80 mg and 120 mg film-coated tablets 
febuxostat

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

Febuxostat Krka 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 this is not treated, larger deposits called tofi can form in and around joints. These tofi can damage joints and bone tissue.

Febuxostat Krka works by lowering uric acid levels. By taking Febuxostat Krka once every day, uric acid levels are kept low, which prevents the formation of crystals, and over time the symptoms decrease. By keeping uric acid levels low enough for a long time, tofus can also be reduced.

Febuxostat Krka 120 mg tablets are also used to treat and prevent high levels of uric acid in the blood, which may occur when starting chemotherapy for blood cancer.

When chemotherapy is given, the cancer cells are destroyed, and therefore the uric acid levels in the blood rise unless the production of uric acid is prevented.

Febuxostat Krka is used in adults.

2. What you need to know before using Febuxostat Krka

Do not use Febuxostat Krka

  • 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 or pharmacist before taking Febuxostat Krka:

  • 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 Krka, stop taking this medicine (see also section 4). Possible symptoms of an allergic reaction are:

  • rash including severe forms (eg blisters, lumps, itchy and scaly rash), itching
  • swelling in the legs or 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 Krka.

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 after using febuxostat, you must never use Febuxostat Krka 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 Krka 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 Krka, and especially during the first weeks or months of treatment. You must continue to take Febuxostat Krka even if you have an attack, as Febuxostat Krka 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 Krka 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 urinary tract xanthine and possible stones, although this has not been observed in patients treated with febuxostat 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 Krka

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 Krka 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, breastfeeding,g, and fertility

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.

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

Driving and using machines

You should be aware that you may experience dizziness, drowsiness, blurred vision, and numbness or tingling during treatment with this medicine and should not drive or use machines if you are affected.

Febuxostat Krka contains lactose and sodium

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 (23 mg) sodium per tablet, ie essentially ‘sodium-free’.

3. How to use Febuxostat Krka

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

  • The recommended dose is one tablet daily. The breaker is only for you to be able to divide the tablet if you have difficulty swallowing it whole.
  • The tablets should be taken orally and can be taken with or without food.

Gout

Febuxostat Krka 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 Krka every day even when you have no gout attack.

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

Febuxostat Krka is available as a 120 mg tablet.

Start taking Febuxostat Krka two days before the chemotherapy and continue using it according to your doctor’s instructions. The treatment is usually short-lived.

If you use more Febuxostat Krka then you should 

If you have accidentally taken an overdose, ask your doctor what to do or contact your nearest emergency department.

If you forget to use Febuxostat Krka

If you miss a dose of Febuxostat Krka, 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 using Febuxostat Krka

Do not stop taking Febuxostat Krka unless your doctor tells you to, even if you feel better. If you stop taking Febuxostat Krka, your uric acid levels may start to rise and your symptoms may worsen due to the formation of new urate crystals in and around your 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 (may affect up to 1 in 1,000 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, hepatitis (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 people) are:

  • 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 en ( edema )

Other side effects not mentioned above are listed below.

Less common side effects are (may affect up to 1 in 100 people) 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 people) 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, hepatitis (up to liver failure), elevated white blood cell levels ( leukocytosis, with or without eosinophilia )
  • redness ( erythema ), various types of rash (eg itchy rash with white spots, with blisters, var-containing blisters, scaly skin, measles-like rash), widespread redness ( 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 in the kidneys (tubulointerstitial nephritis)
  • inflammation of the liver ( hepatitis )
  • yellow skin (jaundice)
  • liver damage
  • elevated creatine phosphokinase levels in the blood (signs of muscle damage)
  • sudden cardiac death

5. How to store Febuxostat Krka

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 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 film-coated tablet contains 80 mg febuxostat. Each film-coated tablet contains 120 mg of febuxostat.
  • The other ingredients are lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, colloidal hydrated silica and magnesium stearate in the tablet core and polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc, yellow iron oxide (E172) tablets only (120 mg) – only for 80 mg film-coated tablets in the film-coating. See section 2 “Febuxostat Krka contains lactose and sodium”.

What the medicine looks like and the contents of the pack

Febuxostat Krka 80 mg film-coated tablets (tablets) are pale pink, oval, biconvex, film-coated tablets with a scoreline on one side. Tablet size: about 16 mm × 8 mm. The breaker is not for dividing the tablet into equal doses but only for easier swallowing.

Febuxostat Krka 120 mg film-coated tablets (tablets) are brownish yellow, slightly biconvex, capsule-shaped film-coated tablets with a scoreline on both sides. Tablet size: about 19 mm × 8 mm. The breaker is not for dividing the tablet into equal doses but only for easier swallowing.

Febuxostat Krka is supplied in cartons containing 14, 28, 56, or 84 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

The representative of the holder of the sale

KRKA Sverige AB

Tel: + 46 (0) 8 643 67 66 (SE)

Muhammad Nadeem

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