Argadopin

Leaflet accompanying the packaging: patient information

Argadopin, 100 mg, tablets

Argadopin, 300 mg, tablets

Allopurinol

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What Argadopin is and what it is used for
• 2. Important information before taking Argadopin
• 3. How to take Argadopin
• 4. Possible side effects
• 5. How to store Argadopin
• 6. Contents of the packaging and other information

1. What Argadopin is and what it is used for

• Argadopin belongs to a group of medicines called enzyme inhibitors, which control the rate at which certain chemical changes occur in the body.
• Argadopin is used long-term to prevent 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.

2. Important information before taking Argadopin

When not to take Argadopin

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 Argadopin, the patient should discuss it with their doctor or pharmacist if they:

are of Chinese, African, or Indian origin
have liver or kidney problems. The doctor may prescribe a lower dose of the medicine or recommend taking it less frequently than once a day. They will also closely monitor the patient's condition
have heart problems or high blood pressure and are taking diuretics and/or ACE inhibitors.
are currently experiencing a gout attack
have thyroid problems.
If in doubt whether these circumstances apply to the patient, they should consult their doctor or pharmacist before starting allopurinol treatment.
During treatment with allopurinol, severe skin reactions have been reported, including hypersensitivity syndrome, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Often, the rash can involve ulcers of the mouth, throat, nose, genitals, and conjunctivitis (redness and swelling of the eyes). Such severe skin reactions are often preceded by symptoms similar to the flu, fever, headache, body aches (so-called flu-like symptoms). The rash can progress to generalized blisters and skin peeling. These 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, the patient should stop taking allopurinol immediately and consult their doctor.
In cancer or Lesch-Nyhan syndrome, the amount of uric acid in the urine may increase. To prevent this, the patient should be properly hydrated to dilute the urine.
If the patient has kidney stones, they may decrease in size and enter the urinary tract.

Children

The use of this medicine in children is rarely justified, except for certain types of cancer (especially leukemia) and certain enzymatic disorders, such as Lesch-Nyhan syndrome.

Argadopin and other medicines

Before starting treatment with this medicine, the patient should tell their doctor about taking:

6-mercaptopurine (a medicine used to treat blood cancer)
azathioprine, cyclosporine (medicines used to suppress the immune system). Note: It is possible that side effects of cyclosporine may occur more frequently
the patient should avoid taking 6-mercaptopurine or azathioprine with allopurinol at the same time. When taking 6-mercaptopurine or azathioprine with Argadopin, the dose of 6-mercaptopurine or azathioprine should 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 count during treatment.
the patient should seek medical help immediately if they notice any unexplained bruising, bleeding, fever, or sore throat.
vidarabine (a medicine used to treat herpes virus infection). Note: It is possible that side effects of vidarabine may occur more frequently. In such cases, the patient should be particularly careful
salicylates (medicines used to relieve pain, fever, or inflammation, e.g., acetylsalicylic acid)
probenecid (a medicine used to treat gout)
chlorpropamide (a medicine used to treat diabetes). It may be necessary to reduce the dose of chlorpropamide, especially in patients with kidney problems
warfarin, phenprocoumon, acenocoumarol (anticoagulant medicines). The doctor will monitor the patient's blood clotting more frequently and may reduce the dose of these medicines if necessary
phenytoin (an antiepileptic medicine)
theophylline (a medicine used to treat asthma and other respiratory diseases). The doctor will monitor the theophylline levels in the blood, especially at the beginning of allopurinol treatment or after any change in its dose
ampicillin or amoxicillin (medicines used to treat bacterial infections). The doctor may prescribe other antibiotics if possible, as there is a higher risk of allergic reactions
medicines used to treat heart conditions or high blood pressure, such as ACE inhibitors or diuretics (diuretics)
medicines used to treat cancer, such as:

• cyclophosphamide
• doxorubicin
• bleomycin
• procarbazine
• alkylating agents The doctor will monitor the patient's blood morphology more frequently. didanosine (a medicine used to treat HIV infection) captopril (a medicine used to treat high blood pressure). It is possible that the risk of skin reactions may increase, especially in patients with chronic kidney disease.

