Instructions for Lekadol long tablets No. 16
Composition
active ingredients: ibuprofen, paracetamol;
1 film-coated tablet contains 200.00 mg of ibuprofen and 500.00 mg of paracetamol;
excipients: corn starch, crospovidone (E 1202), colloidal anhydrous silicon dioxide (E 551), povidone (E 1201), pregelatinized starch, talc (E 553b), stearic acid; shell: polyvinyl alcohol (E 1203), talc (E 553b), macrogol 3350 (E 1521), titanium dioxide (E 171).
Dosage form
Film-coated tablets.
Main physicochemical properties: white or almost white, oval-shaped tablet, film-coated.
Pharmacotherapeutic group
Nonsteroidal anti-inflammatory and antirheumatic drugs. Propionic acid derivatives. Combinations with ibuprofen.
ATX code M01A E51.
Pharmacological properties
Pharmacodynamics.
The pharmacological action of ibuprofen and paracetamol differs in site and mode of action, but is synergistic, enhancing analgesic and antipyretic properties compared to those of each substance used separately.
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID), a propionic acid derivative, which has been shown to be effective in inhibiting the synthesis of prostaglandins, mediators of pain and inflammation. Prostaglandins increase the sensitivity of nociceptive afferent nerve endings to mediators such as bradykinin. Thus, ibuprofen exerts its analgesic effect through peripheral inhibition of the cyclooxygenase-2 (COX-2) isoenzyme, with subsequent reduction in the sensitization of nociceptive nerve endings. Ibuprofen has also been shown to inhibit leukocyte-induced migration into the area of inflammation. Ibuprofen has a pronounced effect in the spinal cord, partly through inhibition of COX. The antipyretic effect of ibuprofen is due to central inhibition of prostaglandins in the hypothalamus. Thus, ibuprofen exerts analgesic, antipyretic and anti-inflammatory effects. In addition, ibuprofen reversibly inhibits platelet aggregation. In humans, ibuprofen reduces inflammatory pain, swelling, and fever.
Experimental data suggest that ibuprofen may competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when these drugs are used concomitantly. Some pharmacodynamic studies have shown that when single doses of ibuprofen 400 mg were administered within 8 hours before or within 30 minutes after immediate-release acetylsalicylic acid (81 mg), a reduction in the effect of aspirin (acetylsalicylic acid) on thromboxane formation or platelet aggregation was observed. Although it is not certain that these data can be extrapolated to the clinical situation, it cannot be excluded that regular long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid. With non-systematic use of ibuprofen, such a clinically significant effect is considered unlikely.
The mechanism of action of paracetamol is still not fully understood; however, there is convincing evidence of analgesic effects on the central nervous system. Biochemical studies indicate inhibition of COX-2 activity in the central nervous system. Paracetamol can also stimulate descending pathways of activation of 5-hydroxytryptamine (serotonin), which inhibits the transmission of pain signals in the spinal cord. Evidence suggests that paracetamol is a very weak inhibitor of COX-1 and -2 isoenzymes at the peripheral level.
The clinical efficacy of ibuprofen and paracetamol has been demonstrated in headache, toothache, dysmenorrhea, and fever; in addition, efficacy has been shown in patients with pain and fever associated with colds and influenza, and in pain models such as sore throat, muscle pain or soft tissue injuries, and back pain.
The drug is particularly suitable for the treatment of pain that requires a stronger analgesic effect than ibuprofen 400 mg or paracetamol 1000 mg alone.
Studies using this combination in acute pain models (postoperative dental pain) and chronic knee pain have shown high efficacy of this combination in acute pain (93.2%) and chronic pain (60.2%). This drug has a rapid onset of action with a confirmed significant reduction in pain, which is noted on average after 18.3 minutes. Significant pain reduction is noted on average after 44.6 minutes. The analgesic effect of this drug is significantly longer (9.1 hours) than that of paracetamol 500 mg (4 hours) or 1000 mg (5 hours).
Pharmacokinetics.
