Milurit tab 300mg vial No. 30 in the pack. #1

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Milurit tab 300mg vial. No. 30 in the pack. #1
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Milurite® contains a drug called allopurinol. It works by slowing down the rate of certain chemical reactions in your body and lowers the levels of uric acid in your blood and urine. The main active ingredient Allopurinol Release form Active ingredient: 100 mg or 300 mg of allopurinol in each tablet. Excipients: Tablets 100 mg: lactose monohydrate, potato starch, povidone K-25, talc, magnesium stearate, sodium starch glycolate (type A). Tablets 300 mg: microcrystalline cellulose, sodium starch glycolate (type A), gelatin, magnesium stearate, anhydrous colloidal silicon dioxide. 30, 40, 50, 60, 70, 80, 90, 100 or 120 tablets in brown glass bottles with polyethylene caps with a first opening control, equipped with an accordion shock absorber. One bottle is packed in a cardboard box along with instructions for medical use for patients. Dosage 300mg per bottle. #30 Warnings Each tablet of Milurit® 100 mg contains 50 mg of lactose If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before taking this medicine. Indications for use For the prevention of gout. This is the name of a disease in which your body produces too much of a substance called uric acid. Uric acid accumulates in the joints and tendons in the form of crystals. These crystals cause an inflammatory response. As a result of inflammation, swelling of the skin is formed in certain joints, its increased sensitivity and soreness even with a light touch. When moving, you may experience severe pain in the joint. For the prevention of other conditions in which uric acid accumulates in the body. These include kidney stones and certain other types of kidney disorders, as well as conditions in the treatment of malignant tumors or certain enzyme disorders. Dosage and Administration Always take this medicine exactly as directed by your doctor. If you are in doubt about the correctness of your actions, once again consult with your doctor or pharmacist. How to use Milurit® should be taken once a day after meals with water. Drink plenty of fluids (2 to 3 liters a day) while you are taking this drug. If the daily dose exceeds 300 mg and if you experience adverse gastrointestinal effects such as nausea or vomiting (see section 4), your doctor may divide the daily dose of allopurinol into several doses to reduce these effects. The attending physician always establishes an individual dose for you. Dosage regimen The following doses are generally recommended: Adults The recommended starting dose is 100 mg once daily. The physician may gradually increase the dose if changes in serum urate levels are not sufficient. Maintenance doses are recommended in the following ranges: 100-200 mg per day for mild conditions, 300-600 mg per day for moderate conditions, and 700-900 mg per day for severe conditions. If a dose determination in mg per kg of body weight is required, then a range of 2-10 mg / kg / day should be followed. Your healthcare provider may also prescribe an anti-inflammatory drug or colchicine for one month or more in the early stages of treatment to prevent attacks of gouty arthritis. Children and adolescents (under 15 years of age) Use in children is rarely indicated, with the exception of malignant conditions (especially leukemia) and certain enzymatic disorders (eg, Lesch-Nyhan syndrome). The recommended dose is 10-20 mg/kg of body weight per day. The daily dose should not exceed 400 mg divided into 3 doses. Elderly Patients Your healthcare provider will prescribe the lowest dose of Milurit® for you to minimize your symptoms. If you have impaired kidney function, you may be prescribed less than 100 mg per day. You may be prescribed 100 mg less frequently than every day. If you are on hemodialysis two or three times a week, your doctor may prescribe a dose of 300 or 400 mg immediately after each hemodialysis session. If you have impaired kidney function, your doctor may test your kidney function, especially if you are taking diuretics (particularly thiazide diuretics such as hydrochlorothiazide). If you have impaired liver function, your doctor may reduce the dose of the drug. Periodic liver function tests may be necessary, especially at the start of treatment. Treatment of conditions with increased urate production (eg, neoplasms, certain enzyme dysfunctions) It is advisable to correct high uric acid levels with Milurit® before initiating cytotoxic therapy. It is important to ensure plenty of fluid intake. Skin reactions In the event of skin reactions, allopurinol should be discontinued immediately. When you return to normal after mild reactions, your doctor may decide to resume the use of allopurinol at a low dose (50 mg / day). Thereafter, the dose can be gradually increased while monitoring for skin reactions and other possible adverse events. If skin reactions reappear, allopurinol should be permanently discontinued as more severe hypersensitivity reactions may occur (see section 4). If you have taken more Milurit® than prescribed If you have taken more Milurit® than prescribed, or if you think your child has swallowed the tablets, contact your doctor or hospital immediately. You need to take this leaflet, the remaining tablets and the package of the drug with you so that you know which tablets have