80 mg, 120 mg Film-coated tablets
Febuxostat
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 substance called uric acid (urate). In some people, the amount of uric acid builds up in the blood and can become too high to still be soluble. When this occurs, urate crystals can form in and around joints and kidneys. These crystals can cause sudden, severe pain, redness, heat, and swelling in a joint (this is called a gout attack). If left untreated, larger deposits called tofi can form in and around joints. These tofi can damage joints and bone tissue.
ADENURIC works by lowering uric acid levels. By taking ADENURIC once a day, uric acid levels are kept low, which prevents the formation of crystals, and over time the symptoms decrease. By keeping uric acid levels low enough for a long time, tofus can also be reduced
ADENURIC 120 mg tablets are also used to treat and prevent high levels of uric acid in the blood that may occur when starting your chemotherapy for blood cancer.
Chemotherapy destroys the cancer cells and therefore the uric acid levels in the blood rise unless the production of uric acid is prevented.
ADENURIC is used in adults.
2. What you need to know before using ADENURIC
Do not use ADENURIC
- if you are allergic to febuxostat or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor before taking ADENURIC:
- if you have or have had heart failure, heart problems, or strokes
- if you have or have had kidney disease and/o a severe allergic reaction to allopurinol (a medicine used to treat gout )
- if you have or have had liver disease or abnormal liver values’
- if you are treated for high uric acid levels due to Lesch-Nyhan syndrome (a rare hereditary condition that causes too much uric acid in the blood)
- if you have thyroid problems.
If you get an allergic reaction to ADENURIC, stop taking this medicine (see also section 4). Possible symptoms of an allergic reaction are:
- severe forms of rash (eg blisters, lumps, itchy and scaly rash), itching
- swelling of the legs and face
- breathing difficulties
- fever with enlarged lymph nodes
- but also severe life-threatening allergic conditions with cardiac and circulatory arrest.
Your doctor may decide to permanently discontinue treatment with ADENURIC.
There have been rare reports of life-threatening skin rash ( Stevens-Johnson syndrome) associated with the use of ADENURIC. These first appear as reddish dots or round spots, often with a blister in the middle, on the torso. It can also include sores in the mouth, throat, nose, genitals, and eye inflammation (red and swollen eyes). The rash can develop into blisters over large areas of skin detachment.
If you have had Stevens-Johnson syndrome while using ADENURIC, you should never use febuxostat again. If you get a rash or these skin symptoms, contact your doctor immediately and tell them that you are taking this medicine.
If you have a gout attack right now (sudden onset of severe pain, tenderness, redness, heat, and swelling in a joint), wait until the gout attack has subsided before starting treatment with ADENURIC for the first time.
In some people, gout attacks may flare up when they start taking certain medications that control the levels of uric acid. Not everyone gets attacks, but you can get an attack even if you take ADENURIC, and especially during the first weeks or months of treatment. It is important that you continue to take ADENURIC even if you have an attack, as ADENURIC still works by lowering the uric acid level. Over time, gout attacks will occur less frequently and be less painful
if you continue to take ADENURIC every day.
Your doctor will often prescribe other medicines, if needed, to help prevent or treat the symptoms of seizures (such as pain and swelling in a joint).
Treatment of patients with very high urate levels (eg patients undergoing chemotherapy for cancer) with uric acid-lowering drugs may lead to an increase in urinary tract xanthine and possible stones, although this has not been observed in patients treated with ADENURIC for tumor lysis syndrome.
Your doctor may ask you to provide blood tests to check that your liver is functioning normally.
Children and young people
Do not give this medicine to children under 18 years of age as safety and efficacy have not been established.
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 important that you tell your doctor or pharmacist if you are taking medicines that contain any of the following substances, as they may affect or be affected by ADENURIC and your doctor may want to consider the necessary measures:
- Mercaptopurine (used to treat cancer)
- Azathioprine (used to reduce the immune response )
- Theophylline (used to treat asthma )
Pregnancy, breastfeeding, and fertility
It is not known if ADENURIC can harm your unborn baby. ADENURIC should not be used during pregnancy. It is not known whether ADENURIC is excreted in human milk. You should not use ADENURIC if you are breast-feeding or if you are planning to breast-feed.
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 medicine.
Driving and using machines
You should be aware that you may feel dizzy, drowsy, blurred vision, and numbness or tingling during treatment and should not drive or use machines if you are affected.
ADENURIC contains lactose
ADENURIC tablets contain lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to use ADENURIC
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
- The recommended 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 orally and can be taken with or without food.
Gout
ADENURIC is available as an 80 mg tablet or 120 mg tablet. Your doctor has prescribed the strength that suits you best.
Continue to take ADENURIC every day even when you have no gout attack.
Prevention and treatment of high uric acid levels in patients undergoing chemotherapy for cancer
ADENURIC is available as a 120 mg tablet.
