Argadopin

Patient Information Leaflet

Argadopin, 100 mg, tablets
Argadopin, 300 mg, tablets
Allopurinolum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• 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. This medicine may harm other people, 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.

Leaflet Contents

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 pack 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 of specific chemical reactions in the body.
• Argadopin is used long-term to prevent 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 disease.

2. Important information before using Argadopin

When not to use 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, discuss this with your doctor or pharmacist if the
patient:
is of Chinese (Han ethnic group), African or Indian descent
has liver or kidney function disorders. The doctor may prescribe a lower dose of the medicine
or recommend taking the medicine less frequently than daily. The patient's condition will also
be closely monitored
has heart function disorders or high blood pressure and is taking diuretics and/or medicines
called ACE inhibitors
is currently experiencing a gout attack
has thyroid function disorders.
If in doubt whether any of the above conditions apply to the patient, consult the attending doctor
or pharmacist before starting allopurinol treatment.
Severe skin rashes (hypersensitivity syndrome, Stevens-Johnson syndrome and toxic epidermal
necrolysis) have been reported during allopurinol treatment. Skin rashes often involve ulceration
of the mouth, throat, nose, genital organs and conjunctivitis (redness and swelling of the eyes).
Such severe skin rashes are often preceded by flu-like symptoms, fever, headache and body aches
(so-called flu-like symptoms). The rash may progress to widespread blistering and skin peeling.
These severe skin reactions may occur more frequently in patients 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 treatment must be stopped immediately
and medical advice must be sought.
In cancer diseases or in Lesch-Nyhan syndrome, the amount of uric acid in the urine may increase.
To prevent this, adequate hydration of the patient should be ensured to dilute the urine.
If the patient has kidney stones, they may decrease in size and pass into the urinary tract.
Children
Use of this medicine in children is rarely indicated, except in certain types of cancer (particularly
leukemias) and certain enzymatic disorders such as Lesch-Nyhan syndrome.
Argadopin and other medicines
Before starting treatment with this medicine, inform your doctor if you are taking:
6-mercaptopurine (a medicine used in the treatment of blood cancer)
azathioprine, cyclosporine (medicines used to suppress the immune system). Warning: increased
risk of adverse effects of cyclosporine
concomitant administration of 6-mercaptopurine or azathioprine with allopurinol should be avoided.
When 6-mercaptopurine or azathioprine are administered concomitantly 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.
vidarabine (a medicine used to treat Herpes virus infection). Warning: increased risk of adverse
effects of vidarabine. Special caution is required in such cases
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). A dose reduction of chlorpropamide may be
necessary, especially in patients with kidney function disorders
warfarin, phenprocoumon, acenocoumarol (anticoagulant medicines). The doctor will monitor the
patient's blood clotting parameters more frequently and may reduce the dose of these medicines if
necessary
phenytoin (an anticonvulsant medicine)
theophylline (a medicine used to treat asthma and other respiratory diseases). The doctor will monitor
theophylline blood levels, especially at the beginning of allopurinol treatment or after any dose
change
ampicillin or amoxicillin (medicines used to treat bacterial infections). The doctor will use alternative
antibiotics if possible, as the likelihood of allergic reactions is higher
medicines used for heart diseases or high blood pressure, such as ACE inhibitors or diuretics
medicines used to treat malignant tumors, such as:

• cyclophosphamide
• doxorubicin
• bleomycin
• procarbazine
• alkylating halides. 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). Increased risk of skin reactions is possible,
  especially in patients with chronic kidney disease.

If aluminium hydroxide is taken concomitantly, allopurinol may have reduced effectiveness. An interval
of at least 3 hours should be maintained between taking both medicines.
Blood count disorders occur more frequently when allopurinol is taken concomitantly with cytostatics
(e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating halides) than when these
active substances are taken separately. Therefore, regular blood morphology tests should be performed.
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines
you plan to take.
Pregnancy, breastfeeding and fertility
Allopurinol is excreted in breast milk. Allopurinol use during breastfeeding is not recommended.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child,
she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
Argadopin may cause dizziness, drowsiness and impair coordination. If such effects occur, DO NOT
drive, operate machinery or engage in hazardous activities.
Argadopin contains lactose
If the patient has been diagnosed with intolerance to certain sugars, consult a doctor before using this
medicine.

3. How to use Argadopin

This medicine should always be taken exactly as directed by the doctor. In case of doubt, consult
your doctor or pharmacist. The doctor usually starts treatment with a low dose of allopurinol (e.g.
100 mg/day) to reduce the risk of adverse effects. If necessary, the dose will be
increased.
The tablets should be swallowed with water. The break line on the tablet is intended only to facilitate
breaking the tablet in half if the patient has difficulty swallowing the whole tablet. Tablets should be taken
after a meal. During treatment with this medicine, it is recommended to drink plenty of fluids (2–3 litres daily).
Recommended dose:
Adults (including elderly people)
Initial dose: 100–300 mg per day.
At the beginning of treatment, the doctor may also prescribe an anti-inflammatory drug or colchicine
to be taken for one month or longer to prevent gouty arthritis attacks.
The doctor may adjust the allopurinol dose 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 adjust the dose in patients with impaired kidney or liver function, especially in elderly
patients.
If the daily dose exceeds 300 mg and the patient experiences gastrointestinal adverse effects (e.g.
nausea or vomiting, see section 4), the doctor may recommend dividing the dose to alleviate these
symptoms.
Patients with severe kidney disease

• The doctor may recommend taking less than 100 mg of allopurinol daily, or
• may recommend taking 100 mg of allopurinol less frequently than daily.

