Instructions for use Diclac ID modified-release tablets 150 mg No. 100
Composition
active ingredient: diclofenac;
1 tablet contains diclofenac sodium 75 mg or 150 mg;
Excipients: lactose monohydrate, hypromellose (hydroxypropylmethylcellulose), microcrystalline cellulose, calcium hydrogen phosphate, corn starch, sodium starch glycolate (type A), colloidal anhydrous silica, magnesium stearate, red iron oxide (E 172), purified water.
Dosage form
Modified-release tablets.
Main physicochemical properties: bilayer tablets of white-pink color, round, flat, with beveled edges and a smooth surface, the pink layer may contain white inclusions.
Pharmacotherapeutic group
Nonsteroidal anti-inflammatory and antirheumatic drugs. ATC code M01A B05.
Pharmacological properties
Pharmacodynamics. Diclofenac is a nonsteroidal compound with pronounced antirheumatic, antipyretic, analgesic and anti-inflammatory properties. The mechanism of action is due to inhibition of the biosynthesis of prostaglandins, kinins and other mediators of inflammation and pain, reduction of capillary permeability, stabilizing effect on lysosomal membranes. Inhibits platelet aggregation induced by adenosine diphosphate and collagen. In vitro, diclofenac sodium in concentrations equivalent to those achieved in the treatment of patients does not inhibit the biosynthesis of proteoglycans of cartilage tissue.
In rheumatic diseases, the anti-inflammatory and analgesic effects of diclofenac lead to a significant reduction in the severity of pain (both at rest and during movement), morning stiffness, and joint swelling, and thereby to an improvement in the patient's functional status.
In the presence of inflammation caused by trauma or surgery, Diklak® ID rapidly eliminates both spontaneous pain and pain on movement, and also reduces inflammatory tissue swelling and edema in the surgical wound area. When used simultaneously with opioids to eliminate postoperative pain, Diklak® ID significantly reduces the need for opioids.
In clinical studies, it was found that Diklak® ID also exhibits a strong analgesic effect in moderately to severely expressed pain of non-rheumatic origin.
Pharmacokinetics.
Diklak® ID tablets are two-layer tablets with a combination of rapid (1/6 of the total amount) and gradual release (5/6 of the total amount) of diclofenac sodium. This combination of effects in one tablet allows for both a rapid onset of action and long-term circulation of the active substance in the systemic bloodstream and a therapeutic effect throughout the day.
After oral administration of the drug, diclofenac is completely absorbed and, depending on the duration of passage through the stomach, the maximum concentration in the blood plasma is reached after 1–16 hours, on average after 2–3 hours. The amount of absorbed active substance is linearly dependent on the dose of the drug. About half of diclofenac is metabolized during the first passage through the liver. Only 35–70% of the absorbed active substance reaches the post-hepatic circulation unchanged. Approximately 30% of the active substance is metabolized and excreted in the feces. Approximately 70% is excreted by the kidneys in the form of pharmacologically inactive metabolites. The half-life is about 2 hours and this indicator does not depend on the function of the liver and kidneys. Binding to plasma proteins is approximately 99%.
Indication
Pain relief and reduction of inflammation of varying degrees in various conditions, including:
joint pathology: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, acute attacks of gout;
acute musculoskeletal diseases such as periarthritis (e.g., shoulder scapular periarthritis), tendonitis, tendovaginitis, bursitis;
other pathological conditions caused by trauma, including fractures, back pain, sprains, dislocations, orthopedic, dental and other minor surgical procedures.
Contraindication
Hypersensitivity to the active substance or to any other component of the drug.
Acute gastric or intestinal ulcer; gastrointestinal bleeding or perforation, history of gastrointestinal bleeding or perforation after taking nonsteroidal anti-inflammatory drugs (NSAIDs), history of acute or recurrent gastric or intestinal ulcer (two or more separate episodes of established ulceration or bleeding in history).
Diclofenac, like other NSAIDs, is contraindicated in patients who develop angioedema, nasal polyps, asthma attacks, urticaria, acute rhinitis, and other allergic symptoms in response to the use of acetylsalicylic acid or other NSAIDs.
