InfoCons Consumer Protection informs you – Adenuric – Package Leaflet

Before anything else

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effec ts talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 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 of a chemical 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. When this happens, urate crystals may form in and around the joints and kidneys. T hese crystals can cause sudden, severe pain, redness, warmth and swelling in a joint (known as a gout attack). Left untreated, larger deposits called tophi may form in and around joints. These tophi may cause joint and bone damage.

ADENURIC works by reduc ing uric acid levels. Keeping uric acid levels low by taking ADENURIC once every day stops crystals building up, and over time it reduces symptoms. Keeping uric acid levels sufficiently low for a long enough period can also shrink tophi.

ADENURIC 120 mg t ablets is also used to treat and prevent high blood levels of uric acid that may occur when you start to receive chemotherapy for blood cancers.

When chemotherapy is given, cancer cells are destroyed, and uric acid levels increase in the blood accordingly, unless the formation of uric acid is prevented.

ADENURIC is for adults.

⚠️ 2. What you need to know before you take ADENURIC

Do not take ADENURIC

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

47 Warnings and precautions Talk to your doctor before taking ADENURIC:

• If you have or have had heart failure , heart problems or stroke
• If you have or have had renal disease and/or serious allergic reaction to Allopurinol (a medication used for the treatm ent of Gout)
• If you have or have had liver disease or liver function test abnormalities
• If you are being treated for high uric acid levels as a result of Lesch -Nyhan syndrome (a rare inherited condition in which there is too much uric acid in the blood)
• If you have thyroid problems.

Should you experience allergic reactions to ADENURIC, stop taking this medicine (see also section 4). Possible symptoms of allergic reactions might be:

• rash including severe forms (e.g. blisters, nodules, itchy -, exfoliative rash), itchiness
• swelling of limbs or face
• difficulties in breathing
• fever with enlarged lymph nodes
• but also serious life threatening allergic conditions with cardiac and circulatory arrest.

Your doctor might decide to permanently stop treatment with ADENURIC.

There have been rare reports of potentially life -threatening skin rashes (Stevens -Johnson Syndrome) with the use of ADENURIC, appearing initially as reddish target -like spots or circular patches often with central blister on the trunk. It m ay also include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). The rash may progress to widespread blistering or peeling of the skin.

If you have developed Stevens -Johnson Syndrome with the use of febuxostat, you mus t not be re – started on ADENURIC at any time. If you develop a rash or these skin symptoms, seek immediate advice from a doctor and tell that you are taking this medicine.

If you are having a gout attack at the moment (a sudden onset of severe pain, tender ness, redness, warmth and swelling in a joint), wait for the gout attack to subside before first starting treatment with ADENURIC.

For some people, gout attacks may flare up when starting certain medicines that control uric acid levels. Not everyone gets flares, but you could get a flare -up even if you are taking ADENURIC, and especially during the first weeks or months of treatment. It is important to keep taking ADENURIC even if you have a flare, as ADENURIC is still working to lower uric acid. Over time , gout flares will occur less often and be less painful if you keep taking ADENURIC every day.

Your doctor will often prescribe other medicines, if they are needed, to help prevent or treat the symptoms of flares (such as pain and swelling in a joint).

In patients with very high urate levels (e.g. those undergoing cancer chemotherapy), treatment with uric acid-lowering medicines could lead to the build -up of xanthine in the urinary tract, with possible stones, even though t his has not been observed in pat ients being treated with ADENURIC for Tumor Lysis Syndrome.

Your doctor may ask you to have blood tests to check that your liver is working normally.

Children and adolescents

Do not give this medicine to children under the age of 18 because the safety a nd efficacy have not been established.

48 Other medicines and ADENURIC Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

It is especially importan t to tell your doctor or pharmacist if you are taking medicines containing any of the following substances as they may interact with ADENURIC and your doctor may wish to consider necessary measures:

• Mercaptopurine (used to treat cancer)
• Azathioprine (used to reduce immune response)
• Theophylline (used to treat asthma) Pregnancy and breast -feeding It is not known if ADENURIC may harm your unborn child. ADENURIC should not be used during pregnancy. It is not known if ADENURIC may pass into human breast milk. You should not use ADENURIC if you are breast feeding, or if you are planning to breastfeed.

If you are pregnant or breast -feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medi cine.

Driving and using machines

Be aware that you may experience dizziness, sleepiness, blurred vision and numbness or tingling sensation during treatment and should not drive or operate machines if affected.

ADENURIC contains lactose

ADENURIC tablets contain lactose (a type of sugar). If you have been told that you have an intolerance to some sugars contact your doctor before taking this medicine.

ADENURIC contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium – free’.

💊 3. How to take ADENURIC

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

• The usual dose is one tablet daily. The back of the blister pack is marked w ith the days of the week to help you check that you have taken a dose each day.
• The tablets should be taken by mouth and can be taken with or without food.

Gout ADENURIC is available as either an 80 mg tablet or a 120 mg tablet. Your doctor will have pres cribed the strength most suitable for you.

Continue to take ADENURIC every day even when you are not experiencing gout flare or attack.