Ibuprofen is metabolized in the liver to two major metabolites, which are almost entirely excreted by the kidneys in unchanged form or as complex compounds with a small amount of unchanged ibuprofen. Renal excretion of the drug is complete and rapid. The half-life is approximately 2 hours.
In some studies, ibuprofen has been found in breast milk at very low concentrations.
Paracetamol is rapidly absorbed from the gastrointestinal tract. At therapeutic concentrations, the level of binding to plasma proteins is low, although it depends on the dose. Paracetamol in the blood plasma is determined after 5 minutes, reaching a maximum concentration after 0.5–0.67 hours after administration on an empty stomach. When using the drug, peak concentrations of paracetamol in the blood plasma were reduced and delayed by an average of 25 minutes, but the total extent of absorption was equivalent.
Paracetamol is metabolized in the liver and excreted in the urine mainly as glucuronide and sulfate conjugates, about 10% as glutathione conjugates. Less than 5% of paracetamol is excreted unchanged. The hydroxylated metabolite, which is formed in very small quantities in the liver under the influence of mixed oxidases and is detoxified by binding to hepatic glutathione, can accumulate in case of paracetamol overdose and cause liver tissue damage.
The half-life is approximately 3 hours.
No significant difference in the pharmacokinetic profile of paracetamol and ibuprofen was found in elderly patients. The bioavailability and pharmacokinetic profile of ibuprofen and paracetamol in this preparation do not change when taking a single or repeated dose of this combination.
The composition of this medicine is developed using technology that ensures the simultaneous release of ibuprofen and paracetamol in such a way as to potentiate the effects of each of the active ingredients.
Indication
Use for the symptomatic treatment of back and muscle pain, rheumatic pain, pain in mild forms of arthritis, headache, including migraine, toothache, dysmenorrhea, symptoms of colds, flu and fever. This medicine is particularly suitable for the treatment of pain that requires a stronger analgesic effect than that of ibuprofen or paracetamol used alone.
Contraindication
This medicine is contraindicated:
patients with individual hypersensitivity to ibuprofen, paracetamol or other components of the drug;
patients with a history of hypersensitivity reactions (e.g. bronchospasm, angioedema, bronchial asthma, rhinitis or urticaria) after taking ibuprofen, aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs);
with active gastric and duodenal ulcer/bleeding or with a history of recurrence (two or more severe episodes of ulcer or bleeding);
patients with a history of gastrointestinal bleeding or perforation associated with the use of NSAIDs;
patients with blood clotting disorders;
patients with severe hepatic, severe renal or severe heart failure (New York Heart Association (NYHA) class IV);
when used simultaneously with other drugs containing paracetamol;
with concomitant use of other NSAIDs, including specific cyclooxygenase-2 (COX-2) inhibitors, and aspirin in doses exceeding 75 mg once daily;
during the third trimester of pregnancy.
Interaction with other medicinal products and other types of interactions
This medicine, like other paracetamol-containing medicines, is contraindicated when used with other medicines containing paracetamol due to an increased risk of serious adverse reactions.
This medicine, like other NSAIDs, should not be used in combination with the following drugs:
Aspirin (acetylsalicylic acid). Increased risk of adverse reactions, unless aspirin (dose not exceeding 75 mg per day) has been prescribed by a doctor.
Experimental data suggest that ibuprofen may inhibit the effect of low-dose acetylsalicylic acid (aspirin) on platelet aggregation when used concomitantly. It is possible that regular long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid. Such clinically significant effects are considered unlikely with non-systematic use of ibuprofen.
Other NSAIDs (including selective COX-2 inhibitors): Increased incidence of side effects.
This medicine, like other NSAIDs, should be used with caution in combination with the following medicines:
Antihypertensives (angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor antagonists) and diuretics. NSAIDs may inhibit the effects of these agents. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with compromised renal function), the concomitant use of ACE inhibitors or angiotensin II receptor antagonists and agents that inhibit cyclooxygenase synthesis may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered when coxibs are administered concomitantly with ACE inhibitors or angiotensin II receptor antagonists. Therefore, such combinations should be prescribed with caution, especially in elderly patients. The patient should be adequately hydrated and consideration should be given to monitoring renal function at the start of treatment and periodically thereafter. Diuretics increase the risk of nephrotoxicity when used concomitantly with NSAIDs.
