What does Nalgesin help with, dosage regimens, where to buy

Cautions for taking the drug

Nalgesin tablets are contraindicated for:

• hypersensitivity to the main substance;
• the presence of attacks of bronchial obstruction, runny nose or urticaria after taking aspirin or another non-steroidal anti-inflammatory drug in the past;
• erosions and ulcers in the stomach or duodenum;
• complaints of gastrointestinal or other bleeding;
• acute intestinal inflammation;
• being in a state after coronary artery bypass surgery;
• violation of the blood clotting process;
• liver diseases in the active phase, including obvious liver failure;
• severe renal dysfunction, negative dynamics of kidney disease;
• pregnancy and lactation.

For some diseases, Nalgesin can be prescribed according to the instructions for use, but with caution. Among them: diabetes mellitus, coronary heart disease, arterial pathologies.

Also, under the supervision of a physician, it can be used in old age, with long-term use of NSAIDs, with simultaneous therapy with warfarin, prednisolone or acetylsalicylic acid.

There are possible undesirable reactions that can occur from different organs and systems, mainly when taking high doses of the medication:

• disruptions in the functioning of the digestive system: attacks of nausea, diarrhea, abdominal pain, stool retention, vomiting blood;
• skin manifestations: itching, baldness, increased sweating;
• disruption of the central nervous system: difficulty falling asleep or drowsiness, muscle weakness, disorder of thought processes, dizziness, problems with concentration;
• disruption of the cardiovascular system: increased heart rate, swelling, shortness of breath;
• deterioration of visual function, presence of tinnitus;
• problems in the urogenital tract: blood in the urine, disruption of the menstrual cycle, kidney failure;
• disturbances in the functioning of the hematopoietic organs;
• feeling of thirst, increase/decrease in blood glucose;
• allergies in the form of skin rash, angioedema.

To reduce the likelihood of discomfort from the digestive system, you need to take tablets in the minimum effective dose and for a short course.

In what situations is Nalgesin taken?

The instructions for Nalgesin tablets indicate that use is advisable for:

• diseases of the musculoskeletal system: various arthritis, soft tissue rheumatism, bursitis, osteoarthritis of the spinal column and joints, tendovaginitis;
• mild or moderate pain - with neuralgia, myalgia, pain due to muscle strains and bruises, after surgical interventions in various areas, with headaches, migraines, toothache, adnexitis;
• heat and pain due to acute respiratory viral infections and diseases of infectious origin;
• alleviation of the condition and pain in infectious and inflammatory diseases of the ENT organs (otitis, pharyngitis, sore throat).

Release forms of Nalgesin

The drug is available only in film-coated tablets. The main active substance is sodium naproxen. There are two types available in pharmacies:

• regular Nalgesin, one tablet of which contains 275 mg of active ingredient. The package contains 20 pieces;
• Nalgesin forte, one tablet of which contains 550 mg of naproxen. The box contains 10 or 20 pieces.

Auxiliary ingredients include povidone, microcrystalline cellulose, talc, magnesium stearate and purified water.

You can buy Nalgesin without a prescription at a regular pharmacy or through the website.

Instructions for use NALGESIN® (NALGESIN)

Side effects can be minimized by using the drug at the lowest effective dose for the shortest period of time necessary to relieve symptoms.

Patients with gastrointestinal diseases, especially ulcerative colitis or Crohn's disease (including a history) taking naproxen sodium should be closely monitored by their physician, because the disease may recur or worsen. Serious gastrointestinal adverse reactions can occur without any preexisting medical conditions. As with other NSAIDs, the cumulative incidence of serious adverse reactions, gastrointestinal bleeding or perforation, increases linearly with duration of treatment. Taking naproxen sodium in high doses will also likely increase the risk of adverse effects.

The anti-inflammatory and antipyretic effects of naproxen sodium should be taken into account in infectious diseases, as it may mask the signs of these diseases.

Since naproxen sodium and its metabolites are eliminated primarily by the kidneys via glomerular filtration, it should be used with great caution in patients with renal impairment. In patients with renal failure, CC should be determined and then monitored during treatment. If QC is less than 20 ml/min, 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 naproxen sodium concentration is reduced, while the plasma concentration of unbound naproxen sodium is increased. It is recommended to take the drug in the lowest effective doses.

