Patient leaflet - FEBUXOSTAT ARISTO 120 MG FILM-COATED TABLETS
1. what febuxostat aristo is and what it is used for
Febuxostat Aristo 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.
Febuxostat Aristo works by reducing uric acid levels. Keeping uric acid levels low by taking Febuxostat Aristo 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.
Febuxostat Aristo 120 mg tablets are 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.
Febuxostat Aristo is for adults.
2. what you need to know before you take febuxostat aristo
Do not take Febuxostat Aristo
- 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 Febuxostat Aristo:
- If you have or have had heart failure or heart problems
- If you have or have had renal disease and/ or a 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 Febuxostat Aristo, 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 Febuxostat Aristo.
There have been rare reports of potentially life-threatening skin rashes (Stevens-Johnson-Syndrome) with the use of Febuxostat Aristo, appearing initially as reddish target-like spots or circular patches on the trunk, often with a central blister. 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 Febuxostat Aristo at any time. If you develop a rash or these skin symptoms, seek immediate advice from a doctor and tell him/her 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 Febuxostat Aristo.
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 Febuxostat Aristo, and especially during the first weeks or months of treatment. It is important to keep taking Febuxostat Aristo even if you have a flare, as Febuxostat Aristo is still working to lower uric acid. Over time, gout flares will occur less often and be less painful if you keep taking Febuxostat Aristo 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 Febuxostat Aristo 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 Febuxostat Aristo Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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 Febuxostat Aristo 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 Febuxostat Aristo may harm your unborn child. Febuxostat Aristo should not be used during pregnancy. It is not known if Febuxostat may pass into human breast milk. You should not use Febuxostat Aristo 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 sensations during treatment and you should not drive or operate machines if affected.
Febuxostat Aristo contains lactose Febuxostat Aristo 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.
Febuxostat Aristo 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 febuxostat aristo
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
- The recommended dose is one tablet daily.
- The tablets should be taken by mouth and can be taken with or without food.
Gout
Febuxostat Aristo 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 Febuxostat Aristo 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
Febuxostat Aristo is available as a 120 mg tablet.
Start taking Febuxostat Aristo two days before chemotherapy and continue its use according to your doctor’s advice. Usually treatment is short-term.
Your doctor may ask you to have blood tests to check that your liver is working normally.
If you take more Febuxostat Aristo 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 Febuxostat Aristo If you miss a dose of Febuxostat Aristo 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 Febuxostat Aristo
Do not stop taking Febuxostat Aristo without the advice of your doctor even if you feel better. If you stop taking Febuxostat Aristo, 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 side effects occur (may affect up to 1 in 1,000 people), because a serious allergic reaction might follow:
- anaphylactic reactions, drug hypersensitivity (see also section 2 “Warnings and precautions”)
- potentially life-threatening skin rashes characterised 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), increase in white blood cell count (Drug Reaction with Eosinophilia and Systemic Symptoms-DRESS) (see section 2)
- generalised skin rashes
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
- localised 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 sense of taste, diminished sense of smell (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 measleslike 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
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 Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store febuxostat aristo
- 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.
6. contents of the pack and other information
What Febuxostat Aristo contains
The active substance is febuxostat.
Each tablet contains 80 mg or 120 mg of febuxostat (as hemihydrate).
The other ingredients are:
Tablet core: lactose monohydrate, cellulose, microcrystalline, croscarmellose sodium, hydroxypropylcellulose, poloxamer 407, silica, colloidal anhydrous, magnesium stearate
Film-coating: Opadry II yellow, containing: polyvinyl alcohol – part. hydrolyzed, titanium dioxide (E171), macrogol/polyethylene glycol, talc, iron oxide yellow (E172)
What Febuxostat Aristo looks like and contents of the pack
Febuxostat Aristo film-coated tablets are yellow, oblong biconvex film-coated tablets. 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’.
Febuxostat Aristo 80 mg and 120 mg is packed in PVC/PCTFE/Aluminium blister strips of 14 tablets or PVC/PVDC/Aluminium blister strips of 14 tablets.
Febuxostat Aristo 80 mg and 120 mg is available in packs containing 14, 28, 56 and 84 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Aristo Pharma GmbH
Wallenroder StraBe 8–10
13435 Berlin
Germany
ArasTo
This leaflet was last revised in January 2020.
| ARTWORK DETAILS | |
| Customer | Aristo Pharma GmbH |
| Product Name | Febuxostat Aristo Combi PIL UK ver01 |
| Market | United Kingdom (UK) |
| Language/s | English |
| Client Job No.: | N/A |
| Item Code | N/A |
| Manufacturer Code | N/A |
| Our Ref | Febuxostat Aristo_combi_PIL_UK_ ver05 — (** to follow final proof ) |
| Issue | 05 |
| Date | 14 January 2020 |
| SPECIFICATION DETAILS | |
| Origination | 16 August 2018 — (as Issue 01) |
| Dimensions | 148 × 420 mm |
| Border | 10 mm |
| Pharmacode No. | n/a |
| Font details | Main title: Frutiger LT Std – 75 Black – 18pt Sub-titles: Frutiger LT Std – 75 Black — 10pt Body copy: Frutiger LT Std – 55 Roman — 8 pt |
| Colours | Black – K |