Adenuric 80 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ADENURIC 80mg film-coated tablets.

ADENURIC 120mg film-coated tablets.

febuxostat

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as 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 and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What ADENURIC is and what it is used for

ADENURIC tablets contain the active substance febuxostat and are used to treat gout, which is associated with an excess in the body of a chemical compound called uric acid (urate). In some people, uric acid accumulates in the blood to the point where it can no longer dissolve. When this occurs, urate crystals form both within and around the joints and kidneys. These crystals can cause sudden, intense pain, redness, heat, and swelling in the joints (this is known as gout attacks). If left untreated, large deposits called tophi may form around and within the joints. Tophi can damage joints and bones.

ADENURIC works by reducing the concentration of uric acid. Keeping uric acid levels low by taking ADENURIC once daily helps prevent crystal formation and, over time, reduces symptoms. If uric acid levels are kept low for a sufficient period, the size of tophi also decreases.

ADENURIC 120 mg tablets are also used for the treatment and prevention of high levels of uric acid in the blood that may occur when starting chemotherapy for blood cell cancers.

When chemotherapy is administered, cancer cells are destroyed, and as a result, levels of uric acid in the blood rise, unless its formation is prevented.

ADENURIC is for use in adults.

2. What you need to know before taking ADENURIC

Do not take ADENURIC

• 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 or pharmacist before taking ADENURIC:

• if you have or have had heart failure, heart problems, or stroke
• 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 impaired liver function
• if you are being treated for high levels of uric acid due to Lesch-Nyhan syndrome (a rare inherited condition causing excessive uric acid in the blood)
• if you have thyroid problems.

If you experience allergic reactions to ADENURIC, stop taking this medicine (see also section 4).

Possible symptoms of allergic reactions may include:

• rash including severe forms (e.g. blisters, nodules, exfoliative rashes causing itching), itching
• swelling of the limbs or face
• difficulty breathing
• fever with swollen lymph nodes
• also severe allergic reactions which may be life-threatening, associated with cardiovascular arrest.

Your doctor may decide to permanently discontinue treatment with ADENURIC.

Rare cases of life-threatening skin rashes (Stevens-Johnson Syndrome) have been reported with the use of ADENURIC, initially appearing on the trunk as red target-like spots or circular lesions, often with a blister in the center. It may also include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes). The rash may progress to widespread blistering or skin peeling.

If you have developed Stevens-Johnson Syndrome while using febuxostat, you must never restart treatment. If you develop a rash or these skin symptoms, seek immediate medical attention and inform your doctor that you are taking this medicine.

If you are experiencing a gout attack (sudden, intense pain accompanied by tenderness, redness, warmth, and swelling in a joint), wait until the attack subsides before starting treatment with ADENURIC.

Some people may experience gout attacks when beginning treatment with medicines that control uric acid levels. Not everyone experiences these attacks, but they may occur even while taking ADENURIC, especially during the first weeks or months of treatment. It is important to continue taking ADENURIC even during a gout attack, as the medicine continues to work in reducing uric acid. With daily use of ADENURIC, gout attacks will become less frequent and less painful over time.

If needed, your doctor may prescribe additional medicines to prevent or treat symptoms of gout attacks (such as joint pain and swelling).

In patients with very high urate levels (e.g., those undergoing chemotherapy for cancer), treatment with uric acid-lowering medicines could lead to xanthine accumulation in the urinary tract, potentially causing kidney stones, although this has not been observed in patients treated with ADENURIC for Tumor Lysis Syndrome.

Your doctor may perform 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, as safety and efficacy have not been established.

Taking ADENURIC with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

It is especially important to inform your doctor or pharmacist if you are taking medicines containing any of the following active substances, as they may interact with ADENURIC, and your doctor may need to take special measures:

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

Pregnancy and breastfeeding

It is not known whether ADENURIC may harm the fetus. ADENURIC must not be used during pregnancy. It is not known whether ADENURIC passes into breast milk. Do not use ADENURIC if you are breastfeeding or planning to breastfeed.

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Be aware that you may experience dizziness, drowsiness, blurred vision, or numbness or tingling sensations during treatment. If you experience any of these symptoms, you should not drive or operate machinery.