Hematopoiesis disorders of unknown origin.
Cerebrovascular bleeding or other type of bleeding.
Inflammatory bowel disease (Crohn's disease or ulcerative colitis).
Liver failure.
Kidney failure.
Congestive heart failure (NYHA II-IV).
Ischemic heart disease in patients with angina pectoris or previous myocardial infarction.
Peripheral artery disease.
Treatment of perioperative pain in coronary artery bypass grafting (or the use of a cardiopulmonary bypass machine).
Treatment of postoperative pain after coronary artery bypass graft surgery (or the use of a cardiopulmonary bypass machine).
Interaction with other medicinal products and other types of interactions
The following interactions have been observed with diclofenac tablets coated with a gastro-resistant coating and/or other diclofenac dosage forms.
Lithium: Diclofenac may increase plasma lithium concentrations when used concomitantly. Monitoring of plasma lithium levels is recommended.
Digoxin: Plasma concentrations of digoxin may increase when co-administered with diclofenac. Monitoring of digoxin plasma levels is recommended.
Diuretics and antihypertensive drugs. As with other NSAIDs, the simultaneous use of Diklak® ID may weaken the antihypertensive effect of diuretics or antihypertensive drugs (e.g. beta-blockers, angiotensin-converting enzyme (ACE) inhibitors) by inhibiting the synthesis of vasodilator prostaglandins. Therefore, such a combination should be used with caution; patients, especially the elderly, should have their blood pressure regularly monitored. Patients should be adequately hydrated and renal function should be checked at the beginning of combination therapy and regularly thereafter, in particular due to the increased risk of nephrotoxicity when using diuretics and ACE inhibitors.
Anticoagulants and antithrombotic agents: Caution is recommended as concomitant use may increase the risk of bleeding.
Close monitoring of patients receiving concomitant diclofenac and anticoagulants is recommended and, if necessary, dosage adjustment of the anticoagulant is recommended. Like other NSAIDs, diclofenac in high doses may reversibly inhibit platelet aggregation.
Other NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors and corticosteroids. Concomitant use of diclofenac and other systemic NSAIDs or corticosteroids may increase the risk of gastrointestinal bleeding or ulceration. The concomitant use of two or more NSAIDs should be avoided. Concomitant use of diclofenac and corticosteroids may increase the frequency of adverse reactions.
Antidiabetic agents: Isolated reports of both hypoglycaemic and hyperglycaemic reactions have been received after the use of diclofenac, requiring dose adjustment of antidiabetic agents. For this reason, monitoring of blood glucose levels is recommended as a precautionary measure during combination therapy.
Probenecid: Medicinal products containing probenecid may delay the elimination of diclofenac.
Methotrexate: Diclofenac may inhibit the renal tubular clearance of methotrexate, leading to increased methotrexate levels. NSAIDs, including diclofenac, should be used with caution when administered less than 24 hours before treatment with methotrexate, as plasma levels of methotrexate and its toxicity may increase.
Cases of serious toxicity have been observed when methotrexate and NSAIDs, including diclofenac, were administered less than 24 hours apart. This interaction is mediated by accumulation of methotrexate as a result of impaired renal excretion in the presence of NSAIDs.
Cyclosporine: Diclofenac, like other NSAIDs, may potentiate the nephrotoxicity of cyclosporine through its effects on renal prostaglandins. Therefore, the drug should be used at lower doses than in patients not receiving cyclosporine.
Tacrolimus: There may be an increased risk of nephrotoxicity if NSAIDs are administered concomitantly with tacrolimus.
Quinolone antibiotics. The interaction of quinolone antibiotics with NSAIDs may lead to the occurrence of seizures. This may occur in patients with or without a history of epilepsy or seizures. Therefore, quinolone antibiotics should be used with caution in patients already receiving NSAIDs.
Phenytoin: When phenytoin and diclofenac are used concomitantly, phenytoin plasma concentrations should be monitored, taking into account the expected increase in phenytoin exposure.