If the patient is dialysed two or three times a week, the doctor may prescribe 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 body weight of 15 kg or more
Argadopin, 300 mg
Use in children (under 15 years of age) with body weight of 45 kg or more
Usual dose: 10 to 20 mg per kilogram of body weight per day, divided into 3 doses.
Maximum dose: 400 mg of allopurinol per day.
The doctor may start treatment with an anti-inflammatory drug or colchicine, adjust the dose in patients
with impaired kidney or liver function, or recommend dividing the dose to alleviate gastrointestinal
adverse effects, as in adults (see above).
Taking more Argadopin than prescribed
If a patient (or another person) has swallowed many tablets at once, or if there is suspicion that a child
has taken any amount of tablets, contact the nearest hospital emergency department or doctor immediately.
Overdose may cause symptoms such as nausea, vomiting, diarrhoea, or dizziness.
Bring this leaflet, any remaining tablets, and the medicine packaging along, so that medical staff know
which medicine has been taken.
If you forget to take Argadopin
If the patient forgets to take a tablet, they should take it as soon as they remember, unless it is almost time
for the next dose.
DO NOT take a double dose to make up for a missed dose. Continue taking the tablets at the usual time.
Stopping Argadopin treatment
Argadopin should be taken for as long as your doctor recommends. DO NOT stop treatment
without first consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur during treatment with this medicine.
If the patient experiences any of the adverse reactions listed below, treatment must be discontinued immediately and medical advice must be sought.
Hypersensitivity
Symptoms may include:
Not very common adverse reactions (may occur in fewer than 1 in 100 people)
If the patient experiences an allergic reaction, treatment with Argadopin must be stopped and medical advice must be sought immediately. Symptoms may include:
skin peeling, ulceration of the lips and oral cavity
very rarely sudden wheezing, palpitations or chest tightness and collapse.
Do not take any more tablets until advised by a doctor.
Rare adverse reactions (may occur in fewer than 1 in 1,000 people)
fever and chills, headache, muscle pain (flu-like symptoms) and general malaise
any skin changes, e.g. ulceration in the oral cavity, throat, nose, genital organs and conjunctivitis (redness and swelling of the eyes), disseminated blisters or skin peeling
severe hypersensitivity reactions, including fever, rash, joint pain, abnormal liver function test results (these may be symptoms of multi-organ hypersensitivity)
bleeding from lips, eyes, mouth, nose and genital organs.
Other adverse reactions
Common (may occur in fewer than 1 in 10 people)

• skin rash
• increased blood concentration of thyrotropin hormone

Not very common (may occur in fewer than 1 in 100 people)

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

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

• liver disease, such as hepatitis

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

• Argadopin may occasionally affect the blood, which may manifest as bruising more easily than usual, sore throat or other signs of infection. These symptoms usually occur in patients with liver or kidney disease. Such symptoms should be reported to a doctor as soon as possible
• Argadopin may affect the lymph glands
• high temperature
• presence of blood in the urine
• high blood cholesterol levels (hyperlipidaemia)
• general malaise or feeling of weakness
• weakness, numbness, instability when standing, sensation of inability to move muscles (paralysis) or loss of consciousness
• headache, dizziness, drowsiness or visual disturbances
• chest pain (angina), high blood pressure or slow heart rate
• male infertility or erectile dysfunction
• breast enlargement (in both women and men)
• change in frequency of bowel movements
• altered taste
• cataract
• hair loss and change in hair colour
• depression
• lack of muscle coordination (ataxia)
• sensation of tingling, tickling, pricking or burning of the skin (paraesthesia)
• fluid retention leading to swelling, especially around the ankles
• abnormal glucose metabolism (diabetes). The doctor may recommend blood sugar testing to detect this disorder.

Frequency unknown (cannot be estimated from available data):

• aseptic meningitis (inflammation of the membranes surrounding the brain and spinal cord): symptoms include neck stiffness, headache, nausea, fever or disturbances in consciousness. If such symptoms occur, seek immediate medical help
• lichenoid skin eruption (itchy reddish-purple skin rash and/or thread-like white-grey lines on mucous membranes)

If any of the adverse reactions worsen or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorisation holder.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Argadopin

Keep the medicine out of the 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 stated month.
No special storage instructions are required 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. Such measures help protect the environment.

6. Contents of the pack and other information

What Argadopin contains
The active substance is allopurinol.
Each tablet of Argadopin 100 mg contains 100 mg of allopurinol.
Each tablet of Argadopin 300 mg contains 300 mg of allopurinol.
The other ingredients are: monohydrate lactose, 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 symbols "I" and "56" on each side of the line on one side, and smooth on the other side. Diameter: approximately 8 mm.
The medicine is available in PVC/Aluminium foil blisters in cardboard boxes containing 20, 30, 50, 60, 100 tablets, or in 30 x 1 (unit dose divisible blister), or in HDPE bottles with PP child-resistant cap or PP cap without child-resistant feature, with 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 symbols "I" and "57" on each side of the line on one side, and smooth on the other side. Diameter: approximately 11 mm.
The medicine is available in PVC/Aluminium foil blisters in cardboard boxes containing 30, 60, 100 tablets, or in 30 x 1 (unit dose divisible blister), or in HDPE bottles with PP child-resistant cap, containing 100, 105, 125 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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-Allee 1
39179 Barleben, Germany

For further information about this medicine and its trade names in the European Economic Area countries, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
Tel. 22 209 70 00