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Instructions for use MILURIT® tablets: 150, 200 mg

There is no current documentation of clinical data for this drug that could be used to support determination of the incidence of adverse events. Adverse events may vary in frequency depending on the dose received, as well as on use in combination with other drugs.

The following frequency categories assigned to adverse drug reactions are estimates:

For most reactions there is no suitable data for frequency calculation. Adverse reactions to the drug identified during post-registration surveillance are considered rare or very rare.

When classifying phenomena by frequency, the following designations are used:

very often (≥1/10), often (from ≥1/100 to <1/10), infrequently (from ≥1/1000 to <1/100), rarely (from ≥1/10,000 to <1/1000 ), very rare (<1/10,000), unknown (cannot be estimated from available data).

Allopurinol-related adverse reactions in the general population of treated patients are rare and mostly minor. A higher frequency is observed in the presence of impaired renal and/or liver function.

Infectious and parasitic diseases:

very rarely - boil.

From the hematopoietic system:

very rarely - agranulocytosis1, aplastic anemia1, thrombocytopenia1, granulocytosis, leukopenia, leukocytosis, eosinophilia and true erythrocyte aplasia.

From the immune system:

uncommon - hypersensitivity2;

very rarely - angioimmunoblastic T-cell lymphoma3.

From the side of metabolism:

very rarely - diabetes mellitus, hyperlipidemia.

Mental disorders:

very rarely - depression.

From the nervous system:

very rarely - coma, paralysis, ataxia, peripheral neuropathy, paresthesia, drowsiness, headache, taste disturbance (dysgeusia).

From the side of the organ of vision:

very rarely - cataracts, visual impairment, maculopathy.

From the organ of hearing and balance:

very rarely - dizziness with a feeling of spinning (vertigo).

From the heart:

very rarely - angina, bradycardia.

From the side of blood vessels:

very rarely - arterial hypertension.

From the gastrointestinal tract:

infrequently - vomiting4, nausea4, diarrhea;

very rarely - bloody vomiting, steatorrhea, stomatitis, change in the rhythm of bowel movements;
unknown - abdominal pain.

From the liver and biliary tract:

uncommon - abnormal liver function tests5;

rarely - hepatitis (including liver necrosis and granulomatous hepatitis)5.

For the skin and subcutaneous tissues:

often - rash;

rarely - Stevens-Johnson syndrome/toxic epidermal necrolysis6;
very rarely - angioedema7, drug rash, hair loss, change in hair color, anaphylactic reactions.

From the musculoskeletal and connective tissue side:

very rarely - muscle pain.

From the kidneys and urinary tract:

rarely - urolithiasis;

very rarely - hematuria, azotemia.

From the genital organs and breast:

very rarely - male infertility, erectile dysfunction, gynecomastia.

General disorders and disorders at the injection site:

very rarely - swelling, feeling of general malaise, asthenia, increased body temperature8.

Influence on the results of laboratory and instrumental studies:

often - increased levels of thyroid-stimulating hormone (TSH)9.

1 There are very rare reports of thrombocytopenia, agranulocytosis and aplastic anemia, especially in patients with impaired renal and/or hepatic function, highlighting the need for special attention to this group of patients.

2 Serious hypersensitivity reactions, including skin reactions with skin peeling, fever, lymph node involvement, joint pain, and/or eosinophilia, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), are rare. Hypersensitivity-related vasculitis and tissue reactions can manifest in a variety of ways, including: hepatitis, kidney damage, acute cholangitis, xanthine stones and very rarely seizures. Reports of acute anaphylactic shock are very rare. If these reactions occur, which can happen at any time during treatment, allopurinol should be immediately and permanently discontinued. Delayed-onset disorder with multiple organ hypersensitivity (known as hypersensitivity syndrome or DRESS-drug reaction with eosinophilia and systemic manifestations) with fever, rash, vasculitis, lymph node involvement, pseudolymphoma, joint pain, leukopenia, eosinophilia, hepato-splenomegaly, abnormal liver function tests and disappearance of the bile ducts syndrome (destruction and disappearance of the intrahepatic bile ducts) occurs in various combinations. Other organs (eg, liver, lungs, kidneys, pancreas, myocardium, and colon) may be affected. If these reactions develop, which can happen at any time during treatment, the use of Milurit® should be immediately and permanently discontinued. Patients with hypersensitivity syndrome and SJS/TEN should not be restarted taking the drug. Corticosteroids may be useful in treating skin hypersensitivity reactions. In cases of generalized hypersensitivity reactions, these patients usually had impaired renal and/or hepatic function, particularly when death occurred.

