Name:
Voltaren retard. Forms of release Tablets. MNNDiclofenac FTGNpvp. Active ingredient: diclofenac sodium; Each tablet contains diclofenac sodium 75 mg; excipients: tablet core – magnesium stearate, anhydrous colloidal silicon dioxide, povidone, cetyl alcohol, sucrose; tablet coating – hypromellose, red iron oxide (E 172), polysorbate 80, talc, titanium dioxide (E 171), macrogol 8000, sucrose, black ink (shellac, isopropyl alcohol, black iron oxide E172, butyl alcohol, propylene glycol, ammonium hydroxide ). Pharmacotherapeutic groupNon-steroidal anti-inflammatory and antirheumatic drugs. Derivatives of acetic acid. ATC code M01A B05. Clinical characteristics Indications for use Inflammatory and degenerative rheumatic diseases: rheumatoid arthritis, ankylosing spondylitis; arthrosis; extra-articular rheumatism. Pain and inflammation of non-rheumatic or post-traumatic origin. Symptomatic treatment of primary dysmenorrhea. Contraindications Known hypersensitivity to the active substance or other components of the drug, to other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs) and, in particular, to acetylsalicylic acid; Active stomach or intestinal ulcer, bleeding or perforation. Inflammatory bowel disease (such as Crohn’s disease or ulcerative colitis); last trimester of pregnancy; Liver failure; Renal failure, (GFR < 15 ml/min/1.73m2); Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease, or cerebrovascular disease; Treatment of postoperative pain after coronary artery bypass grafting (or using a heart-lung machine); Like other NSAIDs, Voltaren Retard is contraindicated in patients in whom the use of acetylsalicylic acid or other NSAIDs provokes attacks of bronchial asthma, angioedema, urticaria or acute rhinitis (i.e. cross-reactivity reactions caused by NSAIDs). Dosage and administration Tablets should be taken whole, without chewing or breaking, washing down with liquid, preferably during meals. The dose should be selected individually. Side effects can be minimized by using the lowest effective dose for the shortest period necessary to control symptoms (see Precautions). The recommended initial dose of the drug for adults is 75-150 mg per day (1-2 tablets of Voltaren Retard 75 mg), depending on the severity of the symptoms of the disease. With long-term therapy, as a rule, the use of 1 tablet of Voltaren Retard 75 mg per day is sufficient. If the symptoms of the disease are most pronounced at night or in the morning, Voltaren Retard must be taken in the evening. Use in special groups of patients. Children (under 18 years of age) Voltaren retard extended-release film-coated tablets 75 mg are not recommended for use in children due to the high content of the active substance. Elderly patients (65 years and older). Elderly patients usually do not require adjustment of the starting dose. However, based on generally accepted approaches, caution is required when prescribing the drug, especially in debilitated or low-weight elderly patients. Patients with congestive heart failure (NYHA-I) or significant cardiovascular risk factors In patients with congestive heart failure (NYHA-I) or uncontrolled hypertension, therapy with Voltaren is generally not recommended. If necessary, the drug is prescribed to patients with cardiovascular diseases or with significant risk factors for their development only after a thorough assessment, and with a duration of therapy of more than 4 weeks - only at doses < 100 mg per day (see Precautions). Patients with impaired renal function. Voltaren Retard is contraindicated in patients with renal insufficiency (GFR < 15 ml/min/1.73 m2) (see Contraindications). Since special studies have not been conducted in patients with impaired renal function, specific recommendations for dose adjustment cannot be made. Caution is advised when using Voltaren Retard in patients with impaired renal function (see Precautions). Patients with impaired liver function. Voltaren Retard is contraindicated in patients with hepatic impairment (see Contraindications). Since special studies have not been conducted in patients with impaired liver function, specific recommendations for dose adjustment cannot be made. Caution is advised when using Voltaren Retard in patients with mild to moderate hepatic impairment (see Precautions). Side effects Adverse reactions to the drug, depending on the frequency, are described in the following order: very often (> 1/10); often (> 1/100, < 1/10); infrequently (> 1/1000, < 1/100); rarely (> 1/10000, < 1/1000); very rarely (< 1/10000). From the gastrointestinal tract. Often: nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, loss of appetite. Rare: gastritis, gastrointestinal bleeding, hematemesis, hemorrhagic diarrhea, melena, gastrointestinal ulcer (with or without bleeding or perforation, gastrointestinal stenosis or perforation, which may lead to peritonitis). Very rarely: colitis (including hemorrhagic colitis, ischemic colitis or exacerbation of ulcerative colitis, or Crohn's disease), constipation, stomatitis, glossitis, diseases of the esophagus, diaphragmatic