URIQUID 80 mg Tabletki Powlekane

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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. Package Contents and Other Information

Febuxostat CT 80 mg film-coated tablets
Febuxostat CT 120 mg film-coated tablets
Febuxostat
Generic medicine

Read 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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 ingredient febuxostat and are used
to treat gout, a disease 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 can become too high to remain soluble.
In this case, urate crystals can form inside and around the
joints and kidneys. These crystals can cause intense and
sudden pain, redness, a feeling of heat and swelling in
a joint (an event known as a gout attack). If left untreated, larger deposits, called tophi, can
form inside and around the joints. Tophi
can damage the joints and bones.
Febuxostat CT works by reducing uric acid levels. Maintaining low levels
of uric acid by taking Febuxostat CT once a day prevents
the build-up of crystals, and over time reduces the symptoms. If uric acid levels are kept low for a sufficient length of time, tophi can also be reabsorbed.

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

2. What you need to 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 suffer from or have suffered from 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 elevated 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 problems with your thyroid

If you experience allergic reactions to Febuxostat CT, stop taking the
medicine (see also section 4). Possible symptoms of
allergic reactions may be:

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

With the use of febuxostat, rare skin rashes (Stevens-Johnson syndrome) have been reported that have put the patient's life in danger, which appeared
initially on the trunk as reddish spots resembling a target or often circular spots with central blisters. They may also include ulcers in the mouth,
throat, nose, genitals and conjunctivitis (red and swollen eyes). The rash can
progress to widespread blisters or skin peeling.
If you develop Stevens-Johnson syndrome with the use of febuxostat, the
treatment with Febuxostat CT should no longer be resumed. If you develop a rash
or these skin symptoms, consult your doctor immediately and tell them that you are
taking this medicine.
If you currently have a gout attack (sudden onset of severe pain, tenderness, redness, heat and swelling in a joint),
wait for the end of the gout attack before starting therapy with Febuxostat CT.
In some people, gout attacks may worsen at the beginning of certain therapies
used to control uric acid levels. Not everyone experiences
exacerbations, but you may experience an exacerbation even when taking
Febuxostat CT, especially during the first weeks or months of therapy. It is
important that you continue to take Febuxostat CT even in the presence of an
exacerbation, as Febuxostat CT continues to act to lower your
uric acid level. If you continue to take Febuxostat CT every day, over time, exacerbations will occur less frequently and will be
less painful.
Your doctor will often prescribe other medicines, if necessary, to help prevent
or treat the symptoms of exacerbations (such as pain and swelling in a
joint).
In patients with very high uric acid levels (e.g. patients undergoing chemotherapy), the
treatment with drugs that lower uric acid levels may cause
accumulation of xanthine in the urinary tract with possible formation of stones, although
this has not been observed in patients treated with febuxostat for Tumor Lysis Syndrome.
Your doctor may prescribe blood tests to check that your liver
is functioning normally.

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

Other medicines and Febuxostat CT
Tell your doctor or pharmacist if you are taking, have recently taken or
may take any other medicines.
It is very important that you tell your doctor or pharmacist if you are taking a
medicine that contains any of the following substances, as these may
interact with Febuxostat CT and your doctor may want to consider
appropriate measures:

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

Pregnancy and breastfeeding
It is not known whether Febuxostat CT can harm the fetus. Febuxostat CT should 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 intend
to do so.
If you are pregnant or breastfeeding, suspect or are planning a pregnancy, ask your doctor or pharmacist for advice before
taking this medicine.

Driving and using machines
Be aware that you may experience dizziness, drowsiness, blurred vision and numbness or tingling during treatment and, if presence of
these symptoms, you should not drive vehicles or use machines.

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 following exactly the instructions of your doctor. If you
have any doubts, consult your doctor or pharmacist.

• The usual dose is one tablet a day. The back of the blister is marked with the days of the week. This way you can check that you have taken a dose every day.
• The tablets must be taken by mouth, both with or without food.

Gout
Febuxostat CT is available in tablet form of 80 mg or 120 mg. Your doctor will
prescribe the most suitable dosage for you.
Continue to take Febuxostat CT every day, even in the absence of flare-ups or
an attack of gout.

Febuxostat CT 120 mg:

Prevention and treatment of high uric acid concentrations in patients undergoing

chemotherapy
Febuxostat CT is available in tablet form of 120 mg.
Start taking Febuxostat CT two days before chemotherapy and continue to
use 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 to find out what to do or
contact the nearest Emergency Room.

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 to take the next dose. In
that case skip the missed dose and take the next dose at the scheduled time.
Do not take a double dose to make up for the missed dose.