Colestipol and cholestyramine. These drugs may delay or reduce the absorption of diclofenac. Therefore, it is recommended to administer diclofenac at least 1 hour before or 4-6 hours after administration of colestipol/cholestyramine.
Cardiac glycosides. The simultaneous use of cardiac glycosides and NSAIDs in patients may contribute to the exacerbation of heart failure, a decrease in glomerular filtration rate, and an increase in the concentration of the glycoside in the blood plasma.
Mifepristone: NSAIDs should not be used for 8–12 days after taking mifepristone, as NSAIDs may reduce the effect of mifepristone.
Potent CYP2C9 inhibitors: Caution is recommended when administering diclofenac concomitantly with potent CYP2C9 inhibitors (e.g. sulfinpyrazone and voriconazole), which may lead to a significant increase in maximum plasma concentrations and exposure to diclofenac due to inhibition of its metabolism.
Agents that may cause hyperkalemia: Concomitant treatment with potassium-sparing diuretics, cyclosporine, tacrolimus or trimethoprim may cause an increase in serum potassium levels, which should be monitored.
Application features
To reduce the risk of adverse reactions, treatment should be initiated at the lowest effective dose for the shortest duration necessary to control symptoms.
General: The concomitant use of diclofenac and other systemic NSAIDs, including selective COX-2 inhibitors, should be avoided due to the lack of any evidence of a synergistic effect and due to potential additive side effects.
Caution should be exercised in prescribing treatment to patients over 65 years of age in accordance with the recommendations for this patient group. In particular, the use of the minimum effective dose is recommended in frail elderly patients or patients with low body weight.
The use of oral dosage forms containing immediate-release diclofenac may increase gastric intolerance to the drug.
When using diclofenac, as with other NSAIDs, allergic reactions may rarely develop, including anaphylactic/anaphylactoid reactions, which may occur even when the drug is used for the first time.
Hypersensitivity reactions may progress to Kounis syndrome, a serious allergic reaction that can lead to myocardial infarction. Symptoms of such reactions include chest pain in combination with allergic reactions to diclofenac.
Like other NSAIDs, diclofenac may mask the signs and symptoms of infection.
Headaches may occur with prolonged use of analgesics. They cannot be treated with increased doses of diclofenac.
Drinking alcohol while taking NSAIDs, including diclofenac, may increase gastrointestinal (GI) or central nervous system (CNS) adverse reactions.
Since Diklak® ID contains lactose, it is not recommended for patients with hereditary conditions accompanied by galactose intolerance, glucose-galactose malabsorption and lactase deficiency.
The patient's need for diclofenac should be periodically reviewed for symptom relief and response to therapy. Use with caution in patients over 65 years of age.
Gastrointestinal effects: Gastrointestinal bleeding (haematemesis, melena), ulceration or perforation, which can be fatal, have been reported with NSAIDs, including diclofenac. They can occur at any time during treatment, with or without warning symptoms and a history of serious gastrointestinal disease. In elderly patients, such complications are usually more serious. If gastrointestinal bleeding or ulceration occurs, the drug should be discontinued.
Close medical supervision and special caution are required when prescribing diclofenac to patients with symptoms suggestive of gastrointestinal disorders or with a history of suspected ulcer, bleeding, or perforation of the stomach or intestines. The risk of these events increases with increasing NSAID dose and in patients with a history of ulcer, particularly complicated by bleeding or perforation.
Elderly patients have an increased incidence of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.
To reduce the risk of gastrointestinal side effects, treatment should be started at the lowest effective dose and maintained at that dose.
Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered in such patients, as well as in patients requiring concomitant use of low-dose acetylsalicylic acid/aspirin or other drugs that may increase the risk of gastrointestinal adverse reactions.
Caution should be exercised with concomitant treatment with drugs that may increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants (e.g. warfarin), SSRIs, antiplatelet agents (e.g. acetylsalicylic acid).
The use of NSAIDs, including diclofenac, may be associated with an increased risk of gastrointestinal anastomotic leakage. Close supervision and caution are recommended when using diclofenac after gastrointestinal surgery.
Hepatic effects: Close medical supervision is required if the drug is to be administered to patients with impaired liver function, as their condition may be exacerbated.