narrowing of the intestine, pancreatitis. Voltaren Retard can cause chronic inflammatory conditions in the lower intestines (in the small and large intestines) with the formation of pseudomembranes and strictures. From the side of the nervous system. Often: headache, dizziness. Rare: drowsiness. Very rarely: paresthesia, memory disorders, convulsions, anxiety, tremor, aseptic meningitis, taste disturbance, cerebrovascular accident. From the side of the cardiovascular system, infrequently * - myocardial infarction, heart failure, palpitations, chest pain; very rarely - arterial hypertension, vasculitis; frequency unknown - Kounis syndrome. On the part of the organ of vision: Very rarely: visual disturbances, blurred vision, diplopia. On the part of the organ of hearing and labyrinth: Often: vertigo. Very rare: tinnitus, hearing impairment. From the skin and subcutaneous tissues. Often: skin rashes. Rare: urticaria. Very rare: bullous dermatitis, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, alopecia, photosensitivity reaction, purpura, Henoch-Schonlein purpura, pruritus. From the side of the kidneys and urinary tract. Often: fluid retention, edema and arterial hypertension. Very rare: acute kidney injury (acute renal failure), hematuria, proteinuria, nephrotic syndrome, tubulointerstitial nephritis, renal papillary necrosis. From the hepatobiliary system. Common: Elevated serum transaminases. Rare: hepatitis, jaundice, liver dysfunction. Very rare: fulminant hepatitis, hepatonecrosis, liver failure. From the circulatory and lymphatic systems. Very rarely: thrombocytopenia, leukopenia, anemia (including hemolytic and aplastic anemia), agranulocytosis. From the respiratory system. Rare: bronchial asthma (including shortness of breath). Very rare: pneumonitis. From the immune system. Rarely: hypersensitivity, anaphylactic and anaphylactoid reactions (including arterial hypotension and shock). Very rare: angioedema (including swelling of the face). Mental disorders. Very rare: confusion, depression, insomnia, nightmares, irritability, psychotic disorders. Clinical studies and epidemiological data suggest that the use of diclofenac, especially at high doses (150 mg per day) and over a long period, may be associated with a slight increase in the risk of serious cardiovascular events of thrombosis (including myocardial infarction and stroke). General disorders. Rare: edema. *Frequency reflects data from long-term therapy using a high dose (150 mg per day).
Description:
of individual side effects. Arteriothrombotic events Clinical studies and data from epidemiological studies indicate that the use of diclofenac increases the risk of thrombotic complications (eg, myocardial infarction or stroke), especially with long-term use or at high doses (150 mg per day). Visual disturbances Visual impairment, blurred vision, or double vision are common side effects of the NSAID class and are usually reversible upon discontinuation. A possible mechanism of occurrence is inhibition of the synthesis of prostaglandins and other compounds that disrupt the regulation of retinal blood flow, causing possible visual disturbances. If such disorders occur during treatment with diclofenac, an ophthalmological examination should be performed to exclude other possible causes of their occurrence. Overdose There is no typical clinical picture of diclofenac overdose. Symptoms of an overdose of diclofenac may include vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, convulsions. In case of significant poisoning, acute renal failure and liver damage are possible. Treatment of acute poisoning with NSAIDs consists of the use of supportive and symptomatic therapy. Supportive and symptomatic treatment is indicated for complications such as hypotension, renal failure, convulsions, gastrointestinal disorders and respiratory depression. It is unlikely that specific therapeutic measures such as forced diuresis, dialysis, or hemoperfusion will be useful in eliminating NSAIDs, since the active substances of these drugs are largely bound to blood proteins and are extensively metabolized. Possible use of activated charcoal after a potentially toxic overdose, as well as gastric decontamination (eg, vomiting, gastric lavage) after a potentially life-threatening overdose. Women of childbearing age, pregnancy, breastfeeding, fertility There are no data to support any recommendations for women of childbearing age. Suppression of prostaglandin synthesis can adversely affect the course of pregnancy and intrauterine development of the fetus. Data from epidemiological studies suggest an increased risk of miscarriage and / or development of heart defects and gastroschisis in the fetus after taking prostaglandin synthesis inhibitors in early pregnancy, but the generalized data are inconclusive. The absolute risk of cardiovascular disease increased from less than 1% to 1.5%. It is believed that the risk increases with increasing dose and duration of therapy. It has been shown that the administration of prostaglandin synthesis inhibitors in animals