Dnor

Leaflet attached to the packaging: information for the user

Dnor, 100 mg, tablets

Dnor, 300 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 you need to.
• If you have 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 Dnor and what is it used for
• 2. Important information before taking Dnor
• 3. How to take Dnor
• 4. Possible side effects
• 5. How to store Dnor
• 6. Contents of the packaging and other information

1. What is Dnor and what is it used for

Allopurinol belongs to a group of medicines called enzyme inhibitors, which work by controlling the speed at which certain chemical changes occur in the body. Dnor tablets are used for the long-term, preventive treatment of gout and can be used in other conditions associated with an excess of uric acid in the body, including kidney stones and other types of kidney disease. Children under 15 years of age:In children under 15 years of age, only 100 mg Dnor tablets can be used. 300 mg tablets contain a dye (orange yellow FCF, aluminum lake, E 110) that is not recommended for use in children and adolescents.

2. Important information before taking Dnor

When not to take Dnor

• if the patient is allergic to allopurinol or any of the other ingredients of this medicine (listed in section 6).
• if the patient is currently experiencing or has recently experienced a gout attack.

Warnings and precautions

Before starting to take Dnor, you should discuss it with your doctor or pharmacist if:

• the patient has liver or kidney problems. The doctor may prescribe a lower dose of the medicine or recommend taking it less frequently than once a day. The doctor will also closely monitor the patient's condition.
• the patient has heart disease or high blood pressure
• the patient has thyroid problems
• the patient is currently experiencing a gout attack.

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 (red and swollen eyes). Such severe skin reactions are often preceded by symptoms similar to flu, fever, headache, and body aches (flu-like symptoms). The rash can progress, transforming into generalized blisters and skin peeling. Such severe skin reactions can 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 the described skin symptoms occur, you should stop taking allopurinol and contact your doctor immediately. If you are unsure whether the above circumstances apply to you, you should consult your doctor before starting treatment with allopurinol.

Dnor and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those obtained without a prescription. Before starting to take this medicine, you should tell your doctor if you are taking:

• 6-mercaptopurine (used to treat blood cancer)
• azathioprine, cyclosporine (used to suppress the immune system). Note that the side effects of cyclosporine may occur more frequently.
• vidarabine (used to treat herpes). Note that the side effects of vidarabine may occur more frequently. You should be particularly careful if they occur.
• salicylates (used to reduce pain, fever, and inflammation, e.g., aspirin - acetylsalicylic acid)
• probenecid (used to treat gout)
• chlorpropamide (used to treat diabetes). It may be necessary to reduce the dose of chlorpropamide, especially in patients with kidney problems.
• warfarin, phenprocoumon, acenocoumarol (used to thin the blood). The doctor will monitor blood clotting values more frequently and reduce the dose of these medicines if necessary.
• furosemide, thiazides, or other diuretics (used to treat high blood pressure)
• phenytoin (used to treat epilepsy)
• theophylline (used to treat asthma and other breathing difficulties). The doctor will measure the theophylline level in the blood, especially after starting treatment with Dnor or changing the dosage.
• ampicillin, amoxicillin (used to treat bacterial infections). If possible, patients should receive other antibiotics, as the risk of an allergic reaction is higher with these two antibiotics.

You should avoid taking 6-mercaptopurine or azathioprine with allopurinol. When taking 6-mercaptopurine or azathioprine with Dnor, you should 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. You should seek medical help immediately if you notice any unexplained bruising, bleeding, fever, or sore throat. If you are taking aluminum hydroxide, allopurinol may have a weaker effect. You should maintain an interval of at least 3 hours between taking both medicines. 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, you should undergo regular blood morphology tests. The doctor will monitor your blood count more frequently if you are taking:

• didanosine (used to treat HIV infection)
• captopril (used to treat high blood pressure). The risk of skin reactions may be increased, especially if you have chronic kidney disease.

Pregnancy, breastfeeding, and fertility

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. Allopurinol passes into breast milk. It is not recommended to take allopurinol during breastfeeding.

