Milurit

Package Leaflet: Information for the User

Milurit, 150 mg, tablets
Milurit, 200 mg, tablets
Allopurinol

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

• Keep this leaflet, you may need to read it again.
• 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

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 occurring in the body.
Milurit is used long-term to prevent gout and may be used in other conditions associated with 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 enzyme function disorders.

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 smaller 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 conjunctivae (redness and swelling of the eyes). These potentially life-threatening severe skin reactions are often preceded by flu-like symptoms such as fever, headache, and body aches. The rash may 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, do not restart treatment with Milurit.

Do not restart treatment with Milurit.
In the early stages of 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 plenty of fluids to 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 enzyme disorders, such as Lesch-Nyhan syndrome.

Milurit and other medicines

Tell your doctor about any medicines you are taking or have recently taken, as well as any medicines you plan to take.
Salicylates (used to reduce pain, fever, or inflammation, e.g., acetylsalicylic acid)
Theophylline, a medicine used for breathing problems. The doctor may order theophylline blood level tests, especially at the start of treatment with Milurit or modify its dose.
Medicines used to treat epilepsy (phenytoin)
Ampicillin or amoxicillin (used in bacterial infections). Because allergic reactions are more common, patients should receive other antibiotics if possible.
Didanosine, used in the treatment of HIV infection
Vidarabine, used in the treatment of viral infections. Note: Vidarabine side effects may occur more frequently. Particular caution is advised if they occur.
Blood disorders occur more frequently when allopurinol is taken with cytostatics (e.g., cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkyl halides) than when these active substances are taken alone.
Therefore, regular blood morphology tests should be performed.
If aluminum hydroxide is taken at the same time, allopurinol may have a weaker effect.
A gap of at least 3 hours should be maintained between taking both medicines.
Medicines used to weaken the immune response (immunosuppressive medicines), such as cyclosporine (cyclosporine side effects may occur more frequently), azathioprine (used to suppress the immune system), and 6-mercaptopurine (used in blood cancer treatment). Avoid taking 6-mercaptopurine or azathioprine with allopurinol. When taking 6-mercaptopurine or azathioprine with Milurit, reduce the dose of 6-mercaptopurine or azathioprine, as their effect will be prolonged. This may increase the risk of serious blood disorders. In such cases, the doctor will closely monitor the patient's blood count during treatment.
Seek medical attention immediately if you notice any unexplained bruising, bleeding, fever, or sore throat.

• Medicines used to treat diabetes (chlorpropamide). The dose of chlorpropamide may need to be reduced, especially in patients with kidney function disorders.
  Medicines used to treat heart disease or high blood pressure, such as ACE inhibitors (e.g., captopril, ramipril) or diuretics (especially thiazide diuretics or furosemide)
  Medicines used to thin the blood (anticoagulants), such as warfarin, phenprocoumon, and acenocoumarol. The doctor will monitor blood clotting parameters more frequently and, if necessary, reduce the dose of these medicines.
  Other medicines used to treat gout (probenecid).

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, including those sold 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 baby, ask your doctor or pharmacist for advice 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 poses a risk to the mother or the unborn child.
Breastfeeding
Allopurinol is excreted in breast milk. It is not recommended to take allopurinol during breastfeeding.

Driving and using machines

Drowsiness, dizziness, or coordination disorders may occur. If such symptoms occur, do not drive or operate machinery.
Milurit contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

• 3. How to take Milurit

Take this medicine always as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
Milurit should be taken 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 you experience 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.
In the early stages of treatment, the doctor may prescribe an anti-inflammatory medicine or colchicine to be taken for at least a month to prevent gout 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 enzyme 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 smaller than 100 mg per 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 (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 start of treatment.
Treatment of conditions with increased uric acid turnover(e.g., cancer, enzyme function disorders)
It is recommended that before starting cytotoxic therapy, elevated uric acid levels be corrected. It is essential to ensure adequate fluid intake.

Skin reactions

If skin reactions occur, stop takingallopurinol immediately. After mild skin reactions have resolved, allopurinol 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 a 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. Bring this leaflet, the 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, 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 directed by your doctor.

Stopping treatment with Milurit

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

4. Possible side effects

Like all medicines, Milurit 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.
Severe skin reactions (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, peeling of the skin, ulcers of the lips and mouth
• swelling of the face, hands, lips, tongue, or throat
• difficulty swallowing or breathing
• rarely, sudden wheezing, palpitations, 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 aches (flu-like symptoms) and general feeling of being unwell
• skin changes, such as mouth ulcers, throat, nose, genitals, and conjunctivitis (redness and swelling of the eyes), widespread blisters, or skin peeling
• severe allergic reactions with fever, rash, joint pain, and abnormal blood test results and liver function tests (may be symptoms of multi-organ hypersensitivity) Rare(may affect up to 1 in 10,000 people):
• severe allergic reaction causing swelling of the face or throat
• 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 stiff 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):

• rash
• increased TSH (thyroid function 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, armpits, 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 tablets may affect the blood, which may manifest as easier bruising than usual or may cause sore throat or other infection symptoms. These symptoms usually occur in people with liver or kidney problems. Tell your doctor 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, loss of balance, tingling, inability to move (paralysis), or loss of consciousness
• headache, dizziness, drowsiness, or vision disturbances
• 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
• changes in bowel habits, 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 the cause.
• hirsutism (excessive hair growth, acne)
• muscle pain

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

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform 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.
There are no special storage requirements.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Milurit contains

The active substance of Milurit is allopurinol.
Tablets 150 mg: each tablet contains 150 mg of allopurinol.
Tablets 200 mg: each tablet contains 200 mg of allopurinol.
Other ingredients are: microcrystalline cellulose, sodium carboxymethylcellulose (type A), gelatin, colloidal anhydrous silica, magnesium stearate.

What Milurit looks like and contents of the pack

Appearance:
Tablets 150 mg: white or grayish, oval tablets, with the inscription "E353" on one side and a dividing line on the other side. The tablet can be divided into equal doses.
Tablets 200 mg: white or grayish, oval tablets, with the inscription "E354" on one side and a dividing line SNAP on the other side. The tablet can be divided into equal doses.
Packaging
30, 50, 60, 70, 80, 90, 100, or 120 tablets in a brown glass bottle type III, closed with a PE cap with a tamper-evident closure, in a cardboard box.

Marketing authorization holder

PROTERAPIA sp. z o.o.
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: PROTERAPIA sp. z o.o.
Komitetu Obrony Robotników 45 D
02-146 Warsaw
Phone: +48 22 417 92 00
Date of last revision of the leaflet:5.12.2024