Prevention and treatment of h igh uric acid levels in patients undergoing cancer chemotherapy ADENURIC is available as a 120 mg tablet.

Start taking ADENURIC two days before chemotherapy and continue its use according to your doctor’s advice. Usually treatment is short -term.

49 The score line on the 80 mg tablet is only there to help you break the tablet if you have difficul ty swallowing it whole.

If you take more ADENURIC than you should

In the event of an accidental overdose ask your doctor what to do, or contact your nearest accident and emergency department.

If you forget to take ADENURIC

If you miss a dose of ADENURI C take it as soon as you remember unless it is almost time for your next dose, in which case miss out the forgotten dose and take your next dose at the normal time. Do not take a double dose to make up for a forgotten dose.

If you stop taking ADENURIC

Do not stop taking ADENURIC without the advice of your doctor even if you feel better. If you stop taking ADENURIC your uric acid levels may begin to rise and your symptoms may worsen due to the formation of new crystals of urate in and around your joints an d kidneys.

If you have any further questions on 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 everybody gets them.

Stop taking this medicine and contact your doctor immediately or go to an emergency department nearby if the following rare (may affect up to 1 in 1,000 people) side effects occur, because a serious allergic reaction might follow:

• anaphylactic reactions, drug hypersensitivity (see als o section 2 “Warnings and precautions”)
• potentially life -threatening skin rashes characteri sed by formation of blisters and shedding of the skin and inner surfaces of body cavities, 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 by enlarged lymph nodes, liver enlargement, hepatitis (up to liver failure), raising of the white -cells count in the blood (drug reaction with eosinophilia and systemic symptoms -DRESS) (see section 2)
• generalised skin rashes The common side effects (may affect up to 1 in 10 people) are:
• abnormal liver test results
• diarrhoea
• headache
• rash (including various types of rash, please see below under “uncom mon” and “rare” sections)
• nausea
• increase in gout symptoms
• localised swelling due to retention of fluids in tissues (oedema)
• dizziness
• shortness of breath
• itching
• pain in extremity , pain/ache in muscles/joints
• fatigue

Other side effects which are not ment ioned above are listed below.

Uncommon side effects (may affect up to 1 in 100 people) are

50 • decreased appetite, change in blood sugar levels (diabetes) of which a symptom may be excessive thirst, increased blood fat levels, weight increase

• loss of sex dri ve
• difficulty in sleeping, sleepiness
• numbness, tingling, reduced or altered sensation (hypoesthesia, hemiparesis or paraesthesia), altered sense of taste , diminished sense of smell (hyposmia)
• abnormal ECG heart tracing, irregular or rapid heartbeats, feel ing your heart beat (palpitation)
• hot flushes or flushing (e.g. redness of the face or neck), increased blood pressure, bleeding (hemorrhage, seen only in patients taking chemotherapy for blood disorders)
• cough, chest discomfort or pain, inflammation of na sal passage and/or throat (upper respiratory tract infection), bronchitis , lower respiratory tract infection
• dry mouth, abdominal pain/discomfort or wind , abdominal pain upper , heartburn/indigestion, constipation, more frequent passing of stools, vomiting, stomach discomfort
• itchy rash, hives, skin inflammation, skin dis coloration, small red or purple spot s on the skin, small, flat red spots on the skin, flat, red area on the skin that is covered with small confluent bumps, rash, areas of redness and spots on the skin, increased sweating , night sweating, alopecia, reddening of the skin (erythema) , psoriasis, eczema , other type of skin conditions muscle cramp, muscle weakness, bursitis or arthritis (inflammation of joints usually accompanied by pain, swelling and/or stiffness), back pain, muscle spasm , muscle and/or joint stiffness
• blood in the urine, abnormal frequent urination, abnormal urine tests (increased level of proteins in the urine), a reduction in the ability of the kidneys to function properly , urinary tract infection
• chest pain, chest discomfort
• stones in the gallbladder or in bile ducts (cholelithiasis)
• increase in blood thyroid stimulating hormone (TSH) level
• changes in blood chemistry or amount of blood cells or platelets (abnormal blood test res ults)
• kidney stones
• erectile difficulties
• decreased activity of thyroid gland , blurred vision, change in vision
• ringing in the ears
• runny nose
• mouth ulceration
• inflammation of the pancreas: common symptoms are abdominal pain, nausea and vomiting
• urgent nee d to urinate
• pain
• malaise
• INR increased
• contusion
• lip swelling