If the patient is taking aluminum hydroxide, allopurinol may have a weaker effect. The patient 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, alkylating agents) than when these active substances are taken alone. Therefore, regular blood morphology tests should be performed.
The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Pregnancy, breastfeeding, and fertility

Allopurinol is excreted in breast milk. It is not recommended to take allopurinol during breastfeeding.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Argadopin may cause dizziness, drowsiness, and impaired coordination. If such effects occur, the patient should not drive vehicles, operate machines, or engage in hazardous activities.

Argadopin contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

3. How to take Argadopin

This medicine should always be taken exactly as prescribed by the doctor. If in doubt, the patient should consult their doctor or pharmacist. The doctor usually starts treatment with a low dose of allopurinol (e.g., 100 mg/day) to reduce the risk of side effects. If necessary, the dose will be increased.
The tablets should be swallowed, preferably with water. The dividing line on the tablet only facilitates breaking it, if the patient has difficulty swallowing the whole tablet. The tablets should be taken after a meal. During treatment with the medicine, it is recommended to drink large amounts of fluids (2-3 liters per day).
Recommended dose:

Adults (including the elderly)

Initial dose: 100-300 mg per day.
At the beginning of treatment, the doctor may also prescribe an anti-inflammatory medicine or colchicine to be taken for a month or longer to prevent gout attacks.
The doctor may adjust the dose of allopurinol depending on the severity of the disease.
Maintenance dose:

• 100 to 200 mg per day in mild cases,
• 300 to 600 mg per day in moderate cases,
• 700 to 900 mg per day in severe cases.

The doctor may change the dose in patients with kidney or liver problems, especially in the elderly.
If the daily dose is more than 300 mg and the patient experiences gastrointestinal side effects (e.g., nausea or vomiting, see section 4), the doctor may recommend taking the medicine in divided doses to alleviate these symptoms.

Patients with severe kidney disease

• The doctor may recommend taking less than 100 mg of allopurinol per day or
• may recommend taking 100 mg of allopurinol less frequently 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.

Use in children and adolescents

Argadopin, 100 mg
Use in children (under 15 years of age)with a body weight of 15 kg or more
Argadopin, 300 mg
Use in children (under 15 years of age)with a body weight of 45 kg or more
Usual dose: 10 to 20 mg per kilogram of body weight per day in 3 divided doses.
Maximum dose: 400 mg of allopurinol per day.
The doctor may start treatment with the use of an anti-inflammatory medicine or colchicine, adjust the dose in patients with kidney or liver problems, or recommend taking the medicine in divided doses to alleviate gastrointestinal side effects, as in adults (see above).

Taking a higher dose of Argadopin than recommended

If the patient (or someone else) has swallowed several tablets at once or if it is suspected that a child has taken any amount of tablets, they should contact the emergency department of the nearest hospital or their doctor.
Overdose may cause symptoms such as nausea, vomiting, diarrhea, or dizziness.
The patient should bring this leaflet, the remaining tablets, and the packaging of the medicine, so the medical staff knows what medicine has been taken.

Missing a dose of Argadopin

If the patient forgets to take a tablet, they should take it as soon as possible after remembering, unless it is almost time for the next dose.
The patient should not take a double dose to make up for the missed dose.The next tablets should be taken at the scheduled time.

Stopping treatment with Argadopin

Argadopin should be taken for as long as the doctor has prescribed. The patient should not stop treatment without consulting their doctor first.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Argadopin can cause side effects, although not everybody gets them.
The following side effects may occur during treatment with this medicine.

If the patient experiences any of the following side effects, they should stop taking the medicine immediately and consult their doctor.