ADENURIC contains lactose

ADENURIC tablets contain lactose (a type of sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.

ADENURIC contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is essentially “sodium-free”.

3. How to take ADENURIC

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

• The recommended dose is one tablet per day. The blister pack has the days of the week printed on the back to help you check that you take your dose every day.
• The tablets are taken orally, with or without food.

Gout

ADENURIC is available as 80 mg and 120 mg tablets. Your doctor will prescribe the most appropriate dose for you.

Continue taking ADENURIC every day, even if you no longer have gout attacks.

Prevention and treatment of high uric acid levels in patients undergoing chemotherapy for cancer

ADENURIC is available as 120 mg tablets.

Start taking ADENURIC two days before chemotherapy and continue taking it as directed by your doctor. In general, treatment is of short duration.

The notch on the 80 mg tablet is intended only for splitting the tablet if you find it difficult to swallow it whole.

If you take more ADENURIC than you should

In case of accidental overdose, consult your doctor or go to the nearest emergency room.

If you forget to take ADENURIC

If you forget a dose of ADENURIC, take it as soon as you remember, unless it is almost time for the next dose; in that case, skip the missed dose and take the next one at the usual time. Do not take a double dose to make up for a missed dose.

If you stop taking ADENURIC

Even if you feel better, do not stop taking ADENURIC unless instructed by your doctor. If you stop taking ADENURIC, uric acid levels may rise again, and symptoms may worsen due to the formation of new urate crystals in the joints and kidneys.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Stop taking this medicine and contact your doctor immediately or go to the nearest hospital if you experience any of the following rare adverse effects (may affect up to 1 in 1,000 people), as you may be experiencing a severe allergic reaction:

• anaphylactic reactions, hypersensitivity to the medicine (see also section 2 “Warnings and precautions”)
• skin rashes that may be life-threatening, characterized by blistering and peeling of the skin and mucous membranes (e.g. mouth and genitals), painful sores in the mouth and/or genital areas, accompanied by fever, sore throat, and fatigue (Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis), or by swollen lymph nodes, enlarged liver, hepatitis (including liver failure), increased number of white blood cells (leukocytes) in the blood (Drug Reaction with Eosinophilia and Systemic Symptoms - DRESS syndrome) (see section 2)
• generalized skin rashes

The frequent adverse effects (may affect up to 1 in 10 people) are the following:

• abnormal liver function test results
• diarrhea
• headache
• rash (including various types of rash; see below under “uncommon” and “rare” sections)
• nausea
• worsening of gout symptoms
• localized swelling due to fluid retention in tissues (edema)
• dizziness
• breathing difficulties
• itching
• pain in limbs, muscle/joint pain
• fatigue

Other adverse effects not mentioned above are listed below.

The uncommon adverse effects (may affect up to 1 in 100 people) are the following:

• decreased appetite, change in blood sugar levels (diabetes) which may present as excessive thirst, increased blood fats, weight gain
• loss of sexual appetite
• difficulty sleeping, drowsiness
• numbness, tingling sensation, decreased or altered sensitivity (hypoesthesia, hemiparesis or paresthesia), altered sense of taste, reduced sense of smell (hyposmia)
• abnormalities in ECG (electrocardiogram), irregular or rapid heartbeat, awareness of heartbeats (palpitations)
• hot flushes or flushing (redness of face or neck), increased blood pressure, bleeding (hemorrhage, observed only in patients receiving chemotherapy for blood disorders)
• cough, chest discomfort or pain, nasal and/or throat inflammation (upper respiratory tract infection), bronchitis, lower respiratory tract infection
• dry mouth, abdominal pain or discomfort or gas, upper abdominal pain, heartburn or indigestion, constipation, more frequent bowel movements, vomiting, stomach discomfort
• itchy rash, hives, skin inflammation or discoloration, small red or purple spots on the skin, small skin bumps, skin bumps covered with interconnected small lumps, rash, hives and skin spots, increased sweating, night sweats, alopecia, skin redness (erythema), psoriasis, eczema, other skin disorders
• muscle cramps, muscle weakness, bursitis or arthritis (joint inflammation, usually accompanied by pain, swelling or stiffness), back pain, muscle spasms, muscle and/or joint stiffness
• blood in urine, abnormally frequent urination, abnormal urine tests (increased concentration of protein in urine), reduced kidney function, urinary tract infection
• chest pain, chest discomfort
• gallstones or bile duct stones (cholelithiasis)
• increased levels of thyroid-stimulating hormone (TSH) in blood
• changes in blood biochemistry or in the number of blood cells or platelets (abnormal blood test results)
• kidney stones
• erectile dysfunction
• decreased activity of the thyroid gland
• blurred vision, vision changes
• ringing in the ears
• runny nose
• mouth ulcers
• pancreatitis: common symptoms are abdominal pain, nausea and vomiting
• urgent need to urinate
• pain
• malaise
• increased INR
• bruising
• swelling of the lips

