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What Milurit is and what it is used for
Milurit tablets contain a medicine called allopurinol. Its action is to slow down the rate of certain chemical reactions in the body to lower uric acid levels in the blood and urine.
Milurit is used:
for the prevention of gout. It is a disease in which the 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 can cause an inflammatory reaction. With inflammation, the skin around some joints swells, becomes painful and sensitive to the slightest touch. In addition, there may be severe pain when moving these joints.
for the prevention of other conditions where uric acid builds up in the body. These are kidney stones and some other types of kidney problems either when you are being treated for cancer or if you have certain enzymatic disorders.
2. What you need to know before taking Millurit
Do not take Milurit:
If you are allergic to allopurinol or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Millurit.
Caution and close medical supervision may be required:
If you are Han Chinese, Thai or Korean.
If you have liver or kidney problems. Your doctor may prescribe you a lower dose or ask you to take the medicine less frequently every day. In addition, your doctor will monitor you more closely.
If you have heart problems or high blood pressure and are taking diuretics (drainage tablets, eg hydrochlorothiazide, furosemide) and / or certain types of blood pressure medications called ACE inhibitors (eg captopril, ramipril) renal function may therefore require a reduction in the dose of Millurite).
If you currently have a gout attack.
If you or your relative suffer from haematochromatosis (a rare disorder characterized by a pathologically high level of iron absorption in the intestinal tract, which leads to excessive iron accumulation, especially in the liver).
If you have problems with your thyroid gland.
If you are being treated with azathioprine (a medicine used to suppress the immune response) or mercaptopurine (used in leukemia).
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Millurit.
Serious skin rashes (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported that have been associated with the use of allopurinol. Often, the rash may have ulcers in the mouth, throat, nose, genitals and conjunctivitis (red or swollen eyes). These potentially life-threatening, serious skin rashes are often accompanied by flu-like symptoms such as fever, headache, and body aches (flu-like symptoms). The rash can progress to widespread blistering and flaking of the skin.
The greatest risk of serious skin reactions occurs during the first weeks of treatment.
These serious skin rashes may be more common in Han Chinese, Thai or Korean people. Chronic kidney disease may further increase the risk in these patients.
If you get a rash or these skin symptoms, stop taking Millurit, contact your doctor as soon as possible and say you are taking this medicine. If you get severe skin rashes, hypersensitivity syndrome, Stevens-Johnson syndrome, or toxic epidermal necrolysis while using Millurit, you should never take Millurit again.
In the initial stages of treatment with Milluritis, it is possible to cause an acute attack of gouty arthritis. Therefore, your doctor may prescribe you prophylactic treatment with an appropriate anti-inflammatory drug or colchicine for at least one month.
If you have cancer or Lesch-Nyhan syndrome, the amount of uric acid in your urine may increase. To prevent it, you must take enough fluid to dilute your urine.
If you have kidney stones, they will become smaller and may pass into the urinary tract.
To monitor the safety and efficacy of Milurit treatment, your doctor may decide to perform one or more laboratory tests. Please do these tests and be sure to show the results to your doctor.
Children and adolescents
Miluritis should not be used in children and adolescents under 15 years of age, except in several cancers (especially leukemia) or in the treatment of certain enzymatic disorders such as Lesch-Nyhan syndrome.
Other Medicines And Milurit
Tell your doctor or pharmacist if you are taking any of the following:
salicylates (for the treatment of pain, fever or inflammation such as acetylsalicylic acid).
Theophylline, a medicine that
immune response (immunosuppressant) drugs, e.g. ciclosporin (adverse reactions to ciclosporin may occur more frequently) and azathioprine (dose reduction of azathioprine is required).
mercaptopurine (used to treat leukemia). A dose reduction of mercaptopurine is required.
diabetes medicines (chlorpropamide). Dose reduction of chlorpropamide may be necessary, especially in patients with impaired renal function.
medicines used for heart problems or high blood pressure, e.g. ACE inhibitors (eg captopril, ramipril) or drainage tablets (diuretics, especially in the thiazide group such as hydrochlorothiazide or furosemide).
blood thinners (coumarin anticoagulants), e.g. warfarin, fenprocoumon and acenocoumarol. Your doctor will monitor your blood clotting more frequently and, if necessary, reduce the dose of these medicines.
any other medicines used to treat gout (probenecid, sulfinpyrazone).
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes over-the-counter medicines, incl. herbal medicines as Millurite may affect the effect of some medicines. In addition, other medicines can also affect the action of Millurite.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
There is insufficient evidence for the safety of Millurit during pregnancy in humans.
Miluritis should not be taken by pregnant women unless there is a safer alternative and when the disease itself poses a risk to the mother and the unborn child.
Millurite falls into human breast milk. Miluritis is not recommended during lactation.
Driving and using machines
You may feel relaxed, dizzy, or have trouble coordinating. In this case, do not drive or operate tools or machines.
3. How to take Milurit
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Milurit should be taken once a day after a meal with water. You should drink plenty of fluids (2-3 liters per day) while taking this medicine.
