PACKAGE LEAFLET: INFORMATION FOR THE USER

FEBUXOSTAT TECNIGEN 80 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before 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, pharmacist, or nurse.
This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What FEBUXOSTAT TECNIGEN is and what it is used for
What you need to know before taking FEBUXOSTAT TECNIGEN
How to take FEBUXOSTAT TECNIGEN
Possible side effects
How to store FEBUXOSTAT TECNIGEN
Contents of the pack and other information

1. What FEBUXOSTAT TECNIGEN is and what it is used for

FEBUXOSTAT TECNIGEN tablets contain the active substance febuxostat and are used
to treat gout, a condition associated with an excess of uric acid (urate) in the body. In
some people, the amount of uric acid accumulating in the blood may become too high to
remain in solution. In this case, urate crystals may form within and around the joints and kidneys. These crystals can cause sudden, intense pain, redness, warmth, and swelling in a joint (a gout attack). If left untreated, larger deposits, called tophi, may form within and around the joints. Tophi can damage joints and bones.
FEBUXOSTAT TECNIGEN works by reducing uric acid levels. Maintaining low uric acid levels by taking FEBUXOSTAT TECNIGEN once daily prevents the accumulation of crystals and, over time, reduces symptoms. If uric acid levels are kept low for a sufficiently long period, tophi may even be reabsorbed.
FEBUXOSTAT TECNIGEN is for use in adults.

2. What you need to know before taking FEBUXOSTAT TECNIGEN

Do not take FEBUXOSTAT TECNIGEN:

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, pharmacist, or nurse before taking FEBUXOSTAT TECNIGEN:

If you have or have had heart failure or other 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 have 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 thyroid problems.

If you experience allergic reactions to FEBUXOSTAT TECNIGEN, stop taking 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 skin 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 TECNIGEN.

Rare, life-threatening skin rashes (Stevens-Johnson syndrome) have been reported during febuxostat treatment, initially appearing on the trunk as reddish spots or circular lesions, often with central blisters. These may also include mouth, throat, nose, genital, or eye ulcers, and conjunctivitis (red, swollen eyes). The rash may progress to widespread blistering or skin peeling.
If you develop Stevens-Johnson syndrome while taking febuxostat, treatment with FEBUXOSTAT TECNIGEN 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 TECNIGEN.
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 TECNIGEN, especially during the first weeks or months of treatment. It is important that you continue taking FEBUXOSTAT TECNIGEN even during a flare-up, as FEBUXOSTAT TECNIGEN continues to work to lower your uric acid levels. If you continue taking FEBUXOSTAT TECNIGEN daily, over time, flare-ups will occur less frequently and become less painful.
Your doctor may prescribe additional medicines, if needed, to help prevent or treat flare-up symptoms (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 lead to xanthine accumulation in the urinary tract, potentially causing kidney stones, although this has not been observed in patients treated with febuxostat for Tumor Lysis Syndrome.
Your doctor may prescribe blood tests to monitor your liver function.
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 TECNIGEN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
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 TECNIGEN and your doctor may 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 TECNIGEN could harm the fetus. FEBUXOSTAT TECNIGEN must not be used during pregnancy. It is not known whether FEBUXOSTAT TECNIGEN passes into breast milk. You must not take FEBUXOSTAT TECNIGEN if you are breastfeeding or planning to breastfeed.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, 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; if so, do not drive or operate machinery.
FEBUXOSTAT TECNIGEN contains lactose
FEBUXOSTAT TECNIGEN tablets contain lactose (a type of sugar). If you know you are intolerant to certain sugars, consult your doctor before taking this medicine.

3. How to take FEBUXOSTAT TECNIGEN

Always take this medicine exactly as instructed by your doctor. If you have any doubts, you must consult your doctor or pharmacist.

The usual dose is one tablet per day. The back of the blister pack shows the days of the week to help you keep track of having taken your daily dose.
The tablets are to be taken orally and may be taken with or without food.

Gout
FEBUXOSTAT TECNIGEN is available as 80 mg tablets.
Continue taking FEBUXOSTAT TECNIGEN every day, even in the absence of flare-ups or a gout attack.
The score line on the tablet is not intended for breaking the tablet.

If you take more FEBUXOSTAT TECNIGEN than you should
In case of accidental overdose, contact your doctor for advice or go immediately to the nearest emergency department.