Antiplatelet and selective serotonin reuptake inhibitors: Increased risk of gastrointestinal bleeding.
Cardiac glycosides. NSAIDs increase the level of glycosides in plasma, can increase cardiac dysfunction, and reduce glomerular filtration function of the kidneys.
Cyclosporine: Increased nephrotoxicity.
Corticosteroids may contribute to the formation of ulcers or bleeding in the gastrointestinal tract.
Lithium and methotrexate: Increased plasma levels of lithium and methotrexate may occur.
Mifepristone: NSAIDs should not be used earlier than 8–12 days after mifepristone administration, as they reduce its effectiveness.
Quinolone antibiotics: Concomitant use of NSAIDs and quinolone antibiotics increases the risk of seizures.
Tacrolimus: The risk of nephrotoxicity is increased with concomitant use of NSAIDs and tacrolimus.
Zidovudine: Increased risk of hematological toxicity with concomitant use of zidovudine and NSAIDs. There is evidence of an increased risk of hemarthrosis and hematoma in HIV-infected patients with hemophilia receiving concomitant treatment with zidovudine and ibuprofen.
This medicine, like other medicines containing paracetamol, should be used with caution in combination with the following medicines:
Cholestyramine: Absorption of paracetamol may be reduced by cholestyramine. Therefore, cholestyramine should not be taken within one hour of taking paracetamol to achieve maximum analgesic effect.
Antiemetics: The rate of absorption of paracetamol may be increased by metoclopramide or domperidone.
Warfarin. Regular long-term use of paracetamol may enhance the anticoagulant effect of warfarin and other coumarins with an increased risk of bleeding; occasional use of the drug has no significant effect.
Application features
Paracetamol should be administered with caution to patients with severe renal and hepatic impairment. The risk of paracetamol overdose is higher in patients with non-cirrhotic alcoholic liver disease. In case of overdose, immediate medical attention should be sought, even if the patient feels well, due to the risk of delayed serious liver damage.
Do not use with other medicines containing paracetamol. In this case, you should immediately consult a doctor, even if the patient feels well, as this may lead to an overdose.
Undesirable effects can be minimized by taking the lowest effective dose needed to relieve symptoms, for the shortest period of time necessary to eliminate symptoms, with food.
Respiratory effects: Bronchospasm may occur in patients who suffer from bronchial asthma or allergic diseases after using nonsteroidal anti-inflammatory drugs or have a history of these diseases.
Renal effects. Risk of renal failure due to deterioration of renal function. Patients with impaired renal function, cardiac disorders, hepatic impairment, patients taking diuretics and elderly patients are at high risk of this reaction. Renal function should be monitored in such patients.
Effect on the liver. The drug may disrupt liver function.
Effects on the cardiovascular and cerebrovascular system: Patients with a history of hypertension and/or heart failure should be treated with caution (consultation with a doctor is necessary), since, as with other NSAIDs, fluid retention, hypertension and edema have been reported with ibuprofen therapy.
Patients with uncontrolled hypertension, congestive heart failure (NYHA class II-III), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease should only be prescribed ibuprofen after careful clinical assessment. High doses (2400 mg/day) should be avoided.
The clinical picture should also be carefully assessed before starting long-term treatment in patients with risk factors for cardiovascular complications (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking), especially if high doses of ibuprofen (2400 mg per day) are required.
Gastrointestinal effects: Gastrointestinal bleeding, perforation, and ulceration, which can be fatal, have been reported at any time during treatment with NSAIDs, regardless of the presence of warning symptoms or a previous history of severe gastrointestinal events.
