Adenurik 120 mg N28 Tablet

ADENURİK, 80 mg, 120 mg immediate-release coated tablets containing active substance.

Adenurik composition

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

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

Contraindications:
Do not use the Adenurik product if an allergy is observed to febuxostat or to any other component contained in the product (“See the “Composition” section”).

Special warnings and precautions:
In the following cases, the doctor must be informed before starting use of the Adenurik product: - 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 level during Lesch-Nyhan syndrome (a rare inherited disease characterized by elevated uric acid levels); - if the patient suffers from thyroid diseases. If allergic reactions occur with the use of the Adenurik product, the use of the product must be stopped (“See “Adverse effects” section). The possible symptoms of allergic reactions are listed below: - rash, including severe forms (e.g., blisters, nodules, itchy and exfoliative rash) including itching of the skin; - swelling of the limbs or face area; - 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 treatment carried out with the use of the Adenurik product. Rare reports exist about the occurrence of potentially life-threatening skin rashes (Stevens-Johnson syndrome) after using the Adenurik product; in such cases, red-shaded target-like spots or circular lesions with blisters in the center are observed across the whole 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 the Adenurik product must not be restarted. If rash and/or the skin symptoms mentioned above develop, you must contact a doctor immediately and inform them about the use of the specified medicinal product. If the patient currently experiences an acute exacerbation of gout (sudden severe pain, redness of the joints, pain in the joints, swelling, and increased joint temperature), before starting use of the Adenurik product it is necessary to wait for the disease to subside. In some cases, during the beginning of treatment with medicinal products that lower uric acid levels, an acute exacerbation of gout may be observed. Such exacerbations are not reported in most patients, but gout attacks may occur in patients during the first weeks or months of treatment with the Adenurik product. If such attacks occur, it is important not to stop treatment, because in this case the Adenurik product leads to a decrease in the concentration of uric acid. If the patient uses the Adenurik product every day according to the doctor’s prescriptions, 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 if this has not been observed in patients using the Adenurik product associated with tumor lysis syndrome. For the purpose of assessing liver function, the doctor may prescribe blood tests. Adenurik tablets contain lactose (a type of sugar). If intolerance to any type of sugar is determined in the patient, consult the doctor before using the product. The safety and effectiveness of the product have not been established in children under 18 years; therefore, this patient group should not use the product.

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 the Adenurik product. It is not recommended to use the Adenurik product during pregnancy. It is also unknown whether the Adenurik product passes into breast milk. During lactation and/or when preparing to feed with breast milk, the product should not be used. When a woman is pregnant or when feeding her baby with breast milk, or when she suspects she is pregnant or plans her pregnancy, she should consult a doctor or pharmacist before taking this product.

Effect on the ability to drive vehicles and operate other potentially dangerous machinery:

It should be considered that during the course of treatment dizziness, drowsiness, blurred vision, and a feeling of numbness or stinging 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

The Adenurik product must always be used in accordance with the doctor’s recommendations. If questions arise, consult the doctor or pharmacist. The standard dosage of the 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. The Adenurik product can be taken orally before meals, during meals, or after meals. For 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 the Adenurik product 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 the Adenurik product 2 days before starting chemotherapy and continue treatment according to the doctor’s instructions. Usually, treatment is short-term. When the use of the Adenurik product 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, a double dose should not be taken. Discontinuation of use of the Adenurik product: The patient must not stop using the Adenurik product 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 and around the joints and in the kidneys. If additional questions arise related to the use of this product, you should contact a doctor or pharmacist.