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 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 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 may become too high to remain dissolved. In such cases, urate crystals may 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 may 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 may 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 may occur during the initiation of 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 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 currently 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 disease 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, itching, exfoliative 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 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 above skin symptoms, contact your doctor immediately and inform them that you are taking this medicine.
If you have a gout attack (sudden onset of severe pain, tenderness, redness, warmth, and swelling of the joint): before starting treatment with Febuxostat Solinea, wait until the attack has subsided.
In some people, gout attacks may worsen when starting treatment with certain medicines that control uric acid levels. Worsening may not occur in everyone, but worsening may occur, even if you are taking Febuxostat Solinea, especially during the first few weeks or months of treatment. It is essential to continue taking Febuxostat Solinea even if you experience worsening, as Febuxostat Solinea still reduces uric acid levels. Over time, gout attacks will become less frequent and less painful if Febuxostat Solinea is taken daily.
Your doctor may prescribe other medicines if necessary to help prevent or treat symptoms of worsening (such as joint pain and swelling).
In patients with very high levels of uric acid (e.g., those undergoing chemotherapy for blood cancer), 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 Solinea for tumor lysis syndrome.
Your doctor may order blood tests to check if your 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 Solinea 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 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 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 whether Febuxostat Solinea may harm an unborn child. Febuxostat Solinea should not be used during pregnancy. It is not known whether Febuxostat Solinea passes into breast milk. Do not use Febuxostat Solinea if you are breastfeeding or plan to breastfeed.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist 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 previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.
This medicine contains less than 1 mmol of 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.
Take the tablets orally; the medicine can be taken with or without food.
Gout
Febuxostat Solinea is available in 80 mg and 120 mg tablet strengths. Your doctor will prescribe the most suitable dose for you.
Take Febuxostat Solinea once daily, even if you do not have a gout attack or worsening.
Prevention and treatment of high uric acid levels in patients undergoing chemotherapy for cancer.
Febuxostat Solinea is available in 120 mg tablet strength.
Start taking Febuxostat Solinea 2 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

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

What to do if you miss a dose of Febuxostat Solinea

If you miss a dose of Febuxostat Solinea, take it as soon as you remember, unless it is almost time for your next dose, in which case skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for the missed 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 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 about the use of this medicine, 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 the following rare (less than 1 in 1000 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 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, hepatitis (leading to liver failure), increased white blood cell count (drug reaction with eosinophilia and systemic symptoms - DRESS) (see section 2).
• widespread skin rashes.

Frequent side effects(in less than 1 in 10 patients):

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

The following are other side effects.
Uncommon side effects(in less than 1 in 100 patients):

• 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 disorders, drowsiness;
• dizziness, numbness, tingling, weakness, or altered sensation

(hypoesthesia, paresis, or paresthesia), taste disturbance or loss of taste;

• abnormal heart rhythm or rapid heartbeat, palpitations;
• hot flashes or flushing, high blood pressure, bleeding (hemorrhage, observed only in patients undergoing chemotherapy for blood cancer);
• cough, shortness of breath, discomfort or pain in the chest, common cold and/or sore throat (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, bursitis or tendonitis (arthritis, which is 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(in less than 1 in 1000 patients):

• muscle damage, a condition that can be severe in isolated cases. Muscle disorders may occur, with accompanying malaise or high fever, caused by muscle damage. Contact your doctor immediately if you experience muscle pain, tenderness, or weakness;
• severe swelling of deep skin layers, particularly in the lips, 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);
• redness of the skin (erythema), various types of rashes (e.g., itching, 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;
• thirst;
• ringing in the ears;
• blurred vision, changes in vision;
• hair loss;
• mouth sores;
• 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 or red blood cell or platelet count);
• sudden urge to urinate;
• changes in urine or decreased urine output related to kidney inflammation (interstitial nephritis);
• hepatitis;
• jaundice;
• liver damage;
• increased creatine phosphokinase levels in the blood (indicator of muscle damage).

If you experience any side effects, including any not listed in this leaflet, please contact 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 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, 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 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 excipients are:
Tablet core:lactose monohydrate, microcrystalline cellulose, magnesium stearate, hydroxypropyl cellulose, 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 more detailed information, please contact the representative of the marketing authorization holder.

Date of last revision of the leaflet