Nalgezin Forte tablets p/o 550mg №10×1

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Nalgezin Forte tabl. pplen. vol., 550 mg in a blister. in pack. No. 10×1
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Film-coated tablets are blue, oval, slightly biconvex, with a notch on one side. The main active ingredient Naproxen Release form tab., pokr. film coated, 550 mg: 10 or 20 pcs. Dosage 550 mg Precautions Side effects can be minimized by using the lowest effective dose for the shortest amount of time needed to relieve symptoms. Patients with gastrointestinal diseases, especially ulcerative colitis or Crohn’s disease (including history), taking naproxen sodium should be under close supervision of the attending physician, because. the disease may recur or worsen. Serious adverse reactions from the gastrointestinal tract can occur without any previous diseases. As with other NSAIDs, the overall incidence of serious adverse reactions, gastrointestinal bleeding or perforation increases linearly with treatment duration. High doses of naproxen sodium are also likely to increase the risk of adverse effects. The anti-inflammatory and antipyretic effects of naproxen sodium should be taken into account in infectious diseases, since the drug may mask the signs of these diseases. Since naproxen sodium and its metabolites are excreted primarily through the kidneys by glomerular filtration, the drug should be used with great caution in patients with renal insufficiency. In patients with renal insufficiency, CC should be determined and then monitored during treatment. If the CC is less than 30 ml / min (0.33 ml / s), the use of naproxen sodium is not recommended. Caution should be exercised in patients with hepatic impairment. In chronic alcoholic liver disease and possibly also in other forms of cirrhosis, the total plasma concentration of naproxen sodium decreases, while the concentration of unbound naproxen sodium in plasma increases. The lowest effective dose is recommended. The risk of gastric bleeding may be higher when taking the drug with alcohol. Patients with epilepsy or porphyria taking naproxen sodium should be under close medical supervision. Gastrointestinal disorders In elderly patients, the frequency of adverse reactions when taking NSAIDs is higher, especially the frequency of gastrointestinal bleeding and perforation, which can be fatal. Gastrointestinal bleeding, ulceration, or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a history of serious GI reactions. The risk of bleeding, ulceration or perforation of the gastrointestinal tract is higher with an increase in the dose of NSAIDs in patients with a history of ulcer, especially if it is complicated by bleeding or perforation, and in the elderly. In such patients, treatment should be initiated at the lowest dose. For patients with a history of ulcers and elderly patients, and for patients who require concomitant use of low-dose acetylsalicylic acid or other drugs that increase the risk of gastrointestinal events, combination therapy with protective drugs (eg, misoprostol or inhibitors) should be considered. proton pump). Patients with a history of symptoms of gastrointestinal toxicity, especially the elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), especially in the initial stages of treatment. Caution should be exercised in patients receiving concomitant drugs that increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants (eg, warfarin), selective serotonin reuptake inhibitors, or antiplatelet drugs (eg, acetylsalicylic acid). If gastrointestinal bleeding or ulceration occurs in patients taking Nalgesin® Forte, treatment should be discontinued. Patients with gastrointestinal diseases (ulcerative colitis, Crohn’s disease) should be careful when taking NSAIDs, as their condition may worsen. Effects from the cardiovascular system Patients with arterial hypertension and / or heart failure in history should be careful, because. there have been reports of fluid retention or edema when taking NSAIDs. Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at high doses and with long-term treatment) may cause a slight increase in the risk of arterial thrombosis (myocardial infarction or stroke). Although data suggest that the use of naproxen (1000 mg/day) may be associated with only a minor risk, this risk cannot be ruled out. Naproxen sodium should be carefully considered in patients with uncontrolled hypertension, congestive heart failure, established coronary artery disease, peripheral arterial disease, and/or cerebrovascular disease. At the beginning of long-term treatment, special attention should be paid to patients with risk factors for cardiovascular disease (eg, hypertension, hyperlipidemia, diabetes mellitus, smoking). As with other drugs, naproxen sodium should be used at the lowest effective dose in elderly patients. Naproxen sodium should be avoided on extensive wound injuries and at least 48 hours before major surgery. Skin and subcutaneous tissue effects The use of NSAIDs can very rarely be associated with serious skin side effects such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, which