Uriquid

Package leaflet: Information for the user

Febuxostat CT 80 mg film-coated tablets
Febuxostat CT 120 mg film-coated tablets
Febuxostat
Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Febuxostat CT tablets contain the active substance febuxostat and are used
to treat gout, a condition associated with an excess of a chemical substance
called uric acid (urate) in the body. In some people, the amount of uric
acid builds up in the blood and may become too high to remain soluble.
In this case, urate crystals may form within and around joints and kidneys.
These crystals can cause sudden, severe pain, redness, warmth, and swelling in a joint
(an event known as a gout attack). If left untreated, larger deposits called tophi may form within and around joints.
Tophi can damage joints and bones.
Febuxostat CT works by reducing uric acid levels. Maintaining low uric acid levels by taking Febuxostat CT once daily prevents the accumulation of crystals and, over time, reduces symptoms. If uric acid levels are kept low for a sufficiently long period, existing tophi may also gradually dissolve.

Febuxostat CT 120 mg:
Febuxostat CT 120 mg is also used for the treatment and prevention of elevated blood levels of uric acid that may occur following chemotherapy for blood cancers.
During chemotherapy, cancer cells are destroyed and uric acid levels in the blood rise, unless the formation of this acid can be prevented.

Febuxostat CT is intended for use in adults.

2. What you should know before taking Febuxostat CT

Do not take Febuxostat CT:

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

Warnings and precautions
Talk to your doctor before taking Febuxostat CT:

• If you have or have had heart failure or heart problems
• 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 tests
• If you are being treated for high levels of uric acid due to Lesch-Nyhan syndrome (a rare inherited condition in which there is too much uric acid in the blood)
• If you have any thyroid problems

If allergic reactions to Febuxostat CT occur, stop treatment with the medicine (see also section 4). Possible symptoms of allergic reactions may include:

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

Rare, life-threatening skin rashes (Stevens-Johnson syndrome) have been reported with the use of febuxostat, initially appearing on the trunk as red, target-like spots or circular lesions, often with central blisters. These may also include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red, swollen eyes). The rash may progress to widespread blistering or skin peeling.
If you have developed Stevens-Johnson syndrome while using febuxostat, treatment with Febuxostat CT must not be restarted. If you develop a rash or these skin symptoms, consult your doctor immediately and inform them that you are being treated with this medicine.
If you are currently experiencing a gout attack (sudden onset of severe pain, tenderness, redness, warmth, and swelling in a joint), wait until the gout attack has resolved before starting treatment with Febuxostat CT.
In some people, gout attacks may recur at the beginning of certain treatments used to control uric acid levels. Not everyone experiences recurrences, but you may have flare-ups even while taking Febuxostat CT, especially during the first weeks or months of treatment. It is important that you continue taking Febuxostat CT even during flare-ups, as Febuxostat CT continues to work to lower your uric acid levels. If you continue taking Febuxostat CT daily, over time flare-ups will occur less frequently and become less painful.
Often, your doctor will prescribe additional medicines, if needed, to help prevent or treat symptoms of flare-ups (such as joint pain and swelling).
In patients with very high urate levels (e.g. patients undergoing chemotherapy), treatment with medicines that lower uric acid levels may cause xanthine accumulation in the urinary tract, potentially leading to stone formation, although this has not been observed in patients treated with febuxostat for Tumor Lysis Syndrome.
Your doctor may prescribe blood tests to monitor whether your liver is functioning normally.
Children and adolescents
Do not administer this medicine to children under 18 years of age, as safety and efficacy have not been established.
Other medicines and Febuxostat CT
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is very important that you inform your doctor or pharmacist if you are taking a medicine containing any of the following substances, as they may interact with Febuxostat CT and your doctor may need to consider appropriate measures:

• Mercaptopurine (used to treat cancer)
• Azathioprine (used to reduce immune response)
• Theophylline (used to treat asthma)

Pregnancy and breastfeeding
It is not known whether Febuxostat CT may harm the fetus. Febuxostat CT must not be used during pregnancy. It is not known whether Febuxostat CT passes into human breast milk. Do not use Febuxostat CT if you are breastfeeding or planning to breastfeed.
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Be aware that you may experience dizziness, drowsiness, blurred vision, numbness, or tingling during treatment, and if you experience these symptoms, you must not drive or operate machinery.
Febuxostat CT contains lactose
Febuxostat CT tablets contain lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Febuxostat CT

Take this medicine exactly as your doctor has told you. If
you have any doubts, consult your doctor or pharmacist.

