Dnor

Package leaflet: Information for the user

Dnor, 100 mg, tablets
Dnor, 300 mg, tablets
Allopurinolum
Please read this leaflet carefully before taking 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 questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on 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 Dnor is and what it is 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 Dnor is and what it is used for

Allopurinol belongs to a group of medicines called enzyme inhibitors, which work by controlling the rate at which certain chemical changes occur in the body.
Dnor tablets are used in long-term preventive treatment of gout and may also be used in other conditions associated with excess uric acid in the body, including kidney stones and other types of kidney diseases.
Children under 15 years of age: In children under 15 years of age, only Dnor 100 mg tablets should be used. The 300 mg tablets contain a colouring agent (Ponceau 4R, aluminium lake, E 110), which 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 currently has or recently had an attack of gout.

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

• the patient has liver or kidney function disorders. The doctor may prescribe a lower dose or recommend taking the medicine less frequently than daily. The patient's condition will also be closely monitored.
• the patient has heart disease or high blood pressure
• the patient has thyroid disorders
• the patient currently has an attack of gout.

Severe skin rashes (hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported during treatment with allopurinol. Rashes often involve ulceration of the mouth, throat, nose, genital organs, and conjunctiva (red and swollen eyes). Such severe skin rashes are often preceded by flu-like symptoms, fever, headache, and body aches (flu-like symptoms). The rash may progress, developing into widespread blisters and skin peeling. These severe skin reactions may occur more frequently in individuals of Chinese, Thai, or Korean descent. Chronic kidney disease may further increase the risk in these patients. If a rash or the described skin symptoms occur, allopurinol must be stopped immediately and medical advice must be sought.
If in doubt whether any of the above conditions apply, consult your doctor or pharmacist before starting treatment with allopurinol.
Dnor and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take, including those available without a prescription.
Before starting this medicine, tell your doctor if the patient is taking:

• 6-mercaptopurine (used in the treatment of blood cancer)
• azathioprine, cyclosporine (used to suppress the immune system). Note that adverse effects of cyclosporine may occur more frequently.
• vidarabine (used in the treatment of herpes). Note that adverse effects of vidarabine may occur more frequently. Exercise particular caution if they occur.
• salicylates (used to relieve pain, fever, and inflammation, e.g., aspirin - acetylsalicylic acid)
• probenecid (used in the treatment of gout)
• chlorpropamide (used in the treatment of diabetes). A dose reduction of chlorpropamide may be necessary, especially in patients with impaired kidney function.
• warfarin, phenprocoumon, acenocoumarol (used to thin the blood). The doctor will monitor blood clotting values more frequently and may reduce the dose of these medicines if necessary.
• furosemide, thiazides, or other diuretics (used in the treatment of high blood pressure)
• phenytoin (used in the treatment of epilepsy)
• theophylline (used in the treatment of asthma and other breathing disorders). The doctor will measure theophylline blood levels, especially after starting treatment with Dnor or after any dosage change.
• ampicillin, amoxicillin (used in the treatment of bacterial infections). Whenever possible, patients should receive alternative antibiotics, as allergic reactions are more likely with these two antibiotics.

Concomitant administration of 6-mercaptopurine or azathioprine with allopurinol should be avoided. If 6-mercaptopurine or azathioprine is administered together with Dnor, the dose of 6-mercaptopurine or azathioprine must be reduced, 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 cell counts during treatment.
Seek immediate medical help if the patient notices any unexplained bruising, bleeding, fever, or sore throat.
If the patient is also taking aluminium hydroxide, allopurinol may be less effective. An interval of at least 3 hours should be maintained between taking both medicines.
Blood disorders 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 taken separately.
Therefore, the patient should undergo regular blood tests to monitor blood morphology. The doctor will monitor blood cell counts more frequently if the patient is taking:

• didanosine (used in the treatment of HIV infection)
• captopril (used in the treatment of high blood pressure). The risk of skin reactions may be increased, especially if the patient has chronic kidney dysfunction. Pregnancy, breastfeeding, and fertility 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 taking this medicine. Allopurinol passes into human milk. The use of allopurinol during breastfeeding is not recommended. Driving and operating machinery Dnor may cause dizziness, drowsiness, or coordination disturbances. If such symptoms occur, do not drive or operate machinery or engage in other hazardous activities. Dnor contains lactose Dnor contains 48.2 mg lactose monohydrate per 100 mg tablet and 145.9 mg lactose monohydrate per 300 mg tablet. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine. Dnor 300 mg contains the colouring agent Orange Yellow FCF, aluminium lake (E 110) Dnor 300 mg tablets contain 2.6 mg of the colouring agent Orange Yellow FCF, aluminium 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, meaning the medicine is considered "sodium-free".
3. How to take Dnor
This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult your doctor or pharmacist.
Tablets may be divided into equal doses. Swallow the tablets with water. Take the tablets after meals. During treatment with this medicine, ensure adequate fluid intake; discuss with your doctor what amount of fluids may be appropriate for the patient.
Recommended doses:
Adults, adolescents (aged 15-18 years), elderly patients
The doctor usually starts with a low dose of allopurinol (e.g., 100 mg daily) to reduce the risk of possible adverse effects. The dose may be increased if necessary.
Initial dose: 100 mg to 300 mg daily.
After starting treatment, the doctor may also prescribe an anti-inflammatory medicine or colchicine for one month or longer to prevent gout attacks.
The allopurinol dose may be adjusted depending on the severity of the patient's condition. The maintenance dose is:

• mild conditions: 100–200 mg daily
• moderate conditions: 300–600 mg daily
• severe conditions: 700–900 mg daily.

