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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the 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 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, the patient should discuss it with their 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 excessive iron absorption from the digestive 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 - immunosuppressant), mercaptopurine (a medicine used in leukemia).

In case of doubt about any of the above situations, the patient should consult their 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 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.

In case of rash or skin symptoms, the patient should stop taking Milurit, seek medical attention immediately, and inform their doctor about taking this medicine. If the patient experiences severe skin reactions, hypersensitivity syndrome, Stevens-Johnson syndrome, or toxic epidermal necrolysis while taking Milurit, they should not restart treatment with Milurit.

Do not restart treatment with Milurit.
During the early period of treatment with Milurit, an acute gout attack may occur. 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. The patient should undergo these tests and show the results to their 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, the patient 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

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes over-the-counter medicines, 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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 breast milk. It is not recommended to take allopurinol while breastfeeding.

Driving and using machines

Drowsiness, dizziness, or coordination disorders may occur. If such symptoms occur, the patient should not drive or operate machinery.

Each Milurit 100 mg tablet contains 50 mg of lactose.

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

Milurit contains sodium.

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

3. How to take Milurit

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
Milurit should be taken once a day after a meal. As long as the patient is taking this medicine, they 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 for mild conditions, 300 to 600 mg per day for moderate conditions, and 700 to 900 mg per day for 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.
During the early period 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 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 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 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, the increased uric acid level should be corrected. It is essential to ensure adequate fluid intake.

Skin reactions

In case of skin reactions, the patient should immediatelystop taking allopurinol. After the mild skin reactions have subsided, the doctor may restart the medicine 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 permanentlydiscontinued, considering the possibility of severe skin reactions (see section 4. Possible side effects).

Overdose of Milurit

In case of overdose of Milurit or if the patient thinks a child has swallowed the tablets, they should contact their doctor or go to the hospital emergency department immediately. The patient should take this leaflet, the remaining tablets, and the packaging of the medicine with them, so the doctor knows which tablets were taken.
The most common symptoms of overdose are nausea, vomiting, diarrhea, or dizziness. Until medical help is provided, the patient should ensure a large intake of fluids.

Missed dose of Milurit

In case of a missed dose, the patient should take it as soon as they remember. However, if it is almost time for the next dose, the patient should skip the missed dose. The patient should not take a double dose to make up for the missed dose. The patient should continue treatment as directed by their doctor.

Stopping treatment with Milurit

The duration of treatment is determined by the doctor.
The patient should not stop taking Milurit without consulting their doctor first, unless they experience allergic reactions or other severe side effects (see section 4.)
In case of any further doubts about the use of this medicine, the patient should consult their 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 usually 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 the patient experiences any of the following side effects while taking Milurit, they should stop taking the medicine and contact their 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, palpitations, or chest tightness and collapse. The patient should not take any more tablets unless their doctor tells them to.

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

• fever and chills, headache, muscle pain (flu-like symptoms) and general malaise
• skin changes, such as mouth ulcers, throat ulcers, nose ulcers, genital ulcers, and conjunctivitis (redness and swelling of the eyes), widespread blisters, or skin peeling
• severe hypersensitivity reactions with fever, 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, the patient should 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 tablets may affect the blood, which may 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. The patient should tell their 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 malaise
• 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
• changes in bowel movements, presence of fat in the stool
• taste disorders
• cataract (clouding of the lens of the eye), macular disease
• hair loss or color change
• 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, especially in women)
• 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-grayish lines on the mucous membranes)

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their 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, more information can be collected on the safety of the medicine.

5. How to store Milurit

The medicine should be stored out of 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. The patient should ask their 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 carboxymethyl cellulose (type A).
300 mg tablets: microcrystalline cellulose, sodium carboxymethyl cellulose (type A), gelatin, colloidal silicon dioxide, magnesium stearate.

What Milurit looks like and contents of the pack

Appearance:
100 mg tablets: white or grayish tablets, odorless, round, flat, with uneven 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 with beveled edges, odorless or almost odorless tablets with a 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 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 Sp. 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, please 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