Milurit

Package leaflet: Information for the patient

Warning! Keep the leaflet, information on the immediate packaging in a foreign language
Milurit
200 mg, tablets
Allopurinolum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Milurit is and what it is 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 Milurit is and what it is used for

The active substance in Milurit tablets is allopurinol. Allopurinol belongs to a group of medicines
called enzyme inhibitors. These substances are effective in controlling the rate of certain
processes occurring in the body.
Milurit is used long-term to prevent gout and may also be used in other conditions associated with excess uric acid in the body, such as kidney stones and other kidney diseases, as well as when the patient is undergoing treatment for cancer or has disorders in the function of certain enzymes.

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 treatment with Milurit, discuss this with your doctor. Special caution and close medical monitoring may be necessary:

• If the patient belongs to the Han Chinese ethnic group or is of Thai or Korean descent.
• If the patient has liver or kidney disease. The doctor may recommend a lower dose or less frequent administration than daily. The patient will also be monitored more closely.
• If the patient has heart disease or high blood pressure and is taking diuretics and/or antihypertensive medicines called ACE inhibitors.
• If an acute gout attack is currently present.
• If the patient or a close relative has haemochromatosis (a rare disorder characterized by abnormally increased intestinal iron absorption, leading to excessive iron storage, particularly in the liver).
• If the patient has thyroid disease.
• If the patient is being treated with azathioprine (an immunosuppressive medicine used to suppress the immune response), or mercaptopurine (a medicine used in leukaemias).

If in doubt whether any of the above situations apply, consult your doctor or pharmacist.
Severe skin rashes (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported during treatment with allopurinol. The rash often involves ulceration of the mouth, throat, nose, genital organs, 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 general body aches. The rash may progress to widespread blistering and skin peeling.
These severe skin reactions may occur more frequently in patients of Chinese, Thai, or Korean descent. Chronic kidney disease may further increase the risk in these patients.
If a rash or skin symptoms occur, stop taking Milurit immediately,
seek urgent medical advice, and inform the doctor that you are taking this medicine. If severe skin rashes,
hypersensitivity syndrome, Stevens-Johnson syndrome, or toxic epidermal necrolysis occur during treatment
with Milurit, re-initiation of Milurit therapy must not be attempted.
An acute attack of gouty arthritis may occur early in treatment with Milurit. Therefore, the doctor may recommend prophylactic use of an appropriate anti-inflammatory medicine or colchicine for at least one month.
To monitor the safety and effectiveness of treatment with Milurit, the doctor may order one or more laboratory tests. These tests should be performed and the results shown to the doctor.
If the patient has been diagnosed with a malignant disease or Lesch-Nyhan syndrome, the amount of uric acid in the urine may increase. To prevent this, it is important to drink sufficient fluids to adequately dilute the urine.
If the patient has urinary stones, kidney stones may shrink during treatment and possibly move into the urinary tract.

Children and adolescents
Children and adolescents under 15 years of age should not use Milurit, except in cases of certain malignancies (particularly leukaemias) or in the treatment of specific enzymatic disorders such as Lesch-Nyhan syndrome.

Milurit with other medicines
Inform your doctor if you are currently using, have recently used, or plan to use any of the following medicines:

• Salicylates (used to relieve pain, fever, or inflammation, e.g. acetylsalicylic acid)
• Theophylline, a medicine used for breathing problems. The doctor may order blood tests to monitor theophylline levels, especially at the beginning of Milurit treatment, or may adjust the dose.
• Medicines used to treat seizures (epilepsy) (phenytoin)
• Ampicillin or amoxicillin (used for bacterial infections). Since allergic reactions are more common, alternative antibiotics should be considered if possible.
• Didanosine, used in the treatment of HIV infection
• Vidarabine, used in the treatment of viral infections. Caution: adverse effects of vidarabine may occur more frequently. Special precautions should be taken if such effects occur.
• Blood count abnormalities occur more frequently when allopurinol is taken together with cytostatic agents (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating halides) than when these active substances are used separately.
  Therefore, regular blood tests to monitor blood cell counts are necessary.
• If aluminium hydroxide is taken simultaneously, allopurinol may have reduced effectiveness. An interval of at least 3 hours should be maintained between taking the two medicines.
• Medicines used to suppress the immune response (immunosuppressive medicines), such as cyclosporine (adverse effects of cyclosporine may occur more frequently), azathioprine (the dose of azathioprine must be reduced)
• Mercaptopurine (used in the treatment of leukaemia). The dose of mercaptopurine must be reduced.
• Medicines used to treat diabetes (chlorpropamide). A reduction in chlorpropamide dose may be necessary, especially in patients with impaired kidney function.
• Medicines used to treat heart conditions or high blood pressure, such as ACE inhibitors (e.g. captopril, ramipril) or diuretics (particularly 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 may reduce the dose of these medicines if necessary.
• Other medicines used to treat gout, such as probenecid.

Inform 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 over-the-counter medicines, including herbal remedies. This is important because Milurit may affect the action of other medicines, and other medicines may affect the action of Milurit.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
The safety of using Milurit during pregnancy is not sufficiently documented. Milurit may be used during pregnancy only if no safer alternative is available and the disease itself poses a risk to the mother or unborn child.

Breastfeeding
Allopurinol is excreted in breast milk. Allopurinol is not recommended during breastfeeding.

Driving and operating machinery
Drowsiness, dizziness, or coordination disturbances 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; therefore, this medicine is considered "sodium-free".