Patients with epilepsy or porphyria taking naproxen sodium should be under close medical supervision.

The use of the drug in combination with NSAIDs, including selective COX-2 inhibitors, should be avoided.

Gastrointestinal effects

Adults

In older patients, the incidence of adverse reactions with NSAIDs is higher, especially the incidence of gastrointestinal bleeding and perforation, which can be fatal.

Gastrointestinal bleeding, ulceration, or perforation, which may be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI reactions.

The risk of bleeding, ulceration or perforation of the gastrointestinal tract is higher with increasing doses of NSAIDs in patients with a history of ulcers, especially if it is complicated by bleeding or perforation and in the elderly. In such patients, treatment should begin with the lowest dose. For such patients, as well as for patients who require concomitant use of low-dose acetylsalicylic acid or other drugs that increase the risk of gastrointestinal events, combination therapy with gastroprotective agents (eg, misoprostol or proton pump inhibitors) should be considered.

Patients with a history of GI toxicity, especially the elderly, should report any unusual abdominal symptoms (especially GI bleeding), especially during the initial stages of treatment. Patients receiving concomitant medications that increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants (eg, warfarin), selective serotonin reuptake inhibitors, or antiplatelet agents (eg, acetylsalicylic acid), should use caution.

If gastrointestinal bleeding or ulceration occurs in patients taking Nalgesin®, 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 on the heart and blood vessels

Patients with a history of arterial hypertension and/or heart failure should exercise caution (consult a doctor or pharmacist) as There have been reports of fluid retention or edema while taking NSAIDs.

Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially in high doses and during long-term treatment) may cause a slight increase in the risk of arterial thrombosis (myocardial infarction or stroke). Although evidence suggests that the use of naproxen (1000 mg/day) may be associated with only a minor risk, it cannot be excluded. Data regarding the effects of low doses of naproxen sodium, for example 275 mg, are insufficient to judge the possible risk of thrombosis.

Effects on the skin and subcutaneous tissues

NSAIDs may very rarely be associated with serious skin side effects such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, some of which can be fatal. Patients are likely to be at greatest risk for these reactions when starting therapy:

• reactions that occur in most cases during the first month of treatment. The drug should be discontinued at the first appearance of skin rash, damage to the mucous membranes or any other signs of hypersensitivity.

Other effects

Nalgesin® should be used only after a thorough assessment of the benefit-risk ratio:

• for acute congenital disorders (for example, intermittent porphyria);
• for systemic lupus erythematosus (SLE) and mixed connective tissue diseases.

Careful monitoring by a doctor is necessary:

• with renal failure;
• with liver failure;
• immediately after major surgery (naproxen sodium should be avoided for serious recent injuries or at least 48 hours before surgery);
• patients with chronic hay fever, nasal polyps or obstructive pulmonary disease, because there is an increased risk of allergic reactions. This may manifest itself as asthma attacks (called aspirin-induced asthma), angioedema or urticaria;
• patients with allergies to other NSAIDs. Nalgesin® may increase the risk of hypersensitivity reactions. Severe acute allergic reactions (eg, anaphylactic shock) are very rare. At the first sign of serious hypersensitivity reactions after taking the drug, treatment should be discontinued. If these symptoms appear, appropriate treatment should be started.

Naproxen, the active ingredient in Nalgesin®, may temporarily inhibit platelet function (platelet aggregation). Therefore, patients with bleeding disorders should be closely monitored.

Long-term use of Nalgesin® requires regular monitoring of liver and kidney function and blood tests.

Long-term use of NSAIDs may cause headaches that do not disappear with increasing dosage of the drug.

The habitual use of analgesics, a specific combination of various analgesic drugs in patients with impaired renal function leads to an increased risk of renal failure (analgesic nephropathy).

Taking NSAIDs simultaneously with alcohol increases side effects, especially from the gastrointestinal tract and central nervous system.