When using NSAIDs, including diclofenac, the level of one or more liver enzymes may increase. During long-term treatment with diclofenac, regular monitoring of liver function is indicated as a precautionary measure.
If liver function tests persist or worsen, clinical signs or symptoms of liver disease appear, or other manifestations are observed (eosinophilia, rash), the drug should be discontinued.
Diclac® ID should only be prescribed after careful risk-benefit assessment in case of congenital disorders of porphyrin metabolism, as it may cause exacerbation.
Renal effects: Since fluid retention and oedema have been reported with NSAIDs, special caution should be exercised in patients with impaired cardiac or renal function, a history of hypertension, the elderly, patients receiving concomitant treatment with diuretics or drugs that may significantly affect renal function, and patients with significant volume depletion from any cause (e.g. before or after surgery). In such cases, monitoring of renal function is recommended as a precautionary measure when using diclofenac. Patients usually recover after discontinuation of therapy.
In general, habitual use of analgesics, especially in combination with multiple analgesic drugs, can lead to long-term kidney damage with the risk of developing renal failure (analgesic nephropathy).
Skin effects: Serious skin reactions (some fatal), including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely with diclofenac. The risk of these reactions is highest at the beginning of therapy and most occur within the first month of treatment. Patients with known allergic reactions to other substances should be monitored closely. The drug should be discontinued at the first sign of hypersensitivity.
Systemic lupus erythematosus and mixed connective tissue diseases: Patients with systemic lupus erythematosus and mixed connective tissue diseases (collagenoses) may be at increased risk of aseptic meningitis.
Cardiovascular and cerebrovascular events: There is an increased risk of thrombotic cardiovascular and cerebrovascular events (including myocardial infarction and stroke) associated with the use of NSAIDs, including diclofenac, especially with long-term treatment at high doses.
Such patients, as well as patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking), should only be prescribed diclofenac after careful clinical evaluation in daily doses ≤ 100 mg if treatment lasts more than 4 weeks.
Since the cardiovascular risks of diclofenac may increase with increasing dose and duration of treatment, it should be used for the shortest possible period and at the lowest effective dose. The dose of the drug should be reviewed periodically, especially if treatment lasts more than 4 weeks.
Treatment with diclofenac is generally not recommended in patients with established cardiovascular disease (congestive heart failure NYHA II-IV, ischemic heart disease, peripheral arterial disease) or with uncontrolled arterial hypertension.
Patients should be informed about the signs and symptoms of serious cardiovascular thrombotic complications (e.g., chest pain, shortness of breath, weakness, slurred speech), which may occur suddenly. If such symptoms occur, they should seek immediate medical attention.
Appropriate medical supervision and counseling are required in patients with a history of hypertension and/or mild to moderate congestive heart failure, as fluid retention and edema have been observed during NSAID use.
Hematological manifestations. During long-term treatment with diclofenac, it is recommended to monitor blood counts with determination of the number of formed elements. Diclofenac can reversibly inhibit platelet aggregation. Patients with impaired hemostasis, hemorrhagic diathesis or hematological abnormalities require careful monitoring.
Respiratory manifestations. In patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (e.g. nasal polyps), chronic obstructive pulmonary disease or chronic respiratory tract infections (especially if associated with symptoms similar to allergic rhinitis), reactions to NSAIDs similar to asthma exacerbations (so-called aspirin asthma with intolerance to analgesics), angioedema and urticaria occur more often than in other patients. In this regard, special precautions are recommended for such patients (readiness for emergency care). This also applies to patients who have allergic skin reactions to other substances.
Like other agents that inhibit prostaglandin synthetase activity, diclofenac may cause bronchospasm when administered to patients with asthma (including a history of it).
Female fertility. There is evidence that the use of NSAIDs may negatively affect female fertility, therefore, drugs of this group are not recommended for women planning pregnancy or patients suffering from infertility.
