ADENURIC 80 mg film-coated tablets

ADENURIC tablets 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. These crystals can cause sudden, severe pain, redness, warmth and swelling in a joint (known as a gout attack). Left untreated, larger deposits called tophi (TOE-FI) may form in and around joints. These tophi may cause joint and bone damage.

ADENURIC works by reducing 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.

Do not take ADENURIC if you are:

• If you are allergic (hypersensitive) to febuxostat, the active ingredient of ADENURIC, or any of the other ingredients in these tablets.

Take special care with ADENURIC

Tell your doctor before you start to take this medicine:

• If you have or have had heart failure or heart problems
• If you are being treated for high uric acid levels as a result of cancer disease or 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 are having a gout attack at the moment (a sudden onset of severe pain, tenderness, 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).

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

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.

It is especially important 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)

Taking ADENURIC with food and drink

The tablets should be taken by mouth and can be taken with or without food.

Pregnancy and breast-feeding

It is not known if ADENURIC may harm your unborn child. Tell your doctor if you think you are pregnant or if you are planning to become pregnant as 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.

Driving and using machines

No studies on the effects of ADENURIC on the ability to drive and use machines have been performed. However, you should be aware that you may experience dizziness, sleepiness and numbness or tingling sensation during treatment and should not drive or operate machines if affected.

Important information about some of the ingredients of ADENURIC

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.

Always take ADENURIC exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

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

• The usual dose is one tablet daily. The back of the blister pack is marked with 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.

It is important that you do not stop taking ADENURIC unless your doctor tells you to.

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

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 ADENURIC 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 and kidneys.

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

Like all medicines, ADENURIC can cause side effects, although not everybody gets them.

Common side effects (reported in more than 1 in 100 patients but less than 1 in 10 patients) are:

• abnormal liver test results
• diarrhoea
• headache
• rashes
• nausea
• increase in gout symptoms

Uncommon side effects (more than 1 in 1,000 patients but less than 1 in 100 patients) are:

• decreased appetite, change in blood sugar levels (diabetes) of which a symptom may be excessive thirst, increased blood fat levels
• loss of sex drive
• difficulty in sleeping, sleepiness
• dizziness, numbness, tingling, reduced or altered sensation (hypoaesthesia or paraesthesia), altered or reduced sense of taste
• abnormal ECG heart tracing, irregular heartbeats, feeling your heart beat
• hot flushes or blushing (e.g. redness of the face or neck), increased blood pressure
• cough, shortness of breath, chest discomfort or pain, inflammation of nasal passage and/or throat (upper respiratory tract infection), bronchitis
• dry mouth, abdominal pain/discomfort or wind, heartburn/indigestion, constipation, more frequent passing of stools, vomiting, stomach discomfort
• itching, hives, skin inflammation or discolouration, other type of skin conditions
• muscle cramp, muscle weakness, pain/ache in muscles/joints, bursitis or arthritis (inflammation of joints usually accompanied by pain, swelling and/or stiffness), pain in extremity, back pain, muscle spasm
• 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
• fatigue, localised swelling due to the retention of fluids in the tissues (oedema), chest pain, chest discomfort
• Stones in the gallbladder or in bile ducts (cholelithiasis)
• changes in blood chemistry or amount of blood cells or platelets (abnormal blood test results)
• kidney stones

Rare side effects (more than 1 in 10,000 patients but less than 1 in 1,000 patients) are:

• allergic reactions (e.g. skin rash, itching, swelling)
• generalised skin rashes Stop taking Adenuric and contact your doctor immediately if these side effects occur, because a serious allergic reaction might follow
• nervousness
• feeling thirsty
• erectile difficulties
• ringing in the ears
• hair loss
• mouth ulceration
• inflammation of the pancreas: common symptoms are abdominal pain, nausea and vomiting
• increased sweating
• weight change (increase/decrease), increased appetite, uncontrolled loss of appetite (anorexia)
• muscle and/or joint stiffness
• abnormally low blood cell counts (white or red blood cells)
• urgent need to urinate

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

• Keep out of the reach and sight of children.
• Do not use 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 medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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.

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 yellow in colour and capsule shaped. The 80 mg film-coated tablets are marked on one side with ?80?. The 120 mg film-coated tablets are marked on one side with ?120?.

ADENURIC is supplied in 1 blisters of 14 tablets (14 tablet pack), 2 blisters of 14 tablets (28 tablet pack), 3 blisters of 14 tablets (42 tablet pack), 4 blisters of 14 tablets (56 tablet pack), 6 blisters of 14 tablets (84 tablet pack), 6 blisters of 14 tablets (84 tablet pack) or 7 blisters of 14 tablets (98 tablet pack). 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 medicinal product, please contact the local representative of the Marketing Authorisation Holder.

BelgiëBelgiqueBelgien Menarini Benelux NVSA TélTel 32 02 721 4545 LuxembourgLuxemburg Menarini Benelux NVSA TélTel 32 02 721 4545

- . 359 2 96 55 365 Magyarország Berlin-ChemieA. Menarini Kft. Tel. 36 23501301

eská republika Berlin-ChemieA.Menarini Ceska republika s.r.o. Tel 420 272 937 381 Malta Menarini International Operations Luxembourg S.A. Tel 352 264976

Danmark Berlin-ChemieA.Menarini Danmark ApS Tlf 4548 217 110 Nederland Menarini Benelux NVSA Tel 32 02 721 4545

Deutschland Berlin-Chemie AG Tel 49 0 30 67070 Norge Menarini International Operations Luxembourg S.A. Tlf 352 264976

Eesti OÜ Berlin-Chemie Menarini Eesti Tel 372 667 5001 Österreich A. Menarini Pharma GmbH. Tel 43 1 879 95 85-0

MENARINI HELLAS AE 30 210 8316111-13 Polska Berlin-ChemieMenarini Polska Sp. z o.o. Tel. 48 22 566 21 00

España Laboratorios Menarini S.A. Tel 34-93 462 88 00 Portugal A. Menarini Portugal Farmacêutica, S.A. Tel 351 210 935 500

France MENARINI France Tél 33 01 45 60 77 20 România Berlin-Chemie Menarini Group Tel 40 211 232 34 32

Ireland A. Menarini Pharmaceuticals Ltd Tel 353 1 284 6744 Slovenija Berlin-Chemie AG, Podrunica Ljubljana Tel 386 01 300 2160

Slovenská republika Berlin-Chemie AG - obchodné zastúpenie v SR Tel 421 2 544 30 730 Ísland Menarini International Operations Luxembourg S.A. Sími 352 264976

Italia A. Menarini Industrie Farmaceutiche Riunite s.r.l.Tel 39-055 56801 SuomiFinland Berlin-ChemieA.Menarini Suomi OY PuhTel 358 403 000 760

MENARINI HELLAS AE 30 210 8316111-13 Sverige Menarini International Operations Luxembourg S.A. Tel 352 264976

Latvija SIA Berlin-ChemieMenarini Baltic Tel 371 67103210 United Kingdom A. Menarini Pharma U.K. S.R.L. Tel 44 01628 856400

Lietuva
UAB ?BERLIN-CHEMIE MENARINI BALTIC?
Tel: +370 52 691 947

This leaflet was last approved in