Febuxostat Genepharm

Febuxostat.

Febuxostat Genepharm 80 mg: Each tablet contains 80 mg of febuxostat.
Febuxostat Genepharm 120 mg: Each tablet contains 120 mg of febuxostat.
Excipients/Inactive Ingredients: The other ingredients are: Tablet core: lactose monohydrate, cellulose microcrystalline, magnesium stearate, hydroxypropylcellulose, croscarmellose sodium, lactose anhydrous, silica colloidal anhydrous, sodium laurilsulfate.
Film-coating: Poly(vinyl alcohol) (E1203), Titanium dioxide (E171), Macrogol 3350 (E1521), Talc (E553b), Iron oxide yellow (E172).

Febuxostat Genepharm works by reducing uric acid levels. Keeping uric acid levels low by taking Febuxostat Genepharm 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.

Febuxostat Genepharm tablets 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.
Febuxostat Genepharm is for adults.

Always take this medicine exactly as told by the doctor. Check with the doctor or pharmacist if unsure.
Gout: The recommended oral dose of Febuxostat Genepharm is 80 mg once daily without regard to food. If serum uric acid is >6 mg/dL (357 μmol/L) after 2-4 weeks, Febuxostat Genepharm 120 mg once daily may be considered.
Febuxostat Genepharm works sufficiently quickly to allow retesting of the serum uric acid after 2 weeks. The therapeutic target is to decrease and maintain serum uric acid below 6 mg/dL (357 μmol/L).
Gout flare prophylaxis of at least 6 months is recommended.
Method of administration: Oral use.
Febuxostat Genepharm should be taken by mouth and can be taken with or without food.
If forgotten to take Febuxostat Genepharm: If a dose of Febuxostat Genepharm is missed, take it as soon as it is remembered unless it is almost time for the next dose, in which case miss out the forgotten dose and take the next dose at the normal time.
Do not take a double dose to make up for a forgotten dose.
If stopping Febuxostat Genepharm intake: Do not stop taking Febuxostat Genepharm without the advice of the doctor even if feeling better. If stopping Febuxostat Genepharm intake, uric acid levels may begin to rise and symptoms may worsen due to the formation of new crystals of urate in and around the joints and kidneys.
If there are any further questions on the use of this medicine, ask the doctor or pharmacist.

In the event of an accidental overdose, ask the doctor what to do, or contact the nearest accident and emergency department.

Do not take Febuxostat Genepharm if allergic to febuxostat or any of the other ingredients of this medicine (listed in Description).

Talk to the doctor before taking Febuxostat Genepharm: If with existing or history of heart failure, heart problems or stroke; If with existing or history of renal disease and/or serious allergic reaction to allopurinol (a medication used for the treatment of gout); If with existing or history of liver disease or liver function test abnormalities; If 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); If with thyroid problems.
Should allergic reactions to Febuxostat Genepharm be experienced, stop taking this medicine (see also Side Effects). Possible symptoms of allergic reactions might be: rash including severe forms (e.g. blisters, nodules, itchy, exfoliative rash), itchiness; swelling of limbs or face; difficulties in breathing; fever with enlarged lymph nodes; serious life-threatening allergic conditions with cardiac and circulatory arrest. The doctor might decide to permanently stop treatment with Febuxostat Genepharm.
There have been rare reports of potentially life-threatening skin rashes (Stevens-Johnson Syndrome) with the use of febuxostat, appearing initially as reddish target-like spots or circular patches often with central blister on the trunk. It may also include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). The rash may progress to widespread blistering or peeling of the skin. If Stevens-Johnson Syndrome has developed with the use of febuxostat, Febuxostat Genepharm must not be restarted at any time. If a rash or these skin symptoms developed, seek immediate advice from a doctor and tell that this medicine is being taken.
If 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 Febuxostat Genepharm.
For some people, gout attacks may flare up when starting certain medicines that control uric acid levels. Not everyone gets flares, but a flare-up could occur even if taking Febuxostat Genepharm, and especially during the first weeks or months of treatment. It is important to keep taking Febuxostat Genepharm even if having a flare, as Febuxostat Genepharm is still working to lower uric acid. Over time, gout flares will occur less often and be less painful if taking Febuxostat Genepharm is kept every day.
The 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).
In patients with very high urate levels (e.g. those undergoing cancer chemotherapy), treatment with uric acid-lowering medicines could lead to the build-up of xanthine in the urinary tract, with possible stones.
The doctor may ask to have blood tests to check that the liver is working normally.
Gout patients with established cardiovascular (CV) disease treated with febuxostat had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study.
Consider the risks and benefits of febuxostat when deciding to prescribe or continue patients on Febuxostat Genepharm. Febuxostat Genepharm should only be used in patients who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable.
Febuxostat Genepharm contains lactose: Febuxostat Genepharm tablets contain lactose (a type of sugar). If with an intolerance to some sugars as told by the doctor, contact the doctor before taking this medicine.
Driving and using machines: Be aware that dizziness, sleepiness, blurred vision and numbness or tingling sensation may be experienced during treatment and driving or operating machines should not be done if affected.
Use in Children: Do not give this medicine to children under the age of 18 because the safety and efficacy have not been established.