If the daily dose is more than 300 mg and you have gastrointestinal side effects such as nausea and vomiting (see section 4), your doctor may prescribe Milurit in several separate doses to reduce these effects.
The dose should be determined individually by your doctor.
The recommended doses are:
The recommended starting dose is 100 mg once a day. Your doctor may gradually increase the dose if serum urate is not sufficient.
The recommended doses for maintenance treatment are the following:
100-200 mg daily for mild forms, 300-600 mg daily for moderately severe forms and 700-900 mg daily for severe forms.
If a dose determination based on body weight (mg / kg) is required, a dose of 2 to 10 mg / kg body weight per day should be administered.
At the start of treatment, your doctor may also prescribe you an anti-inflammatory drug or colchicine, which you should take for one month or longer to prevent attacks of gouty arthritis.
Use in children and adolescents (under 15 years)
In rare cases, there are indications for use in children, except for malignancies (mainly leukemia) and certain enzymatic disorders (eg Lesch Nyhan syndrome). The recommended dose is 10 to 20 mg / kg body weight per day. The daily dose should not exceed 400 mg in three separate doses.
Your doctor will prescribe the lowest dose of Milurit tablets to give you the best control of your symptoms.
Use in kidney disease
Dose reduction is required in case of kidney disease. If you have a serious kidney problem, you may need to take less than 100 mg every day, or you may need to take 100 mg at intervals longer than one day.
If you are taking dialysis twice or thrice a week, your doctor may prescribe a dose of 300 or 400 mg to be taken immediately after dialysis.
If you have kidney problems, your doctor will check their function, especially if you are taking dehydrated tablets (diuretics, mainly in the thiazide group such as hydrochlorothiazide).
If you have a liver problem
Your doctor may prescribe lower doses. Periodic liver function tests may be required, especially at the beginning of treatment.
Treatment of conditions with high urate metabolism (eg cancer, certain enzymatic disorders) It is advisable to correct the presence of high uric acid with Millurite tablets before initiating treatment with cytotoxic drugs. This is important to ensure proper absorption of liquids.
The administration of allopurinol should be discontinued
Other possible side effects:
Common (may affect no more than 1 in 10 people):
increased levels of thyroid stimulating hormone in the blood.
Uncommon (may affect no more than 1 in 100 people):
nausea, vomiting and diarrhea;
deviations in liver function parameters.
Rare (may affect no more than 1 in 1,000 people):
joint pain or painful swelling of the groin, armpits, neck;
jaundice (yellowing of the skin and whites of the eyes);
liver problems, e.g. inflammation;
urinary stones, the symptoms of which include blood in the urine and pain in the abdomen, waist area or groin.
Very rare (may affect no more than 1 in 10,000 people):
sometimes Milurit tablets can affect the blood, which can manifest as flushing, inflammation of the mouth, easier blood formation than usual, bleeding from the lips, mouth or genitals, or you may have a sore throat or other signs of infection. These effects usually occur in people with liver or kidney problems. Tell your doctor as soon as possible;
Miluritis can affect the lymph nodes;
presence of blood in urine (hematuria), renal failure;
vomiting of blood;
high levels of blood fat (hyperlipidemia);
a feeling of general discomfort or weakness;
unusual sensations, weakness, numbness of the palms or soles, instability of the feet, tingling, inability to move muscles (paralysis) or loss of consciousness;
headache, dizziness, drowsiness or impaired vision;
chest pain (angina pectoris), high blood pressure or slow heart rate;
male infertility or inability to obtain or retain an erection;
breast augmentation in men and women;
change in appearance, the presence of fat in the stool;
change in taste sensations;
cataract (blurring of the lens of the eye), macular disease;
hair loss or discoloration;
fluid retention, which causes swelling, especially in the ankles;
feelings of thirst, fatigue and weight loss (may be symptoms of diabetes). Your doctor may decide to measure your blood sugar to see if this is the case;
boil formation (boils - small, painful, red pimples on the skin);
With unknown frequency (cannot be estimated from available data):
How to store Milurit tablets
The product does not require any special storage conditions.
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date (EXP) stated on the pack. The expiry date refers to the last day of that month.
Do not dispose of medicines in sewage or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Milurit contains
The active substance is: 150 mg or 200 mg of allopurinol in each tablet.
The other ingredients are microcrystalline cellulose, sodium starch glycolate (type A), gelatin, colloidal anhydrous silica, magnesium stearate.
What Milurit looks like and contents of the pack
Milurite 150 mg tablets: White or gray-white, oval tablets, engraved with "E 353" on one side and with a bar on the other.
The tablets can be divided into equal doses.
Milurite 200 mg tablets: White or gray-white, oval tablets, engraved with "E 354" on one side and with a SNAP divider on the other.
The tablets can be divided into equal doses.
Type and contents of packaging
30, 50, 60, 70, 80, 90, 100 or 120 tablets in a dark glass glass bottle with a tamper-proof plastic cap with a seal placed in a cardboard box with the patient leaflet, or
30, 40, 50, 60, 70, 80, 90, 100 or 120 tablets in PVC / PVdC / Al foil blisters placed in a cardboard box with the patient leaflet.
Not all pack sizes may be marketed.
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