can be fatal. Patients are likely to be most at risk for these reactions at the start of therapy – reactions that occur in most cases within the first month of treatment. The drug should be discontinued at the first appearance of a skin rash, damage to the mucous membranes or any other sign of hypersensitivity. Renal failure NSAIDs that inhibit vasodilating prostaglandins can lead to kidney failure due to a decrease in GFR. This side effect is dose dependent. At the beginning of treatment or after increasing the dose, diuresis and renal function should be monitored in patients with the following risk factors: advanced age; the simultaneous use of drugs such as ACE inhibitors, angiotensin II receptor antagonists, diuretics; hypovolemia, regardless of the cause; heart failure; chronic renal failure; nephrotic syndrome; lupus nephritis; decompensated cirrhosis of the liver. Fluid and sodium retention Possible fluid and sodium retention with the possible occurrence of edema, hypertension or worsening of pre-existing hypertension, exacerbation of heart failure. It is necessary to carefully monitor the patient’s condition at the beginning of treatment in case of hypertension or heart failure. May reduce the antihypertensive effect of drugs. Hyperkalemia Possible hyperkalemia provoked by diabetes or the simultaneous use of potassium-containing drugs. In such cases, regular monitoring of the concentration of potassium in the blood serum should be carried out. Other effects Naproxen inhibits platelet aggregation and may prolong bleeding time in patients. This should be taken into account when determining bleeding time. When taking naproxen, patients who are prone to increased bleeding or taking drugs that affect hemostasis should be carefully monitored. Rare cases of ophthalmic side effects have been reported. An ophthalmological examination is recommended, if deemed necessary by the physician, for patients who have visual impairment while taking naproxen. With long-term treatment, systematic monitoring of liver and kidney function, peripheral blood patterns is necessary. Excipients 1 tablet of Nalgezin® Forte contains 2.18 mmol (50.16 mg) of sodium, which should be taken into account in patients on a sodium-restricted diet. Use in pediatrics The drug is not recommended for children and adolescents under the age of 16 years. Influence on the ability to drive vehicles and control mechanisms Nalgezin® Forte does not affect the ability to drive a car and work with mechanisms. In the event of the development of adverse reactions from the nervous system, such as dizziness, drowsiness, visual impairment, patients should refrain from driving vehicles or operating mechanisms. Pharmacological action Anti-inflammatory, analgesic. Pharmacodynamics Nalgesin forte is a naproxen drug that has analgesic, antipyretic and anti-inflammatory effects. The mechanism of action is associated with non-selective inhibition of the activity of COX-1, COX-2. Film-coated tablets, Nalgezin forte dissolve well, are rapidly absorbed from the gastrointestinal tract and provide a rapid onset of analgesic effect. Pharmacokinetics Absorption from the gastrointestinal tract is fast and complete, bioavailability is 95% (food intake practically does not affect either completeness or absorption rate). Tmax – 1-2 hours, communication with plasma proteins -> 99%, T1 / 2 – 12-15 hours. Metabolism – in the liver to dimethylnaproxen with the participation of the CYP2C9 enzyme system. Clearance – 0.13 ml / min / kg. 98% is excreted by the kidneys (of which 10% is unchanged), with bile – 0.5–2.5%. Css is determined to receive 4-5 doses of the drug (2-3 days). In renal failure, the accumulation of metabolites is possible. Indications for use In adults and adolescents over 16 years of age: symptomatic long-term treatment of chronic inflammatory diseases of the joints, incl. rheumatoid arthritis, ankylosing spondylitis, Reiter’s syndrome and psoriatic arthritis; symptomatic short-term treatment of acute attacks of extra-articular rheumatism, humeroscapular periarthritis, tendinitis, bursitis, osteoarthritis, pain in the lower back, radiculalgia, pain syndrome with injuries of the musculoskeletal system, acute attack of gout; symptomatic short-term treatment of pain in acute inflammatory processes in the maxillofacial region after assessing the benefit / risk ratio (masking the infectious process and the risk of spreading the infection); symptomatic treatment of dysmenorrhea after establishing its cause. Dosage and administration The drug is taken orally, preferably with meals. The tablet should be swallowed whole, without chewing, with liquid. In order to minimize the risk of developing undesirable effects, the drug should be used in the smallest effective doses for the shortest period of time necessary to relieve symptoms. Do not exceed the recommended dose and duration of use. Adults and adolescents over 16 years old In chronic inflammatory diseases of the joints, the recommended daily dose is 1-2 tab. (550-1100 mg naproxen sodium). Usually the daily dose of the drug is divided into 2 doses. The maintenance dose