Argadopin

Package Leaflet: Information for the Patient

Argadopin, 100 mg, Tablets

Argadopin, 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 any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Argadopin and what is it 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 pack and other information

1. What is Argadopin and what is it 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 you are allergic to allopurinol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Argadopin, discuss with your doctor or pharmacist if you:

are of Chinese, African, or Indian origin
have liver or kidney problems. Your doctor may prescribe a lower dose of Argadopin or recommend taking the medicine less frequently than once daily. They will also closely monitor your 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 you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking allopurinol.
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 flu, fever, headache, body aches (so-called flu-like symptoms). The rash can progress to generalized blisters and peeling of the skin. Such severe skin reactions may 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 immediately and contact your doctor.
In cancer or Lesch-Nyhan syndrome, the amount of uric acid in the urine may increase. To prevent this, ensure the patient is properly hydrated to dilute the urine.
If you have kidney stones, they may decrease in size and enter the urinary tract.

Children

Use in children is rarely indicated, except for certain types of cancer (especially leukemia) and certain enzymatic disorders, such as Lesch-Nyhan syndrome.

Argadopin and other medicines

Before taking this medicine, tell your 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
avoid concomitant administration of 6-mercaptopurine or azathioprine with allopurinol.
When concomitantly administering 6-mercaptopurine or azathioprine with Argadopin, 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, 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.
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, be particularly cautious
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). Your doctor will more frequently monitor your blood clotting and, if necessary, reduce the dose of these medicines
phenytoin (an antiepileptic medicine)
theophylline (a medicine used to treat asthma and other respiratory diseases). Your doctor will monitor theophylline levels in your blood, especially at the beginning of treatment with allopurinol or after any change in its dose
ampicillin or amoxicillin (medicines used to treat bacterial infections). Your doctor may prescribe other antibiotics if possible, as there is a higher likelihood 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 Your doctor will more frequently monitor your blood cell count. 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 you are taking aluminum hydroxide, allopurinol may have a weaker effect. 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 cell count checks should be performed.
Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

Allopurinol is excreted in breast milk. It is not recommended to take allopurinol during breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Argadopin may cause dizziness, drowsiness, and impaired coordination. If you experience such effects, DO NOTdrive, operate machinery, or engage in hazardous activities.

Argadopin contains lactose

If you have been told you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Argadopin

Always take this medicine exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist. Your doctor will usually start 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.
Swallow the tablets with water. The score line on the tablet is only to facilitate breaking and not to divide it into equal doses. Take the tablets after a meal. During treatment, it is recommended to drink plenty of fluids (2-3 liters per day).

Adults (including the elderly)

Initial dose: 100-300 mg per day.
At the beginning of treatment, your doctor may also prescribe an anti-inflammatory medicine or colchicine for you to take for a month or longer to prevent gout attacks.
Your doctor may adjust the dose of allopurinol according to 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.

Your 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 you experience gastrointestinal side effects (e.g., nausea or vomiting, see section 4), your doctor may recommend taking the medicine in divided doses to alleviate these symptoms.

Patient with severe kidney disease

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

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.

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.
Your doctor may start treatment with 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).

Overdose of Argadopin

If you (or someone else) have taken too many tablets or if you suspect that a child has taken some, contact the emergency department of your nearest hospital or your doctor.
Overdose may cause symptoms such as nausea, vomiting, diarrhea, or dizziness.
Bring this leaflet, the remaining tablets, and the packaging of the medicine with you so that the medical staff knows which medicine has been taken.

Missed dose of Argadopin

If you forget to take a tablet, 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 forgotten dose. Take the next tablets at the scheduled time.

Stopping treatment with Argadopin

Take Argadopin for as long as your doctor has told you. DO NOTstop treatment without consulting your doctor first.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following side effects, stop taking the medicine and contact your doctor immediately.

Hypersensitivity

Symptoms may include:
Uncommon side effects (may occur in less than 1 in 100 people)
If you experience an allergic reaction, stop taking Argadopin and contact your doctor immediately. Symptoms may include:
peeling of the skin, ulcers of the lips and mouth
very rarely, sudden wheezing, rapid heartbeat, or tightness in the chest and collapse.
Do not take any more tablets until your doctor tells you to.
Rare side effects (may occur in less than 1 in 1000 people)
fever and chills, headache, muscle pain (flu-like symptoms) and general feeling of being unwell
any skin changes, such as ulcers in the mouth, throat, nose, genitals, and conjunctivitis (redness and swelling of the eyes), generalized blisters, or peeling of the skin
severe hypersensitivity reactions, including fever, rash, joint pain, abnormal liver function tests (these 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 tests
• diarrhea

Rare(may occur in less than 1 in 1000 people)

• liver disease, such as hepatitis

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

• occasionally, Argadopin may affect the blood, which may manifest as easier bruising than usual or sore throat or other signs of infection. These symptoms usually occur in people with liver or kidney disease. Inform your doctor as soon as possible
• Argadopin may affect the lymphatic glands
• high fever
• blood in the urine
• high cholesterol levels in the blood (hyperlipidemia)
• general feeling of being unwell or weakness
• weakness, numbness, instability while standing, feeling of being unable 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 coordination (ataxia)
• tingling, itching, prickling, or burning sensation of the skin (paresthesia)
• fluid retention leading to swelling, especially in the ankles
• abnormal glucose metabolism (diabetes). Your 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, seek medical help immediately
• lichen planus-like rash (itchy, reddish-purple rash and/or white-grayish lines on the mucous membranes)

If any of the side effects get worse or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug 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 Argadopin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
HDPE bottles: after first opening, use within 6 months.
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 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, maize 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 score line and engraved with the symbols "I" and "56" on either side of the score 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 score line and engraved with the symbols "I" and "57" on either side of the score 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 about this medicine and its authorized names in the European Economic Area, please contact:

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