Start taking ADENURIC two days before your chemotherapy and continue using ADENURIC exactly as your doctor has told you. The treatment is usually short-lived.
The notch is only for splitting the tablet if you have difficulty swallowing it whole.
If you use more ADENURIC than you should
If you have accidentally taken an overdose, ask your doctor what to do or contact your nearest emergency department.
If you forget to use 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 that case, skip the missed dose one and take the next dose at the normal time. Do not take a double dose to make up for a forgotten dose.
If you stop using ADENURIC
Do not stop taking ADENURIC unless your doctor tells you to, even if you feel better. If you stop taking ADENURIC, your uric acid levels may start to rise and your symptoms may worsen due to the formation of new urate crystals in and around the joints and kidneys.
If you have any further questions on the use of this product, 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 or nearest emergency department immediately if the following rare (affects up to 1 in 1000 people) side effects occur, as a serious allergic reaction may occur:
- Severe allergic reactions (anaphylactic reactions), hypersensitivity to drugs (see also section 2 “Warnings and precautions”)
- potentially life-threatening skin rash characterized by the formation of blisters and flaking of the skin and the inside of the body cavities, e.g. mouth and genitals, painful sores in the mouth and/or areas in and around the genitals, together with fever, sore throat, and fatigue (Stevens-Johnson syndrome / toxic epidermal necrolysis ) or by an enlarged lymph node, enlarged liver, jaundice (up to liver failure), levels of white blood cells in the blood (a reaction to the drug with eosinophilia and systemic symptoms) (see section 2).
- general skin rash
Common side effects are (may affect up to 1 in 10 people) are:
- abnormal results from liver tests
- diarrhea
- headache rash (includes different types of rash, see below under the sections “uncommon” and “rare”)
- nausea
- increased arthritis symptoms
- local swelling due to fluid accumulation in tissue en ( edema )
Other side effects not mentioned above are listed below.
Less common side effects are (may affect up to 1 in 100 people) are:
- decreased appetite, altered blood sugar levels ( diabetes ) with symptoms such as excessive thirst, increased blood fat levels, weight gain
- lost sexual drive
- difficulty sleeping, drowsiness
- dizziness, numbness, tingling, decreased or altered sensation ( hypoesthesia, hemiparesis or paresthesias ), altered sense of taste, impaired sense of smell ( hyposmia )
- abnormal ECG curve, irregular or fast heartbeat, feel your heartbeat ( palpitation )
- hot flashes or redness (eg redness of the face or neck), high blood pressure, bleeding (only in patients receiving chemotherapy for blood diseases)
- cough, shortness of breath, chest discomfort or pain, inflammation of the nose and/or throat (upper respiratory tract infection), bronchitis
- dry mouth, abdominal pain/discomfort or gas, heartburn/indigestion, constipation, denser stools, vomiting, stomach upset
- itching, hives, skin inflammation, discoloration of the skin, small red or purple spots on the skin, small flat red spots on the skin, flat red areas of skin covered with small converging lumps, rashes, red skin areas, and spots on the skin, other types of skin problems
- muscle cramps, muscle weakness, pain/pain in muscles/joints, bursitis or arthritis ( inflammation of joints usually accompanied by pain, swelling and/or stiffness), pain in arms and legs, back pain, muscle spasm
- blood in the urine, abnormally frequent urination, abnormal urine samples (elevated protein level in the urine), the impaired ability of the kidneys to function properly
- fatigue, chest pain, chest discomfort
- stones in the gallbladder or in the bile ducts ( cholelithiasis )
- elevated levels of thyroid-stimulating hormone ( TSH ) in the blood
- changes in blood chemistry or in the number of blood cells or platelets (abnormal blood test results)
- kidney stone
- potency problem
Rare side effects are (may affect up to 1 in 1000 people) are:
- muscle damage, a condition that in rare cases can be serious. It can cause muscle problems, especially if you also feel unwell or have a high fever as it can be caused by an abnormal muscle breakdown. Contact your doctor immediately if you experience muscle pain, tenderness, or weakness
- severe swelling in the deeper layers of the skin, especially around the lips, eyes, genitals, hands, feet, or tongue, possibly with sudden difficulty breathing
- high fever in combination with measles-like rash, enlarged lymph nodes, enlarged liver, jaundice (up to liver failure), elevated white blood cell levels ( leukocytosis, with or without eosinophilia )
- skin redness ( erythema ), various types of rash (eg itchy rash with white spots, with blisters, var-containing blisters, scaly skin, measles-like rash), widespread redness of the skin ( erythema ), tissue death and loosening of the epidermis with blisters and mucous membranes resulting in scaly skin and possible blood poisoning (Stevens-Johnson syndrome / toxic epidermal necrolysis )
- nervousness
- thirst
- ringing in the ears
- blurred vision, vision changes
- hair loss
- sores in the mouth
- 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 blood cell count (white or red blood cells or platelets )
- urgent need to urinate
- change or decrease in the amount of urine due to inflammation of the kidneys (tubulointerstitial nephritis)
- inflammation of the liver ( hepatitis )
- yellow skin (jaundice)
- liver damage
- elevated creatinase levels in the blood (signs of muscle damage)
- sudden cardiac death
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 blister after EXP. The expiration date is the last day of the specified month.