may be adjusted depending on the patient’s response to treatment. The morning and evening dose need not be the same and should be adjusted according to the predominant symptoms (eg pain at night or stiffness in the morning). In acute diseases of the musculoskeletal system and post-traumatic conditions, the initial recommended dose is 1 tab. (550 mg naproxen sodium), then 0.5 tab. (275 mg naproxen sodium) every 6-8 hours. The maximum daily dose should not exceed 2.5 tab. (1375 mg naproxen sodium). In an acute attack of gout, the initial recommended dose is 1.5 tab. (825 mg naproxen sodium), and then 0.5 tab. (275 mg naproxen sodium) every 8 hours. With dysmenorrhea, the recommended single dose is 1 tab. (550 mg naproxen sodium), and then, if necessary, 0.5 tab. (275 mg naproxen sodium) every 6-8 hours. For the treatment of pain in acute inflammatory processes in the maxillofacial region, it is recommended to take from 0.5 tab. (275 mg naproxen sodium) up to 2 tab. (1100 mg naproxen sodium) per day. Nalgezin® Forte is not recommended for children and adolescents under 16 years of age. Elderly patients are advised to take naproxen sodium at the lowest effective dose. Patients with renal insufficiency should take Nalgesin® Forte with caution. The drug is not recommended for use in patients with moderate or severe renal insufficiency (with CC less than 30 ml / min). Patients with hepatic insufficiency should take Nalgezin® Forte with caution. Use during pregnancy and lactation Pregnancy Inhibition of prostaglandin synthesis may adversely affect pregnancy and / or development of the embryo / fetus. Data from epidemiological studies suggest an increased risk of miscarriage, cardiac malformations and gastroschisis after the use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of developing a cardiovascular malformation was increased from less than 1% to about 1.5%. It is believed that the risk increases with increasing dose and duration of therapy. In animals, the administration of a prostaglandin synthesis inhibitor has been shown to increase the risk of pre- and post-implantation miscarriage and embryo/fetal mortality. In addition, an increase in the incidence of various malformations was observed in animals, incl. cardiovascular, after the introduction of an inhibitor of prostaglandin synthesis in the organogenetic period. Naproxen sodium should not be used in the first and second trimesters of pregnancy unless clearly necessary. If naproxen sodium is used by a woman planning a pregnancy, or in the first or second trimester of pregnancy, the lowest dose and duration of treatment should be set. In the third trimester of pregnancy, all prostaglandin synthesis inhibitors can affect the fetus: cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); renal dysfunction, which may progress to renal failure with oligohydramnios; on mother, newborn, and when taken at the end of pregnancy: possible prolongation of bleeding time, antiplatelet effect, which can occur even at very low doses; inhibition of uterine contractions, leading to a delay or prolonged labor process. Therefore, Nalgezin® Forte is contraindicated in the third trimester of pregnancy. Lactation period During breastfeeding, the use of the drug is not recommended. Fertility Nalgesin® Forte may impair female fertility, therefore, the drug is not recommended for women trying to become pregnant. In women who have difficulty conceiving or whose fertility is being studied, discontinuation of drug treatment should be considered. PrecautionsConsult your doctor before taking Nalgesin® Forte: – if you have or have had in the past diseases of the gastrointestinal tract, your doctor should carefully monitor your condition; special care should be taken in ulcerative colitis and Crohn’s disease, tk. these conditions may recur or worsen. Serious gastrointestinal side effects may occur without any previous illness; possible bleeding and intestinal perforations (holes in the intestinal wall); – if you are being treated for epilepsy or have a very rare disorder of blood pigment metabolism (porphyria); – if you have a blood clotting disorder or if you are simultaneously taking drugs used to prevent blood clotting (anticoagulants, fibrinolytics) (see section “Other drugs and Nalgesin® Forte”); – with extensive fresh wounds and at least 48 hours before a planned major operation; – if you have impaired liver or kidney function; – if you have heart failure. Taking NSAIDs may be associated with a slight increase in cardiovascular risks (myocardial infarction or stroke). Any risk is more likely with high doses and long-term treatment. Do not exceed the recommended dose or duration of treatment. If you have heart problems, have had a stroke, or think you may be at risk for these conditions (for example, if you have high blood pressure, diabetes, high cholesterol, or are a smoker), you should consult your doctor. Very rarely, serious skin reactions (some of which are fatal), skin inflammation with scaling, toxic epidermal necrolysis (severe, extensive skin blistering rash with redness and peeling), and Stevens-Johnson syndrome (severe blistering