The rare adverse effects (may affect up to 1 in 1,000 people) are the following:

• muscle damage, which in rare cases may be severe. It may cause muscle problems and particularly, if you also feel unwell or have a high fever, it may be due to abnormal muscle breakdown. Contact your doctor immediately if you experience muscle pain, tenderness or weakness

• severe swelling of deeper layers of the skin, especially around the eyes, genitals, hands, feet or tongue, which may cause sudden breathing difficulties

• high fever accompanied by a measles-like rash, swollen lymph nodes, enlarged liver (including liver failure), increased number of white blood cells in blood (leukocytosis, with or without eosinophilia)

• different types of rash (e.g. with white spots and blisters, blisters containing pus, skin peeling, measles-like rash), generalized erythema, necrosis, blistering detachment of skin and mucous membranes, leading to exfoliation and possible sepsis (Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis)

• nervousness

• sensation of thirst

• weight loss, increased appetite, uncontrolled loss of appetite (anorexia)

• muscle and/or joint stiffness

• abnormal blood cell count (white cells, red cells or platelets)

• changes or decreased urine volume due to kidney inflammation (tubulointerstitial nephritis)

• liver inflammation (hepatitis)

• yellowing of the skin (jaundice)

• bladder infection

• liver damage

• increased levels of creatine phosphokinase in blood (a marker of muscle damage)

• sudden cardiac death

• low red blood cell count (anemia)

• depression

• sleep disorder

• loss of taste

• burning sensation

• dizziness

• circulatory failure

• lung infection (pneumonia)

• mouth sores; mouth inflammation

• gastrointestinal perforation

• rotator cuff syndrome

• polymyalgia rheumatica

• feeling of warmth

• sudden loss of vision due to blockage of an artery in the eye

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of ADENURIC

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the cardboard box and blister pack after CAD/EXP. The expiry date refers to the last day of the month indicated.
• This medicine does not require any special storage conditions.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to properly dispose of any unused medicine and its packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of ADENURIC

The active substance is febuxostat.

Each tablet contains 80 mg or 120 mg of febuxostat.

The other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose, magnesium stearate, hydroxypropylcellulose, sodium croscarmellose, colloidal hydrated silica.

Tablet coating: Opadry II yellow 85F42129, which contains: polyvinyl alcohol, titanium dioxide (E171), macrogols 3350, talc, yellow iron oxide (E172).

Appearance of the product and contents of the pack

ADENURIC film-coated tablets are yellow or light yellow capsule-shaped tablets.

The 80 mg film-coated tablets are printed with “80” on one side and have a score line on the other side. The 120 mg film-coated tablets are printed with “120” on one side.

ADENURIC 80 mg and 120 mg is supplied in transparent blisters (Aclar/PVC/Aluminium or PVC/PE/PVDC/ALUMINIUM) containing 14 tablets.

ADENURIC 80 mg and 120 mg is available in packs of 14, 28, 42, 56, 84 and 98 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Menarini International Operations Luxembourg S.A.

1, Avenue de la Gare, L-1611 Luxembourg

Luxembourg

Manufacturer:

Patheon France

40 boulevard de Champaret

38300 Bourgoin Jallieu

France

or

Menarini - Von Heyden GmbH

Leipziger Strasse 7-13

01097 Dresden

Germany

Further information on this medicinal product is available upon request to the local representative of the Marketing Authorisation Holder.

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: Hhttp://www.ema.europa.eu