been taken. The most common overdose symptoms are nausea, vomiting, diarrhea or dizziness. The most important thing is to make sure you drink plenty of fluids until medical help arrives. If you forget to take Milurit® If you forget to take a dose, take it as soon as you remember. However, if the next dose is due, do not take the missed dose. Do not take a double dose to make up for a missed dose. Continue treatment as directed. If you stop taking Milurit® The duration of treatment is determined by your doctor. Do not stop taking Milurit® without consulting your doctor, except in the event of an allergic reaction or any other serious adverse event (see section 4). If you have any further questions on the use of this drug, ask your doctor or pharmacist. Use during pregnancy and lactation If you are pregnant or breastfeeding, think you are pregnant or are planning to become pregnant, ask your doctor or pharmacist before taking this medicine. Pregnancy There are insufficient data on the safety of the use of the drug Milurit® during pregnancy in humans. Milurit® should not be taken by pregnant women. Taking the drug is possible only in cases where there is no safer alternative to treatment and if the disease itself poses a greater risk to the mother and unborn child than taking the drug. Breastfeeding period Milurit® is excreted in breast milk. Since there are no reliable safety data, the use of the drug Milurit® during lactation is not recommended. PrecautionsConsult your doctor or pharmacist before using Milurit®. Special care and close medical supervision may be necessary in the following cases: If you have impaired liver or kidney function. Your doctor may reduce your dose or ask you to take the drug less than once a day. You will also be under closer medical supervision. If you have heart problems or high blood pressure and are taking diuretics (eg hydrochlorothiazide, furosemide) and/or certain types of antihypertensive medicines called ACE inhibitors (eg captopril, ramipril). If you are currently experiencing a gout attack. If you or someone in your immediate family has hemochromatosis (a rare disease characterized by abnormally high absorption of iron from the gastrointestinal tract, leading to excess accumulation of iron, especially in the liver). If you have a thyroid disease. If you are being treated with azathioprine (a drug used to reduce the immune response) or mercaptopurine (used for leukemia). If you are Han Chinese or Korean. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Milurit®. When using allopurinol, there have been cases of serious types of skin rash (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis). Often, the rash may be accompanied by sores in the mouth, throat, nose, or genitals and conjunctivitis (redness and swelling of the eyes). These potentially life-threatening, serious skin rashes are often preceded by flu-like symptoms such as fever, headache, and body aches (flu-like symptoms). The rash can progress and cause blistering and peeling of the skin. If you develop a rash or the skin symptoms described above, stop taking Milurit®, contact your doctor immediately and tell your doctor that you are taking this medicine. If you develop severe skin rashes, hypersensitivity syndrome, Stevens-Johnson syndrome, or toxic epidermal necrolysis while using Milurit®, you should never take Milurit® again. In the early stages of treatment with Milurit®, an acute attack of gouty arthritis may develop. Therefore, the doctor may prescribe prophylactic treatment with a suitable anti-inflammatory agent or colchicine for at least one month. To monitor the safety and effectiveness of treatment with Milurit®, your doctor may refer you to one or more laboratory tests. Please turn them in and don’t forget to show the test results to your doctor. If you have cancer or Lesch-Nyhan syndrome, the amount of uric acid in your urine may increase. To prevent this, you should drink plenty of fluids to dilute your urine. If you have kidney stones, they may shrink and enter the urinary tract. Children and adolescents Children and adolescents under 15 years of age should not be prescribed Milurit®, except for certain types of malignant tumors (especially leukemia), as well as the treatment of certain enzymatic disorders, such as Lesch-Nyhan syndrome. Interactions with other drugs Tell your doctor or pharmacist if you are taking any of the following drugs: Salicylates (used to reduce pain, fever or inflammation, such as acetylsalicylic acid). Theophylline (used for respiratory diseases). Your healthcare provider will measure your blood levels of theophylline, especially when you start taking Milurit® or if you change your dose. Medicines used to treat epileptic seizures (phenytoin). Ampicillin or amoxicillin (used to treat bacterial infections). Due to the increased frequency of allergic reactions, patients should be given other antibiotics, if possible. Medicines used to treat HIV (human immunodeficiency virus) infection (didanoside). Medicines used to treat viral infections (vidarabine). Note: Adverse reactions to vidarabine may occur more frequently. Special precautions should be taken if they occur. Medicines used to treat cancer (namely cyclophosphamide, doxorubicin, bleomycin, procarbazine and mechlorethamine). Your health care provider will order regular blood tests. Medicines used to lower the immune response (immunosuppressants), such as ciclosporin (ciclosporin side effects may be more common) and azathioprine (azathioprine dosage needs to be reduced). Mercaptopurine (used in the treatment of leukemia). It is necessary to reduce the dose of mercaptopurine. Medicines used to treat diabetes (chlorpropamide). Dose reduction of chlorpropamide may be necessary, especially in patients with impaired hepatic function. Medicines used to treat heart problems or high blood pressure, such as “ACE inhibitors” (eg captopril, ramipril) or diuretics (diuretics, especially thiazide diuretics such as hydrochlorothiazide or furosemide). Medicines used to thin the blood (anticoagulants), such as warfarin, phenprocoumon, and acenocoumarol. Your healthcare provider will check your blood clotting values more frequently and, if necessary, will lower your dose of these medicines. Any other medicines for the treatment of gout (probenecid, sulfinpyrazone). Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines. This also applies to over-the-counter medicines, including herbal medicines. This information is important because Milurit® may affect the way some other medicines work. Also, some other medicines may affect how Milurit® works. Contraindications If you are allergic to allopurinol or any of the other ingredients of this medicinal product listed in section 6. Composition Active ingredient: 100 mg or 300 mg of allopurinol per tablet. Excipients: Tablets 100 mg: lactose monohydrate, potato starch, povidone K-25, talc, magnesium stearate, sodium starch glycolate (type A). Tablets 300 mg: microcrystalline cellulose, sodium starch glycolate (type A), gelatin, magnesium stearate, anhydrous colloidal silicon dioxide. Side effects Like all medicines, this medicine can cause side effects, although not everyone gets them. Adverse events with the use of the drug Milurit® usually develop rarely and in most cases are characterized by mild severity. Adverse events may vary in frequency depending on the dose received, as well as on the use in combination with other drugs. Their frequency is higher in patients with impaired renal and / or liver function. If you experience any of the following side effects while taking Milurit®, stop taking this medicine and contact your doctor immediately: Uncommon (may affect 1 or less people in 100) Allergic reactions. The following signs are possible: skin rash, peeling of the skin, soreness of the lips and oral cavity; swelling of the face, hands, lips, tongue, or throat; difficulty swallowing or breathing. Very rare signs may include sudden wheezing, rapid heart rate or chest tightness, and collapse. If such reactions develop, do not take Milurit® tablets again without the permission of your doctor. Rare (may affect up to 1 in 1,000 people or less) Fever and chills, headache, muscle aches (flu-like symptoms) and general malaise; Any skin changes, such as mouth, throat, nose, genital ulcers and conjunctivitis (redness and swelling of the eyes), widespread blisters or peeling; Serious hypersensitivity reactions including fever, skin rash, joint pain, and abnormal blood and liver function tests (which may be indicative of multiple organ dysfunction/multiple organ dysfunction/type of hypersensitivity). Other adverse events reported Common (may affect 1 or fewer people in 10) Skin rash Uncommon (may affect 1 or fewer people in 100) Nausea, vomiting, and diarrhea Changes in liver function tests Rare (may affect 1 or less people in 100) less than 1,000) Joint pain or painful swelling in the groin, armpits, or neck Jaundice (yellowing of the skin and whites of the eyes) Liver problems, such as inflammation of the liver Kidney problems Stones in the urinary tract, symptoms may include blood in the urine and pain in the abdomen, flank, or groin Very rare (may affect up to 1 in 10,000 people or less) Milurit® may adversely affect the blood or lymphatic system. Signs of this may include: paleness, sore mouth, bruising, bleeding in the lips, eyes, mouth, or genitals, sore throat, or other signs of infection. These phenomena usually occur in individuals with impaired liver or kidney function. Milurit® may adversely affect the lymph nodes Fever Blood in the urine, kidney failure Hematemesis High levels of lipids (fats) in the blood ) or loss of consciousness Headache, dizziness, drowsiness, or visual disturbances Chest pain, high blood pressure, or slow heart rate Male infertility or inability to achieve or maintain an erection Enlargement of the breasts in men and women Cataracts (clouding of the lens of the eye), macular lesions Hair loss or hair color changes Seizures Depression Fluid retention leading to swelling, especially in the ankles Feeling thirsty, tired, weight loss (possible symptoms of diabetes). Your doctor may test your blood sugar to check this. Boils (furunculosis, small painful red pimples on the skin) Muscle pain Not known (frequency cannot be estimated from the available data) Abdominal pain doctor or pharmacist. By reporting side effects, you can help provide more information about the safety of this medicine. Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see Section 2). Storage conditionsStore at a temperature not exceeding 30°C! Keep out of the reach of children! Buy Milurit tab 300mg in a bottle. No. 30 in the pack. No. 1 Price for Milurit tablets 300 mg in a bottle. No. 30 in the pack. No. 1 Instructions for use for Milurit tablets 300 mg in a bottle. No. 30 in the pack. #1