rash around the mouth) have been reported very rarely. , eyes and genitals) associated with the use of NSAIDs. Patients appear to be most at risk for these reactions early in therapy; treatment should be discontinued at the first appearance of such reactions (skin rash, skin tissue changes, other signs of hypersensitivity). As with all drugs taken by the elderly, naproxen sodium should be used at the lowest effective dose. The concomitant use of Nalgesin® Forte and alcohol may increase the risk of stomach bleeding. Nalgezin® Forte may make it difficult to get pregnant. You must tell your doctor if you are planning a pregnancy or have problems conceiving. NSAIDs that inhibit vasodilating prostaglandins can lead to renal failure due to a decrease in glomerular filtration rate. This side effect is dose dependent. At the beginning of treatment or after increasing the dose, diuresis and renal function should be monitored in patients with the following risk factors: elderly; concurrently taking drugs such as angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), diuretics; hypovolemia, regardless of the cause; heart failure; chronic renal failure; nephrotic syndrome; lupus nephritis; decompensated cirrhosis of the liver. Possible fluid and sodium retention with the possible occurrence of edema, arterial hypertension or worsening of pre-existing hypertension, exacerbation of heart failure. It is necessary to carefully monitor the patient’s condition at the time of initiation of treatment in case of hypertension or heart failure. May reduce the antihypertensive effect of drugs. Possible hyperkalemia provoked by diabetes or treatment with concomitant drugs with a high content of potassium. In this case, there should be regular monitoring of the level of potassium in the blood serum. Naproxen inhibits platelet aggregation and may prolong bleeding time in patients. This should be taken into account when determining bleeding time. When taking naproxen, patients who are prone to increased bleeding or taking drugs that affect hemostasis should be carefully monitored. Rare cases of ophthalmic side effects have been reported, and an ophthalmologic examination is recommended, if considered necessary by the physician, in patients who develop visual impairment while taking naproxen. In the process of long-term treatment, systematic monitoring of the function of the liver and kidneys, the picture of peripheral blood is necessary. Interaction with other drugs It is not recommended to co-administer acetylsalicylic acid and other NSAIDs, including selective COX-2 inhibitors, as this may increase the risk of adverse effects. Naproxen sodium can reduce platelet aggregation and prolong bleeding time, which should be considered when determining bleeding time and while taking anticoagulants. Since naproxen sodium is almost completely bound to plasma proteins, care should be taken when co-administering hydantoin derivatives or sulfonylurea derivatives. Naproxen sodium may reduce the natriuretic effect of furosemide. Naproxen sodium may reduce the hypotensive effect of antihypertensive drugs. The concentration of lithium in plasma increases with the simultaneous administration of lithium preparations and naproxen sodium. Naproxen reduces tubular secretion of methotrexate, so the toxicity of methotrexate may increase with simultaneous use. With simultaneous use with probenecid, the biological T1 / 2 of naproxen sodium is prolonged and the plasma concentration increases. Co-administration of cyclosporine may increase the risk of renal failure. Like other NSAIDs, naproxen may increase the risk of renal failure in patients taking concomitant ACE inhibitors. In vitro studies have shown that the simultaneous use of naproxen sodium and zidovudine increases the plasma concentration of zidovudine. With the simultaneous use of corticosteroids, the risk of ulcers or bleeding of the gastrointestinal tract increases. NSAIDs may increase the effect of anticoagulants such as warfarin. With simultaneous use with antiplatelet drugs and selective serotonin reuptake inhibitors (SSRIs), the risk of gastrointestinal bleeding increases. Risk associated with hyperkalemia Certain drugs or chemicals increase the risk of hyperkalemia: potassium-containing drugs and salt substitutes, diuretics, ACE inhibitors, angiotensin II receptor antagonists, NSAIDs, heparins (low molecular weight or unfractionated), immunosuppressants such as cyclosporine or tacrolimus, trimethoprim . Significantly increases the risk of hyperkalemia when taking potassium-sparing diuretics, especially in combination with each other or with potassium-containing drugs. With simultaneous use with antacids (containing magnesium oxide or aluminum hydroxide) or colistyramine, the absorption of naproxen decreases. When co-administered with tacrolimus, the risk of nephrotoxic effects increases, especially in elderly patients. When naproxen was co-administered with digoxin, an increase in serum digoxin concentrations was reported. If the use of this combination is necessary, the content of digoxin should be monitored. Use with deferasirox increases the risk of