- No special warning instructions.
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.
6. Contents of the packaging and other information
Content declaration
The active substance is febuxostat.
Each tablet contains 80 mg or 120 mg of febuxostat.
Other ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose, magnesium stearate, hydroxypropyl cellulose, croscarmellose sodium, hydrated colloidal silica.
Film coating: Opadry II yellow, 85F42129 containing: polyvinyl alcohol, titanium dioxide (E171), macrogols 3350, talc, yellow iron oxide (E172).
What the medicine looks like and the contents of the pack
ADENURIC film-coated tablets are pale yellow to yellow in color and capsule-shaped.
The film-coated 80 mg tablets are marked with “80” on one side and a breaker notch on the other side. The film-coated 120 mg tablets are marked with “120” on one side.
ADENURIC 80 mg and 120 mg are packaged in clear (Aclar / PVC / Aluminum or
PVC / PE / PVDC / Aluminum) blister with 14 tablets.
ADENURIC 80 mg and 120 mg are available in pack sizes of 14, 28, 42, 56, 84 and 98 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Menarini International Operations Luxembourg SA
1, Avenue de la Gare, L-1611 Luxembourg
Luxembourg
Manufacturer
Patheon France
40 Boulevard de Champaret
38300 Bourgoin Jallieu
France
or
Menarini – Von Heyden HGmBH
Leipziger Strasse 7-13
01097 Dresden
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:
Belgium / Belgique / Belgien
Menarini Benelux NV / SA
Tel: + 32 (0) 2 721 4545
Bulgaria
Berlin-Hemi / A. MENARINI BULGARIA »EOOD
tel .: +359 2 454 0950
Czech Republic
Berlin-Chemie / A.Menarini Ceska republika sro
Tel: +420 267 199 333
Denmark
Pharmaprim AB
Tel: +468355933
Germany
Berlin-Chemie AG
Tel: +49 (0) 30 67070
Eesti
OÜ Berlin-Chemie Menarini Eesti
Tel: +372 667 5001
Greece
MENARINI HELLAS AE
:Ηλ: +30 210 8316111-13
Spain
Laboratorios Menarini SA
Tel: + 34-93 462 88 00
France
MENARINI France
Tel: +33 (0) 1 45 60 77 20
Croatia
Berlin-Chemie Menarini Hrvatska doo
Tel: + 385 1 4821 361
Ireland
A. Menarini Pharmaceuticals Ireland Ltd
Tel: +353 1 284 6744
Iceland
Pharmaprim AB
Phone: +468355933
Italy
A. Menarini Industrie Farmaceutiche Riunite srl
Tel: + 39-055 56801
Κύπρος
MENARINI HELLAS AE
:Ηλ: +30 210 8316111-13
Latvia
SIA Berlin-Chemie / Menarini Baltic
Tel: +371 67103210
Lithuania
UAB “BERLIN-CHEMIE MENARINI BALTIC”
Tel: +370 52 691 947
Luxembourg / Luxemburg
Menarini Benelux NV / SA
Tel: + 32 (0) 2 721 4545
Hungary
Berlin-Chemie / A. Menarini Kft.
Tel .: +36 23501301
Malta
Menarini International Operations Luxembourg SA
Tel: +352 264976
The Netherlands
Menarini Benelux NV / SA
Tel: +32 (0) 2 721 4545
Norway
Pharmaprim AB
Tel: +468355933
Austria
A. Menarini Pharma GmbH.
Tel: +43 1 879 95 85-0
Poland
Berlin-Chemie / Menarini Polska Sp. z oo
Tel .: +48 22 566 21 00
Portugal
A. Menarini Portugal – Pharmaceuticals, SA
Tel: +351 210 935 500
Romania
Berlin-Chemie A.Menarini SRL
Tel: +40 21 232 34 32
Slovenia
Berlin-Chemie / A. Menarini Distribution Ljubljana doo
Tel: +386 01 300 2160
Slovak Republic
Berlin-Chemie / A. Menarini Distribution Slovakia sro
Tel: +421 2 544 30 730
Finland / Finland
Berlin-Chemie / A.Menarini Suomi OY
Puh / Tel: +358 403 000 760
United Kingdom
A. Menarini Farmaceutica Internazionale SRL
Tel: +44 (0) 1628 856400