3 Angioimmunoblastic T-cell lymphoma has been described very rarely in cases of biopsied generalized lymphadenopathy. It appears to be reversible when allopurinol is discontinued.

4 Nausea and vomiting were reported in early clinical studies. More recent reports suggest that this reaction is not a significant problem and can be avoided by taking allopurinol after meals.

5 Liver dysfunction has been described without the manifestation of more generalized hypersensitivity.

6 Skin reactions are the most common type of reaction and can occur at any time during treatment. They may present as a pruritic, maculopapular, sometimes scaly or purpuric rash, and in rare cases exfoliative lesions such as Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN). The greatest risk of developing SJS and TEN or other serious hypersensitivity reactions is observed during the first weeks of allopurinol use. The best treatment results for such reactions are achieved with early diagnosis and immediate cessation of all suspected medications. If such a reaction occurs, Milurit® should be discontinued immediately. Upon return to normal after mild reactions, allopurinol may be restarted at a low dose (such as 50 mg/day), which can be gradually increased. The HLA-B*5801 allele has been shown to be associated with the risk of developing allopurinol-dependent hypersensitivity syndrome and SJS/TEN. The use of genotyping as a screening tool for decision-making regarding allopurinol treatment has not been introduced into practice. If the skin reaction occurs repeatedly, allopurinol should be discontinued immediately and permanently, given the possibility of developing more severe hypersensitivity. If the presence of SJS/TEN or other serious hypersensitivity reactions cannot be excluded, allopurinol SHOULD NOT be restarted due to the possibility of a severe or even fatal reaction. The basis for decision making is the presence of a clinical diagnosis of SJS/TEN. If such reactions develop at any time during treatment, use of allopurinol should be immediately and permanently discontinued.

7 The development of angioedema has been described in combination with and without signs and symptoms of a more generalized hypersensitivity reaction.

8 The development of fever with or without signs and symptoms of a more generalized hypersensitivity reaction has been described.

9 The increase in TSH levels observed in relevant studies did not affect T4 levels and did not indicate the occurrence of subclinical hypothyroidism.

Reports of suspected adverse reactions

Providing data on suspected adverse reactions of the drug is very important, allowing for continuous monitoring of the risk-benefit ratio of the drug. Health care professionals should report any suspected adverse reactions through the national reporting system or to the contacts listed at the end of the instructions.

Allopurinol-Milurit tab 100mg N50 (Egis)

There are no current clinical data to determine the incidence of side effects. Their frequency may vary depending on the dose and whether the drug was prescribed as monotherapy or in combination with other drugs.

The classification of the frequency of side effects is based on an approximate estimate; for most side effects there is no data to determine the frequency of their development.

The classification of adverse reactions depending on the frequency of occurrence is as follows:

very common (≥1/10),

frequent (from ≥1/100 to <1/10),

uncommon (from ≥1/1000 to <1/100),

rare (from ≥1/10000 to <1/1000),

very rare (< 1/10000),

frequency unknown (cannot be determined from available data).

Adverse reactions associated with allopurinol therapy observed in the post-marketing period are rare or very rare. In the general patient population, most cases are mild. The incidence of adverse events increases with impaired renal and (or) liver function.

Infections and parasitic diseases : very rare:

furunculosis.

Blood and lymphatic system disorders:

very rare:

agranulocytosis, aplastic anemia, thrombocytopenia, granulocytosis, leukopenia, leukocytosis, eosinophilia and red blood cell only aplasia.

Thrombocytopenia, agranulocytosis and aplastic anemia have been reported very rarely, particularly in persons with impaired renal and/or hepatic function, highlighting the need for special caution in these patient groups.

Immune system disorders:

infrequent:

