Milurit

Package Leaflet: Information for the User

Milurit, 100 mg, tablets
Milurit, 300 mg, tablets
Allopurinol

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Milurit and what is it used for
• 2. Important information before taking Milurit
• 3. How to take Milurit
• 4. Possible side effects
• 5. How to store Milurit
• 6. Contents of the pack and other information

1. What is Milurit and what is it used for

The active substance of Milurit tablets is allopurinol. Allopurinol belongs to a group of medicines called enzyme inhibitors. These substances are effective in controlling the rate of certain changes in the body.
Milurit is used for a long time to prevent gout and may be used in other conditions related to an excess of uric acid in the body, such as kidney stones and other kidney diseases, and when the patient is receiving treatment for cancer or has disorders of certain enzymes.

2. Important information before taking Milurit

When not to take Milurit

• If the patient is allergic to allopurinol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Milurit, discuss it with your doctor.
Special caution and close medical supervision may be necessary:

• If the patient belongs to the Han Chinese ethnic group or is of Thai or Korean origin.
• If the patient has liver or kidney disease. The doctor may recommend taking a lower dose or taking the medicine less frequently than daily. The doctor will also monitor the patient more closely.
• If the patient has heart disease or high blood pressure and is taking diuretics and/or blood pressure-lowering medicines called ACE inhibitors.
• If the patient is currently experiencing a gout attack.
• If the patient or their close relative has hemochromatosis (a rare disease characterized by abnormally high iron absorption from the gastrointestinal tract, leading to excessive iron storage, especially in the liver).
• If the patient has thyroid disease.
• If the patient is being treated with azathioprine (a medicine used to weaken the immune response - immunosuppressive), mercaptopurine (a medicine used in leukemia).

If you are unsure whether any of the above situations apply to you, talk to your doctor or pharmacist.
Severe skin reactions (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported during treatment with allopurinol. Often, the rash can involve ulcers of the mouth, throat, nose, genitals, and conjunctivitis (redness and swelling of the eyes). These potentially life-threatening severe skin reactions are often preceded by flu-like symptoms such as fever, headache, body aches. The rash can progress to generalized blisters and skin peeling.
These severe skin reactions may occur more frequently in people of Chinese, Thai, or Korean origin. Chronic kidney disease may also increase the risk in these patients.

If a rash or skin symptoms occur, stop taking Milurit, seek medical attention immediately, and inform your doctor that you are taking this medicine. If severe skin reactions occur during treatment with Milurit, hypersensitivity syndrome, Stevens-Johnson syndrome, or toxic epidermal necrolysis, do not restart treatment with Milurit.

Do not restart treatment with Milurit.
Early in the treatment with Milurit, an acute gout attack can be expected. Therefore, the doctor may recommend taking a preventive anti-inflammatory medicine or colchicine for at least a month.
To monitor the safety and efficacy of treatment with Milurit, the doctor may order one or more laboratory tests. You should have these tests done and show the results to your doctor.
If the patient has been diagnosed with cancer or Lesch-Nyhan syndrome, the amount of uric acid in the urine may increase. To prevent this, you should drink enough fluids to properly dilute the urine.
If the patient has kidney stones, the stones in the kidneys will decrease in size (during treatment) and may move into the urinary tract.

Children and adolescents

Children and adolescents under 15 years of age should not take Milurit, except in cases of certain cancers (especially leukemia) or in the treatment of certain enzymatic disorders, such as Lesch-Nyhan syndrome.

Milurit and other medicines

Tell your doctor about all medicines you are taking, have recently taken, or plan to take, including those obtained without a prescription, including herbal medicines. This is necessary because Milurit may affect the action of other medicines. Other medicines may also affect the action of Milurit.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The safety of using Milurit during pregnancy is not well documented. Milurit should only be used during pregnancy if there is no safer alternative, and the disease itself poses a risk to the mother or the unborn child.
Breastfeeding
Allopurinol is excreted in the milk of breastfeeding women. It is not recommended to take allopurinol during breastfeeding.

Driving and using machines

Drowsiness, dizziness, or coordination disorders may occur. If these symptoms occur, do not drive or operate machinery.

Each Milurit 100 mg tablet contains 50 mg of lactose.

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicine.

Milurit contains sodium.