Driving and using machines

Dnor may cause dizziness, drowsiness, or coordination disorders. If such symptoms occur, you must notdrive vehicles or operate machines and participate in other hazardous activities.

Dnor contains lactose

Dnor contains 48.2 mg of lactose (monohydrate) per 100 mg tablet and 145.9 mg of lactose (monohydrate) per 300 mg tablet. If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

Dnor 300 mg contains the dye orange yellow FCF, aluminum lake (E 110)

Dnor 300 mg contains 2.6 mg of the dye orange yellow FCF, aluminum lake (E 110), which may cause allergic reactions. 300 mg tablets are not recommended for use in children under 15 years of age.

Other excipients

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

3. How to take Dnor

This medicine should always be taken as directed by your doctor. If you have any doubts, you should consult your doctor or pharmacist. The tablets can be divided into equal doses. The tablets should be swallowed with water. The tablets should be taken after a meal. While taking this medicine, you should ensure adequate fluid intake; you should discuss with your doctor what amount of fluid is suitable for you. The recommended doses are: Adults, adolescents (15-18 years), elderlyThe doctor usually starts with a low dose of allopurinol (e.g., 100 mg per day) to reduce the risk of possible side effects. If necessary, the dose will be increased. Initial dose: 100 mg to 300 mg per day. After starting treatment, the doctor may also prescribe an anti-inflammatory medicine or colchicine for a month or longer to prevent gout attacks. The dose of allopurinol may be adjusted depending on the severity of the patient's condition. The maintenance dose is:

• mild conditions: 100-200 mg per day
• moderately severe conditions: 300-600 mg per day
• severe conditions: 700-900 mg per day.

The doctor may also change the dose if the patient has kidney or liver problems, especially in elderly patients. If the daily dose exceeds 300 mg and gastrointestinal side effects occur, such as nausea or vomiting (see section 4), the doctor may prescribe allopurinol in divided doses to reduce these symptoms. If the patient has severe kidney disease

• the patient may be advised to take a dose lower 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 two or three times a week, the doctor may recommend a dose of 300 or 400 mg to be taken immediately after dialysis. This only applies to 100 mg Dnor tablets:

Children under 15 years of age100 mg - 400 mg per day. Treatment can be started simultaneously with an anti-inflammatory medicine or colchicine, and the dose can be adjusted if the patient has reduced kidney or liver function or divided to alleviate gastrointestinal side effects, as above, in the case of adults.

Taking a higher dose of Dnor than recommended

If you (or someone else) take a higher dose of Dnor than recommended or suspect that a child has swallowed a tablet, you should immediately go to the emergency department of the nearest hospital or contact your doctor. The most common symptoms of overdose are nausea, vomiting, diarrhea, and dizziness. You should bring this leaflet, the remaining tablets, and the packaging of this medicine with you to the hospital, so that the doctor knows what tablets were taken.

Missing a dose of Dnor

If you miss a dose of Dnor, you should take it as soon as you remember, unless it is almost time for the next dose. You should nottake a double dose to make up for the missed dose. You should take the next doses at the usual time.

Stopping treatment with Dnor

You should continue to take the medicine for as long as your doctor recommends. You must notstop taking Dnor without first consulting your doctor. If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dnor can cause side effects, although not everybody gets them.

You should stop taking Dnor and contact your doctor immediately if you experience:

• an unexpected skin reaction (possibly with accompanying fever, swollen lymph nodes, joint pain, unusual blisters or bleeding, kidney problems, or

sudden seizures). Common ( may affect up to 1 in 10 people):

• skin rash
• increased thyroid-stimulating hormone levels in the blood.

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

• fever and chills, headache, muscle pain (flu-like symptoms), and general malaise
• any skin changes, such as ulcers of the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes), widespread blisters, or skin peeling
• severe allergic reactions, including fever, skin 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): Allergic reactionsIf you have experienced an allergic reaction, you should stop taking allopurinol and contact your doctor immediately. Symptoms may include:
• skin rash, skin peeling, boils, or pain in the lips and mouth
• swelling of the face, hands, mouth, tongue, or throat
• difficulty swallowing or breathing
• rarely, wheezing, rapid heartbeat, or chest tightness and collapse. You should not take more tablets unless your doctor tells you to.