hypersensitivity reactions;
rare:
severe hypersensitivity reactions, including skin reactions with epidermal detachment, fever, lymphadenopathy, arthralgia and/or eosinophilia (including Stevens-Johnson syndrome and toxic epidermal necrolysis) (see section "Skin and subcutaneous tissue disorders") .
Associated vasculitis or tissue reactions may have a variety of manifestations, including hepatitis, renal involvement, acute cholangitis, xanthine stones, and, in very rare cases, seizures. In addition, the development of anaphylactic shock was very rarely observed. If severe adverse reactions develop, allopurinol therapy should be stopped immediately and not restarted.
In delayed multiorgan hypersensitivity (known as drug hypersensitivity syndrome /DRESS), the following symptoms may develop in various combinations: fever, skin rash, vasculitis, lymphadenopathy, pseudolymphoma, arthralgia, leukopenia, eosinophilia, hepatosplenomegaly, changes in liver function tests, syndrome disappearing bile ducts (destruction or disappearance of intrahepatic bile ducts).
If such reactions develop during any period of treatment, Allopurinol-EGIS should be immediately discontinued and never restarted. Generalized hypersensitivity reactions developed in patients with impaired renal and (or) liver function. Such cases were sometimes fatal; very rare:
angioimmunoblastic lymphadenopathy. Angioimmunoblastic lymphadenopathy has very rarely been diagnosed after lymph node biopsy for generalized lymphadenopathy. Angioimmunoblastic lymphadenopathy is reversible and regresses after cessation of allopurinol therapy.

Metabolic and nutritional disorders:

very rare:

diabetes mellitus, hyperlipidemia

Mental disorders:

very rare:

depression

Nervous system disorders:

very rare:

coma, paralysis, ataxia, neuropathy, paresthesia, drowsiness, headache, taste disturbance

Visual disorders:

very rare:

cataracts, visual impairment, macular changes

Hearing and labyrinth disorders:

very rare:

dizziness (vertigo)

Heart disorders:

very rare:

angina, bradycardia.

Vascular disorders:

very rare:

increased blood pressure

Gastrointestinal disorders: uncommon:

vomiting, nausea, diarrhea;

Nausea and vomiting were observed in earlier clinical studies, but more recent observations have confirmed that these reactions are not a clinically significant problem and can be avoided by administering allopurinol after meals.

very rare:

recurrent hematemesis, steatorrhea, stomatitis, changes in bowel movements

Frequency unknown

: abdominal pain

Disorders of the liver and biliary tract:

infrequent:

asymptomatic increase in the concentration of liver enzymes (increased levels of alkaline phosphatase and transaminases in the blood serum)
rare:
hepatitis (including necrotizing and granulomatous forms).

Liver dysfunction may develop without obvious signs of generalized hypersensitivity

Skin and subcutaneous tissue disorders:

frequent:

rash;
rare:
severe skin reactions: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN),
very rare:
angioedema, local drug rash, alopecia, hair bleaching.

Skin adverse reactions are the most common in patients taking allopurinol. During drug therapy, these reactions can develop at any time. Skin reactions may include itching, maculopapular and scaly rashes. In other cases, purpura may develop. In rare cases, exfoliative skin lesions (SSD/TEN) are observed. If such reactions develop, allopurinol therapy should be discontinued immediately. If the skin reaction is mild, then allopurinol can be resumed at a lower dose (for example, 50 mg per day) after these changes have resolved. Subsequently, the dose can be gradually increased. If skin reactions recur, allopurinol therapy should be stopped and not restarted, since further use of the drug may lead to the development of more severe hypersensitivity reactions (see “Immune system disorders”).

According to existing information, during therapy with allopurinol, angioedema developed in isolation, as well as in combination with symptoms of a generalized hypersensitivity reaction.

Musculoskeletal and connective tissue disorders:

very rare

: myalgia.

Nocturnal and urinary tract disorders:

very rare:

hematuria, renal failure, uremia,
frequency unknown:
urolithiasis.

Reproductive system and breast disorders:

very rare:

male infertility, erectile dysfunction, gynecomastia.

General disorders and disorders at the injection site:

very rare:

swelling, general malaise, general weakness, fever.

According to existing information, during therapy with allopurinol, fever developed both in isolation and in combination with symptoms of a generalized hypersensitivity reaction (see “Immune system disorders”)

Reports of possible adverse reactions

If adverse reactions occur, including those not listed in this instruction, you should stop using the drug.

In the post-registration period, any information about possible adverse reactions is important, since these reports help to continuously monitor the safety of the drug. Healthcare professionals are required to report any suspected adverse reactions to local pharmacovigilance authorities.

Milurit tablet 300 mg in bottle. No. 30 in pack. No. 1

Name

Milurit tablet 300 mg in bottle. No. 30 in pack. No. 1

Description

Milurit® contains a drug called allopurinol. It works by slowing the rate of certain chemical reactions in your body and reduces the level of uric acid in your blood and urine.