The risk of gastrointestinal bleeding, ulceration or perforation increases with increasing NSAID dose, with a history of ulcer, especially ulcer complicated by bleeding or perforation, and in elderly patients. In such patients, treatment should be initiated at the lowest effective dose. For these patients, as well as patients requiring concomitant low-dose acetylsalicylic acid or other medicinal products that increase gastrointestinal risk, the physician should consider the use of combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors).
Patients with a history of gastrointestinal disorders, especially elderly patients, should be informed of any adverse gastrointestinal symptoms (especially bleeding), especially at the beginning of treatment.
The drug should be prescribed with caution to patients receiving concomitant medications that increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors, or antiplatelet agents such as aspirin.
The occurrence of gastrointestinal bleeding or ulceration in patients receiving ibuprofen-containing drugs requires immediate discontinuation of treatment with this drug.
Nonsteroidal anti-inflammatory drugs are prescribed with caution to patients with a history of gastrointestinal disorders (ulcerative colitis and Crohn's disease), as these conditions may be exacerbated.
Systemic lupus erythematosus and mixed connective tissue disease. When using the drug in patients with systemic lupus erythematosus and mixed connective tissue disease, the risk of developing aseptic meningitis increases.
Skin disorders: Very rarely, severe, sometimes fatal, skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have occurred with long-term use of NSAIDs. The risk of developing such reactions is highest at the beginning of treatment: in most cases, such reactions occur within the first month of taking the drug. This medicinal product should be discontinued at the first sign of skin rash, mucous membrane lesions or other manifestations of hypersensitivity.
Effects on female fertility. There is some evidence that cyclooxygenase/prostaglandin synthesis inhibitors may interfere with ovulation and are therefore not recommended for women attempting to conceive. This is reversible upon discontinuation of treatment. Women who have difficulty conceiving or are undergoing investigation for infertility should discontinue the drug.
Elderly patients: Elderly patients are more likely to experience adverse reactions to NSAIDs, especially gastrointestinal bleeding or perforation, which can be fatal. If the use of NSAIDs is necessary, the lowest effective dose should be used for the shortest duration possible.
The patient should be regularly monitored for gastrointestinal bleeding during NSAID therapy.
Use during pregnancy or breastfeeding
Use of ibuprofen from the 20th week of pregnancy may cause oligohydramnios due to fetal renal dysfunction. This may occur shortly after initiation of treatment and is usually reversible after discontinuation of the drug. In addition, cases of narrowing of the ductus arteriosus have been reported after treatment in the second trimester of pregnancy, most of which resolved after discontinuation of treatment. Therefore, ibuprofen should not be given during the first and second trimesters of pregnancy unless clearly necessary. If ibuprofen 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 in the event of exposure to ibuprofen for several days from the 20th week of gestation. Ibuprofen should be discontinued if oligohydramnios or narrowing of the ductus arteriosus is detected.
Risks to the fetus:
cardiopulmonary toxicity (premature narrowing/closure of the ductus arteriosus and pulmonary hypertension);
renal dysfunction.
Risks for the woman at the end of pregnancy and for the newborn:
possible prolongation of bleeding time, anti-aggregation effect, which may occur even when using very low doses;
suppression of uterine contractions, leading to delayed or prolonged labor.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug has a minor influence on the ability to drive or use machines. After taking NSAIDs, side effects such as dizziness, drowsiness, fatigue and visual disturbances may occur. Patients who experience such reactions should refrain from driving or using machines.
Method of administration and doses
For oral short-term use only.
The lowest effective dose should be used for the shortest duration necessary to control symptoms.
Adults should take 1 tablet up to 3 times a day with an interval of at least 6 hours between doses. Swallow the tablets with water.
If 1 tablet does not relieve the symptoms of the disease, 2 tablets should be taken at a time, but not more than 3 times a day. The interval between doses should be at least 6 hours. Do not take more than 6 tablets (3000 mg of paracetamol, 1200 mg of ibuprofen) per day. To minimize undesirable effects, patients are advised to take this medicine with food.
