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 taking 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 taking Milurit
• 3. How to take 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 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, 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 once a day. 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 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 - immunosuppressant), mercaptopurine (a medicine used in leukemia).

In case of doubt as to whether any of the above situations apply, you should consult a 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 can progress, transforming into 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, you should stop taking Milurit, seek urgent medical attention, and inform your doctor that you are 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.

During the early stages of treatment with Milurit, an acute gout attack may 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 undergo these tests 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 enzyme disorders, such as Lesch-Nyhan syndrome.

Milurit and other medicines

You should tell your doctor about any medicines you are currently 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 in case of 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 (seizures) (phenytoin)
• ampicillin or amoxicillin (used in bacterial infections). Since 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. Special precautions should be taken 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 taking the two medicines.
• medicines used to weaken the immune response (immunosuppressants), such as cyclosporine (cyclosporine side effects may occur more frequently), azathioprine (azathioprine dose reduction is necessary)
• mercaptopurine (used in the treatment of 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 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 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 currently taking or have recently taken, as well as any medicines you 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 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. Allopurinol should not be used during breastfeeding.

Driving and using machines

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

Milurit contains sodium

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

3. How to take Milurit

This medicine should always be taken as directed by your doctor. In case of doubt, 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 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 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.
During 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 certain cancers (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 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 start of treatment.
Treatment of conditions with increased uric acid turnover(e.g., cancer, enzyme function disorders)
It is recommended that uric acid levels be normalized before starting cytotoxic therapy. It is essential to ensure adequate fluid intake.

Skin reactions

In case of skin reactions, you should immediatelystop taking allopurinol. After the mild skin reactions have subsided, you can restart treatment with a small dose (e.g., 50 mg/day) after careful consideration of the risks. Then, the dose can be gradually increased, 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).

Taking a higher dose of Milurit than recommended

In case of taking a higher dose of Milurit than recommended, 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 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, you should take it as soon as you remember. However, if it is close to the time for 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 treatment with 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 taking 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 while taking Milurit, you should 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, 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, headaches, muscle pains (flu-like symptoms) and general feeling of being unwell
• 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 allergic reactions with fever, rash, joint pains, and abnormal blood test results and liver function tests (these 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 attention immediately.

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

• 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 pains 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. 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 feeling of being unwell
• weakness, numbness of the hands or feet, loss of balance, tingling, inability to move muscles (paralysis), or loss of consciousness
• headaches, 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 hair color change
• seizures
• depression
• fluid retention leading to swelling, especially around the ankles
• increased thirst, fatigue, weight loss (these may be symptoms of diabetes). The doctor may recommend a blood sugar test to determine the cause.
• hirsutism (excessive hair growth)
• muscle pains

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

• abdominal pains

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 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.
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 stated on the packaging. The expiry date refers to the last day of the month stated.
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. Each tablet contains 200 mg of allopurinol.
The other ingredients are: microcrystalline cellulose, sodium carboxymethylcellulose (type A), gelatin, colloidal anhydrous silica, magnesium stearate.

What Milurit looks like and contents of the packaging

White or grayish, oval tablets, with the inscription "E354" on one side and a snap line on the other side. The tablet can be divided into equal doses.
Packaging
30 tablets in a brown glass bottle, type III, with a child-resistant closure and a guarantee ring, in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

Egis Pharmaceuticals PLC
Keresztúri út 30 – 38
1106 Budapest
Hungary

Manufacturer:

Egis Pharmaceuticals PLC
Mátyás király út 65
9900 Körmend
Hungary
Egis Pharmaceuticals PLC
Bökényföldi út 118-120
1165 Budapest
Hungary

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Romanian marketing authorization number, country of export:11092/2018/01

Parallel import authorization number: 120/23

Date of leaflet approval: 26.06.2023

[Information about the trademark]