Main active ingredient

Allopurinol

Release form

Active ingredient: 100 mg or 300 mg 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, colloidal anhydrous silicon dioxide. 30, 40, 50, 60, 70, 80, 90, 100 or 120 tablets in brown glass bottles with polyethylene caps with tamper evident, equipped with an accordion shock absorber. One bottle is packed in a cardboard box along with instructions for medical use for patients.

Dosage

300 mg per bottle. No. 30

special instructions

Each Milurit® 100 mg tablet contains 50 mg of lactose. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before starting to take 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 at certain joints is formed, its increased sensitivity and pain even with a light touch. You may experience severe pain in the joint when moving. To prevent other conditions in which uric acid accumulates in the body. These include kidney stones and certain other types of kidney problems, as well as conditions during the treatment of cancer or certain enzyme dysfunctions.

Directions for use and doses

Always take this medication exactly as directed by your doctor. If you doubt the correctness of your actions, consult your doctor or pharmacist again. Directions for use: Milurit® should be taken once a day after meals with water. While you are taking this drug, drink plenty of fluids (2 to 3 liters per day). If the daily dose is more than 300 mg and if you experience gastrointestinal side effects such as nausea or vomiting (see section 4), your doctor may divide the daily dose of allopurinol into several divided doses to reduce these side effects. The individual dose for you is always set by your attending physician. Dosage regimen The following doses are generally recommended: Adults The recommended starting dose is 100 mg once daily. The doctor may increase the dose gradually 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 you need to determine the dose in mg per kg of body weight, then you should adhere to the range of 2-10 mg/kg/day. During the initial phase of treatment to prevent attacks of gouty arthritis, your doctor may also prescribe an anti-inflammatory drug or colchicine for one month or more. 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 (for example, Lesch-Nyhan syndrome). The recommended dose is 10-20 mg/kg body weight per day. The daily dose should not exceed 400 mg when divided into 3 doses. Elderly patients Your doctor will prescribe the lowest dose of Milurit® for maximum relief of symptoms of the disease. If you have impaired kidney function, you may be prescribed less than 100 mg per day. You may be prescribed 100 mg less often than every day. If you undergo 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 do a kidney function test, 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 beginning of treatment. Treatment of conditions accompanied by increased urate production (for example, neoplasms, certain enzyme dysfunctions) It is advisable to correct high uric acid levels with Milurit® before starting cytotoxic therapy. It is important to ensure plenty of fluid intake. Skin reactions If skin reactions occur, use of allopurinol should be discontinued immediately. If you return to normal after mild reactions, your doctor may decide to resume using allopurinol at a low dose (50 mg/day). After this, the dose can be gradually increased while monitoring the appearance of skin reactions and other possible adverse effects. If skin reactions recur, allopurinol should be permanently discontinued as more severe hypersensitivity reactions may occur (see section 4). If you take more Milurit® than prescribed If you take more Milurit® than prescribed or you think your child has swallowed the tablets, call your doctor or go to the hospital immediately. You should take these instructions, the remaining tablets and the packaging of the medicine with you so that you know which tablets you took. The most common symptoms of overdose are nausea, vomiting, diarrhea, or dizziness. The most important thing until medical help arrives is to ensure you drink plenty of fluids. If you forget to take Milurit® If you forget to take a dose, take it as soon as you remember. However, if it is near time for your next dose, do not take the missed dose. Do not take a double dose to make up for a missed dose. Continue treatment as prescribed. If you stop taking Milurit® The duration of treatment is determined by your doctor. Do not stop taking Milurit® without consulting your doctor unless you have an allergic reaction or any other serious adverse event (see section 4). If you have any additional questions about the use of this medicine, contact 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, talk to your doctor or pharmacist before taking this medicine. Pregnancy There is insufficient data on the safety of 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 treatment alternative and if the disease itself poses a greater risk to the mother and unborn child than taking the drug. Breastfeeding Milurit® is excreted into breast milk. Since there are no reliable safety data, the use of Milurit® during breastfeeding is not recommended.