ulcerogenic effects and gastrointestinal bleeding. Combined use with pemetrexed is undesirable, because. increased risk of pemetrexed toxicity, especially in patients with impaired renal function. Contraindications acute or recurrent erosive and ulcerative lesions of the gastrointestinal tract (two or more recorded episodes of ulceration or bleeding); gastrointestinal bleeding or perforation associated with NSAIDs; severe renal failure; severe liver failure; severe heart failure; postoperative period with coronary artery bypass grafting; last trimester of pregnancy; hypersensitivity to salts of salicylic acid and other non-steroidal anti-inflammatory and antirheumatic drugs, which manifests itself in the form of bronchial asthma, urticaria and rhinitis; hypersensitivity to the active substance or any of the excipients. CompositionOverdoseSymptoms: after accidental or deliberate ingestion of large amounts of naproxen sodium, abdominal pain, nausea, vomiting, dizziness, tinnitus, irritability, and in more severe cases, hematemesis, melena, impaired consciousness, respiratory disorders, convulsions and renal failure may occur. Treatment: gastric lavage, activated charcoal, antacids, histamine H2 receptor blockers, proton pump inhibitors, misoprostol, and other symptomatic therapy are indicated. Side effect The following undesirable effects that may occur when taking naproxen sodium are classified by frequency as follows: very often (? 1/10), often (from? 1/100 to <1/10), infrequently (from? 1/1000 to <1/100), rare (?1/10,000 to <1/1000), very rare (<1/10,000), frequency unknown (frequency cannot be determined based on the available data). Gastrointestinal disorders The most frequently reported side effects are from the gastrointestinal tract. When taking the drug, peptic ulcers, perforations or gastrointestinal bleeding may occur, which can be fatal, especially in elderly patients. Within each frequency group, possible adverse reactions are presented in decreasing order of severity. From the hemopoietic system: infrequently - eosinophilia, granulocytopenia, leukopenia, thrombocytopenia. From the nervous system: often - headache, vertigo, dizziness, drowsiness; infrequently - depression, sleep disturbances, impaired concentration, insomnia. On the part of the organ of vision: often - visual disturbances. From the side of hearing and balance: often - ringing in the ears, hearing disorders; infrequently - hearing loss. From the side of the cardiovascular system: often - palpitations; infrequently - congestive heart failure. From the respiratory system: often - dyspnea; infrequently - eosinophilic pneumonitis. From the digestive system: often - constipation, abdominal pain, nausea, dyspepsia, diarrhea, stomatitis, flatulence; infrequently - gastrointestinal bleeding and / or gastric perforation, hematemesis, melena, vomiting, increased activity of liver enzymes, jaundice; very rarely - ulcerative stomatitis, relapse or exacerbation of ulcerative colitis or Crohn's disease; frequency unknown - gastritis. From the urinary system: infrequently - glomerulonephritis, hematuria, interstitial nephritis, nephrotic syndrome, renal failure, impaired renal function, renal papillary necrosis. From the skin and subcutaneous tissue: often - itching, skin rash, bruising, purpura; infrequently - alopecia, photocontact dermatitis; very rarely - bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. From the musculoskeletal system: infrequently - muscle pain and muscle weakness. Other: often - swelling, thirst, sweating; infrequently - weakness, hypersensitivity reactions, menstrual irregularities, pyrexia (chills and fever). There have been reports of edema, hypertension and heart failure associated with NSAIDs. Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at high doses and in long-term treatment) may be associated with a slight increased risk of arterial thrombosis (eg, myocardial infarction or stroke). Undesirable effects for which a causal relationship with naproxen sodium is unknown On the part of the hematopoietic system: aplastic anemia, hemolytic anemia. From the nervous system: aseptic meningitis, cognitive dysfunction. From the side of the cardiovascular system: vasculitis. From the skin and subcutaneous tissue: erythema multiforme, photosensitivity reactions resembling skin-hepatic porphyria and epidermolysis bullosa. Allergic reactions: urticaria, angioedema. Others: hyperglycemia, hypoglycemia. If serious adverse effects occur, treatment should be discontinued. Reporting Suspected Adverse Reactions It is important to report suspected adverse reactions after registration of a medicinal product in order to ensure continuous monitoring of the benefit-risk balance of the medicinal product. Medical professionals should report any suspected adverse reactions to the drug through the national system for reporting adverse reactions. Storage conditions The drug should be stored in its original packaging to protect from light, out of the reach of children at a temperature not exceeding 30 ° C. Buy Nalgezin Forte tablets p/o 550mg №10x1 The price of Nalgezin Forte tablets p/o 550mg №10x1