Faspik tablets 400mg, No. 6

• Feverish syndrome of various origins;

• pain syndrome of various etiologies (including sore throat, headache, migraine, toothache, neuralgia, postoperative pain, post-traumatic pain, primary algodismenorrhea); inflammatory and degenerative diseases of the joints and spine (including rheumatoid arthritis, ankylosing spondylitis).

The drug is taken orally. For adults and children over 12 years of age, the drug is prescribed in the form of tablets at an initial dose of 400 mg; if necessary, 400 mg every 4-6 hours. The maximum daily dose is 1200 mg. The tablet is washed down with a glass of water (200 ml). To reduce the risk of dyspeptic side effects, it is recommended to take the drug with meals and should not be taken for more than 7 days or in higher doses. If it is necessary to use it for a longer time or in higher doses, a doctor's consultation is required.In the form of a solution for oral administration, the drug is prescribed for adults and children over 12 years of age, the drug is prescribed in a daily dose of 800-1200 mg (4-6 sachets of 200 mg each or 2-3 sachets 400 mg each). The maximum daily dose is 1200 mg.Before taking, the contents of the sachet are dissolved in water (50-100 ml) and taken orally immediately after preparation of the solution during or after a meal. To overcome morning stiffness in patients with arthritis, it is recommended to take the first dose of the drug immediately after waking up. In patients with impaired renal function, the liver or heart, the dose of the drug should be reduced.

Film-coated tablets, white, capsule-shaped, with a score on one side.

1 tab. ibuprofen 400 mg

Excipients: L-arginine, sodium bicarbonate, crospovidone, magnesium stearate.

• Erosive and ulcerative diseases of the gastrointestinal tract (including peptic ulcer of the stomach and duodenum in the acute phase, Crohn's disease, NUC);

• aspirin asthma;

• hemophilia and other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis;

• bleeding of various etiologies;

• diseases of the optic nerve; pregnancy;

• lactation period;

• children under 12 years of age;

• hypersensitivity to drug components;

• a history of hypersensitivity to acetylsalicylic acid or other NSAIDs.

The drug should be used with caution in patients with heart failure, arterial hypertension, liver cirrhosis with portal hypertension, hepatic and / or renal failure, nephrotic syndrome, hyperbilirubinemia, gastric ulcer and duodenal ulcer (in history), gastritis, enteritis, colitis, diseases blood of unclear etiology (leukopenia and anemia), as well as in elderly patients.

pharmachologic effect

NSAIDs. Ibuprofen, the active substance of Faspik, is a derivative of propionic acid and has analgesic, antipyretic and anti-inflammatory effects due to the indiscriminate blockade of COX-1 and COX-2, as well as inhibiting the synthesis of prostaglandins. The analgesic effect is most pronounced for inflammatory pain. The analgesic activity of the drug is not of the opioid type. Like other NSAIDs, ibuprofen has antiplatelet activity. The analgesic effect when using the drug Faspik develops 10-45 minutes after taking it.

Pharmacokinetics

Suction

After oral administration, the drug is well absorbed from the gastrointestinal tract. After taking Faspik on an empty stomach in the form of tablets at a dose of 200 mg and 400 mg, Cmax of ibuprofen in plasma is approximately 25 ?g / ml and 40 ?g / ml, respectively, and is achieved within 20-30 minutes. After taking the drug Faspik on an empty stomach in the form of a solution at a dose of 200 mg and 400 mg, Cmax of ibuprofen in plasma is approximately 26 ?g / ml and 54 ?g / ml, respectively, and is achieved within 15-25 minutes.

Distribution

Plasma protein binding is about 99%. It is slowly distributed in the synovial fluid and is excreted from it more slowly than from plasma.

Metabolism

Ibuprofen is metabolized in the liver mainly by hydroxylation and carboxylation of the isobutyl group. The metabolites are pharmacologically inactive.

Withdrawal

It is characterized by two-phase elimination kinetics. T1 / 2 from plasma is 1-2 hours. Up to 90% of the dose can be detected in urine in the form of metabolites and their conjugates. Less than 1% is excreted unchanged in the urine and, to a lesser extent, in the bile.

Side effect

From the digestive system: NSAIDs-gastropathy - abdominal pain, nausea, vomiting, heartburn, loss of appetite, diarrhea, flatulence, constipation; rarely - ulceration of the gastrointestinal mucosa (in some cases, complicated by perforation and bleeding); possibly - irritation or dryness of the oral mucosa, pain in the mouth, ulceration of the gingival mucosa, aphthous stomatitis, pancreatitis, hepatitis.

From the respiratory system: shortness of breath, bronchospasm.

From the senses: hearing loss, ringing or tinnitus, toxic damage to the optic nerve, blurred vision or double vision, scotoma, dryness and irritation of the eyes, edema of the conjunctiva and eyelids (allergic genesis).

From the side of the central nervous system and peripheral nervous system: headache, dizziness, insomnia, anxiety, nervousness and irritability, psychomotor agitation, drowsiness, depression, confusion, hallucinations; rarely - aseptic meningitis (more often in patients with autoimmune diseases).

From the side of the cardiovascular system: heart failure, tachycardia, increased blood pressure.

From the urinary system: acute renal failure, allergic nephritis, nephrotic syndrome (edema), polyuria, cystitis.

From the hematopoietic system: anemia (including hemolytic, aplastic), thrombocytopenia, thrombocytopenic purpura, agranulocytosis, leukopenia.

On the part of laboratory parameters: an increase in bleeding time, a decrease in serum glucose concentration, a decrease in CC, a decrease in hematocrit or hemoglobin, an increase in serum creatinine concentration, an increase in the activity of hepatic transaminases are possible.