Use during pregnancy or breastfeeding
From the 20th week of pregnancy, the use of Diklak® ID may cause oligohydramnios due to fetal renal dysfunction. This may occur shortly after the start of treatment and is usually reversible after discontinuation of treatment. In addition, there are reports of narrowing of the ductus arteriosus after treatment in the second trimester of pregnancy, most of which resolved after discontinuation of treatment. Therefore, Diklak® ID should not be administered during the first and second trimesters of pregnancy unless clearly necessary. If Diklak® ID is used by a woman attempting to conceive or during the first and second trimesters of pregnancy, the dose should be kept as low and the duration of treatment as short as possible. Antenatal monitoring for oligohydramnios and narrowing of the ductus arteriosus should be considered after exposure to Diklak® ID for several days, starting from the 20th week of gestation. Diklak® ID should be discontinued if oligohydramnios or narrowing of the ductus arteriosus is detected.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may pose risks:
Risks to the fetus:
cardiopulmonary toxicity (with premature narrowing/closure of the ductus arteriosus and pulmonary hypertension);
renal dysfunction (see above);
Risks for the mother at the end of pregnancy and for the newborn:
possible prolongation of bleeding time, anti-aggregation effect, which can occur even at very low doses;
suppression of uterine contractions, leading to delayed or prolonged labor.
Therefore, Diclac® ID is contraindicated during the third trimester of pregnancy.
Breast-feeding
Like other NSAIDs, diclofenac passes into breast milk in small amounts, so this drug is contraindicated during breastfeeding.
Female fertility
As with other NSAIDs, diclofenac may impair female fertility and is therefore not recommended in women attempting to conceive. Discontinuation of diclofenac should be considered in women who are unable to conceive or in women undergoing investigation of infertility.
Ability to influence reaction speed when driving vehicles or other mechanisms
Patients who experience dizziness, vertigo, drowsiness, lethargy or fatigue, CNS disorders, including visual impairment, while taking the drug are not recommended to drive vehicles or operate other mechanisms.
Method of administration and doses
The dose of the drug is selected by the doctor individually, starting with the minimum effective dose. To minimize undesirable effects, the lowest effective dose should be used for the shortest period of time to control symptoms, taking into account the treatment objectives of each individual patient.
The recommended initial dose for adults is 75–150 mg per day, depending on the severity of the symptoms. For long-term therapy, 1 tablet (75 mg) per day is usually sufficient. If the symptoms of the disease are most pronounced at night or in the morning, Diclac® ID should be taken in the evening.
The maximum daily dose is 150 mg and should not be exceeded. Diclac® ID is intended for short-term use (maximum 2 weeks).
The duration of treatment is determined by the doctor.
The tablets should be swallowed whole, without chewing, with sufficient liquid, preferably during or after a meal.
Children: Diclac® ID is not recommended for use in children.
Elderly patients: No clinically significant changes in pharmacokinetics have been observed in elderly patients. However, NSAIDs should be used with caution in such patients, as they are more susceptible to adverse reactions. It is recommended to use the lowest effective dose in elderly patients or patients with low body weight, as well as in patients who require constant monitoring for possible gastrointestinal bleeding during the use of NSAIDs.
Patients with established cardiovascular disease and a significant risk of developing it. In such patients, as well as in patients with uncontrolled arterial hypertension, treatment with diclofenac is usually not recommended. If necessary, the drug may be prescribed only after a careful assessment of the risk-benefit ratio at a dose of ≤ 100 mg per day and a duration of treatment of no more than 4 weeks.
Patients with renal impairment. Diclofenac is contraindicated in renal failure. The drug should be used with caution in patients with mild to moderate renal impairment.
Patients with hepatic impairment. Diclofenac is contraindicated in hepatic insufficiency. The drug should be used with caution in patients with mild or moderate hepatic impairment.
Children.
Diclac® ID is contraindicated for the treatment of children due to the high content of the active substance in the tablet.
Overdose
Treatment of acute NSAID poisoning consists of supportive and symptomatic measures. Symptomatic and supportive measures are indicated for complications such as hypotension, renal failure, convulsions, gastrointestinal disorders and respiratory depression. It is unlikely that such specific therapeutic measures as forced diuresis, dialysis or hemoperfusion will be useful for the removal of NSAIDs, since the active substances of these drugs are largely bound to blood proteins and undergo intensive metabolism. Activated charcoal can be used after taking potentially toxic doses, and gastric decontamination (induction of vomiting, gastric lavage) after taking potentially life-threatening doses.
