ADENURIC tablets

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 gout, uric acid builds up in your joints and tendons as crystals. These crystals cause an inflammatory reaction. This causes symptoms such as:

• Sudden attacks of severe joint pain (flares).
• The joint is red and warm and may feel swollen.
• Gout flares may be accompanied by fever.

Gout is often characterised by growths where gout crystals have accumulated around elbows, fingers, toes or on the ear (tophi). Although gout attacks can occur in any joint in the body, the disease has a preference for the big toe. Gout usually develops into a chronic condition, with repeated episodes of inflammation in multiple joints.

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.

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.

• 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.

Other indications

Please consult the package leaflet for recommended dosage for other indications.

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 you should skip 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.

For more information on how to use ADENURIC, please see the package leaflet.

Do not take ADENURIC if you are allergic to febuxostat or any of the other ingredients of this medicine.

Warnings and precautions

Talk to your doctor before taking ADENURIC if:

• You have or have had heart failure or heart problems.
• You have or have had renal disease and/or serious allergic reaction to allopurinol (a medication used for the treatment of gout).
• You have or have had liver disease or liver function test abnormalities.
• 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).
• You have thyroid problems.

Should you experience allergic reactions to ADENURIC, stop taking this medicine. Possible symptoms of allergic reactions might be:

• Rash including severe forms (e.g., blisters, nodules, itchy or 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.

More warnings about ADENURIC are listed in the package leaflet.

• Patients should be aware that they may experience dizziness, sleepiness, blurred vision and numbness or tingling sensation during treatment and should not drive or operate machines if affected.
• ADENURIC should not be used during pregnancy. You should not use ADENURIC if you are breastfeeding, or if you are planning to breastfeed.

ADENURIC is only available on prescription. A doctor can write a prescription for ADENURIC after an online consultation. With this prescription you can get ADENURIC at the pharmacy.

Would you like to know what ADENURIC tablets cost? You can find the current price of ADENURIC on our order page. The price listed includes the cost of the consultation and a service fee. You won’t be charged extra for these costs.

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

Serious side effects

Get emergency medical help immediately if you notice rare but serious side effects such as a severe allergic reaction (see the package leaflet for the symptoms).

Common side effects (may affect up to 1 in 10 people):

• 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).

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

• 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 (hypoaesthesia, hemiparesis or paraesthesia), altered or reduced sense of taste (hyposmia).
• Abnormal ECG heart tracing, irregular or rapid heartbeats, feeling your heart beat (palpitation).
• Hot flashes or flushing (e.g., redness of the face or neck), increased blood pressure, bleeding (haemorrhage, 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.

This list is not exhaustive. For a list of all possible side effects, see the package leaflet.

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

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).