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Milurit

Always take this medicine exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.
Take Milurit once a day after a meal. As long as you are taking this medicine, you should drink plenty of fluids (2-3 liters per day). If the daily dose exceeds 300 mg and the patient experiences gastrointestinal side effects such as nausea and vomiting (see section 4), the doctor may prescribe allopurinol in divided doses.
Dosing should always be determined individually by the doctor.

Recommended doses

Adults

The doctor usually starts treatment with a low dose of allopurinol (e.g., 100 mg/day) to reduce the risk of side effects. If necessary, the dose will be increased.
Recommended maintenance doses are:
100 to 200 mg per day in mild conditions, 300 to 600 mg per day in moderate conditions, and 700 to 900 mg per day in severe conditions.
If it is necessary to determine the dose in mg/kg body weight, a dose of 2 to 10 mg/kg body weight/day should be used.
Early in the treatment with Milurit, the doctor may prescribe an anti-inflammatory medicine or colchicine to be taken for at least a month to prevent the occurrence of gouty arthritis attacks.

Use in children and adolescents (under 15 years of age)

In children under 15 years of age, Milurit is used in doses of 10 to 20 mg/kg body weight per day, up to a maximum dose of 400 mg per day in 3 divided doses. The use of Milurit in children is rarely indicated, except in cases of cancer (especially leukemia) and certain enzymatic disorders, such as Lesch-Nyhan syndrome.

Elderly patients (over 65 years of age)

The doctor will recommend the smallest dose of Milurit that will best control the symptoms.

If the patient has severe kidney disease

The patient may be advised to take a dose lower than 100 mg every day or to take a dose of 100 mg at intervals longer than once a day.
If the patient is dialyzed 2 or 3 times a week, the doctor may recommend a dose of 300 or 400 mg to be taken immediately after dialysis.
In the case of kidney disease, the doctor may monitor kidney function, especially if the patient is also taking diuretics (diuretics, especially thiazide diuretics).

If the patient has liver disease

The doctor may recommend taking smaller doses. Periodic liver function tests may be necessary, especially at the beginning of treatment.
Treatment of conditions with increased uric acid turnover(e.g., cancer, enzymatic disorders)
It is recommended that before starting cytotoxic therapy, the increased uric acid level should be corrected. It is important to ensure adequate fluid intake.

Skin reactions

If skin reactions occur, stop takingallopurinol immediately. After mild skin reactions have resolved, the medicine can be restarted at a low dose (e.g., 50 mg/day) after careful consideration of the risks. The dose can then be gradually increased, monitoring for skin reactions and other potential side effects. If the rash recurs, the medicine should be permanently discontinued, considering the possibility of severe skin reactions (see section 4. Possible side effects).

Overdose of Milurit

If you have taken more than the recommended dose of Milurit, or if you think a child has swallowed the tablets, contact your doctor or go to the hospital emergency department immediately. Take this leaflet, any remaining tablets, and the packaging with you, so the doctor knows which tablets were taken.
The most common symptoms of overdose are nausea, vomiting, diarrhea, or dizziness. Until medical help is obtained, ensure a large intake of fluids.

Missing a dose of Milurit

If you miss a dose of Milurit, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for the missed dose. Continue treatment as recommended by your doctor.

Stopping treatment with Milurit

The duration of treatment is determined by the doctor.
Do not stop taking Milurit without consulting your doctor first, unless you experience allergic reactions or other severe side effects (see section 4.)
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects related to the use of Milurit are rare in the treated patient population and are mostly mild. The frequency of side effects increases in cases of concomitant kidney and/or liver disease. Cases of potentially life-threatening skin rash (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see section 2.)

If you experience any of the following side effects while taking Milurit, stop taking the medicine and contact your doctor immediately.

Uncommon(may affect up to 1 in 100 people):
Allergic reactions
Symptoms may include:

• skin rash, skin peeling, ulcers of the lips and mouth
• swelling of the face, hands, lips, tongue, or throat
• difficulty swallowing or breathing
• rarely, sudden wheezing, rapid heartbeat, or chest tightness and collapse. Do not take any more tablets unless your doctor tells you to.

Rare(may affect up to 1 in 1,000 people):

• fever and chills, headache, muscle pain (flu-like symptoms) and general feeling of being unwell
• skin changes, such as ulcers of the mouth, throat, nose, genitals, and conjunctivitis (redness and swelling of the eyes), widespread blisters, or skin peeling
• severe allergic reactions with fever, skin rash, joint pain, and abnormal blood test results and liver function tests (may be symptoms of multi-organ hypersensitivity)

Very rare(may affect up to 1 in 10,000 people):

• severe allergic reaction causing swelling of the face or throat
• severe, potentially life-threatening allergic reaction

Frequency not known(cannot be estimated from the available data):

• aseptic meningitis (inflammation of the membranes surrounding the brain and spinal cord): symptoms include stiffness of the neck, headache, nausea, fever, or changes in consciousness. If such symptoms occur, seek medical attention immediately.

