears;
• blurred vision, changes in vision;
• hair loss;
• mouth ulcers;
• pancreatitis: common symptoms include abdominal pain, nausea, and vomiting;
• excessive sweating;
• weight loss, increased appetite, uncontrolled loss of appetite (anorexia);
• muscle stiffness and/or joint stiffness;
• abnormal blood cell count (low white blood cell, red blood cell, or platelet count);
• sudden urge to urinate;
• changes in urine or decreased urine output related to kidney inflammation (interstitial nephritis);
• liver inflammation;
• jaundice (yellowing of the skin);
• liver damage;
• elevated creatine phosphokinase levels in the blood (a marker of muscle damage).

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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, e-mail: ndl@urpl.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 Solinea

Keep out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister pack after "Expiry date". 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 pack and other information

What Febuxostat Solinea contains

The active substance is febuxostat. Each tablet contains 80 mg or 120 mg of febuxostat. The other ingredients are: Tablet core:lactose monohydrate, microcrystalline cellulose, magnesium stearate, hydroxypropylcellulose, sodium croscarmellose, silicon dioxide, poloxamer 407. Tablet coating:Opadry II Yellow (85F32004) containing: polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172).

What Febuxostat Solinea looks like and contents of the pack

Febuxostat Solinea film-coated tablets are yellow and oval, biconvex. The 80 mg film-coated tablets are marked with the symbol "80" on one side. The 120 mg film-coated tablets are marked with the symbol "120" on one side. Febuxostat Solinea 80 mg and 120 mg are packaged in blisters (PVC/PVDC/Aluminum or PVC/PCTFE/Aluminum) containing 14 tablets. Febuxostat Solinea 80 mg and 120 mg are available in packs containing 14, 28, and 56 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder: Solinea Sp. z o.o. Sp. K. Elizówka 65, Hala I 21-003 Ciecierzyn Tel. 81-4634882 Fax 81-4634886 e-mail: info@solinea.pl Manufacturer: Bluepharma Indústria Farmacêutica, S.A. São Martinho do Bispo 3045-016 Coimbra Portugal For further information, contact the marketing authorization holder.

Date of last revision of the leaflet