Information on excipients

1 tablet of Nalgesin® contains 1.09 mmol (25.097 mg) sodium, which should be taken into account in patients on a sodium-restricted diet.

Preclinical Safety Data

The results of toxicological studies showed relatively low toxicity of naproxen sodium:

• undesirable effects mainly arise from the gastrointestinal tract. After oral administration, the LD50 was about 0.5 g/kg body weight in rats and more than 1.0 g/kg body weight in mice, hamsters and dogs.

Toxicity studies have demonstrated that mice, rabbits, monkeys, and pigs tolerate repeated doses of naproxen sodium and that toxicity is more severe in rats, especially dogs. Adverse effects are more likely to occur in the gastrointestinal tract and kidneys, as is the case with repeated administration of other NSAIDs.

No effects on fertility or embryotoxic or teratogenic effects were observed. If naproxen sodium is administered late in gestation, pregnancy is prolonged and delivery is delayed. It has also been found that naproxen sodium may have adverse effects on the fetal cardiovascular system (premature closure of the ductus arteriosus, congestive heart failure, pulmonary hypertension).

No mutagenic or carcinogenic effects of naproxen sodium have been reported.

Effects in preclinical studies were observed only at exposures sufficiently above the maximum human exposure, indicating little relevance for clinical use.

Special precautions when disposing of used medicinal products or waste resulting from the use or handling of medicinal products

There are no special requirements for disposal. All remaining medicinal product and waste should be destroyed in an appropriate manner.

Impact on the ability to drive vehicles and operate machinery

Nalgesin® usually does not affect or has a minor effect on the ability to drive a car and operate machinery. When driving or operating machinery, the occurrence of certain side effects from the central nervous system (for example, fatigue and dizziness) should be taken into account. Driving a car or using other machinery may be difficult. These effects are aggravated when used simultaneously with alcohol.

Nalgesin Forte tablets p/o 550 mg No. 10x1

Name

Nalgesin Forte tablet. pplen. vol., 550 mg per blister. in pack №10x1

Description

Blue film-coated tablets, oval, slightly biconvex, with a notch on one side.

Main active ingredient

Naproxen

Release form

tab., cover film-coated, 550 mg: 10 or 20 pcs.

Dosage

550mg

special instructions

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 a history) taking naproxen sodium should be closely monitored by their physician, because the disease may recur or worsen. Serious gastrointestinal adverse reactions can occur without any preexisting medical conditions. As with other NSAIDs, the cumulative incidence of serious adverse reactions, gastrointestinal bleeding or perforation increases linearly with duration of treatment. Taking naproxen sodium in large doses will also likely increase the risk of unwanted 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 eliminated primarily through the kidneys by glomerular filtration, the drug should be used with great caution in patients with renal failure. In patients with renal failure, CC should be determined and then monitored during treatment. If 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 naproxen sodium concentration is reduced, while the plasma concentration of unbound naproxen sodium is increased. It is recommended to take the lowest effective dose. The risk of stomach 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 Elderly patients have a higher incidence of adverse reactions when taking NSAIDs, especially the incidence of gastrointestinal bleeding and perforation, which can be fatal. Gastrointestinal bleeding, ulceration, or perforation, which may 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 increasing doses of NSAIDs in patients with a history of ulcers, especially if complicated by bleeding or perforation, and in the elderly. In such patients, treatment should be started with the lowest dose. For patients with a history of ulcers and elderly patients, as well as 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 GI toxicity, especially the elderly, should report any unusual abdominal symptoms (especially GI bleeding), especially during the initial stages of treatment. Patients receiving concomitant medications 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), should exercise caution. 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 on the cardiovascular system Patients with arterial hypertension and/or a history of heart failure should be careful because There have been reports of fluid retention or edema while taking NSAIDs. Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially in high doses and during 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 excluded. Patients with uncontrolled hypertension, congestive heart failure, established coronary artery disease, peripheral arterial disease, and/or cerebrovascular disease should carefully consider taking naproxen sodium. 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 doses in elderly patients. Naproxen sodium should be avoided for large wounds and for at least 48 hours before major surgery. Skin and subcutaneous tissue effects NSAIDs may 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 probably at greatest risk for these reactions early in therapy, with reactions occurring in most cases within the first month of treatment. The drug should be discontinued at the first appearance of skin rash, damage to the mucous membranes or any other signs of hypersensitivity. Renal failure NSAIDs that inhibit vasodilatory prostaglandins may lead to renal failure due to a decrease in GFR. This side effect is dose dependent. At the beginning of treatment or after increasing the dose, it is necessary to monitor diuresis and renal function in patients with the following risk factors: advanced age; 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, arterial hypertension or worsening of pre-existing hypertension, exacerbation of heart failure. The patient's condition should be carefully monitored at the start of treatment in case of hypertension or heart failure. The antihypertensive effect of drugs may be reduced. Hyperkalemia Hyperkalemia is possible, provoked by diabetes or the simultaneous use of potassium-containing drugs. In such cases, regular monitoring of serum potassium concentrations 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 who are taking medications that affect hemostasis should be carefully monitored. Rare cases of ophthalmic side effects have been reported. An ophthalmologic examination is recommended, if deemed necessary by the physician, for patients who experience visual impairment while taking naproxen. With long-term treatment, systematic monitoring of liver and kidney function and peripheral blood patterns is necessary. Excipients 1 tablet of Nalgesin® Forte contains 2.18 mmol (50.16 mg) sodium, which should be taken into account in patients on a diet with limited sodium intake. Use in pediatrics The drug is not recommended for children and adolescents under the age of 16 years. Effect on the ability to drive vehicles and operate machinery Nalgesin® Forte does not affect the ability to drive a vehicle or operate machinery. In case of development of undesirable reactions from the nervous system, such as dizziness, drowsiness, blurred vision, patients should refrain from driving vehicles or operating machinery.