leads to disruption of embryo implantation. In addition, in animals treated with a prostaglandin synthesis inhibitor during organogenesis, the incidence of various malformations, including developmental disorders of the cardiovascular system, increased. The use of diclofenac in pregnant women has not been studied. Therefore, Voltaren Retard should not be given during the first two trimesters of pregnancy unless the benefits outweigh the risks to the fetus. As with other NSAIDs, the use of the drug during the third trimester of pregnancy is contraindicated. When taking inhibitors of prostaglandin synthesis in the third trimester of pregnancy in the fetus, the following are possible: premature closure of the arterial duct and pulmonary hypertension, renal dysfunction, the progression of which develops renal failure with oligohydroamnion. When taking diclofenac at the end of pregnancy, it is possible to develop weakness in labor and increase the duration of labor. In the mother and fetus / newborn, bleeding time may be prolonged, and an antiplatelet effect may occur even after taking very low doses of diclofenac. Thus, diclofenac is contraindicated in the third trimester of pregnancy. Like other NSAIDs, diclofenac is excreted in breast milk in small amounts. Thus, Voltaren Retard should not be used during breastfeeding to prevent adverse reactions in the child. Like other NSAIDs, Voltaren Retard can adversely affect female fertility, so it is not recommended to prescribe the drug to women planning a pregnancy. In women who have difficulty conceiving or are undergoing evaluation for infertility, discontinuation of the drug should be considered. Children Voltaren Retard is not recommended for the treatment of children aged 14-18 years due to the high content of the active substance in the tablet. The drug is contraindicated in children under 14 years of age. Precautions Gastrointestinal effects Gastrointestinal bleeding, ulcers and perforations are possible with all NSAIDs, which can be fatal and occur during treatment with or without a history of warning symptoms or serious gastrointestinal disturbances. In general, such phenomena are most dangerous for elderly patients. In some cases, when these complications develop in patients taking Voltaren Retard, treatment with this drug should be discontinued. While taking the drug Voltaren Retard, medical supervision is necessary for patients who have diseases of the gastrointestinal tract or a history of ulcerative lesions of the stomach or intestines, ulcerative colitis or Crohn's disease. The risk of gastrointestinal bleeding increases with increasing dose of NSAIDs, and in patients with a history of ulcers, especially if the ulcer was complicated by bleeding or perforation, or occurred in the elderly. To reduce the risk of toxic effects on the gastrointestinal tract in patients with a history of peptic ulcer, in particular, complicated by bleeding and perforation, as well as in elderly patients, treatment should be started with the lowest effective dose and adhere to it in the future. In the above patients and patients requiring concomitant use of low doses of acetylsalicylic acid or other drugs that may increase the risk of adverse reactions from the gastrointestinal tract, combination therapy in combination with protective drugs (for example, proton pump inhibitors or misoprostol) should be considered. . Caution is advised in patients receiving concomitant therapy with systemic corticosteroids, anticoagulants, antiplatelet agents, or selective serotonin reuptake inhibitors. Cardiovascular effects Clinical studies and epidemiological data strongly suggest an increased risk of arterial thrombotic events (eg, myocardial infarction or stroke) that may be associated with the use of diclofenac, in particular when used at high doses (150 mg per day) and with prolonged use. Patients with significant risk factors for cardiovascular events (eg, hypertension, hyperlipidemia, diabetes mellitus, smoking) should only be given diclofenac after careful consideration. Due to the possible increased risk of cardiovascular events with long-term use or at a high dose of the drug, patients should be prescribed diclofenac at the lowest effective dose and take it for the shortest possible time necessary to reduce the severity of symptoms. The need for symptomatic relief and response to treatment should be re-evaluated periodically. In patients with congestive heart failure (NYHA-I) or significant risk factors for the development of cardiovascular events (eg, arterial hypertension, hyperlipidemia, diabetes mellitus, smoking), diclofenac should only be used after careful evaluation, and with a duration of therapy of more than 4 weeks - only at doses <100 mg per day. Patients should be alert for signs and symptoms of severe arteriothrombotic events (eg, chest pain, dyspnoea, weakness, slurred speech), which may occur suddenly. Patients should be instructed to seek immediate medical attention in such cases. Hematological effects With long-term use of Voltaren Retard, it is recommended, as