Precautionary measures

Talk to your doctor or pharmacist before starting to use Milurit®. Special caution 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 often 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 a close relative has hemochromatosis (a rare disease characterized by abnormally high absorption of iron in 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 medicine used to reduce the immune response) or mercaptopurine (used for leukemia). If you are Han Chinese or Korean. If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking Milurit®. Cases of serious types of skin rashes (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of allopurinol. Often the rash may be accompanied by ulcers 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 may progress and cause blistering and peeling of the skin. If you develop a rash or the skin symptoms described above, stop taking Milurit®, call your doctor immediately and tell him that you are taking this drug. If you develop serious 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 drug or colchicine for at least one month. To monitor the safety and effectiveness of Milurit® treatment, your doctor may order one or more laboratory tests. Please take them and do not forget to show the test results to your doctor. If you have cancer or Lesch-Nyhan syndrome, your urine may have high levels of uric acid. To prevent this, you should drink plenty of fluids to ensure your urine is diluted. If you have kidney stones, they may shrink in size and enter the urinary tract. Children and adolescents Milurit® should not be prescribed to children and adolescents under the age of 15 years, with the exception of certain types of malignant tumors (especially leukemia), as well as the treatment of certain enzymatic disorders, such as Lesch-Nyhan syndrome.

Interaction with other drugs

Tell your doctor or pharmacist if you are taking any of the following medicines: Salicylates (used to relieve pain, fever or inflammation, such as acetylsalicylic acid). Theophylline (used for respiratory diseases). Your doctor will measure your theophylline levels in your blood, especially when you start using Milurit® or if your dose changes. 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 prescribed 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 be more common. Special precautions should be taken if they occur. Medicines used to treat cancer (namely cyclophosphamide, doxorubicin, bleomycin, procarbazine and mechlorethamine). Your doctor will order regular blood tests. Medicines used to reduce the immune response (immunosuppressants), such as cyclosporine (adverse effects of cyclosporine may be more common) and azathioprine (the dose of azathioprine may need to be reduced). Mercaptopurine (used in the treatment of leukemia). It is necessary to reduce the dose of mercaptopurine. Medicines used to treat diabetes mellitus (chlorpropamide). A reduction in the dose of chlorpropamide may be necessary, especially in patients with impaired liver 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 doctor will check your blood clotting levels more frequently and, if necessary, reduce your dose of these medications. 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 medicines purchased without a prescription, including herbal medicines. This information is important because Milurit® may affect the action of some other medicines. Also, some other drugs may affect the effect of Milurit®.

Contraindications

If you are allergic to allopurinol or any of the other substances in this medicine listed in section 6.

Compound

Side effect

Like all medicines, this medicine can cause side effects, although not all people experience them. Adverse events when using 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 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 adverse reactions while taking Milurit®, stop taking this medicine and contact your doctor immediately: Uncommon (may occur in 1 person or less in 100) Allergic reactions. The following signs are possible: skin rash, peeling of the skin, soreness of the lips and mouth; swelling of the face, hands, lips, tongue, or throat; difficulty swallowing or breathing. Very rare signs may include sudden wheezing, rapid heartbeat, or chest tightness and collapse. If such reactions develop, do not take Milurit® tablets again without the permission of your doctor. Rare (may affect 1 person or less in 1,000) Fever and chills, headache, muscle aches (flu-like symptoms) and general malaise; Any skin changes, such as sores of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes), widespread blistering or peeling; Serious hypersensitivity reactions, including fever, skin rash, joint pain, and abnormal laboratory blood tests and liver function tests (which may be signs of multiple organ dysfunction/multiple organ dysfunction/hypersensitivity type). Other adverse events have been reported Common (may occur in 1 or less people in 10) Skin rash Uncommon (may occur in 1 person or less in 100) Nausea, vomiting and diarrhea Changes in liver function test results Rare (may occur in 1 person or less less than in 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 liver inflammation Kidney problems Stones in the urinary tract, symptoms may include blood in the urine and pain in the abdomen, side or groin area Very rare (may affect 1 person or less in 10,000) Milurite® may have adverse effects on 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 persons with impaired liver or kidney function. Milurit® may adversely affect the lymph nodes Increased body temperature Blood in the urine, kidney failure Hematemesis High levels of lipids (fats) in the blood General malaise Weakness, numbness in the arms or legs, unsteadiness in a standing position, tingling sensation, inability to move voluntary muscle movements (paralysis ) or loss of consciousness Headache, dizziness, drowsiness, or visual disturbances Chest pain, high blood pressure, or slow pulse Male infertility or inability to get or keep an erection Enlarged breasts in men and women Changes in normal bowel habits, fat in stool Changes in taste sensations Cataract (clouding of the lens of the eye), damage to the macula of the eye Hair loss or change in hair color 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 levels to check this. Boils (furunculosis, small, painful red bumps on the skin) Muscle pain Frequency unknown (frequency cannot be estimated from available data) Abdominal pain Reports of adverse reactions If you experience any of the side effects listed or if any effects not listed in this leaflet occur, please contact doctor or pharmacist. By reporting side effects, you can help provide more information about the safety of this drug. Potentially life-threatening skin rashes have been reported (Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2).