If you experience any of the following symptoms while taking Dnor, you should stop taking the tablets and inform your doctor as soon as possible:

Uncommon ( may affect up to 1 in 100 people):

• nausea, vomiting (rarely with blood) and diarrhea
• symptoms of an allergic reaction, including itchy rash
• 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)
• kidney or liver function disorders
• 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):
• fever
• blood in the urine
• changes in normal bowel movements or unusual bowel movements with an unpleasant odor
• high levels of fats in the blood
• general malaise
• weakness, numbness, difficulty walking, inability to move muscles (paralysis), or loss of consciousness, feeling of tingling or prickling
• seizures, convulsions, or depression
• headache, dizziness, drowsiness, or vision disturbances
• chest pain, high blood pressure, or slow pulse
• fluid accumulation leading to swelling, especially in the ankles
• infertility in men or inability to achieve or maintain an erection, nocturnal emissions ("wet dreams")
• breast enlargement in men and women
• change in taste, inflammation of the oral mucosa
• cataract (clouding of the lens of the eye), and other vision disorders
• boils (small, painful red bumps on the skin)
• hair loss or discoloration
• excessive thirst, fatigue, and weight loss (may be symptoms of diabetes); your doctor may recommend a blood sugar test to determine the cause
• muscle pain
• enlarged lymph nodes, usually resolving after completion of allopurinol treatment
• severe allergic reaction, causing facial or throat swelling
• severe, potentially life-threatening allergic reaction. Frequency not known ( frequency 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.
• lichenoid skin rash (itchy reddish-purple skin rash and/or white-gray thread-like lines on the mucous membranes). From time to time, nausea may occur, but it can usually be avoided by taking allopurinol after a meal. If this problem persists, you should tell your doctor.

Sometimes, allopurinol tablets may affect the blood, which can manifest as easier-than-usual bruising or throat pain or other infection symptoms. These symptoms usually occur in people who have liver or kidney problems. You should tell your doctor as soon as possible.

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, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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 Dnor

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after "Expiry Date (EXP)". The expiry date refers to the last day of the month. This medicine does not require any special storage conditions. 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 Dnor contains

• The active substance of Dnor is allopurinol. Each 100 mg tablet contains 100 mg of allopurinol. Each 300 mg tablet contains 300 mg of allopurinol.
• The other ingredients are: lactose monohydrate, corn starch, povidone, sodium carboxymethyl starch, stearyl acid. Dnor 300 mg also contains the dye orange yellow FCF, aluminum lake (E 110).

What Dnor looks like and contents of the pack

Dnor 100 mg tablets are round, biconvex, uncoated white or almost white tablets, approximately 7.5 mm in diameter, with the inscription "AL" and "100" on either side of the break line on one side and smooth on the other. Dnor 300 mg tablets are round, biconvex, uncoated peach-colored tablets, approximately 11 mm in diameter, with the inscription "AL" and "300" on either side of the break line on one side and smooth on the other. Dnor 100 mg tablets are available in packs of 50 tablets. Dnor 300 mg tablets are available in packs of 30 tablets.

Marketing authorization holder:

Orion Corporation Orionintie 1 02200 Espoo Finland

Manufacturer/Importer:

Orion Corporation Orion Pharma Orionintie 1 02200 Espoo Finland Orion Corporation Orion Pharma Joensuunkatu 7 24100 Salo Finland For more detailed information on this medicine, you should contact the local representative of the marketing authorization holder: Orion Pharma Poland Sp. z o. o. kontakt@orionpharma.info.pl

This medicine is authorized in the Member States of the European Economic Area under the following names:

Finland, Sweden: Allopurinol Orion Poland: Dnor Date of last revision of the leaflet:27.02.2025