Side effects
The frequency category of adverse reactions is defined as follows: very common (> 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10000, < 1/1000); very rare (< 1/10000), unknown, including isolated reports.
The following undesirable effects include those associated with administration under conditions of short-term and long-term use.
Blood and lymphatic system disorders
Very rare: thrombocytopenia, leukopenia, anemia (including hemolytic and aplastic anemia), pancytopenia, agranulocytosis.
The first signs of blood and lymphatic system disorders may be: fever, sore throat, superficial mouth sores, flu-like symptoms, fatigue, nosebleeds, and skin hemorrhages.
On the part of the immune system:
Rare: hypersensitivity reactions, anaphylactic and anaphylactoid reactions (including hypotension and shock).
Very rare: angioedema (including swelling of the face, tongue, larynx).
Mental disorders
Very rare: disorientation, depression, insomnia, nightmares, irritability, psychotic disorders.
From the nervous system
Common: headache, dizziness
Rare: drowsiness, increased fatigue
Very rare: paresthesia, memory impairment, convulsions, anxiety, tremor, aseptic meningitis, taste disturbance, cerebrovascular accident
Not known: confusion, hallucinations, sensory disturbances, malaise, apoplexy.
From the organs of vision
Very rare: visual impairment, blurred vision, diplopia
Not known: optic neuritis
Hearing and balance disorders
Often vertigo
Very rare: tinnitus, hearing impairment
Cardiovascular system
Rare: palpitations, chest pain, heart failure, myocardial infarction
Very rare: hypertension, hypotension, vasculitis
Unknown: Kounis syndrome
Respiratory system
Rare: bronchial asthma (including dyspnoea)
Very rare: pneumonitis
From the digestive tract
Common: nausea, vomiting, diarrhea, dyspepsia, abdominal pain, abdominal cramps, flatulence, loss of appetite
Rare: gastritis, gastrointestinal bleeding, hematemesis, hemorrhagic diarrhea, melena, gastric and intestinal ulcers with or without bleeding or perforation (sometimes fatal, especially in elderly patients)
Very rare: colitis (including hemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, esophageal disorders, development of diaphragmatic strictures in the intestine, pancreatitis.
Hepatobiliary system
Common: increased transaminase activity
Rare: hepatitis, jaundice, liver dysfunction.
Very rare: fulminant hepatitis, liver necrosis, hepatic failure.
Skin and subcutaneous tissue disorders
Common: rash
Rare: urticaria
Very rare: bullous rash, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, erythroderma, hair loss, photosensitivity reactions, purpura, allergic purpura, pruritus, inflammatory skin changes
Renal and urinary disorders
Very rare: acute renal failure, hematuria, proteinuria, nephrotic syndrome, tubulointerstitial nephritis, renal papillary necrosis, fluid retention in the body, edema.
From the reproductive system
Very rare: impotence.
Infectious diseases
Exacerbation of inflammation associated with infections (e.g., development of necrotizing fasciitis), symptoms of aseptic meningitis.
Clinical trial data and epidemiological data suggest an increased risk of thrombotic complications (e.g. myocardial infarction or stroke) associated with the use of diclofenac, particularly at high therapeutic doses (150 mg/day) and with long-term use.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 tablets in a blister; 2 (10 ´ 2) or 10 (10 ´ 10) blisters in a cardboard box.
Vacation category
According to the recipe.
Producer
For tablets of 75 mg:
Producer.
Salutas Pharma GmbH.
Location of the manufacturer and address of its place of business.
Otto-von-Güricke-Allee 1, 39179 Barleben, Germany.
For tablets of 150 mg:
Producer
Salutas Pharma GmbH.
(bulk production, packaging, series production).
Lek S. A.
Location of the manufacturers and address of the place of business.
Otto-von-Güricke-Allee 1, 39179 Barleben, Germany.
50 C, Domaniewska Street, 02-672 Warsaw, Poland.
