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Adenuric (febuxostat) – Package leaflet - M04AA03

Updated on site: 11-Jul-2017

Medication nameAdenuric
ATC CodeM04AA03
Substancefebuxostat
ManufacturerMenarini International Operations Luxembourg S.A. (MIOL)

Package leaflet: Information for the user

ADENURIC 80 mg film-coated tablets

ADENURIC 120 mg film-coated tablets

Febuxostat

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 effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What ADENURIC is and what it is used for

2.What you need to know before you take 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 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 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.

ADENURIC 120 mg tablets 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).

Warnings and precautions

Talk to your doctor before taking ADENURIC:

If you have or have had heart failure or heart problems

If you have or have had renal disease and/or serious allergic reaction to Allopurinol (a medication used for the treatment 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 may 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 must not be restarted on ADENURIC at any time. If you developed 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, 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).

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 this has not been observed in patients 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 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 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 medicine.

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.

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 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.

Gout

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.

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

Prevention and treatment of high 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.

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 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 also section 2 “Warnings and precautions”)

potentially life-threatening skin rashes characterized 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 “uncommon” and “rare” sections)

nausea

increase in gout symptoms

localized swelling due to retention of fluids in tissues (oedema)

Other side effects which are not mentioned above are listed below.

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

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 drive

difficulty in sleeping, sleepiness

dizziness, numbness, tingling, reduced or altered sensation (hypoesthesia, hemiparesis or paraesthesia), altered or reduced sense of taste (hyposmia)

abnormal ECG heart tracing, irregular or rapid heartbeats, feeling 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, 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, skin discoloration, small red or purple spot 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, 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, 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 results)

kidney stones

erectile difficulties

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 time, 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 lips, eyes, 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 (leukocytosis, with or without eosinophilia)

reddening of the skin (erythema), rash in various types (e.g. itchy, 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 mucous membranes, resulting in exfoliation and possible sepsis (Stevens-Johnson Syndrome/Toxic epidermal necrolysis)

nervousness

feeling thirsty

ringing in the ears

blurred vision, change in vision

hair loss

mouth ulceration

inflammation of the pancreas: common symptoms are abdominal pain, nausea and vomiting

increased sweating

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

muscle and/or joint stiffness

abnormally low blood cell counts (white or red blood cells or platelets)

urgent need to urinate

changes or decrease in urine amount due to inflammation in the kidneys (tubulointerstitial nephritis)

inflammation of the liver (hepatitis)

yellowing of the skin (jaundice)

liver damage

increased level of creatine phosphokinase in blood (an indicator of muscle damage)

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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 throw 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.

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 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

Lietuva

Menarini Benelux NV/SA

UAB “BERLIN-CHEMIE MENARINI

Tél/Tel: + 32 (0)2 721 4545

BALTIC”

 

Tel: +370 52 691 947

България

Luxembourg/Luxemburg

ТП Берлин-Хеми АГ

Menarini Benelux NV/SA

тел.: +359 2 96 55 365

Tél/Tel: + 32 (0)2 721 4545

Česká republika

Magyarország

Berlin-Chemie/A.Menarini Ceska republika s.r.o.

Berlin-Chemie/A. Menarini Kft.

Tel: +420 267 199 333

Tel.: +36 23501301

Danmark

Malta

Berlin-Chemie/A.Menarini Danmark ApS

Menarini International Operations Luxembourg

Tlf: +4548 217 110

S.A.

 

Tel: +352 264976

Deutschland

Nederland

Berlin-Chemie AG

Menarini Benelux NV/SA

Tel: +49 (0) 30 67070

Tel: +32 (0)2 721 4545

Eesti

Norge

Berlin-Chemie Menarini Eesti

Menarini International Operations Luxembourg

Tel: +372 667 5001

S.A.

 

Tlf: +352 264976

Ελλάδα

Österreich

MENARINI HELLAS AE

A. Menarini Pharma GmbH.

Τηλ: +30 210 8316111-13

España

Polska

Laboratorios Menarini S.A.

Berlin-Chemie/Menarini Polska Sp. z o.o.

Tel: +34-93 462 88 00

Tel.: +48 22 566 21 00

France

Portugal

MENARINI France

A. Menarini Portugal – Farmacêutica, S.A.

Tél: +33 (0)1 45 60 77 20

Tel: +351 210 935 500

Hrvatska

România

Berlin-Chemie Menarini Hrvatska d.o.o.

Berlin-Chemie A.Menarini S.R.L.

Tel : + 385 1 4821 361

Tel: +40 21 232 34 32

Ireland

Slovenija

A. Menarini Pharmaceuticals Ireland Ltd

Berlin-Chemie AG, Podružnica Ljubljana

Tel: +353 1 284 6744

Tel: +386 01 300 2160

Ísland

Slovenská republika

Menarini International Operations Luxembourg

Berlin-Chemie AG - obchodné zastúpenie v SR

S.A.

Tel: +421 2 544 30 730

Sími: +352 264976

 

Italia

Suomi/Finland

A. Menarini Industrie Farmaceutiche Riunite s.r.l.

Berlin-Chemie/A.Menarini Suomi OY

Tel: +39-055 56801

Puh/Tel: +358 403 000 760

Κύπρος

Sverige

MENARINI HELLAS AE

Menarini International Operations Luxembourg

Τηλ: +30 210 8316111-13

S.A.

 

Tel: +352 264976

Latvija

United Kingdom

SIA Berlin-Chemie/Menarini Baltic

A. Menarini Farmaceutica Internazionale S.R.L.

Tel: +371 67103210

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.

ANNEX IV

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS

OF THE MARKETING AUTHORISATION(S)

Scientific conclusions

Taking into account the PRAC Assessment Report on the PSUR(s) for febuxostat, the scientific conclusions of the CHMP are as follows:

The Marketing Authorization Holder (MAH) had suggested including blood creatine phosphokinase (CPK) increase in the Summary of Product Specifications (SmPC) and provided supportive data accordingly.

The Pharmacovigilance Risk Assessment Committee (PRAC) agreed to include blood creatine phosphokinase increase in 4.8 of the SmPC, based on one case from literature and some evidence from clinical trials and in order to create awareness in medical staff to focus on elevated levels of CPK at an early stage.

Therefore, in view of the data presented in the reviewed Periodic Safety Update Report (PSUR), the PRAC considered that changes to the product information of medicinal products containing febuxostat were warranted.

The CHMP agrees with the scientific conclusions made by the PRAC.

Grounds for the variation to the terms of the Marketing Authorisation(s)

On the basis of the scientific conclusions for febuxostat the CHMP is of the opinion that the benefit- risk balance of the medicinal product(s) containing febuxostat is unchanged subject to the proposed changes to the product information.

The CHMP recommends that the terms of the Marketing Authorisation(s) should be varied.

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