80 mg and 120 mg film-coated tablets 
febuxostat

1. What Febuxostat Accord is and what it is used for

Febuxostat Accord tablets contain the active substance febuxostat and are used to treat gout, which is associated with an excess in the body of a chemical substance called uric acid (urate). In some people, the amount of uric acid builds up in the blood and can become too high to still be soluble. When this occurs, urate crystals can form in and around joints and kidneys. These crystals can cause sudden, severe pain, redness, heat, and swelling in a joint (this is called a gout attack). If left untreated, larger deposits called tofi can form in and around joints. These tofi can damage joints and bone tissue.

Febuxostat Accord works by lowering uric acid levels. By taking

Febuxostat Accord once a day keeps uric acid levels low, which prevents the formation of crystals, and over time reduces symptoms. By keeping uric acid levels low enough for a long time, tofus can also be reduced.

Febuxostat Accord 120 mg tablets are also used to treat and prevent high levels of uric acid in the blood that may occur when starting chemotherapy for blood cancer. Chemotherapy destroys the cancer cells and therefore the uric acid levels in the blood rise unless the production of uric acid is prevented.

Febuxostat Accord is used for adults.

Febuxostat contained in Febuxostat Accord may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before taking Febuxostat Accord

Do not take Febuxostat Accord

  • if you are allergic to febuxostat or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor before taking Febuxostat Accord:

  • if you have or have had heart failure, heart problems, or strokes
  • if you have or have had kidney disease and/or a severe allergic reaction to allopurinol (a medicine used to treat gout )
  • if you have or have had liver disease or abnormal liver values
  • if you are treated for high uric acid levels due to Lesch-Nyhan syndrome (a rare hereditary condition that causes too much uric acid in the blood)
  • if you have thyroid problems.

If you get an allergic reaction to Febuxostat Accord, stop taking this medicine (see also section 4). Possible symptoms of an allergic reaction are:

  • severe forms of rash (eg blisters, lumps, itchy and scaly rash), itching
  • swelling of the legs and face
  • breathing difficulties
  • fever with enlarged lymph nodes
  • but also severe life-threatening allergic conditions with cardiac and circulatory arrest.

Your doctor may decide to permanently discontinue treatment with Febuxostat Accord.

There have been rare reports of life-threatening skin rash ( Stevens-Johnson syndrome ) associated with the use of febuxostat. These first appear as reddish dots or round spots, often with a blister in the middle, on the torso. It can also include sores in the mouth, throat, nose, genitals, and eye inflammation (red and swollen eyes). The rash can develop into blisters over large areas of skin detachment.

If you have had Stevens-Johnson syndrome while using febuxostat, you must never use Febuxostat Accord again. If you get a rash or these skin symptoms, contact your doctor immediately and tell them that you are taking this medicine.

If you have a gout attack right now (sudden onset of severe pain, tenderness, redness, heat, and swelling in a joint), wait until the gout attack has subsided before starting treatment with Febuxostat Accord for the first time.

In some people, gout attacks may flare up when they start taking certain medications that control the levels of uric acid. Not everyone gets attacks, but you can get an attack even if you take Febuxostat Accord, and especially during the first weeks or months of treatment. You must continue to take Febuxostat Accord even if you have an attack, as Febuxostat Accord still works by lowering the uric acid level. Over time, gout attacks will occur less frequently and be less painful if you continue to take Febuxostat Accord every day.

Your doctor will often prescribe other medicines, if needed, to help prevent or treat the symptoms of seizures (such as joint pain and swelling).

Treatment of patients with very high urate levels (eg patients undergoing chemotherapy for cancer) with uric acid lowering drugs may lead to an increase in xanthine in the urinary tract and possibly

stones, although this has not been observed in patients treated with Febuxostat Accord for tumor lysis syndrome.

Your doctor may ask you to provide blood tests to check that your liver is functioning normally.

Children and young people

Do not give this medicine to children under 18 years of age as safety and efficacy have not been established.

Other medicines and Febuxostat Accord

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

You must tell your doctor or pharmacist if you are taking medicines that contain any of the following substances, as they may affect or be affected by Febuxostat Accord and your doctor may want to consider the necessary measures:

  • Mercaptopurine (used to treat cancer)
  • Azathioprine (used to reduce the immune response )
  • Theophylline (used to treat asthma ).