3. How to take Milurit

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Milurit should be taken once daily after a meal. While taking this medicine, the patient should drink plenty of fluids (2–3 litres per day). If the daily dose exceeds 300 mg and the patient experiences gastrointestinal adverse effects such as nausea and vomiting (see section 4), to reduce these effects, the doctor may prescribe allopurinol in divided doses.
Dosage should always be individually determined 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 adverse effects. If necessary, the dose may be increased.
Recommended maintenance doses are:
100 to 200 mg daily in mild conditions, 300 to 600 mg daily in moderate conditions, and 700 to 900 mg daily in severe conditions.
If a dose in mg/kg body weight is required, a dose of 2 to 10 mg/kg body weight/day should be used.
During the early phase of treatment, the doctor may prescribe an anti-inflammatory medicine or colchicine to be taken for at least one month to prevent attacks of gouty arthritis.

Use in children and adolescents (under 15 years of age)
In children under 15 years of age, Milurit is administered at a dose of 10 to 20 mg/kg body weight per day, up to a maximum dose of 400 mg per day in three divided doses. Use in children is rarely indicated, except in neoplastic diseases (particularly leukaemia) and certain enzymatic disorders such as Lesch-Nyhan syndrome.

Elderly patients (over 65 years of age)
The doctor will recommend the lowest dose of Milurit that effectively controls symptoms.

If the patient has severe kidney disease

• the patient may be advised to take a dose lower than 100 mg daily
• or to take a 100 mg dose at intervals longer than once daily.

If the patient is dialysed two or three 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 (particularly thiazide diuretics).

If the patient has liver disease
The doctor may recommend lower doses. Periodic liver function tests may be necessary, especially at the beginning of treatment.

Treatment of conditions associated with increased uric acid turnover (e.g. neoplastic diseases, disorders of certain enzyme functions)
It is recommended to normalize elevated uric acid levels before starting cytotoxic therapy. Adequate fluid intake is important.

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

Taking more Milurit than prescribed
If more Milurit than prescribed is taken, or if a child has swallowed the tablets, contact a doctor immediately or go to the nearest hospital emergency department. Bring this leaflet, any remaining tablets, and the packaging so the doctor knows which tablets have been taken.
Common symptoms of overdose include nausea, vomiting, diarrhoea, or dizziness.
Until medical help is received, ensure a generous fluid intake.

If you miss a dose of Milurit
If a dose is missed, 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 a missed dose. Continue treatment as directed by your doctor.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions associated with the use of Milurit occur rarely in the treated patient population and are mostly mild in severity. The frequency of adverse reactions 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 any of the following adverse reactions occur in a patient during treatment with Milurit, the drug should be discontinued immediately and the patient should contact a physician without delay.

Not common (may occur in up to 1 in 100 people)
Allergic reactions
Symptoms may include:

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

Rare (may occur in up to 1 in 1,000 people)

• fever and chills, headache, muscle pain (flu-like symptoms), and general malaise
• skin changes, such as ulceration of the mouth, throat, nose, or genital organs, and conjunctivitis (red, swollen eyes), widespread blisters or skin peeling
• severe hypersensitivity reactions with fever, skin rash, joint pain, and abnormal blood test results or liver function tests (these may be symptoms of multi-organ hypersensitivity)

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

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

Frequency unknown (cannot be estimated from available data)

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

Other possible adverse reactions
Common (may occur in up to 1 in 10 people):

• rash
• increased TSH (thyroid-stimulating hormone) levels in blood

Not common (may occur in up to 1 in 100 people):

• nausea, vomiting, diarrhoea
• abnormal liver function test results

Rare (may occur in 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 disorders
• formation of kidney stones; symptoms may include blood in the urine and abdominal, flank or groin pain

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

• allopurinol tablets may sometimes affect the blood, leading to easier bruising than usual, or sore throat or other signs of infection. These symptoms usually occur in people who have liver or kidney problems. Inform your doctor as soon as possible. Milurit may affect the lymph nodes.
• high temperature
• blood in the urine, kidney failure
• vomiting blood
• high levels of fats in the blood
• general malaise
• weakness, numbness in hands or feet, loss of balance, tingling, inability to move muscles (paralysis), or loss of consciousness
• headache, dizziness, drowsiness, or visual disturbances
• chest pain, high blood pressure, or slow heart rate
• male infertility or inability to achieve or maintain an erection
• breast enlargement in men and women
• changes in bowel habits, presence of fat in stool
• taste disturbances
• cataract (clouding of the eye lens), maculopathy (eye yellow spot disease)
• hair loss or change in hair colour
• seizures
• depression
• fluid retention leading to oedema, particularly around the ankles
• excessive thirst, fatigue, weight loss (these may be symptoms of diabetes). Your doctor may recommend a blood glucose test to determine if this is the cause.
• boils (boil-like, small tender red nodules on the skin)
• muscle pain

Frequency unknown (cannot be estimated from available data):

• abdominal pain

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Poland
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Milurit

Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date (month, year) stated on the cardboard
package after: "expiry date". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the packaging and other information

What Milurit contains
The active substance is allopurinol.
200 mg tablets: each tablet contains 200 mg of allopurinol.
The other ingredients are: microcrystalline cellulose, sodium carboxymethyl starch (type A), gelatin,
colloidal anhydrous silica, magnesium stearate.

What Milurit looks like and contents of the pack
Appearance
200 mg tablets: white or greyish, oval tablets, engraved with the code "E354" on one side and a SNAP division line on the other side. The tablet can be divided into equal doses.

Pack
30, 50, 60, 70, 80, 90, 100 or 120 tablets in a brown glass bottle closed with a plastic cap, containing a tablet immobilizing insert and a tamper-evident seal, packed in a cardboard box.

For more detailed information, please contact the responsible party or parallel importer.

Marketing Authorisation Holder in Hungary, 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
Poland

Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Hungary (country of export) Marketing Authorisation numbers:
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 Licence Number: 295/24