Milurit

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet, information on the immediate packaging in a foreign language

Milurit

200 mg, tablets

Allopurinol

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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 using Milurit
• 3. How to use Milurit
• 4. Possible side effects
• 5. How to store Milurit
• 6. Contents of the packaging 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 using Milurit

When not to use 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 to use Milurit, you should 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 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 - immunosuppressive), mercaptopurine (a medicine used in leukemia).

In case of doubts about any of the above situations, you should consult a doctor or pharmacist. Severe skin reactions (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported during the use of 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, 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.

In case of a rash or skin symptoms, you should stop using Milurit, seek urgent medical attention, and inform your doctor that you are taking this medicine. If severe skin reactions occur during the use of Milurit, hypersensitivity syndrome, Stevens-Johnson syndrome, or toxic epidermal necrolysis, you should 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 prophylactic use of an appropriate 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 dilute the urine. If the patient has kidney stones, the stones in the kidneys will decrease in size and may move into the urinary tract during treatment.

Children and adolescents

Children and adolescents under 15 years of age should not use 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

You should tell your doctor about the use of the following medicines, currently or recently, and about the planned use of:

salicylates (used to reduce pain, fever, or inflammation, e.g., acetylsalicylic acid)
theophylline, a medicine used in case of breathing problems. The doctor may order the determination of theophylline levels in the blood, especially at the beginning 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 frequent, 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 in case of their occurrence.
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. An interval of at least 3 hours should be maintained between the administration of both medicines.
medicines used to weaken the immune response (immunosuppressive medicines), such as cyclosporine (cyclosporine side effects may occur more frequently), azathioprine (azathioprine dose reduction is necessary),
mercaptopurine (used in leukemia). Mercaptopurine dose reduction is necessary.
medicines used to treat diabetes (chlorpropamide). Chlorpropamide dose reduction may be necessary, especially in patients with kidney function disorders.
medicines used to treat heart diseases 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 closely and, if necessary, reduce the dose of these medicines.
other medicines used to treat gout (probenecid).
You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. This includes medicines 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 child, you should consult your doctor or pharmacist before using 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. The use of allopurinol is not recommended during breastfeeding.

Driving and using machines

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

Milurit contains sodium

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

3. How to use Milurit

This medicine should always be used as directed by your doctor. In case of doubts, you should consult 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 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 small 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, the doctor may prescribe an anti-inflammatory medicine or colchicine to be used 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 certain cancers (especially leukemia) and certain enzyme disorders, such as Lesch-Nyhan syndrome.
Older adults (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 every day
• or be advised 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 (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, enzyme function disorders)
It is recommended that before starting cytotoxic therapy, elevated uric acid levels should be normalized. It is important to ensure adequate fluid intake.

Skin reactions

In case of skin reactions, you should immediatelystop taking allopurinol. After the resolution of mild skin reactions, 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 while monitoring for skin reactions and other potential side effects.
In case of a rash relapse, you should permanentlydiscontinue the medicine, considering the possibility of severe skin reactions (see section 4 Possible side effects).

Use of a higher than recommended dose of Milurit

In case of taking a higher than recommended dose of Milurit, or if you think a child has swallowed the tablets, you should contact a doctor or immediately go to the hospital emergency department. You should bring this leaflet, the remaining tablets, and the medicine packaging so that the doctor knows which tablets were taken.
The most common symptoms of overdose are nausea, vomiting, diarrhea, or dizziness. Until medical help is provided, you should ensure a large intake of fluids.

Missing a dose of Milurit

In case of missing a dose of Milurit, you should take it as soon as you remember. However, if it is close to the time of taking the next dose, you should skip the missed dose. You should not take a double dose to make up for the missed dose. You should continue treatment as directed by your doctor.

Stopping the use of Milurit

The duration of treatment is determined by the doctor.
You should not stop taking Milurit without consulting your doctor first, unless you experience allergic reactions or other severe side effects (see section 4).
In case of any further doubts about the use of this medicine, you should consult 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 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 you experience any of the following side effects during the use of Milurit, you should stop using the medicine and immediately consult your doctor.

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. You should 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 malaise
• skin changes, such as ulcers of the mouth, throat, nose, genitals, and conjunctivitis (redness and swelling of the eyes), generalized blisters, or peeling of the skin
• 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, which causes 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 stiffness of the neck, headache, nausea, fever, or changes in consciousness. If such symptoms occur, you should seek medical help immediately.

Other possible side effects
Common(may affect up to 1 in 10 people):

• rash
• increased TSH (thyroid function-controlling 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 diseases
• 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-than-usual bruising or may cause throat pain or other infection symptoms. These symptoms usually occur in people with liver or kidney problems. You should 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 malaise
• weakness, numbness of the hands or feet, loss 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 habits, presence of fat in the stool
• taste disorders
• cataract (clouding of the lens of the eye), macular disease
• 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, small, painful red bumps on the skin)
• muscle pain

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

• abdominal pain

Reporting side effects

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

5. How to store Milurit

The medicine should be stored out of sight and reach of children.
There are no special storage instructions.
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. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Milurit contains

The active substance of Milurit is allopurinol.
200 mg tablets: 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 packaging

Appearance
200 mg tablets: white or grayish, oval tablets, with the inscription "E354" on one side and a score line 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 with a plastic cap and a desiccant plug, in a cardboard box.

Marketing authorization holder in Hungary, the country of export:

Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Manufacturer:

Egis Pharmaceuticals PLC
Mátyás király u. 65.
9900 Körmend
Hungary

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Hungary, the country of export: OGYI-T-3431/31
OGYI-T-3431/34
OGYI-T-3431/36
OGYI-T-3431/38
OGYI-T-3431/40
OGYI-T-3431/42
OGYI-T-3431/44
OGYI-T-3431/46

Parallel import authorization number: 295/24

Date of leaflet approval: 22.07.2024

[Information about the trademark]