If the symptoms of the disease persist for more than 3 days, it is necessary to consult a doctor to clarify the diagnosis and adjust the treatment regimen. The duration of treatment is determined by the doctor individually, depending on the course of the disease and the patient's condition.
There is no need to adjust the dose for elderly patients.
Elderly people are at increased risk of serious adverse reactions. If the use of NSAIDs is considered necessary, the lowest effective dose should be used for the shortest duration possible. The patient should be regularly monitored for the risk of gastrointestinal bleeding during NSAID therapy.
Children.
Should not be used in children under 18 years of age.
Overdose
Paracetamol: Liver damage is possible in adults who have taken 10 g (equivalent to 20 tablets) or more of paracetamol. Taking 5 g (equivalent to 10 tablets) or more of paracetamol may cause liver damage if:
the patient is receiving long-term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St. John's wort, or drugs that induce liver enzymes;
the patient regularly consumes alcohol in quantities exceeding the recommended amount;
There is a possibility of a glutathione deficiency in the patient, for example in fibrocystic degeneration, cystic fibrosis, HIV infection, cachexia, or starvation.
Symptoms. Symptoms of paracetamol overdose during the first 24 hours are pallor, nausea, vomiting, aversion to food and abdominal pain. Liver damage may occur 12–48 hours after overdose, manifested by abnormal liver function tests. Glucose metabolism disorders and metabolic acidosis may occur. In severe poisoning, liver failure may progress to encephalopathy, hemorrhage, hypoglycemia, coma and be fatal. Acute renal failure with acute tubular necrosis may present with severe back pain, hematuria, proteinuria and may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have also been reported.
Treatment. Paracetamol overdose requires immediate medical attention. The patient should be taken to hospital for medical examination immediately, even if there are no early symptoms of overdose. Symptoms may be limited to nausea and vomiting and may not reflect the severity of the overdose or the risk of organ damage. Treatment should be carried out in accordance with established recommendations.
Treatment with activated charcoal should be considered within 1 hour of ingestion of an overdose of paracetamol. Plasma paracetamol concentrations should be measured 4 hours or later after ingestion (earlier concentrations are unreliable).
Treatment with N-acetylcysteine can be given within 24 hours of paracetamol ingestion, but the maximum protective effect is obtained when it is administered within 8 hours of taking an overdose of the drug. The effectiveness of the antidote decreases sharply after this time.
If necessary, the patient should be given intravenous N-acetylcysteine according to current guidelines. In the absence of vomiting, oral methionine may be used as a suitable alternative in remote areas outside the hospital.
Patients who develop severe liver dysfunction within 24 hours of taking paracetamol should be treated according to current guidelines.
Symptoms. Most patients who have taken clinically significant amounts of NSAIDs may experience only nausea, vomiting, epigastric pain or, very rarely, diarrhea. Tinnitus, headache and gastrointestinal bleeding may also occur. In more severe poisoning, toxic lesions of the central nervous system may occur in the form of drowsiness, sometimes - nervous excitement and disorientation or coma. In other cases, patients have convulsions. In severe poisoning, metabolic acidosis may occur; the prothrombin index/international normalized ratio (INR) may be elevated, probably due to effects on blood clotting factors. Acute renal failure and liver damage may occur in the presence of dehydration. Patients with bronchial asthma may experience an exacerbation of the disease.
Treatment. Treatment should be symptomatic and supportive, and include maintaining a patent airway and monitoring cardiac symptoms and vital signs until the condition returns to normal. Oral administration of activated charcoal is recommended within 1 hour of ingestion of a potentially toxic amount. Diazepam or lorazepam should be administered intravenously for frequent or prolonged seizures. Bronchodilators should be used for the treatment of bronchial asthma.
Side effects
During clinical trials of the drug, no other adverse reactions were identified than those observed when ibuprofen or paracetamol were used separately.
The following are adverse reactions observed in patients who used ibuprofen or paracetamol alone during short-term and long-term use.
The following classification was used to assess the frequency of adverse reactions: very common (≥ 1/10), common (≥ 1/100 - < 1/10), uncommon (≥ 1/1000 - < 1/100), rare (≥ 1/10000 - < 1/1000), frequency unknown (frequency cannot be estimated from the available data).