with long-term use of other NSAIDs, to monitor blood counts. Voltaren Retard, like other NSAIDs, may temporarily inhibit platelet aggregation. Therefore, patients with impaired hemostasis require careful monitoring. Respiratory effects In patients with asthma, allergic rhinitis, swelling of the nasal mucosa (nasal polyps), chronic obstructive airway disease (especially if associated with rhinitis-like allergic symptoms), reactions to NSAIDs such as asthma provocation, angioedema or urticaria occur more often. Therefore, such patients are advised to exercise caution (preparedness for an emergency). This also applies to patients who are allergic to other substances, eg skin reactions, itching or urticaria. Hepatobiliary effects Careful monitoring is necessary when prescribing Voltaren Retard to patients with impaired liver function, as their condition may worsen. While taking the drug, as well as during treatment with other NSAIDs, the level of one or more liver enzymes may increase. Therefore, during long-term therapy with Voltaren Retard, a regular study of liver function is indicated as a precautionary measure. If liver function abnormalities persist or worsen, or if complaints or symptoms suggestive of liver disease develop, or if other side effects occur (eg, eosinophilia, rash, etc.), Voltaren Retard should be cancel. In addition to elevated liver enzymes, rare cases of severe hepatic reactions have been reported, including jaundice and, in very rare cases, fulminant hepatitis, hepatic necrosis and liver failure, in some cases fatal. It must be borne in mind that hepatitis while taking the drug can occur without prodromal phenomena. Caution is necessary when prescribing Voltaren Retard to patients with hepatic porphyria, as the drug can provoke attacks of porphyria. Skin reactions Severe, even fatal, skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been very rarely reported with NSAIDs, including Voltaren Retard (see Adverse Reactions). The highest risk of these reactions exists at the beginning of therapy, and the development of these reactions is noted in most cases in the first month of treatment. Voltaren Retard should be discontinued at the first appearance of skin rash, mucosal ulcers, or any other sign of hypersensitivity. In patients who have not previously taken Voltaren Retard, during the period of treatment with the drug, as well as during therapy with other NSAIDs, in rare cases, allergic reactions, including anaphylactic and anaphylactoid reactions, may develop. Renal effects NSAID therapy, including Voltaren Retard, may be associated with fluid retention or edema. Particular care is required in the treatment of patients with impaired cardiac or renal function, elderly patients, patients receiving diuretics, as well as patients who have a significant decrease in circulating plasma volume of any etiology, for example, before and after massive surgical interventions. In such cases, regular monitoring of renal function is recommended as a precautionary measure while taking Voltaren Retard. After discontinuation of the drug, kidney function usually returns to baseline. Elderly patients The drug should be used with caution in elderly patients, debilitated elderly patients and patients with low body weight. Interaction with NSAIDs It is necessary to avoid the simultaneous use of Voltaren Retard and other NSAIDs, including cyclooxygenase-2 inhibitors, to reduce the risk of additional side effects (see Interaction with other medicinal products and other forms of interaction). Masking of infection Voltaren Retard may mask the symptoms characteristic of infectious and inflammatory diseases. Excipients Voltaren retard contains sucrose, so it is not recommended in patients with rare hereditary conditions of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency. Influence on the ability to drive vehicles and control mechanisms Patients who experience dizziness or other unpleasant sensations from the central nervous system, including visual impairment, while taking Voltaren Retard, are not recommended to drive a car or operate mechanisms. Interaction with other drugs Caution is advised when co-administering Voltaren Retard with CYP2C9 inhibitors (such as voriconazole), which can lead to a significant increase in peak plasma concentration and exposure of diclofenac. Voltaren Retard may increase plasma concentrations of lithium and digoxin. It is recommended to monitor the levels of lithium and digoxin in the blood serum. Voltaren Retard, as well as other NSAIDs, may inhibit the activity of diuretics or antihypertensive drugs (eg, beta-blockers, angiotensin-converting enzyme (ACE) inhibitors). Therefore, the combination should be used with caution, and the blood pressure of patients, especially the elderly, should be monitored periodically. Patients should be adequately hydrated and monitoring of renal function after initiation of concomitant therapy and on a regular basis thereafter is recommended, especially in the case of diuretics and ACE inhibitors due to an increased risk of nephrotoxicity. The