ADENURIC 80 mg film-coated tablets

ADENURIC 120 mg film-coated tablets

Febuxostat

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.

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.

The score line on the 80 mg tablet is only there to help you break the tablet if you have difficulty swallowing it whole.

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:

• 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), 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
• localised swelling due to retention of fluids in tissues (oedema)
• dizziness
• shortness of breath
• itching
• pain in extremity, pain/ache in muscles/joints,
• fatigue

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
• 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, chest discomfort or pain, inflammation of nasal passage and/or throat (upper respiratory tract infection), bronchitis, lower respiratory tract infection
• dry mouth, abdominal pain/discomfort or wind, abdominal pain upper, heartburn/indigestion, constipation, more frequent passing of stools, vomiting, stomach discomfort
• itchy rash, hives, skin inflammation, skin discoloration, small red or purple spots 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, increased sweating, night sweating, alopecia, reddening of the skin (erythema), psoriasis, eczema, other type of skin conditions
• muscle cramp, muscle weakness, bursitis or arthritis (inflammation of joints usually accompanied by pain, swelling and/or stiffness), back pain, muscle spasm, muscle and/or joint stiffness
• 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, urinary tract infection
• 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
• decreased activity of thyroid gland, blurred vision, change in vision
• ringing in the ears
• runny nose
• mouth ulceration
• inflammation of the pancreas: common symptoms are abdominal pain, nausea and vomiting
• urgent need to urinate
• pain
• malaise
• INR increased
• contusion
• lip swelling

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 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)
• rash in various types (e.g. 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
• weight decrease, increased appetite, uncontrolled loss of appetite (anorexia)
• abnormally low blood cell counts (white or red blood cells or platelets)
• changes or decrease in urine amount due to inflammation in the kidneys (tubulointerstitial nephritis)
• inflammation of the liver (hepatitis)
• yellowing of the skin (jaundice)
• infection of the bladder
• liver damage
• increased level of creatine phosphokinase in blood (an indicator of muscle damage)
• sudden cardiac death
• low red blood cell counts (anaemia)
• depression
• sleep disturbance
• loss of sense of taste
• burning sensation
• vertigo
• circulatory failure
• lung infection (pneumonia)
• mouth sores; inflammation of the mouth
• gastrointestinal perforation
• rotator cuff syndrome
• polymyalgia rheumatic
• feeling hot
• sudden vision loss due to blockage of an artery in the eye

• 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.