pharmachologic effect

anti-inflammatory, analgesic.

Pharmacodynamics

Nalgesin forte, a naproxen drug, 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 Nalgesin Forte dissolve well, are quickly 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 has virtually no effect on either the completeness or the rate of absorption). Tmax - 1-2 hours, binding to 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. It is excreted 98% by the kidneys (of which 10% is unchanged), with bile - 0.5–2.5%. Css is determined by taking 4–5 doses of the drug (2–3 days). In case of renal failure, 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, glenohumeral periarthritis, tendinitis, bursitis, osteoarthritis, pain in the lower back, radiculalgia, pain syndrome due to injuries of the musculoskeletal system, acute attack of gout; symptomatic short-term treatment of pain in acute inflammatory processes in the maxillofacial area after assessing the benefit/risk ratio (masking of the infectious process and the risk of spreading the infection); symptomatic treatment of dysmenorrhea after identifying its cause.

Directions for use and doses

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 unwanted effects, the drug should be used in the lowest 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 of age For chronic inflammatory diseases of the joints, the recommended daily dose is 1-2 tablets. (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 dosages do not have to be the same, but should be adjusted according to the prevailing symptoms (eg, pain at night or stiffness in the morning). For acute diseases of the musculoskeletal system and post-traumatic conditions, the initial recommended dose is 1 tablet. (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 tablets. (1375 mg naproxen sodium). For an acute attack of gout, the initial recommended dose is 1.5 tablets. (825 mg naproxen sodium), and then 0.5 tab. (275 mg naproxen sodium) every 8 hours. For dysmenorrhea, the recommended single dose is 1 tablet. (550 mg naproxen sodium), and then, if necessary, 0.5 tab. (275 mg of naproxen sodium) every 6-8 hours. For the treatment of pain in acute inflammatory processes in the maxillofacial area, it is recommended to take from 0.5 tablet. (275 mg naproxen sodium) up to 2 tablets. (1100 mg naproxen sodium) per day. Nalgesin® Forte is not recommended for use by children and adolescents under 16 years of age. Elderly patients are advised to take naproxen sodium at the lowest effective dose. Patients with renal failure should take Nalgesin® Forte with caution. The drug is not recommended for use in patients with moderate or severe renal failure (creatinine clearance less than 30 ml/min). Patients with liver failure should take Nalgesin® Forte with caution.