If you forget to take FEBUXOSTAT TECNIGEN
If you forget to take a dose of FEBUXOSTAT TECNIGEN, take it as soon as you remember, unless it is almost time for your next dose. In this 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 forgotten dose.

If you stop taking FEBUXOSTAT TECNIGEN
Do not stop treatment with FEBUXOSTAT TECNIGEN without consulting your doctor, even if you feel better. If you stop treatment with FEBUXOSTAT TECNIGEN, 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 the use of 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 the medicine and contact your doctor immediately or go to the nearest emergency room if you experience any of the following rare side effects (may affect up to 1 in 1,000 people), as they could indicate a severe allergic reaction:

anaphylactic reactions, hypersensitivity to the drug (see also section 2 "Warnings and Precautions");
skin rashes that may be life-threatening, characterized by blistering and peeling of the skin and internal body surfaces, e.g. mouth and genitals, 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, liver enlargement, hepatitis (up to liver failure), increased white blood cell count (drug reaction with eosinophilia and systemic symptoms - DRESS) (see section 2);
generalized rash.

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

abnormal liver function test results;
diarrhoea;
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 (oedema).

Other side effects not listed 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 libido (sexual desire);
difficulty sleeping, drowsiness;
dizziness, numbness, tingling, reduced or altered sense of touch (hypoesthesia, hemiparesis or paraesthesia), taste disturbances, reduced sense of smell (hyposmia);
abnormal ECG readings, irregular or rapid heartbeat, awareness of heartbeat (palpitations);
hot flushes or redness (e.g. redness of the face or neck), increased blood pressure, bleeding (haemorrhage, observed only in patients undergoing chemotherapy for blood disorders);
cough, shortness of breath, chest pain, inflammation of the nasal passage and/or throat (respiratory tract infection), bronchitis;
dry mouth, abdominal pain or discomfort, excess intestinal gas, heartburn/indigestion, constipation, more frequent defecation, vomiting, gastric discomfort;
itching, hives, skin inflammation, skin colour changes, 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 (inflammation of the joints usually accompanied by pain, swelling and/or stiffness), limb pain, back pain, muscle spasms;
blood in urine, increased frequency of urination, abnormal urine test results (increased 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 may rarely be serious. Muscle problems may develop, and in particular, if you also feel unwell or have a 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 the deeper layers of the skin, especially around the lips, eyes, genitals, hands, feet or tongue, possibly causing sudden difficulty breathing;
high fever associated with a measles-like skin rash, swollen lymph nodes, liver enlargement, hepatitis (up to liver failure), increased white blood cell count (leucocytosis, with or without eosinophilia);
skin redness (erythema), skin eruptions of various types (e.g. itching, with white spots, with blisters, with pus-filled blisters, with 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;
thirst;
ringing in the ears;
blurred vision, changes in vision;
hair loss;
mouth ulceration;
inflammation of the pancreas: common symptoms are abdominal pain, nausea and vomiting;
increased 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 reduced urine output due to kidney inflammation (tubulo-interstitial nephritis);
inflammation of the liver (hepatitis);
yellowing of the skin (jaundice);
liver damage;
increased blood levels of creatine phosphokinase (an indicator of muscle damage).

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FEBUXOSTAT TECNIGEN

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and on the blister foil of the tablets after "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 TECNIGEN contains
The active substance is febuxostat.
Each tablet contains 80 mg of febuxostat.
The other components are:
Tablet core: monohydrate lactose, microcrystalline cellulose, magnesium stearate,
hydroxypropylcellulose, sodium croscarmellose, hydrated colloidal silica.
Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc,
yellow iron oxide (E172).

Appearance of FEBUXOSTAT TECNIGEN and pack sizes
FEBUXOSTAT TECNIGEN 80 mg film-coated tablets are pale yellow/yellow in colour, elongated in shape, and have a score line on one side.
FEBUXOSTAT TECNIGEN 80 mg is supplied in blister packs.
FEBUXOSTAT TECNIGEN 80 mg is available in a pack size of 28 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TECNIGEN S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI)
Italy

Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2
Abrunheira, 2710-089 Sintra
Portugal

This medicinal product is authorised in the EEA Member States under the following names:
Portugal: Febuxostate Tecnigen
Italy: Febuxostat TecniGen
Spain: Febuxostat TecniGen

This Patient Information Leaflet was last revised on