It is not known if febuxostat may harm the unborn child. Febuxostat Genepharm should not be used during pregnancy.
It is not known if febuxostat may pass into human breast milk. Febuxostat Genepharm should not be used if breastfeeding, or if planning to breastfeed.
If pregnant or breastfeeding, thinking may be pregnant, or planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking this medicine and contact the 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 Precautions); potentially life-threatening skin rashes characterized 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 Precautions); generalised skin rashes.
Common side effects (may affect up to 1 in 10 people): abnormal liver test results; diarrhea; headache; rash (including various types of rash, see Uncommon side effects and Rare side effects as follows); nausea; increase in gout symptoms; localized swelling due to retention of fluids in tissues (oedema).
Other side effects which are not previously mentioned are listed as follows.
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; numbness, tingling, reduced or altered sensation (hypoesthesia, hemiparesis or paresthesia), altered sense of taste, diminished sense of smell (hyposmia); abnormal ECG heart tracing, irregular or rapid heartbeats, feeling the 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, 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; itching, hives, skin inflammation, skin discoloration, small red or purple spot 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, other type of skin conditions; muscle cramp, muscle weakness, pain/ache in muscles/joints, bursitis or arthritis (inflammation of joints usually accompanied by pain, swelling and/or stiffness), pain in extremity, back pain, muscle spasm; 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; fatigue, 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.
Rare side effects (may affect up to 1 in 1,000 people): muscle damage, a condition which on rare occasions can be serious (see as follows); severe swelling of the deeper layers of the skin, especially around the lips, 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); reddening of the skin (erythema), rash in various types (e.g. itchy, 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; ringing in the ears; blurred vision, change in vision; hair loss; mouth ulceration; inflammation of the pancreas (common symptoms are abdominal pain, nausea and vomiting); increased sweating; weight decrease, increased appetite, uncontrolled loss of appetite (anorexia); muscle and/or joint stiffness; abnormally low blood cell counts (white or red blood cells or platelets); urgent need to urinate; changes or decrease in urine amount due to inflammation in the kidneys (tubulointerstitial nephritis); inflammation of the liver (hepatitis); yellowing of the skin (jaundice); liver damage; increased level of creatine phosphokinase in blood (an indicator of muscle damage); sudden cardiac death.
Muscle damage may cause muscle problems and particularly, if at the same time, feeling unwell or having a high temperature, it may be caused by an abnormal muscle breakdown. Contact the doctor immediately if experiencing muscle pain, tenderness or weakness.
Reporting of side effects: If any side effects occur, talk to the doctor or pharmacist. This includes any possible side effects not previously listed. Side effects can also be reported directly via the national reporting system. By reporting side effects, more information on the safety of this medicine can be provided.

Tell the doctor or pharmacist if taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
It is especially important to tell the doctor or pharmacist if taking medicines containing any of the following substances as they may interact with Febuxostat Genepharm and the doctor may wish to consider necessary measures: Mercaptopurine (used to treat cancer); Azathioprine (used to reduce immune response); Theophylline (used to treat asthma).

Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.

Store at temperature ≤25°C.

Hyperuricemia & Gout Preparations

M04AA03 - febuxostat ; Belongs to the class of preparations inhibiting uric acid production. Used in the treatment of gout.

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