Use during pregnancy and lactation

Pregnancy Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryonic/fetal development. Data from epidemiological studies indicate an increased risk of miscarriage, cardiac malformations and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of developing cardiovascular malformation was increased from less than 1% to approximately 1.5%. The risk is believed to increase with increasing dose and duration of therapy. In animals, 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 cases of various developmental defects was observed in animals, incl. cardiovascular, after administration of a prostaglandin synthesis inhibitor during 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 trimesters of pregnancy, the lowest dose and duration of treatment should be established. 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 the mother, the 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 delayed or prolonged labor. Therefore, Nalgesin® 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 and is therefore not recommended for women trying to become pregnant. In women who are experiencing difficulty conceiving or whose fertility is being studied, discontinuation of drug treatment should be considered.

Precautionary measures

Consult your doctor before taking Nalgesin® Forte: - if you have or have had gastrointestinal diseases in the past, your doctor should carefully monitor your condition; Particular care should be taken in case of ulcerative colitis and Crohn's disease, because These conditions may recur or worsen. Serious gastrointestinal side effects may occur without any preexisting medical conditions; possible bleeding and intestinal perforations (holes in the intestinal wall); - if you are being treated for epilepsy or have a very rare blood pigment metabolism disorder (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”); - for large 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 small increase in cardiovascular risk (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 are at risk for these conditions (for example, if you have high blood pressure, diabetes, high cholesterol or are a smoker), you should talk to your doctor. Very rarely, serious skin reactions (some of which are fatal), skin inflammation with peeling, toxic epidermal necrolysis (severe, widespread blistering skin rash with redness and peeling), and Stevens-Johnson syndrome (severe blistering rash in the mouth area) have been reported , eyes and genitals) associated with the use of NSAIDs. Patients appear to be at greatest risk for these reactions early in therapy; Treatment should be discontinued at the first appearance of such reactions (skin rash, changes in skin tissue, other signs of hypersensitivity). As with all drugs taken by elderly patients, naproxen sodium should be used at the lowest effective dose. Concomitant use of Nalgesin® Forte and alcohol may increase the risk of gastric bleeding. Nalgesin® Forte may make it difficult to become pregnant. You should tell your doctor if you are planning a pregnancy or if you are having problems conceiving. NSAIDs that inhibit vasodilatory prostaglandins may 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, it is necessary to monitor diuresis and renal function in patients with the following risk factors: elderly people; concurrently taking medications 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. Fluid and sodium retention is possible with the possible occurrence of edema, arterial hypertension or worsening of pre-existing hypertension, exacerbation of heart failure. The patient's condition should be carefully monitored during initiation of treatment in the case of hypertension or heart failure. The antihypertensive effect of drugs may be reduced. Hyperkalemia is possible, provoked by diabetes or treatment with concomitant drugs with a high potassium content. In this case, there should be regular monitoring of serum potassium levels. 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 who are taking medications that affect hemostasis should be carefully monitored. Rare cases of ophthalmic side effects have been reported, and an ophthalmic examination is recommended, if deemed necessary by the physician, in patients who experience visual impairment while taking naproxen. During long-term treatment, systematic monitoring of liver and kidney function and peripheral blood patterns is necessary.