simultaneous use of potassium-sparing diuretics, cyclosporine, tacrolimus or trimethoprim can lead to an increase in the level of potassium in the blood serum (this indicator should be regularly monitored). Simultaneous use with other systemic NSAIDs or corticosteroids may increase the frequency of adverse reactions of Voltaren Retard from the gastrointestinal tract. Co-administration of systemic NSAIDs and SSRIs may increase the risk of bleeding in the digestive tract. Although clinical studies have not established the effect of Voltaren Retard on the action of anticoagulants, there are separate reports of an increased risk of bleeding in patients who took both Voltaren Retard and anticoagulants. Therefore, such patients are recommended to be closely monitored. In clinical studies, it has been established that Voltaren Retard can be used in conjunction with oral antidiabetic agents, and does not change their therapeutic effect. However, there are separate reports of the development in such cases of both hypoglycemia and hyperglycemia, which caused changes in the dose of hypoglycemic drugs during the use of Voltaren Retard. For this reason, blood glucose monitoring is recommended as a precautionary measure during concomitant therapy. Caution should be exercised when prescribing NSAIDs less than 24 hours before or after taking methotrexate, since in such cases the concentration of methotrexate in the blood may increase and its toxic effect may increase. The effect of NSAIDs, including Voltaren Retard, on the synthesis of prostaglandins in the kidneys may increase the nephrotoxicity of cyclosporine. In this regard, Voltaren Retard should be used at lower doses than in patients who do not receive cyclosporine. When phenytoin is co-administered with Voltaren Retard, it is recommended to monitor plasma concentrations of phenytoin due to a possible increase in phenytoin exposure. Colestipol and cholestyramine may delay or decrease the absorption of diclofenac. It is recommended to take diclofenac at least one hour before or 4-6 hours after colestipol/cholestyramine. There are separate reports of the development of seizures in patients receiving both quinolone derivatives and NSAIDs. Pharmacological properties Pharmacodynamics. Diclofenac - the active substance of Voltaren Retard, is a non-steroidal compound with a pronounced antirheumatic, anti-inflammatory, analgesic and antipyretic effect. The main mechanism of action of diclofenac, established in the experimental conditions, is the inhibition of prostaglandin biosynthesis. Prostaglandins play an important role in the genesis of inflammation, pain and fever. In vitro, diclofenac sodium at concentrations equivalent to those achieved in the treatment of patients does not inhibit the biosynthesis of cartilage proteoglycans. Voltaren Retard is suitable for patients in whom a daily dose of 75 mg is appropriate, taking into account the clinical picture. The possibility of prescribing the drug, suggesting the possibility of a single application of the entire daily dose, greatly simplifies long-term treatment and helps to avoid possible errors in dosage. Voltaren Retard allows the use of a maximum daily dose of 150 mg as a balanced regimen twice a day. In rheumatic diseases, the anti-inflammatory and analgesic properties of Voltaren Retard provide a significant reduction in the severity of pain (both at rest and during movement), morning stiffness, joint swelling and, thus, an improvement in the functional state of the patient. In the presence of inflammation caused by trauma or surgery, Voltaren Retard quickly eliminates both spontaneous pain and pain on movement, and also reduces inflammatory tissue swelling and swelling at the site of a surgical wound. In clinical studies, it was found that Voltaren Retard also exhibits a strong analgesic effect with moderate and severe pain of non-rheumatic origin. Pharmacokinetics. Analysis of urinary excreted unchanged diclofenac and its hydroxylated metabolites showed that the amount of released and absorbed diclofenac is the same as in the case of an equivalent dose of diclofenac sodium in the form of enteric-coated tablets. However, the systemic bioavailability of diclofenac (released from Voltaren Retard) is, on average, 82% of the corresponding value after ingestion of Voltaren's enteric tablet at the same dose. Due to the prolonged release of the active substance from Voltaren Retard, the maximum concentrations of the drug that are achieved in plasma are lower than after taking enteric-coated tablets. The average peak concentration of 0.4 μg / ml or 0.5 μg / ml (1.25 or 1.6 μmol / l) is reached, on average, 4 hours after taking a 75 mg or 100 mg tablet. Food intake does not clinically affect the absorption and systemic bioavailability of Voltaren Retard. On the other hand, an average plasma concentration of 13 ng / ml (40 nmol / l) can be observed 24 hours (16 hours) after taking Voltaren Retard 75 mg. The amount of absorbed active substance is linearly dependent on the dose of the drug. Since about half of diclofenac is