ADENURIC 80 mg film-coated tablets
ADENURIC 120 mg film-coated tablets
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
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.
Talk to your doctor before taking ADENURIC:
Should you experience allergic reactions to ADENURIC, stop taking this medicine (see also section 4). Possible symptoms of allergic reactions might be:
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 re-started 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.
Do not give this medicine to children under the age of 18 because the safety and efficacy have not been established.
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:
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.
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 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 this medicine exactly as your doctor has told you. 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.
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.
In the event of an accidental overdose ask your doctor what to do, or contact your nearest accident and emergency department.
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.
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.
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:
The common side effects (may affect up to 1 in 10 people) are:
Other side effects which are not mentioned above are listed below.
Uncommon side effects (may affect up to 1 in 100 people) are:
Rare side effects (may affect up to 1 in 1,000 people) are:
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
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.
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)
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
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.