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

• muscle damage, a condition which on rare occasions can be serious. It may cause muscle problems and particularly, if at the same tim e, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown. Contact your doctor immediately if you experience muscle pain, tenderness or weakness
• severe swelling of the deeper layers of the skin, especially around the ey es, genitals, hands, feet or tongue, with possible sudden difficult breathing
• high fever in combination with measles -like skin rash, enlarged lymph nodes, liver enlargement, hepatitis (up to liver failure), raising of the white -cells count in the blood (le ukocytosis, with or without eosinophilia)
• rash in various types (e.g. with white spots, with blisters, with blisters containing pus, with shedding of the skin, measles -like rash), widespread erythema, necrosis, and bullous detachment of the epidermis and m ucous membranes, resulting in exfoliation and possible sepsis (Stevens- Johnson Syndrome/Toxic epidermal necrolysis)
• nervousness 51 • feeling thirsty
• weight decrease, increased appetite, uncontrolled loss of appetite (anorexia)
• abnormally low blood cell counts ( white or red blood cells or platelets)
• changes or decrease in urine amount due to inflammation in the kidneys (tubulointerstitial nephritis)
• inflammation of the liver (hepatitis)
• yellowing of the skin (jaundice)
• infection of the bladder
• liver damage
• increased level of creatine phosphokinase in blood (an indicator of muscle damage)
• sudden cardiac death
• low red blood cell counts (anaemia)
• depression
• sleep disturbance
• loss of sense of taste
• burning sensation
• vertigo
• circulatory failure
• lung infection (pneumoni a)
• mouth sores; inflammation of the mouth
• gastrointestinal perforation
• rotator cuff syndrome
• polymyalgia rheumatic
• feeling hot
• sudden vision loss due to blockage of an artery in the eye

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.

🌡️ 5. How to store ADENURIC

• 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 carton and the tablet blister foil after ‘EXP.’ The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.

Do not th row away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

📦 6. Contents of the pack and other information

What ADENURIC contains

The active substance is febuxostat.

Each tablet contains 80 mg or 120 mg of febuxostat.

The other ingredients are:

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

52 Film-coating: Opadry II yellow, 85F42129 containing: polyvinyl alcohol, titanium dioxide (E171), macrogols 3350, talc, iron oxide yellow (E172)

What ADENURIC looks like and contents of the pack

ADENURIC film -coated tablets are pale yellow to yel low in colour and capsule shaped.

The 80 mg film-coated tablets are marked on one side with ‘80’ and on the other side with a score line .

The 120 mg film-coated tablets are marked on one side with ‘120’.

ADENURIC 80 mg and 120 mg is packed in clear (Aclar /PVC/Aluminium or PVC/PE/PVDC/Aluminium ) blister of 14 tablets.

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

Not all 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 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Menarini Benelux NV/SA Tél/Tel: + 32 (0)2 721 4545 Lietuva UAB “BERLI N-CHEMIE MENARINI BALTIC” Tel: +370 52 691 947 България “Берлин-Хеми/А. Менарини България ” EООД тел.: +359 2 454 0950 Luxembourg/Luxemburg Menarini Benelux NV/SA Tél/Tel: + 32 (0)2 721 4545 Česká republika Berlin-Chemie/A.Menarini Ceska republika s.r.o .

Tel: +420 267 199 333 Magyarország Berlin-Chemie/A. Menarini Kft.

Tel.: +36 1799 7320 Danmark Pharmaprim AB Tlf: +468355933 Malta Menarini International Operations Luxembourg S.A.

Tel: +352 264976 Deutschland Berlin-Chemie AG Tel: +49 (0) 30 67070 Nederland Menarini Benelux NV/SA Tel: +32 (0)2 721 4545 Eesti OÜ Berlin -Chemie Menarini Eesti Tel: +372 667 5001 Norge Pharmaprim AB Tlf: +468355933 Ελλάδα MENARINI HELLAS AE Τηλ: +30 210 8316111 -13 Österreich A. Menarini Pharma GmbH.

Tel: +43 1 879 95 85 -0 España Laboratorios Menarini S.A.

Tel: +34-93 462 88 00 Polska Berlin-Chemie/Menarini Polska Sp. z o.o.

Tel.: +48 22 566 21 00 France MENARINI France Tél: +33 (0)1 45 60 77 20 Portugal A. Menarini Portugal – Farmacêutica, S.A.

Tel: +351 210 935 500 Hrvatska Berlin-Chemie Menarini Hrvatska d.o.o.

Tel : + 385 1 4821 361 România Berlin-Chemie A.Menarini S.R.L.

Tel: +40 21 232 34 32 Ireland A. Menarini Pharmaceuticals Ireland Ltd Tel: +353 1 284 6744 Slovenija Berlin-Chemie / A. Menarini Distribution Ljubljana d.o.o.

Tel: +386 01 300 2160 Ísland Pharmaprim AB Sími: +468355933 Slovenská republika Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o Tel: +421 2 544 30 730 Italia A. Menarini Industrie Farmaceutiche Riunite s.r.l.

Tel: +39-055 56801 Suomi/Finland Berlin-Chemie/A.Menarini Suomi OY Puh/Tel: +358 403 000 760 Κύπρος MENARINI HELLAS AE Τηλ: +30 210 8316111 -13 Sverige Pharmaprim AB Tel: +468355933 Latvija SIA Berlin -Chemie/Menarini Baltic Tel: +371 67103210 United Kingdom (Northern Ireland) A. Menarini Farmaceutica Internazionale S.R.L.

Tel: +44 (0)1628 856400

This leaflet was last revised in

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

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Adenuric (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/08/447).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.