Adenurik 80 mg N28 Tablet

ADENURİK, 80 mg, 120 mg coated tablets with immediate release of the active substance.

Adenurik composition

Active substance:1 tablet contains 80 mg and/or 120 mg febuxostat. Excipients: lactose monohydrate, microcrystalline cellulose, magnesium stearate, hydroxypropylcellulose, sodium croscarmellose, hydrated colloidal silicon dioxide. Coating: Opadry II yellow, 85F42129 – polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E172).

Indications:

 Gout (use of the Adenurik medicinal product is intended only for adults).

Contraindications:
 Do not use Adenurik if hypersensitivity/allergy is observed to febuxostat or to any other component of the medicinal product (“See the “Composition” section”).

Special warnings and precautions:
 In the following cases, you must inform your doctor before starting to use Adenurik:

 - if the patient currently (or previously) has heart failure or other heart diseases;

 - if the patient currently (or previously) has kidney diseases and/or if severe allergic reactions to allopurinol (a medicinal product used to treat gout) have been reported;

 - if the patient currently (or previously) has liver diseases or if functional indicators of the liver change compared to normal;

 - if the patient is receiving treatment associated with an increase in uric acid levels during Lesch-Nyhan syndrome (a rare inherited disease characterized by elevated uric acid levels);

 - if the patient suffers from thyroid-like gland diseases. If allergic reactions occur to the use of Adenurik, the use of the medicinal product must be discontinued (“See “Adverse effects”). The possible symptoms of allergic reactions are listed below:

 - skin itching, including severe forms of rash (e.g., blisters, nodules, itchy and exfoliative rash);

 - swelling of the limbs or face;

 - difficulty breathing;

 - fever and enlargement of lymph nodes;

 - also, life-threatening allergic conditions accompanied by stopping of the heart and blood circulation. The doctor may decide to permanently discontinue the treatment carried out with the use of Adenurik. After using Adenurik, rare reports exist about the occurrence of potentially life-threatening skin rashes (Stevens-Johnson syndrome); in this case, red-toned target-like spots or circular lesions with a blister in the center may be observed over the entire body. Also, ulcers may develop in the mouth, pharynx, nose, and in the genital organs, and conjunctivitis (redness and swelling of the eyes) may occur. Rash progression may be accompanied by spread of blisters and/or peeling of the skin. After using febuxostat, if Stevens-Johnson syndrome develops, the use of Adenurik must not be restarted. If rash or the above-mentioned skin symptoms develop, you must contact a doctor immediately and inform him/her about the use of the specified medicinal product. If, in the patient, an acute exacerbation of gout is currently observed (sudden severe pain, redness of the joints, pain in the joints, swelling, and increased joint temperature), it is necessary to wait for the disease to subside before starting to use Adenurik. In some cases, at the beginning of treatment with medicinal products that lower uric acid levels, an acute exacerbation of gout may be noted. Such exacerbations are not observed in most patients, but in the first weeks or months of treatment with Adenurik, gout attacks may occur in patients. If such attacks occur, it is important not to stop treatment, because in this case Adenurik leads to a further decrease in the concentration of uric acid. If the patient uses Adenurik every day in accordance with the doctor’s appointments, gout attacks will occur later over time and will be less painful. The doctor may prescribe medicinal products that cause gout symptoms (joint pain and swelling) to disappear or become milder. In patients with high urate levels (for example, those receiving chemotherapy for the treatment of malignant diseases), treatment with medicinal products that lower uric acid levels may lead to accumulation of xanthines in the urinary excretion pathways and, possibly, to formation of stones, even though this was not observed in patients using Adenurik associated with tumor lysis syndrome. For the purpose of assessing liver function, the doctor may prescribe a blood test. Adenurik tablets contain lactose (a type of sugar). If intolerance to any type of sugar is determined in the patient, consult a doctor before using the medicinal product. The safety and effectiveness of the medicinal product have not been established in children and adolescents under 18 years of age; therefore, this medicinal product should not be used in this patient group.

Use during pregnancy and lactation:
 The risk of adverse effects on the fetus has not been determined for treatment carried out with the use of Adenurik. It is not recommended to use Adenurik during pregnancy. It is also unknown whether Adenurik passes into breast milk. During lactation and/or when preparing to feed with breast milk, the medicinal product should not be used. If a woman is pregnant or is feeding her baby with breast milk, or if she suspects she is pregnant or plans her pregnancy, she should consult a doctor or pharmacist before taking this medicinal product.

Effect on the ability to drive vehicles and operate other potentially dangerous machinery:
 It should be taken into account that during treatment dizziness, drowsiness, blurred vision, a feeling of numbness or tingling may occur; if such cases develop, it is recommended to avoid driving a vehicle or operating other potentially dangerous machinery.

How to use Adenurik, dosage

 Adenurik should always be used in accordance with the doctor’s recommendations. If questions arise, consult your doctor or pharmacist. The standard dosage of the medicinal product is 1 tablet once daily. To monitor regular use, the days of the week are indicated on the opposite side of the blister packaging. Adenurik can be taken orally before meals, during meals, or after meals. Gout Adenurik is available in tablet form in doses of 80 mg or 120 mg. The doctor should determine the most appropriate dose based on the patient’s condition. It is important to take Adenurik every day, even if gout attacks are not reported. In patients receiving chemotherapy related to the treatment of malignant disease, prophylaxis and treatment of increased uric acid levels are provided with Adenurik in tablet form at a dose of 120 mg. Start using Adenurik 2 days before starting chemotherapy and continue treatment according to the doctor’s instructions. Usually, treatment is short-term. When the use of Adenurik is missed, the next dose must be taken immediately. If there is little time left before the next dose, it is necessary to skip the missed dose and take the next dose at the usual time. To compensate for the missed dose, do not take a double dose. Discontinuation of Adenurik use The patient must not stop using Adenurik without consulting a doctor in advance, even if the patient feels significantly better. Stopping treatment may be accompanied by worsening of symptoms due to an increase in uric acid concentration and the formation of new urate crystals in the joints and around them and in the kidneys. If additional questions arise regarding the use of this medicinal product, you should contact your doctor or pharmacist.