The doctor may also adjust the dose if the patient has kidney or liver function disorders, especially in elderly patients.
If the daily dose exceeds 300 mg and gastrointestinal adverse effects occur, such as nausea or vomiting (see section 4), the doctor may prescribe allopurinol in divided doses to reduce these effects.
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 dialyzed two or three times a week, the doctor may recommend a dose of 300 or 400 mg to be taken immediately after dialysis. Applies only to Dnor 100 mg tablets:

Children under 15 years of age
100 mg – 400 mg daily.
Treatment may be initiated concomitantly with an anti-inflammatory medicine or colchicine. The dose may be adjusted if the patient has reduced kidney or liver function, or divided to alleviate gastrointestinal side effects, as described above for adults.
Taking more than the recommended dose of Dnor
If the patient (or someone else) takes more than the recommended dose or if there is suspicion that a child has swallowed a tablet, seek immediate medical help at the nearest hospital emergency department or contact your doctor.
Common symptoms of overdose include nausea, vomiting, diarrhoea, and dizziness.
Bring this leaflet, any remaining tablets, and the medicine's packaging to the hospital so the doctor knows which tablets were taken.
Missing a dose of Dnor
If a dose is missed, take it as soon as remembered, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose. Take the next doses at the usual time.
Stopping Dnor treatment
Continue taking the medicine for as long as your doctor recommends. Do not stop taking Dnor without first consulting your doctor.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Treatment with Dnor must be discontinued and immediate medical advice sought if the patient develops:

• unexpected skin reaction (possibly accompanied by 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 blood concentration of thyroid-stimulating hormone.

Uncommon ( 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 ulceration of the mouth, throat, nose, or genital organs, and conjunctivitis (red, swollen eyes), widespread blisters or skin peeling
• severe hypersensitivity reactions including 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 affect up to 1 in 10,000 people ):
Allergic reactions If the patient experiences an allergic reaction, allopurinol must be discontinued immediately and a doctor contacted without delay. Symptoms may include:

• skin rash, skin peeling, sores or pain in lips and mouth
• swelling of the face, hands, lips, tongue or throat
• difficulty swallowing or breathing
• very rare symptoms include sudden wheezing, palpitations or chest tightness, and collapse. Do not take any more tablets unless otherwise advised by a doctor. If any of the following symptoms occur while taking Dnor, stop taking the tablets and inform your doctor immediately:

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

• nausea, vomiting (very rarely with blood), and diarrhoea
• symptoms of 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, armpits or neck
• jaundice (yellowing of the skin and whites of the eyes)
• liver or kidney dysfunction
• formation of kidney stones; symptoms may include blood in urine and abdominal, flank or groin pain.

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

• fever
• blood in urine
• changes in normal bowel habits or unusual stools with unpleasant odour
• high levels of fats in the blood
• general malaise
• weakness, numbness, difficulty standing, inability to move muscles (paralysis), or loss of consciousness, tingling or pricking sensations
• seizures, convulsions or depression
• headache, dizziness, drowsiness or visual disturbances
• chest pain, high blood pressure or slow pulse
• fluid retention leading to swelling, particularly in the ankles
• male infertility or inability to achieve or maintain an erection, nocturnal emission (‘wet dreams’)
• breast enlargement in men and women
• altered taste, inflammation of the mucous membrane of the mouth
• cataract (clouding of the eye lens), and other visual disturbances
• pimples (small tender red lumps on the skin)
• hair loss or discolouration
• excessive thirst, fatigue and weight loss (these may be symptoms of diabetes); your doctor may recommend a blood glucose test to determine if this is the cause
• muscle pain
• swollen lymph nodes, usually resolving after discontinuation of 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 neck stiffness, headache, nausea, fever, or altered consciousness. If such symptoms occur, seek immediate medical help.
• lichenoid skin eruption (itchy reddish-purple rash and/or white lacy lines on mucous membranes).

Nausea may occasionally occur, but this can usually be avoided by taking allopurinol after food. If this problem persists, inform your doctor.

Sometimes allopurinol tablets may affect the blood, which may present as bruising more easily than usual, sore throat, or other signs of infection. These symptoms usually occur in patients who have liver or kidney problems. Inform your doctor as soon as possible.

Reporting of adverse reactions

If any adverse reactions occur, including any 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

Adverse reactions may also be reported to the marketing authorization holder.

Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine 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 pack following "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such measures 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: monohydrate lactose, corn starch, povidone, sodium carboxymethyl starch, stearic acid. The 300 mg Dnor tablet also contains the colouring agent Sunset Yellow FCF, aluminium lake (E 110).

What Dnor looks like and contents of the pack
Dnor 100 mg tablets are round, biconvex, uncoated tablets of white or almost white colour, approximately 7.5 mm in diameter, with the engraved mark 'AL' and '100' on both sides of the break line on one side and smooth on the other side.
Dnor 300 mg tablets are round, biconvex, uncoated peach-coloured tablets, approximately 11 mm in diameter, with the engraved mark 'AL' and '300' on both sides of the break line on one side and smooth on the other side.
Dnor 100 mg tablets are available in packs of 50 tablets.
Dnor 300 mg tablets are available in packs of 30 tablets.

Marketing Authorisation 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 further information about this medicinal product, please contact the local representative of the marketing authorisation holder:
Orion Pharma Poland Sp. z o.o.
[email protected]

This medicinal product is authorised in the European Economic Area countries under the following names:
Finland, Sweden: Allopurinol Orion
Poland: Dnor