Interaction with other drugs

It is not recommended to use acetylsalicylic acid and other NSAIDs together, including selective COX-2 inhibitors, as this may increase the risk of unwanted effects. Naproxen sodium may reduce platelet aggregation and prolong bleeding time, which should be taken into account when determining bleeding time and when taking anticoagulants concomitantly. Because naproxen sodium is almost completely bound to plasma proteins, caution should be used when coadministering hydantoin derivatives or sulfonylureas. Naproxen sodium may reduce the natriuretic effect of furosemide. Naproxen sodium may reduce the hypotensive effect of antihypertensive drugs. Plasma lithium concentrations increase when lithium and naproxen sodium are taken concomitantly. Naproxen reduces the tubular secretion of methotrexate, so the toxicity of methotrexate may be increased with concomitant use. When used simultaneously with probenecid, the biological half-life of naproxen sodium is prolonged and the plasma concentration increases. Coadministration of cyclosporine may increase the risk of renal failure. Like other NSAIDs, naproxen may increase the risk of renal failure in patients taking ACE inhibitors concomitantly. In vitro studies have shown that concomitant use of naproxen sodium and zidovudine increases plasma concentrations of zidovudine. With simultaneous use of corticosteroids, the risk of gastrointestinal ulcers or bleeding increases. NSAIDs may enhance the effect of anticoagulants such as warfarin. When used simultaneously 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 . The risk of hyperkalemia increases significantly when taking potassium-sparing diuretics, especially in combination with each other or with potassium-containing drugs. When used simultaneously with antacids (containing magnesium oxide or aluminum hydroxide) or colistyramine, the absorption of naproxen is reduced. When taken together with tacrolimus, the risk of nephrotoxic effects increases, especially in elderly patients. Increased serum digoxin concentrations have been reported when naproxen is coadministered with digoxin. If the use of this combination is necessary, digoxin levels should be monitored. Use with deferasirox increases the risk of ulcerogenic effects and gastrointestinal bleeding. Combined use with pemetrexed is undesirable, because the risk of pemetrexed toxicity increases, 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 during coronary artery bypass grafting; last trimester of pregnancy; increased sensitivity to salicylic acid salts 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.

Compound

Overdose

Symptoms: After accidental or intentional ingestion of large amounts of naproxen sodium, abdominal pain, nausea, vomiting, dizziness, tinnitus, irritability, and in more severe cases, hematemesis, melena, disturbances of consciousness, respiratory problems, seizures, 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 while taking naproxen sodium are classified by frequency as follows: very often (?1/10), often (from?1/100 to

Storage conditions

The drug should be stored in its original packaging to protect it from light, out of reach of children at a temperature not exceeding 30°C.

NALGEZIN

Directions for use and doses

Inside.
The tablets should be taken with enough water. Follow your doctor's instructions strictly. You should not stop treatment or change the dosage without first consulting your doctor. Ask your doctor how long you should use the drug.

The usual daily dose used for pain relief is 2-4 tablets (550 - 1100 mg).
If the pain is very severe and there is no history of gastrointestinal diseases, the doctor may increase the daily dose to 6 tablets (1650 mg), but not more than for 2 weeks.

When using the drug as an antipyretic, the initial dose is 2 tablets of Nalgesin, then 1 tablet of Nalgesin (275 mg) is taken every 6-8 hours.

To prevent migraine attacks, 2 tablets (550 mg) twice a day are recommended. However, treatment should be discontinued if the frequency, intensity and duration of migraine attacks do not decrease within 4-6 weeks. At the first signs of a migraine attack, you should take 3 tablets (825 mg), and, if necessary, another 1-2 tablets (275 - 550 mg) 30 minutes later.

To relieve menstrual pain and cramps, pain after insertion of an IUD (intrauterine device) and other gynecological pain, it is recommended to prescribe the drug in an initial dose of 2 tablets (550 mg), then 1 tablet (275 mg) every 6-8 hours.

For an acute attack of gout, the initial dose is 3 tablets (825 mg), then 2 tablets (550 mg) after 8 hours, and then 1 tablet (275 mg) every 8 hours until the attack stops.

For rheumatoid diseases (rheumatoid arthritis, osteoarthritis and ankylosing spondylitis), the usual initial dose of the drug is 2-4 tablets (550-1100 mg), twice a day in the morning and evening. An initial daily dose of 3 (825 mg) to 6 tablets (1650 mg) is recommended for patients with severe night pain and/or severe morning stiffness, patients switching to naproxen sodium treatment from high doses of other nonsteroidal anti-inflammatory drugs, and patients with in which pain is the leading symptom. Usually the daily dose is 2 tablets (550 mg) - 4 tablets (1100 mg), prescribed in two doses.

Morning and evening doses may not be the same. With the consent of the attending physician, you can change them depending on the prevalence of symptoms, i.e. night pain and/or morning stiffness.

For children over 9 years of age and/or weighing more than 27 kg, a daily dose of 10 mg/kg in 1-2 doses is recommended.

If you feel that the effect of the drug is very strong or weak, tell your doctor or pharmacist.