Hypersensitivity

Symptoms may include:
Uncommon side effects (may occur in less than 1 in 100 people)
If the patient experiences an allergic reaction, they should stop taking Argadopin and consult their doctor immediately. Symptoms may include:
skin peeling, ulcers of the lips and mouth
very rarely, sudden wheezing, palpitations, or tightness in the chest and collapse.
The patient should not take any more tablets until their doctor advises them to do so.
Rare side effects (may occur in less than 1 in 1,000 people)
fever and chills, headache, muscle pain (flu-like symptoms), and general malaise
any skin changes, such as ulcers in the mouth, throat, nose, genitals, and conjunctivitis (redness and swelling of the eyes), generalized blisters, or skin peeling
severe hypersensitivity reactions, including fever, rash, joint pain, abnormal liver function test results (which may be symptoms of multi-organ hypersensitivity).
bleeding from the lips, eyes, mouth, nose, and genitals.

Other side effects

Common(may occur in less than 1 in 10 people)

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

Uncommon(may occur in less than 1 in 100 people)

• nausea or vomiting
• abnormal liver function test results
• diarrhea

Rare(may occur in less than 1 in 1,000 people)

• liver disease, such as hepatitis

Very rare(may occur in less than 1 in 10,000 people)

• Argadopin can affect the blood, which may manifest as easier-than-usual bruising or sore throat or other signs of infection. Such symptoms usually occur in people with liver or kidney disease. The patient should inform their doctor about them as soon as possible
• Argadopin can affect the lymphatic glands
• high fever
• blood in the urine
• high cholesterol levels in the blood (hyperlipidemia)
• general malaise or feeling of weakness
• weakness, numbness, instability while standing, feeling of inability to move muscles (paralysis), or loss of consciousness
• headache, dizziness, drowsiness, or vision disturbances
• chest pain (angina pectoris), high blood pressure, or slow heart rate
• infertility in men or erectile dysfunction
• breast enlargement (in men and women)
• change in bowel movements
• change in taste
• cataract
• hair loss and change in hair color
• depression
• lack of muscle coordination (ataxia)
• feeling of tingling, itching, pricking, or burning of the skin (paresthesia)
• fluid retention leading to swelling, especially in the ankles
• abnormal glucose metabolism (diabetes). The doctor may order a blood sugar test to detect this disorder.

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, the patient should seek medical help immediately
• lichenoid skin rash (itchy reddish-purple skin rash and/or white-gray thread-like lines on the mucous membranes)

If any side effect gets worse or if the patient experiences any side effects not listed in this leaflet, they should tell their doctor or pharmacist.

Reporting side effects

If side effects occur, including any not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Argadopin

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 after EXP. The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
HDPE bottles: after the first opening, use for 6 months.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Argadopin contains

The active substance is allopurinol.
Each Argadopin 100 mg tablet contains 100 mg of allopurinol.
Each Argadopin 300 mg tablet contains 300 mg of allopurinol.
The other ingredients are: lactose monohydrate, corn starch, povidone, magnesium stearate.

What Argadopin looks like and contents of the pack

Argadopin, 100 mg
White or almost white, flat cylindrical tablet with a dividing line and engraved symbols "I" and "56" on either side of the line on one side and smooth on the other side. Diameter: approximately 8 mm.
The medicine is available in blisters of PVC/Aluminum in a cardboard box, containing 20, 30, 50, 60, 100 tablets, and 30 x 1 (single-dose blister) or in HDPE bottles with a PP cap, child-resistant or non-child-resistant, with a protective foil, containing 50, 100, 105, 125, 250, 500 tablets.
Argadopin, 300 mg
White or almost white, flat cylindrical tablet with a dividing line and engraved symbols "I" and "57" on either side of the line on one side and smooth on the other side. Diameter: approximately 11 mm.
The medicine is available in blisters of PVC/Aluminum in a cardboard box, containing 30, 60, 100 tablets, and 30 x 1 (single-dose blister) or in HDPE bottles with a PP cap, child-resistant, containing 100, 105, 125 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer/Importer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Alle 1
39179 Barleben
Germany

For more information on the medicine and its names in the Member States of the European Economic Area, please contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
phone: 22 209 70 00
Sandoz logo
Date of last revision of the leaflet: 01/2025