• The usual dose is one tablet per day. The back of the blister is marked with the days of the week. This will help you check that you have taken a dose each day.
• The tablets should be taken by mouth, either with or without food.

Gout
Febuxostat CT is available as 80 mg or 120 mg tablets. Your doctor will prescribe the dosage most suitable for you.
Continue taking Febuxostat CT every day, even if you do not have flare-ups or a gout attack.
Febuxostat CT 120 mg:
Prevention and treatment of high uric acid levels in patients undergoing
chemotherapy
Febuxostat CT is available as 120 mg tablets.
Start taking Febuxostat CT two days before chemotherapy and continue taking it as prescribed by your doctor. This is usually a short-term treatment.

If you take more Febuxostat CT than you should
In case of accidental overdose, contact your doctor or the nearest emergency department for advice.

If you forget to take Febuxostat CT
If you forget to take a dose of Febuxostat CT, 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 one at the scheduled time.
Do not take a double dose to make up for the forgotten dose.

If you stop taking Febuxostat CT
Do not stop treatment with Febuxostat CT without consulting your doctor, even if you feel better. If you stop treatment with Febuxostat CT, your uric acid levels may start to rise again and your symptoms may worsen due to the formation of new urate crystals in and around your joints and kidneys.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although
not everyone experiences them.
Stop taking this medicine and contact your doctor immediately or go to the nearest
Emergency Room if you experience the following rare side effects (may affect up to 1 in 1,000 people), as they may indicate a severe allergic reaction:

• Anaphylactic reactions, hypersensitivity to the drug (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. mouth and genital areas, painful ulcers in the mouth and/or genital areas, accompanied by fever, sore throat and fatigue (Stevens-Johnson syndrome/toxic epidermal necrolysis), or swollen lymph nodes, enlarged liver, hepatitis (up to liver failure), increased white blood cell count (drug reaction with eosinophilia and systemic symptoms - DRESS) (see section 2).
• Generalized skin rash

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

• Abnormal liver function test results
• Diarrhea
• Headache
• Rash (including various types of skin eruptions, see below in the "uncommon" and "rare" sections)
• Nausea
• Worsening of gout symptoms
• Localized swelling due to fluid retention in tissues (edema)

Other side effects not mentioned above are listed below.
Uncommon side effects (may affect up to 1 in 100 people) are:

• Decreased appetite, changes in blood glucose levels (diabetes), one symptom of which may be excessive thirst, increased blood lipid levels, weight gain
• Loss of sexual desire
• Difficulty sleeping, drowsiness
• Dizziness, numbness, tingling, reduced or altered tactile sensation (hypoesthesia, hemiparesis or paresthesia), reduced or altered sense of taste (hypogeusia)
• Abnormal ECG readings, irregular or rapid heartbeat, awareness of heartbeat (palpitations)
• Hot flushes or redness (e.g. redness of face or neck), increased blood pressure, bleeding (hemorrhage, observed only in patients undergoing chemotherapy for blood disorders)
• Cough, shortness of breath, chest pain or discomfort, inflammation of nasal passages and/or throat (upper respiratory tract infection), bronchitis
• Dry mouth, abdominal pain or discomfort or intestinal gas, heartburn/indigestion, constipation, more frequent bowel movements, vomiting, stomach discomfort
• Itching, hives, skin inflammation, change in skin color, small red or purple spots on the skin, small flat red spots on the skin, red area of skin covered with small confluent bumps, skin rashes, areas of redness and spots on the skin, other skin disorders
• Muscle cramps, muscle weakness, muscle or joint pain, bursitis or arthritis (joint inflammation usually accompanied by pain, swelling and/or stiffness), pain in extremities, back pain, muscle spasms
• Blood in urine, increased frequency of urination, abnormal urine test results (elevated protein levels in urine), reduced kidney function
• Fatigue, chest pain, chest discomfort
• Gallstones or bile duct stones (cholelithiasis)
• Increased blood levels of thyroid-stimulating hormone (TSH)
• Changes in blood biochemical test values or red blood cell or platelet counts (abnormal blood test results)
• Kidney stones
• Difficulty achieving erection

