Febuxostat-NAN

Do not take Febuxostat-NAN

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

Warnings and precautions

Talk to your doctor before taking Febuxostat-NAN:

• If you have or have had heart failure, heart problems or stroke.
• If you have or have had renal disease and/or serious allergic reaction to Allopurinol (a medication used for the treatment of Gout).
• If you have or have had liver disease or liver function test abnormalities.
• If you are 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 you have thyroid problems.

Should you experience allergic reactions to Febuxostat-NAN, stop taking this medicine (see also section 4). 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;
• but also serious life threatening allergic conditions with cardiac and circulatory arrest.

Your doctor might decide to permanently stop treatment with Febuxostat-NAN.

There have been rare reports of potentially life-threatening skin rashes (Stevens-Johnson Syndrome) with the use of Febuxostat-NAN, 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 you have developed Stevens-Johnson Syndrome with the use of febuxostat, you must not be restarted on Febuxostat-NAN at any time. If you develop a rash or these skin symptoms, seek immediate advice from a doctor and tell that you are taking this medicine.

If you are 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-NAN.

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 Febuxostat-NAN, and especially during the first weeks or months of treatment. It is important to keep taking Febuxostat-NAN even if you have a flare, as Febuxostat-NAN is still working to lower uric acid. Over time, gout flares will occur less often and be less painful if you keep taking Febuxostat-NAN 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).
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, even though this has not been observed in patients being treated with Febuxostat-NAN for Tumor Lysis Syndrome.

Your doctor may ask you to have blood tests to check that your liver is working normally.

Children and adolescents

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

Interaction with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
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 Febuxostat-NAN. In that case your doctor may wish to consider necessary measures:

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

Pregnancy and lactation

It is not known if Febuxostat-NAN may harm your unborn child. Febuxostat-NAN should not be used during pregnancy. It is not known whether Febuxostat-NAN is excreted in human milk. You should not use Febuxostat-NAN if you are breast feeding, or if you are planning to breastfeed.

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.

Effects on ability to drive and use machines

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.

Febuxostat-NAN contains lactose

Febuxostat-NAN tablets contain lactose (a type of sugar). Patients with rare hereditary forms of galactose intolerance, lactase deficiency syndrome or glucose-galactose malabsorption syndrome should not take Febuxostat-NAN.

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 of Febuxostat-NAN is one tablet taken orally once daily.
• Febuxostat-NAN tablets are taken orally with or without food.

Gout
Febuxostat-NAN 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 Febuxostat-NAN 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

Febuxostat-NAN is available as 120 mg tablet.
Start taking Febuxostat-NAN 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 take more Febuxostat-NAN tablets than you should

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

If you forget to take Febuxostat-NAN

If you miss a dose of Febuxostat-NAN take it as soon as you remember. Unless it is almost time for your next dose, in which case miss out the forgotten dose and take your next dose at the normal time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Febuxostat-NAN

Do not stop taking Febuxostat-NAN without the advice of your doctor even if you feel better. If you stop taking Febuxostat-NAN your uric acid levels may begin to rise and your symptoms may worsen due to the formation of new crystals of urate in and around your joints and kidneys.
If you have any further questions on the use of Febuxostat-NAN, ask your doctor or pharmacist.

Like all medicines Febuxostat-NAN 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 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 Section 2);
• generalized skin rashes.

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 side effects and Rare side effects sections);
• nausea;
• increase in gout symptoms;
• localized swelling due to retention of fluids in tissues (oedema).

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 and other skin disorders;
• 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;
• 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) 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;
• ear buzzing;
• blurred vision, change in visual perception;
• loss of hair;
• ulceration of the oral mucosa;
• inflammation of the pancreas: abdominal pain, nausea and vomiting are common;
• hyperhidrosis;
• 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);
• urge to urinate immediately;
• 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 disease;
• increased level of creatine phosphokinase in blood (an indicator of muscle damage);
• sudden cardiac death.

Reporting of adverse reactions

If you get any side effects, address your healthcare provider. This recommendation applies to any possible side effects, including those not listed in the leaflet. You can report to the information database on adverse reactions (side effects), or on inefficiency of medicinal products (Center for Examinations and Tests in Health Service: http://www.rceth.by) or to the manufacturer ACADEMPHARM via an electronic application form on their website: http://academpharm.by/en

When you report adverse reactions, you help to get more information about the safety of the medicinal product.

Febuxostat-NAN does not require any special storage conditions.
Keep away from children.
Do not use this medicinal product after the expiry date which is stated on the carton.

What Febuxostat-NAN contains

The active substance is febuxostat. Each tablet contains 80 mg or 120 mg of febuxostat.
Other ingredients: microcrystalline cellulose, lactose monohydrate, hydroxypropyl cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, polyvinyl alcohol, titanium dioxide (E171), macrogol (polyethylene glycol), talc, iron oxide yellow (E172), sunset yellow (E110), iron oxide black (E172).

What Febuxostat-NAN looks like and contents of the package

The 80 mg tablets: light-brown oval biconvex film-coated tablets scored on one side.
The 120 mg tablets: light-brown oval biconvex film-coated tablets.
14 or 15 tablets in a blister made of a double-layer PVC/PVDC film and flexible packing based on aluminum foil. 2 blisters with a patient information leaflet, packed in a carton.

Manufacturer

State enterprise ACADEMPHARM
220141, 5/3 Kuprevicha Street, Minsk, Belarus
Phone / Fax +375 17 268 63 64
production@academpharm.by
To report adverse reactions use the electronic application form on the manufacturer’s website: https://academpharm.by/en