Blood and lymphatic system disorders: Rare: haematopoietic disorders (agranulocytosis, anaemia, aplastic anaemia, haemolytic anaemia, leukopenia, neutropenia, pancytopenia and thrombocytopenia). The first signs are: fever, sore throat, mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding, bruising and nosebleeds.
Immune system disorders Uncommon: hypersensitivity reactions including urticaria and pruritus; rare: severe hypersensitivity reactions. Symptoms may include swelling of the face, tongue and larynx, dyspnoea, tachycardia and hypotension (anaphylaxis, angioedema or severe shock). Hypersensitivity reactions may include: non-specific allergic reactions and anaphylaxis, airway reactivity including asthma, exacerbation of asthma, bronchospasm and dyspnoea, various forms of skin reactions including pruritus, urticaria, purpura, angioedema and, less commonly, exfoliative and bullous dermatoses including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme.
Psychiatric disorders: Rare: confusion, depression and hallucinations.
Nervous system disorders: Uncommon: headache, dizziness; rare: paresthesia, optic neuritis and drowsiness, aseptic meningitis, some symptoms of which (rigidity of the occipital muscles, headache, nausea, vomiting, fever or disorientation) may occur in patients with autoimmune diseases such as systemic lupus erythematosus, mixed connective tissue disease.
On the part of the organs of vision. Rare: visual impairment.
From the side of the organs of hearing and vestibular apparatus. Rare: tinnitus and dizziness.
Cardiac system: Rare: heart failure, edema.
Clinical trial data and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg per day), and for long periods of time, may be associated with an increased incidence of arterial thrombotic complications (e.g. myocardial infarction or stroke).
Vascular disorders: Rare: arterial hypertension.
Respiratory, thoracic and mediastinal disorders: Rare: airway reactivity including: bronchial asthma, exacerbation, bronchospasm and dyspnoea. See also immune system adverse reactions above.
Gastrointestinal: Gastrointestinal adverse reactions were most frequently observed. Common: abdominal pain, vomiting, diarrhea, nausea, dyspepsia, stomach discomfort; uncommon: peptic ulcer, gastrointestinal perforation or gastrointestinal bleeding, melena, haematemesis (sometimes fatal, especially in elderly patients), ulcerative stomatitis, exacerbation of colitis and Crohn's disease, gastritis, pancreatitis, flatulence, constipation.
Skin and subcutaneous tissue disorders: Common: hyperhidrosis; uncommon: skin rash (see also immune system adverse reactions above); rare: bullous reactions including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis (see also immune system adverse reactions above), exfoliative dermatitis, purpura, photosensitivity; frequency unknown: drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), photosensitivity reactions.
Renal and urinary disorders: Rare: nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome and acute and chronic renal failure, acute renal failure, especially with prolonged use of NSAIDs, in combination with increased serum urea and edema. Papillonecrosis.
General disorders and administration site conditions: Rare: fatigue and malaise.
Laboratory investigations: Common: increased alanine aminotransferase, increased gamma-glutamyltransferase and liver function tests abnormal, increased blood creatinine, increased blood urea; uncommon: increased aspartate aminotransferase, increased blood alkaline phosphatase, increased blood creatine phosphokinase, decreased haemoglobin and increased platelets.
Expiration date
3 years.
Storage conditions
No special storage conditions are required. Keep out of the reach of children.
Packaging
6, 8 or 10 tablets in a blister; 1 blister of 6 tablets or 2 blisters of 8 tablets or 1 or 2 blisters of 10 tablets in a cardboard box.
Vacation category
Without a prescription.
Producer
Lek Pharmaceutical Company Ltd.
Rontis Hellas Medical and Pharmaceutical Products S.A.
Location of the manufacturer and address of its place of business.
Verovškova 57, Ljubljana 1526, Slovenia.
P.O. Box 3012 Larissa Industrial Area, Larissa, 41500, Greece
