Adenuric

• Used to treat gout and kidney stones
• Reduces uric acid levels in the blood
• Tablets for oral use
• Not to be used while pregnant or breastfeeding

Adenuric is a medicine used to treat kidney stones and gout. Gout 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. These crystals can cause sudden, severe pain, redness and swelling in a joint (known as a gout attack). Too much uric acid in the body can also lead to small stones forming in the kidneys.

The active ingredient febuxostat works by reducing uric acid levels. Keeping uric acid levels low stops crystals building up, which lowers the risk of kidney stones and reduces symptoms of gout.

Adenuric tablets should be taken with some liquid. They can be taken with or without food. Continue to take this medicine every day even when you are not suffering from kidney stones or gout.

Dosage

Adenuric is available as 80-mg or 120-mg tablets. The doctor will prescribe the strength most suitable for you. The recommended dose in gout is:

• Adults: one tablet once a day.

Other conditions may require a different dose. This medicine is not suitable for use in children and adolescents under 18 years of age.

Driving/alcohol

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.

If you use too much/forget to use/stop using Adenuric

If you take more tablets than you were told to, consult your doctor or pharmacist.

If you have forgotten to take a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, 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 one.

Do not stop using Adenuric without talking to your doctor.

Do not use Adenuric if you are allergic to any of the ingredients in this medicine (see section ‘What Adenuric contains').

When should this medicine be used with caution?

Talk to your doctor before taking this medicine 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 LeschNyhan syndrome (a
• rare inherited condition in which there is too much uric acid in the blood).
• You have thyroid problems.

You are having a gout attack at the moment, 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).

For more information on warnings associated with the use of Adenuric, see the package leaflet.

Pregnancy and breastfeeding

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 breastfeeding, or if you are planning to breastfeed.

Other medicines and Adenuric

Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal 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 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).

Like all medicines, Adenuric can cause side effects, although some people may not experience any.

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 the package leaflet for symptoms).
• Potentially lifethreatening 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), raising of the white-cells count in the blood (drug reaction with eosinophilia and systemic symptoms, the DRESS syndrome) (see the package leaflet for more information).
• Generalised skin rashes.

Other side effects of Adenuric include:

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

• Abnormal liver test results.
• Diarrhoea.
• Headache.
• Skin rash.
• Nausea.
• Increase in gout symptoms.
• Localised swelling due to retention of fluids in tissues (oedema).

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

• Decreased appetite, change in blood sugar levels (diabetes).
• 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 (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.
• Gastrointestinal symptoms, such as dry mouth, abdominal pain/discomfort or wind, heartburn/indigestion, constipation, more frequent passing of stools, vomiting.
• Itching, hives, skin inflammation, or other type of skin problems (see the package leaflet).
• Pain/ache in muscles/joints (see the package leaflet).
• Blood in the urine, abnormal frequent urination, abnormal urine tests, 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.
• Abnormal blood test results.
• Kidney stones.
• Erectile dysfunction.

See the package leaflet for a full list of possible side effects. Consult a doctor if these or other side effects are severe.

The active substance is febuxostat. Each tablet contains 80 mg or 120 mg of febuxostat.

Read the package leaflet before use. The official package leaflet of Adenuric is available for download here.