Storage conditions

Store at a temperature not exceeding 30°C! Keep out of the reach of children!

Milurit, 30 pcs., 300 mg, tablets

The classification of the frequency of side effects is based on an approximate estimate; for most side effects there is no data to determine the frequency of their development.

The classification of adverse reactions depending on the frequency of occurrence is as follows:

very common (≥1/10),

frequent (from ≥1/100 to <1/10),

uncommon (from ≥1/1000 to <1/100),

rare (from ≥1/10000 to <1/1000),

very rare (< 1/10000),

frequency unknown (cannot be determined from available data).

Infections and parasitic diseases: very rare: furunculosis.

Disorders of the blood and lymphatic system:

very rare: agranulocytosis, aplastic anemia, thrombocytopenia, granulocytosis, leukopenia, leukocytosis, eosinophilia and aplasia affecting only red blood cells.

Immune system disorders:

uncommon: hypersensitivity reactions; rare: severe hypersensitivity reactions, including skin reactions with epidermal detachment, fever, lymphadenopathy, arthralgia and/or eosinophilia (including Stevens-Johnson syndrome and toxic epidermal necrolysis) (see section "Skin and subcutaneous tissue disorders") . Associated vasculitis or tissue reactions may have a variety of manifestations, including hepatitis, renal involvement, acute cholangitis, xanthine stones, and, in very rare cases, seizures. In addition, the development of anaphylactic shock was very rarely observed. If severe adverse reactions develop, allopurinol therapy should be stopped immediately and not restarted. In delayed multiorgan hypersensitivity (known as drug hypersensitivity syndrome /DRESS), the following symptoms may develop in various combinations: fever, skin rash, vasculitis, lymphadenopathy, pseudolymphoma, arthralgia, leukopenia, eosinophilia, hepatosplenomegaly, changes in liver function tests, syndrome disappearing bile ducts (destruction or disappearance of intrahepatic bile ducts). If such reactions develop during any period of treatment, Allopurinol-EGIS should be immediately discontinued and never restarted. Generalized hypersensitivity reactions developed in patients with impaired renal and (or) liver function. Such cases were sometimes fatal; very rare: angioimmunoblastic lymphadenopathy. Angioimmunoblastic lymphadenopathy has very rarely been diagnosed after lymph node biopsy for generalized lymphadenopathy. Angioimmunoblastic lymphadenopathy is reversible and regresses after cessation of allopurinol therapy.

Metabolic and nutritional disorders:

very rare: diabetes mellitus, hyperlipidemia

Mental disorders:

very rare: depression

Nervous system disorders:

very rare: coma, paralysis, ataxia, neuropathy, paresthesia, drowsiness, headache, taste disturbance

Visual disorders:

very rare: cataracts, visual disturbances, macular changes

Hearing and labyrinth disorders:

very rare: dizziness (vertigo)

Cardiac disorders:

very rare: angina, bradycardia.

Vascular disorders:

very rare: increased blood pressure

Gastrointestinal disorders: uncommon: vomiting, nausea, diarrhea;

very rare: recurrent hematemesis, steatorrhea, stomatitis, changes in frequency of bowel movements

Frequency unknown: abdominal pain

Disorders of the liver and biliary tract:

uncommon: asymptomatic increase in the concentration of liver enzymes (increased levels of alkaline phosphatase and transaminases in the blood serum) rare: hepatitis (including necrotizing and granulomatous forms).

Liver dysfunction may develop without obvious signs of generalized hypersensitivity

Disorders of the skin and subcutaneous tissues:

common: rash; rare: severe skin reactions: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), very rare: angioedema, local drug rash, alopecia, hair bleaching.

According to existing information, during therapy with allopurinol, angioedema developed in isolation, as well as in combination with symptoms of a generalized hypersensitivity reaction.

Musculoskeletal and connective tissue disorders:

very rare: myalgia.

Nocturnal and urinary tract disorders:

very rare: hematuria, renal failure, uremia, frequency unknown: urolithiasis.

Reproductive system and breast disorders:

very rare: male infertility, erectile dysfunction, gynecomastia.

General disorders and disorders at the injection site:

very rare: swelling, general malaise, general weakness, fever.

Reports of possible adverse reactions

If adverse reactions occur, including those not listed in this instruction, you should stop using the drug.