Other possible side effects:

• Common(may affect up to 1 in 10 people):
• skin rash
• increased TSH (thyroid-stimulating hormone) levels in the blood

Uncommon(may affect up to 1 in 100 people):

• nausea, vomiting, and diarrhea
• abnormal liver function test results

Rare(may affect up to 1 in 1,000 people):

• joint pain or painful swelling in the groin, armpit, or neck
• jaundice (yellowing of the skin and whites of the eyes)
• liver disorders, such as hepatitis
• kidney disease
• formation of stones in the urinary tract, symptoms may include blood in the urine and abdominal, side, or groin pain

Very rare(may affect up to 1 in 10,000 people):

• Sometimes allopurinol in tablet form may affect the blood, which can manifest as easier bruising than usual or may cause sore throat or other signs of infection. These symptoms usually occur in people who have liver or kidney problems. You should tell your doctor about this as soon as possible. Milurit may affect the lymph nodes
• high fever
• blood in the urine, kidney failure
• vomiting blood
• high levels of fats in the blood
• general feeling of being unwell
• weakness, numbness of the hands or feet, lack of balance, tingling, inability to move muscles (paralysis), or loss of consciousness
• headache, dizziness, drowsiness, or vision disorders
• chest pain, high blood pressure, or slow heart rate
• infertility in men or inability to achieve or maintain an erection
• breast enlargement in men and women
• change in bowel movements, presence of fat in the stool
• taste disorders
• cataract (clouding of the lens of the eye), macular disease of the eye
• hair loss or change in hair color
• seizures
• depression
• fluid retention leading to swelling, especially around the ankles
• increased thirst, fatigue, weight loss (may be symptoms of diabetes). The doctor may recommend a blood sugar test to determine if this is the cause.
• hirsutism (excessive hair growth, especially in women)
• muscle pain

Frequency not known(cannot be estimated from the available data):

• abdominal pain
• lichen planus-like skin rash (itchy reddish-purple skin rash and/or white-gray thread-like lines on the mucous membranes)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Milurit

Keep the medicine out of the sight and reach of children.
Store in the original packaging.
Do not use this medicine after the expiry date (month, year) stated on the carton after "expiry date". The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Milurit contains

The active substance of Milurit is allopurinol.
100 mg tablets: each tablet contains 100 mg of allopurinol
300 mg tablets: each tablet contains 300 mg of allopurinol
Other ingredients are:
100 mg tablets: lactose monohydrate, potato starch, povidone K-25, talc, magnesium stearate, sodium carboxymethylcellulose (type A).
300 mg tablets: microcrystalline cellulose, sodium carboxymethylcellulose (type A), gelatin, colloidal anhydrous silica, magnesium stearate.

What Milurit looks like and contents of the pack

Appearance:
100 mg tablets: white or grayish tablets, odorless, round, flat, with unbeveled edges, with the inscription "E 351" engraved on one side and a dividing line on the other side.
The tablet can be divided into equal doses.
300 mg tablets:
White or off-white, round, flat, and beveled tablets with the stylized inscription "E 352" engraved on one side and a dividing line on the other side.
The dividing line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses.

Packaging

100 mg tablets
40, 50, 60, 70, 80, or 120 tablets in a brown glass bottle with a PE cap in a cardboard box.
300 mg tablets
30, 40, 60, 70, 80, or 100 tablets in a brown glass bottle with a PE cap in a cardboard box.

Marketing authorization holder

PROTERAPIA Spółka z o.o.
ul. Komitetu Obrony Robotników 45 D
02-146 Warsaw

Manufacturer

EGIS PHARMACEUTICALS PLC
Mátyás király u. 65
9900 Körmend
Hungary
To obtain more detailed information, contact the representative of the Marketing Authorization Holder in Poland.
Name:EGIS Polska Sp. z o.o.
Address:ul. Komitetu Obrony Robotników 45 D
02-146 Warsaw
Phone:+48 22 417 92 00
Date of last revision of the leaflet:6.12.2024