Febuxostat solinea

Febuxostat Solinea, 80 mg, film-coated tablets
Febuxostat Solinea, 120 mg, film-coated tablets
Febuxostatum
Please read the entire leaflet before taking the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• Consult your doctor or pharmacist if you have any doubts.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm someone else, even if their symptoms are similar.
• If any adverse reactions occur, including any possible side effects not listed in this leaflet, inform 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 in the treatment of
gout, a condition 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 to such a level that the compound can no longer remain dissolved. In such cases, urate crystals may form within and around joints and kidneys. These crystals may cause sudden, severe pain, redness, warmth, and swelling of a joint (known as a gout attack). If the disease remains untreated, larger deposits called tophi may form inside and around joints. Tophi may lead to joint and bone damage.
Febuxostat Solinea works by lowering uric acid levels. Maintaining low uric acid concentrations through daily administration of Febuxostat Solinea prevents the formation of crystals and, over time, reduces symptoms. Maintaining sufficiently low uric acid levels for a sufficiently long period may also lead to a reduction in tophi.
Febuxostat Solinea 120 mg tablets are also used in the treatment and prevention of high uric acid levels in the blood that may occur at the start of chemotherapy for blood cancer.
When chemotherapy is administered, tumor cells are destroyed, leading to a corresponding increase in uric acid levels in the blood, unless uric acid formation is prevented.
Febuxostat Solinea is intended for use in adults.

2. Important information before using Febuxostat Solinea

When not to use Febuxostat Solinea:

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

Warnings and precautions
Before starting treatment with Febuxostat Solinea, consult a doctor:

• if the patient has or has had heart failure or heart disease;
• if the patient currently has or has previously had kidney disease and (or) severe allergic reactions to allopurinol (a medicine used to treat gout);
• if the patient currently has or has previously had liver disease or abnormal liver function test results;
• if the patient is 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 the patient has a thyroid disorder. If an allergic reaction to Febuxostat Solinea occurs, the medicine should be discontinued immediately (see also 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 enlarged lymph nodes;
• severe, life-threatening allergic reactions with cardiac arrest and circulatory collapse. The doctor may decide to permanently discontinue treatment with Febuxostat Solinea.

Rare cases of potentially life-threatening skin rashes (Stevens-Johnson syndrome) have been reported during treatment with Febuxostat Solinea, initially presenting as reddish, concentric spots or round lesions, often with a centrally located blister on the trunk. Symptoms may also include ulceration of the mouth, throat, nose, and genital organs, and conjunctivitis (redness and swelling around the eyes). The rash may spread and lead to peeling and detachment of the outer layer of skin.
If Stevens-Johnson syndrome occurs during treatment with Febuxostat Solinea, febuxostat treatment must never be restarted. If a rash or any of the mentioned skin symptoms occur, contact a doctor immediately and inform them about taking this medicine.
If the patient experiences a gout attack (sudden onset of severe pain, tenderness, redness, warmth, and swelling in a joint): treatment with Febuxostat Solinea should not be started until the gout attack has subsided.
In some people, gout attacks may worsen when starting certain medicines that control uric acid levels. Flare-ups do not occur in everyone, but they may occur, even if the patient is taking Febuxostat Solinea, especially during the first weeks or months of treatment. It is important to continue taking Febuxostat Solinea even if a flare-up occurs, because Febuxostat Solinea continues to reduce uric acid levels. Over time, gout attacks will become less frequent and less painful if Febuxostat Solinea is taken daily.
The doctor may often prescribe additional medicines, if necessary, to help prevent or treat flare-up symptoms (such as joint pain and swelling).
In patients who have very high levels of uric acid (e.g. those undergoing chemotherapy), treatment with uric acid-lowering medicines may lead to xanthine accumulation in the urinary tract with a risk of stone formation, although this has not been observed in patients treated with Febuxostat Solinea for tumor lysis syndrome.
The doctor may order blood tests to check whether liver function is normal.

Children and adolescents
Febuxostat Solinea should not be used in children under 18 years of age, as the efficacy and safety have not been established.

Febuxostat Solinea and other medicines
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned for use, including those available without a prescription.
It is especially important to inform the doctor or pharmacist if the patient is taking medicines containing any of the following substances, as they may interact with Febuxostat Solinea, and the doctor may then consider taking necessary measures:

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

Pregnancy and breastfeeding
It is unknown whether Febuxostat Solinea may harm the unborn child. Febuxostat Solinea should not be used during pregnancy. It is unknown whether Febuxostat Solinea passes into human breast milk. Febuxostat Solinea should not be used if the patient is breastfeeding or planning to breastfeed.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and using machines
Be aware that during treatment dizziness, drowsiness, blurred vision, or numbness or tingling may occur. If such symptoms occur, the patient should not drive or operate machinery.

Febuxostat Solinea contains lactose and sodium
Febuxostat Solinea tablets contain lactose (a type of sugar). If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, i.e. is essentially "sodium-free".

3. How to use Febuxostat Solinea

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
The usual dose is one tablet daily.
The tablets should be taken orally; the medicine can be taken with or without food.

Gout
Febuxostat Solinea is available as 80 mg tablets and 120 mg tablets. Your doctor will prescribe the most appropriate dose for you.
Febuxostat Solinea should be taken every day, even if you do not have a flare-up or an attack of gout.

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

Taking more Febuxostat Solinea than prescribed
In case of accidental overdose, consult your doctor immediately or contact the nearest hospital emergency department.

