Dnor

Package Leaflet: Information for the User

Dnor, 100 mg, tablets

Dnor, 300 mg, tablets

Allopurinol

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 pack 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.
Tablets of Dnor 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 tablets of Dnor 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 you are allergic to allopurinol or any of the other ingredients of this medicine (listed in section 6).
• if you are currently having or have recently had a gout attack.

Warnings and precautions

Before starting treatment with Dnor, discuss with your doctor or pharmacist if:

• you have liver or kidney problems. Your doctor may prescribe a lower dose of Dnor or recommend taking the medicine less frequently than once a day. Your doctor will also closely monitor your condition.
• you have heart disease or high blood pressure
• you have thyroid problems
• you are currently having 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, body aches (flu-like symptoms). The rash can progress, transforming into generalized blisters and peeling of the skin. 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 skin symptoms occur, stop taking allopurinol and contact your doctor immediately.
In case of doubt, whether the above circumstances apply to you, consult your doctor or pharmacist before starting treatment with allopurinol.

Dnor and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.
Before starting treatment with this medicine, 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. Particular caution is advised 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). Your doctor will monitor your blood clotting values more frequently and may 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). Your doctor will measure the theophylline level in your blood, especially after starting treatment with Dnor or after any change in dosage.
• ampicillin, amoxicillin (used to treat bacterial infections). Whenever possible, patients should receive other antibiotics, as the risk of an allergic reaction is higher with these two antibiotics.

It is recommended to avoid taking 6-mercaptopurine or azathioprine with allopurinol. When taking 6-mercaptopurine or azathioprine with Dnor, the dose of 6-mercaptopurine or azathioprine should be reduced, as their effect may be prolonged. This may increase the risk of serious blood disorders. In this case, your doctor will closely monitor your blood cell count during treatment.
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 reduced effect.
A gap of at least 3 hours should be maintained 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.
Your doctor will monitor your blood cell 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Allopurinol passes into human milk. It is not recommended to take allopurinol during breastfeeding.

Driving and using machines

Dnor may cause dizziness, drowsiness, or coordination problems. If these symptoms occur, do notdrive or operate machinery 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 been diagnosed with an intolerance to some sugars, 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 it is considered "sodium-free".

3. How to take Dnor

Always take this medicine exactly as your doctor has told you. If you are not sure, ask 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, ensure adequate fluid intake; discuss with your doctor what amount of fluid may be appropriate for you.
Recommended doses are:
Adults, adolescents (15-18 years), elderly
Your doctor will usually start 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, your 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 according to the severity of your condition. The maintenance dose is:

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

Your doctor may also change the dose if you have liver or kidney problems, especially in elderly people.
If the daily dose exceeds 300 mg and you experience side effects from the gastrointestinal tract, such as nausea or vomiting (see section 4), your doctor may prescribe allopurinol in divided doses to reduce these symptoms.
If you have severe kidney disease

• you may be advised to take a dose lower than 100 mg per day
• or take a dose of 100 mg at intervals longer than once a day. If you are dialyzed two or three times a week, your doctor may recommend a dose of 300 or 400 mg to be taken immediately after dialysis. This only applies to Dnor 100 mg:

Children under 15 years of age
100 mg - 400 mg per day.
Treatment can be started at the same time as an anti-inflammatory medicine or colchicine, and the dose can be adjusted if you have reduced liver or kidney function or divided to alleviate gastrointestinal side effects, as above, in 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, 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.
Bring this leaflet, any remaining tablets, and the packaging of this medicine with you to the hospital, so the doctor knows what tablets were taken.

Missing a dose of Dnor

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

Stopping treatment with Dnor

Continue to take Dnor for as long as your doctor recommends. Do notstop taking Dnor without first talking to your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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 seizure).
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 peeling of the skin
• 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 had an allergic reaction, stop taking allopurinol and contact your doctor immediately. Symptoms may include:
• skin rash, peeling of the skin, boils, or pain in the lips and mouth
• swelling of the face, hands, lips, tongue, or throat
• difficulty swallowing or breathing
• to very rare symptoms, including sudden wheezing, palpitations, or chest tightness and collapse. Do not take any more tablets unless your doctor tells you to.

If you experience any of the following symptoms while taking Dnor, 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)
• liver or kidney problems
• 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 abnormal 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 problems
• 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 problems
• 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 stopping treatment with allopurinol
• severe allergic reaction, causing swelling of the face or throat
• 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, 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, tell your doctor.

Sometimes, allopurinol tablets may affect the blood, which can manifest as easier-than-usual bruising or may cause sore throat or other infection symptoms. These symptoms usually occur in people who have liver or kidney problems. Tell your doctor as soon as possible if you notice any of these symptoms.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please 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, 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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Dnor contains

• The active substance 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
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
[email protected]

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