metabolized during the first passage through the liver ("first pass effect"), the area under the concentration-time curve (AUC) after taking a Voltaren Retard tablet is almost two times less than in the case of parenteral administration of an equivalent dose of the drug. After repeated administration of Voltaren Retard, pharmacokinetic indicators do not change. At observance of the recommended intervals between receptions of separate doses of drug, cumulation is not noted. The corresponding concentrations are 22 ng / ml or 25 ng / ml (70 nmol / l or 80 nmol / l) when taking Voltaren Retard 75 mg 2 times a day. Pharmacokinetic behavior does not change after repeated use. No accumulation occurs provided that the recommended intervals between applications are observed. Distribution. 99.7% of diclofenac binds to serum proteins, mainly to albumin (99.4%). The volume of distribution is 0.12-0.17 l/kg. Diclofenac penetrates into the synovial fluid, where its maximum concentration is reached 2-4 hours later than in plasma. The apparent half-life from the synovial fluid is 3-6 hours. 2 hours after reaching maximum plasma concentrations, the concentration of the active substance in the synovial fluid is higher than in plasma, and remains higher for 12 hours. Diclofenac was found at low concentration (100 ng/mL) in the breast milk of one breastfeeding woman. The amount consumed by an infant with breast milk is equivalent to a dose of 0.03 mg/kg/day. Biotransformation. The biotransformation of diclofenac is carried out partly by glucuronization of the unchanged molecule, but mainly through single and multiple hydroxylation and methoxylation, which leads to the formation of several phenolic metabolites (3'-hydroxy-, 4'-hydroxy-, 5'-hydroxy, 4', 5-dihydroxy- and 3'-hydroxy-4'-methoxydiclofenac), most of which are conjugated with glucuronic acid. Two of these phenolic metabolites are pharmacologically active, but to a much lesser extent than diclofenac. Withdrawal. The total systemic plasma clearance of diclofenac is 263 ± 56 ml/min. The terminal half-life in plasma is 1-2 hours. The half-life of 4 metabolites, including 2 pharmacologically active ones, is also short and is 1-3 hours. One of the metabolites, 3'-hydroxy-4'-methoxydiclofenac, has a longer half-life. However, this metabolite is completely pharmacologically inactive. About 60% of the applied dose of the drug is excreted in the urine in the form of glucuronic conjugates of the intact molecule of the active substance, as well as in the form of metabolites, most of which are also converted into glucuronic conjugates. Less than 1% of diclofenac is excreted unchanged. The rest of the applied dose of the drug is excreted as metabolites through the bile, with feces. Linearity. The amount absorbed is linearly related to dosage. Special groups of patents. No age-related differences in drug absorption, metabolism or excretion have been identified. However, in several elderly patients, a 15-minute intravenous infusion resulted in plasma concentrations 50% higher than expected based on data from young healthy subjects. In patients with impaired renal function, no accumulation of unchanged active substance was detected based on single-dose kinetics using the usual regimen. When creatinine clearance is less than 10 ml/min, the calculated equilibrium levels of hydroxymetabolites in blood plasma are approximately 4 times higher than in healthy individuals. Metabolites are finally excreted in the bile. In patients with chronic hepatitis or undecompensated cirrhosis, the kinetics and metabolism of diclofenac are the same as in patients without liver disease. Pharmaceutical characteristics Basic physical and chemical properties: pale pink, triangular-shaped, biconvex tablets with beveled edges, with the inscription “ID” on one side and “CG” - on the other - in black ink. Shelf life 3 years. Do not use after the expiry date stated on the packaging. Storage conditionsStore at a temperature not exceeding 30°C, in the original packaging to protect against moisture. Keep out of the reach of children. Packing: 10 tablets in a blister, 2 blisters in a carton box with leaflet. Terms of dispensing from pharmaciesBy prescription. Buy Voltaren retard tablets p/o prolonged action 75mg №10x2
Voltaren retard pills p / o prolonged action 75mg №10×2
$32.00
SKU: 52354
Category: Medicines for pain and inflammation
INN | DICLOFENAC |
---|---|
The code | 52 354 |
Barcode | 7 612 797 498 620 |
Dosage | 75mg |
Active substance | Diclofenac |
Manufacturer | Novartis Pharma S.p.A., Italy |
Importer | "VitPharmMarket" LLC Vitebsk, Republic of Belarus, 210004 Vitebsk, 5th Kooperativnaya st., 8; LLC "Iskamed", Republic of Belarus, 220036, Minsk, K. Liebknekhta st., 70, office 6; ODO "TISHAS", Minsk, 220028 Belarus, Minsk, Mayakovsky st., 144, room 7; [x] ALC "Dominantafarm", Minsk, 220140 Minsk, Dombrovskaya str., 15, room 10a, room 10a-41; [x] SZAO "Medvaks", Minsk, Republic of Belarus, 220002, Minsk, st. V. Khoruzhey, 31 letter A 1/K, VSTR, 1st floor. |
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