Pregnancy and breastfeeding

It is not known if Febuxostat Accord can harm your unborn baby. Febuxostat Accord should not be used during pregnancy. It is not known whether Febuxostat Accord is excreted in human milk. You should not use Febuxostat Accord if you are breast-feeding or if you are planning to breast-feed.

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

You should be aware that you may feel dizzy, drowsy, blurred vision and numbness, or tingling during treatment and should not drive or use machines if you are affected.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Febuxostat Accord contains lactose and sodium

Febuxostat Accord tablets contain lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, so it is essentially ‘sodium-free’.

3. How to take Febuxostat Accord

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

  • The recommended 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 orally and can be taken with or without food.

Gout

Febuxostat Accord is available as an 80 mg tablet or 120 mg tablet. Your doctor has prescribed the strength that suits you best.

Continue to take Febuxostat Accord every day even when you have no gout attack.

Prevention and treatment of high uric acid levels in patients undergoing chemotherapy for cancer

Febuxostat Accord is available as a 120 mg tablet.

Start taking Febuxostat Accord two days before your chemotherapy and continue using Febuxostat Accord exactly as your doctor has told you. The treatment is usually short-lived.

If you take more Febuxostat Accord then you should

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Febuxostat Accord

If you miss a dose of Febuxostat Accord, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose one and take the next dose at the normal time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Febuxostat Accord

Do not stop taking Febuxostat Accord, except at the request of your doctor, even if you feel better. If you stop taking Febuxostat Accord, your uric acid levels may start to rise and your symptoms may worsen due to the formation of new urate crystals in and around the joints and kidneys.

If you have any further questions on the use of this product, 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 or nearest emergency department immediately if the following rare (affects up to 1 in 1000 people) side effects occur, as a serious allergic reaction may occur:

  • severe allergic reactions (anaphylactic reactions), drug hypersensitivity (see also section 2 “Warnings and precautions”).
  • potentially life-threatening skin rash characterized by the formation of blisters and flaking of the skin and the inside of the body cavities, e.g. mouth and genitals, painful sores in the mouth and/or areas in and around the genitals, together with fever, sore throat, and fatigue (Stevens-Johnson syndrome / toxic epidermal necrolysis ) or by enlarged lymph nodes, enlarged liver, jaundice (up to liver failure), elevated levels of white blood cells in the blood (a reaction to the drug with eosinophilia and systemic symptoms-DRESS) (see section 2).
  • general skin rash.

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

  • abnormal results from liver tests
  • diarrhea
  • headache
  • rash (includes different types of rash, see below under the sections “uncommon” and “rare”) 
  • nausea
  • increased arthritis symptoms
  • local swelling due to fluid accumulation in tissue one ( edema ).

Other side effects not mentioned above are listed below.

Less common side effects are (may affect up to 1 in 100) are:

  • decreased appetite, altered blood sugar levels ( diabetes ) with symptoms such as excessive thirst, increased blood fat levels, weight gain
  • lost sexual drive
  • difficulty sleeping, drowsiness
  • dizziness, numbness, tingling, decreased or altered sensation ( hypoesthesia, hemiparesis, or paresthesias ),
  • altered sense of taste, impaired sense of smell ( hyposmia )
  • abnormal ECG curve, irregular or fast heartbeat, feel your heartbeat ( palpitation )
  • hot flashes or redness (eg redness of the face or neck), high blood pressure, bleeding (only in patients receiving chemotherapy for blood diseases)
  • cough, shortness of breath, chest discomfort or pain, inflammation of the nose and/or throat (upper respiratory tract infection), bronchitis
  • dry mouth, abdominal pain/discomfort or gas, heartburn/indigestion, constipation, denser stools, vomiting, stomach upset
  • itching, hives, skin inflammation, discoloration of the skin, small red or purple spots on the skin, small flat red spots on the skin, flat red areas of skin covered with small converging lumps, rashes, red skin areas, and spots on the skin, other types of skin problems
  • muscle cramps, muscle weakness, pain/pain in muscles/joints, bursitis or arthritis ( inflammation of joints usually accompanied by pain, swelling, and/or stiffness), pain in arms and legs, back pain, muscle spasm
  • blood in the urine, abnormally frequent urination, abnormal urine samples (increased protein level in the urine), the impaired ability of the kidneys to function properly
  • fatigue, chest pain, chest discomfort
  • stones in the gallbladder or the bile ducts ( cholelithiasis )
  • elevated levels of thyroid-stimulating hormone ( TSH ) in the blood
  • changes in blood chemistry or the number of blood cells or platelets (abnormal blood test results)
  • kidney stone
  • potency problem