If you stop taking Febuxostat CT
Do not stop treatment with Febuxostat CT without your doctor's consent,
even if you feel better. If you stop treatment with Febuxostat CT, your
uric acid levels may start to rise and your symptoms may worsen due to the
formation of new urate crystals inside and around your
joints and your kidneys.
If you have any doubts about the use of this medicine, ask your doctor or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop treatment with the medicine and immediately contact your doctor 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 a serious allergic reaction may occur:

• Anaphylactic reactions, hypersensitivity to the drug (see also section 2 "Warnings and Precautions")
• Skin rashes potentially fatal, characterized by the formation of blisters and peeling of the skin and internal surfaces of the body, such as the mouth and genitals, painful ulcers in the mouth and/or genital area, accompanied by fever, sore throat and fatigue (Stevens-Johnson syndrome/toxic epidermal necrolysis), or enlarged 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:

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

Other side effects that are 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 fat levels, weight gain
• Loss of sexual desire
• Difficulty sleeping, drowsiness
• Dizziness, numbness, tingling, reduced or altered sense of touch (hypoesthesia, hemiparesis or paresthesia), reduced or altered sense of taste (hyposmia)
• ECG abnormalities, irregular or accelerated heartbeat, perception of heartbeat (palpitations)
• Hot flashes or redness (e.g., flushing of the 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 the nasal passages and/or throat (upper respiratory tract infection), bronchitis
• Dry mouth, abdominal pain or discomfort or gas, heartburn/indigestion, constipation, more frequent bowel movements, vomiting, gastric discomfort
• Itching, hives, skin inflammation, changes in skin color, small red or purple spots on the skin, small flat red spots on the skin, red area on the 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 (inflammation of the joints usually accompanied by pain, swelling and/or stiffness), pain in the extremities, back pain, muscle spasms
• Blood in the urine, increased frequency of urination, abnormalities in urine tests (increased protein levels in the urine), decreased kidney function
• Fatigue, chest pain, chest discomfort
• Gallstones or bile duct stones (cholelithiasis)
• Increased levels in the blood of thyroid-stimulating hormone (TSH)
• Changes in blood biochemical test values or red blood cell or platelet count (alteration of blood test results)
• Kidney stones
• Difficulty achieving an erection

Rare side effects(may affect up to 1 in 1000 people) are:

• Muscle damage, a condition that can rarely be severe. Muscle problems can develop and, in particular, if you simultaneously feel unwell or have a high fever, this could be a consequence of abnormal breakdown of muscle cells. Contact your doctor immediately if you experience muscle pain, tenderness or weakness.
• Marked swelling of the deeper layers of the skin, especially around the lips, eyes, genitals, hands, feet or tongue, with possible sudden difficulty breathing
• High fever associated with a measles-like rash, enlarged lymph nodes, enlarged liver, hepatitis (up to liver failure), increased white blood cell count (leukocytosis, associated or not with eosinophilia)
• Redness of the skin (erythema), skin rash of various types (e.g., itching, with white spots, with blisters, with blisters containing pus, with peeling of the skin, measles-like rash), widespread erythema, necrosis and blistering detachment of the epidermis and mucous membranes, resulting in exfoliation and possible sepsis (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• Nervousness
• Feeling of thirst
• Ringing in the ears
• Blurred vision, altered vision
• Hair loss
• Ulcerations in the oral cavity
• Inflammation of the pancreas: common symptoms are abdominal pain, nausea and vomiting
• Excessive sweating.
• Weight loss, increased appetite, 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 decrease in amount in urine due to inflammation in the kidneys (tubulo-interstitial nephritis)
• Inflammation of the liver (hepatitis)
• Jaundice (icterus)
• Liver damage
• Increased levels of creatine phosphokinase in the blood (an indicator of muscle damage)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the packaging or on the blister after the words “EXP.” The expiry date refers to the last day of that month.
• The medicine does not require any particular storage conditions.

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

6. Package Contents and Other Information

What Febuxostat CT contains

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

Description of the appearance of Febuxostat CT and package contents

Febuxostat CT 80 mg:film-coated tablets, yellow to pale yellow in color,
capsule-shaped, with “80” imprinted on one side and smooth on the other side, with
dimensions of 16.5 mm x 7.0 mm ± 5%.

Febuxostat CT 120 mg:film-coated tablets, yellow to pale yellow in color,
capsule-shaped, with “120” imprinted on one side and smooth on the other side, with
dimensions of 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)
Manufacturer:
Rontis Hellas Medical and Pharmaceutical Products S.A
P.O. Box 3012 LarisaIndustrial 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 denominations:
MALTA:Febuxostat PharOs 80mg and 120mg film-coated tablets

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