If you miss a dose of Febuxostat Solinea
If you forget to take a dose of Febuxostat Solinea, 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 Solinea
Do not stop taking Febuxostat Solinea without first 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 within joints and in the kidneys.

If you have any further questions about the use of 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 should stop taking the medicine and contact your doctor immediately or go to
the nearest emergency department if any of the following rare (occurring in no more than 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, e.g. oral cavity and genital organs, painful ulceration of the mouth and (or) genital area accompanied by fever, sore throat, and fatigue (Stevens-Johnson syndrome or toxic epidermal necrolysis) or swollen lymph nodes, enlarged liver, 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 adverse reactions (in no more than 1 in 10 patients):

• abnormal liver function test results;
• diarrhoea;
• headache;
• rash (including various types of rash, see below under "not common" and "rare");
• nausea;
• worsening of gout symptoms;
• localized swelling due to fluid accumulation in tissues (oedema).

The following are other adverse reactions.
Not common adverse reactions (in no more than 1 in 100 patients):

• decreased appetite, change in blood sugar level (diabetes), which may present as excessive thirst, increased blood lipid levels, weight gain;

• decreased libido;

• sleep disturbances, drowsiness;

• dizziness, numbness, tingling, weakness, or altered sensation (hypoesthesia, hemiparesis, or paraesthesia), disturbances or reduced sense of taste (reduced sense of smell);

• abnormalities in ECG, irregular or rapid heartbeat, palpitations;

• hot flushes or skin redness (e.g. face or neck), elevated blood pressure, bleeding (haemorrhage, observed only in patients receiving chemotherapy for blood disorders);

• cough, shortness of breath, discomfort or chest pain, catarrh and (or) sore throat (upper respiratory tract infection), bronchitis;

• dry mouth, abdominal pain or bloating and flatulence, heartburn or indigestion, constipation, more frequent bowel movements, vomiting, stomach discomfort;

• itching, 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 papules, rash, local redness and spots on the skin, other types of skin disorders;

• muscle cramps, muscle weakness, muscle or joint pain, bursitis or arthritis (joint inflammation usually accompanied by pain, swelling and (or) stiffness), limb pain, back pain, muscle spasms;

• blood in urine, abnormally frequent urination, abnormal urine test results (increased protein in urine), kidney function disorders;

• excessive fatigue, chest pain, discomfort in the chest;

• gallstones in the gallbladder or bile ducts (cholelithiasis);

• increased level of thyroid hormone in blood (TSH);

• changes in blood chemical composition or blood cell or platelet count (abnormal blood test results);

• kidney stones;

• erectile dysfunction.

Rare adverse reactions (in no more than 1 in 1,000 patients):

• muscle injury, a condition which in isolated cases may be severe. Muscle disorders may occur, accompanied by malaise or high fever, caused by muscle damage. Contact your doctor immediately if muscle pain, tenderness or weakness occurs;
• severe swelling of deep skin layers, particularly around lips, eyes, genital organs, hands, feet or tongue, possibly with sudden breathing difficulties;
• high fever with rash resembling measles, swollen lymph nodes, enlarged liver, hepatitis (leading to liver failure), elevated white blood cell count (leukocytosis with or without eosinophilia);
• skin redness (erythema), various types of rashes (e.g. itchy, with white spots, with blisters, with pustular blisters, with skin peeling, measles-like rash), diffuse erythema, necrosis, blisters on skin and mucous membranes leading to separation and risk of sepsis (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• nervousness;
• feeling of thirst;
• ringing in the ears;
• blurred vision, change in vision;
• hair loss;
• oral ulceration;
• pancreatitis: common symptoms include abdominal pain, nausea and vomiting;
• excessive sweating;
• weight loss, increased appetite, uncontrolled loss of appetite (anorexia);
• stiffness of muscles and (or) joints;
• abnormally low number of blood cells (white or red blood cells or platelets);
• sudden urge to urinate;
• changes in urine or reduced urine output related to kidney inflammation (tubulointerstitial nephritis);
• hepatitis;
• yellowing of the skin (jaundice);
• liver damage;
• elevated blood creatine phosphokinase levels (a marker of muscle damage).

If any adverse reactions occur, including any possible adverse reactions
not listed in this leaflet, consult your doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in
this leaflet, 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, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309,
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder. Reporting
adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Febuxostat Solinea

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and on the foil blister
pack after the words "Expiry date". The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. Such measures 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: monohydrate lactose, microcrystalline cellulose, magnesium stearate,
hydroxypropylcellulose, sodium croscarmellose, colloidal anhydrous silica, poloxamer 407.
Tablet coating: Opadry II Yellow (85F32004) containing: partially hydrolyzed polyvinyl alcohol,
titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172).

What Febuxostat Solinea looks like and contents of the pack
Febuxostat Solinea coated tablets are yellow, elongated, and biconvex.
80 mg coated tablets are marked on one side with the symbol " 80".
120 mg coated tablets are marked on one side with the symbol " 120".
Febuxostat Solinea 80 mg and 120 mg is packed in blisters (PVC/PVDC/Aluminium or
PVC/PCTFE/Aluminium) containing 14 tablets.
Febuxostat Solinea 80 mg and 120 mg is available in packs containing 14, 28, and 56 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Solinea Sp. z o.o. Sp. K.
Elizówka 65, Hala I
21-003 Ciecierzyn
Tel. 81-4634882
Fax 81-4634886
e-mail: [email protected]

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 Authorisation Holder.

Date of the most recent authorisation of the package leaflet