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

• Muscle damage, a condition which in rare cases may be severe. Muscle problems may develop, and particularly if you also feel unwell or have high fever, this could be due to abnormal breakdown of muscle cells. Contact your doctor immediately if you experience muscle pain, tenderness or weakness.
• Marked swelling of deeper layers of the skin, especially around the lips, eyes, genitals, hands, feet or tongue, possibly with sudden difficulty breathing
• High fever associated with measles-like rash, swollen lymph nodes, enlarged liver, hepatitis (up to liver failure), increased white blood cell count (leukocytosis, with or without eosinophilia)
• Skin redness (erythema), various types of skin eruptions (e.g. itching, white spots, blisters, pustules, skin peeling, measles-like rash), widespread erythema, necrosis and blistering detachment of the epidermis and mucous membranes, leading to exfoliation and possible sepsis (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• Nervousness
• Feeling of thirst
• Ringing in the ears
• Blurred vision, visual disturbances
• Hair loss
• Oral mucosal ulcers
• Inflammation of the pancreas: common symptoms are abdominal pain, nausea and vomiting
• Excessive sweating
• Weight loss, increased appetite, uncontrolled loss of appetite (anorexia)
• Muscle and/or joint stiffness
• Abnormally low levels of blood cells (white blood cells or red blood cells or platelets)
• Urgency to urinate
• Changes or decreased urine output due to kidney inflammation (tubulointerstitial nephritis)
• Inflammation of the liver (hepatitis)
• Yellowing of the skin (jaundice)
• Liver damage
  • Increased levels of creatine phosphokinase in the blood (an indicator of muscle damage)

Reporting of side effects
If you experience any side effect, including those not listed in this
leaflet, talk to your doctor or pharmacist. You can also report side
effects directly via the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-
avversa. By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Febuxostat CT

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging or blister after the wording “EXP.” The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.

Do not dispose of medicines via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help
protect the environment.

6. Package contents and other information

What Febuxostat CT contains

• The active substance is febuxostat. Febuxostat CT 80 mg: each tablet contains 80 mg of febuxostat, equivalent to 82.28 mg of febuxostat hydrate. Febuxostat CT 120 mg: each tablet contains 120 mg of febuxostat, equivalent to 123.42 mg of febuxostat hydrate.
• The other components are: Tablet core: lactose monohydrate, microcrystalline cellulose (E460), hydroxypropylcellulose (E463), sodium croscarmellose, anhydrous colloidal silica (E551), magnesium stearate (E470b). Tablet coating: (alcohol) poly (vinyl) (E1203), talc (E553b), titanium dioxide (E171), macrogol 3350 (E1521), methacrylic acid-ethyl acrylate copolymer (1:1) (Type A), iron oxide yellow (E172), sodium hydrogen carbonate (E500(ii)).

Description of the appearance of Febuxostat CT and contents of the pack
Febuxostat CT 80 mg: film-coated tablets, yellow to pale yellow in colour,
capsule-shaped, with "80" engraved on one side and smooth on the other side,
measuring 16.5 mm x 7.0 mm ± 5%.
Febuxostat CT 120 mg: film-coated tablets, yellow to pale yellow in colour,
capsule-shaped, with "120" engraved on one side and smooth on the other side,
measuring 18.5 mm x 9.0 mm ± 5%.
Febuxostat CT 80 mg and 120 mg are supplied in aluminum-PVC/PE/PVDC blisters.
Febuxostat CT 80 mg and 120 mg are available in packs of 14 and 28 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Laboratorio Farmaceutico CT Srl – Via Dante Alighieri, 71 – 18038 Sanremo (IM), Italy
Manufacturers:
Rontis Hellas Medical and Pharmaceutical Products S.A
P.O. Box 3012 Larisa Industrial Area, Larisa
41004, Greece
PharOS MT Ltd
HF 62X, Hal-Far Industrial Estate,
Birzebbugia BBG 3000,
Malta

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
MALTA: Febuxostat PharOs 80mg and 120mg film-coated tablets

This patient information leaflet was last updated on