Rare side effects are (may affect up to 1 in 1000) are:

  • muscle damage, a condition that in rare cases can be serious. It can cause muscle problems, especially if you also feel unwell or have a high fever as it can be caused by an abnormal muscle breakdown. Contact your doctor immediately if you experience muscle pain, tenderness, or weakness
  • severe swelling in the deeper layers of the skin, especially around the lips, eyes, genitals, hands, feet, or tongue, possibly with sudden difficulty breathing
  • high fever in combination with measles-like rash, enlarged lymph nodes, enlarged liver, jaundice (up to liver failure), elevated white blood cell levels ( leukocytosis, with or without eosinophilia )
  • skin redness ( erythema ), various types of rash (eg itchy rash with white spots, with blisters, var-containing blisters, scaly skin, measles-like rash), widespread redness of the skin ( erythema ), tissue death, and loosening of the epidermis with blisters and mucous membranes resulting in scaly skin and possible blood poisoning (Stevens-Johnson syndrome / toxic epidermal necrolysis )
  • nervousness
  • thirst
  • ringing in the ears
  • blurred vision, vision changes
  • hair loss
  • sores in the mouth
  • inflammation of the pancreas: common symptoms are abdominal pain, nausea, and vomiting
  • increased sweating
  • weight loss, increased appetite, uncontrolled loss of appetite ( anorexia )
  • muscle and/or joint stiffness
  • abnormally low blood cell count (white or red blood cells or platelets )
  • urgent need to urinate
  • changes or decrease in the amount of urine due to inflammation of the kidneys (tubulointerstitial nephritis)
  • inflammation of the liver ( hepatitis )
  • yellow skin (jaundice)
  • liver damage
  • elevated creatine kinase levels in the blood (signs of muscle damage)
  • sudden cardiac death

5. How to store Febuxostat Accord

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 blister after EXP. The expiration date is the last day of the specified month.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is febuxostat. Each tablet contains 80 mg or 120 mg of febuxostat (as magnesium salt).
  • Other ingredients are Tablet core: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium oxide, hydrated colloidal silica, magnesium stearate. 
    Film coating: Coating medium (yellow) contains: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172).

What the medicine looks like and the contents of the pack

Febuxostat Accord 80 mg film-coated tablets

Pale yellow to yellow in color and capsule-shaped. The film-coated tablets are marked “80” on one side and are 17.2 ± 0.2 mm long, 6.2 ± 0.2 mm wide, 5.6 ± 0.2 mm thick.

Febuxostat Accord 120 mg film-coated tablets

Pale yellow to yellow in color and capsule-shaped. The film-coated tablets are marked “120” on one side and are 19.2 ± 0.2 mm long, 8.2 ± 0.2 mm wide, 6.1 ± 0.2 mm thick.

Febuxostat Accord is packaged in a carton containing PVC / PCTFE-Aluminum blister (Aclar) with a package leaflet.

Pack sizes:

Febuxostat Accord 80 mg

Packs containing 14, 28, 30, 56 or 84 film-coated tablets.

Febuxostat Accord 120 mg

Packs containing 14, 28, 56, or 84 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare BV

Winthontlaan 200

3526 KV Utrecht

Netherlands

Manufacturer

Pharmathen SA

6, Dervenakion str.

Pallini, Attiki, 15351

Greece

Pharmathen International SA

Industrial Park Sapes,

Rodopi Prefecture, Block No 5,

Rodopi 69300

Greece

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park,

Paola PLA 3000

Malta

Muhammad Nadeem

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