Allergic reactions: skin rash (usually erythematous or urticarial), pruritus, Quincke's edema, anaphylactoid reactions, anaphylactic shock, bronchospasm, dyspnea, fever, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal syndrome (epidermal toxicity) Lyell), eosinophilia, allergic rhinitis.

Long-term use of the drug in high doses increases the risk of ulceration of the gastrointestinal tract, bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), visual impairment (color vision disorders, scotoma, optic nerve damage).

Application during pregnancy and lactation

The drug is contraindicated for use during pregnancy and lactation (breastfeeding). The use of Faspik can adversely affect female fertility and is not recommended for women planning a pregnancy.

Application for violations of liver function

In patients with impaired liver function, the dose of the drug should be reduced. Ibuprofen can increase the activity of liver enzymes. During treatment, it is necessary to monitor the functional state of the liver.

Application for impaired renal function

In patients with impaired renal function, the dose of the drug should be reduced. During treatment, it is necessary to monitor the functional state of the kidneys.

Application in children

Contraindication: children under 12 years of age.

Use in elderly patients

The drug should be used with caution in elderly patients.

special instructions

If there are signs of bleeding from the gastrointestinal tract, Faspik should be canceled. The use of Faspik can mask the objective and subjective symptoms of infection, therefore, the drug should be prescribed with caution to patients with infectious diseases. The occurrence of bronchospasm is possible in patients with bronchial asthma or allergic reactions in history or in the present. Side effects can be reduced by using the drug in the lowest effective dose. With prolonged use of analgesics, the risk of developing analgesic nephropathy is possible. Patients who notice visual impairment during Faspic therapy should discontinue treatment and undergo an ophthalmological examination. Ibuprofen can increase the activity of liver enzymes.During treatment, it is necessary to control the picture of peripheral blood and the functional state of the liver and kidneys. When symptoms of gastropathy appear, careful monitoring is shown, including esophagogastroduodenoscopy, blood test with determination of hemoglobin, hematocrit, fecal occult blood test. To prevent the development of NSAID gastropathy, ibuprofen is recommended to be combined with prostaglandin E preparations (misoprostol). If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. During the period of treatment, it is not recommended to take ethanol. The drug contains sucrose (1 tablet - 16.7 mg, 1 sachet of granules - 1.84 g), which should be taken into account if patients have an appropriate hereditary fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency.including esophagogastroduodenoscopy, blood test with determination of hemoglobin, hematocrit, fecal occult blood test. To prevent the development of NSAID gastropathy, ibuprofen is recommended to be combined with prostaglandin E preparations (misoprostol). If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. During the period of treatment, it is not recommended to take ethanol. The drug contains sucrose (1 tablet - 16.7 mg, 1 sachet of granules - 1.84 g), which should be taken into account if patients have an appropriate hereditary fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency.including esophagogastroduodenoscopy, blood test with determination of hemoglobin, hematocrit, fecal occult blood test. To prevent the development of NSAID gastropathy, ibuprofen is recommended to be combined with prostaglandin E preparations (misoprostol). If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. During the period of treatment, it is not recommended to take ethanol. The drug contains sucrose (1 tablet - 16.7 mg, 1 sachet of granules - 1.84 g), which should be taken into account if patients have an appropriate hereditary fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency.To prevent the development of NSAID gastropathy, ibuprofen is recommended to be combined with prostaglandin E (misoprostol). If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. During the period of treatment, it is not recommended to take ethanol. The drug contains sucrose (1 tablet - 16.7 mg, 1 sachet of granules - 1.84 g), which should be taken into account if patients have an appropriate hereditary fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency.To prevent the development of NSAID gastropathy, ibuprofen is recommended to be combined with prostaglandin E preparations (misoprostol). If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. During the period of treatment, it is not recommended to take ethanol. The drug contains sucrose (1 tablet - 16.7 mg, 1 sachet of granules - 1.84 g), which should be taken into account if patients have an appropriate hereditary fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency.which should be taken into account if patients have a corresponding hereditary fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency.which should be taken into account if patients have a corresponding hereditary fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency.

Influence on the ability to drive vehicles and use mechanisms

Patients should refrain from all activities that require increased attention and speed of psychomotor reactions.

Overdose

Symptoms: abdominal pain, nausea, vomiting, lethargy, drowsiness, depression, headache, tinnitus, metabolic acidosis, coma, acute renal failure, decreased blood pressure, bradycardia, tachycardia, atrial fibrillation, respiratory arrest.

Treatment: gastric lavage (only within 1 hour after ingestion), activated charcoal, alkaline drinking, forced diuresis, symptomatic therapy (correction of acid-base state, blood pressure).

Drug interactions

A decrease in the effectiveness of furosemide and thiazide diuretics is possible due to sodium retention associated with inhibition of prostaglandin synthesis in the kidneys. Ibuprofen can enhance the effect of indirect anticoagulants, antiplatelet agents, fibrinolytics (increasing the risk of hemorrhagic complications). When administered simultaneously with acetylsalicylic acid, ibuprofen reduces its antiplatelet effect (it is possible to increase the incidence of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as an antiplatelet agent). Ibuprofen can reduce the effectiveness of antihypertensive drugs (including slow calcium channel blockers and ACE inhibitors). In the literature, isolated cases of an increase in plasma concentrations of digoxin, phenytoin and lithium have been described while taking ibuprofen. Facilities,blocking tubular secretion, reduce excretion and increase the plasma concentration of ibuprofen. Faspik, like other NSAIDs, should be used with caution in combination with acetylsalicylic acid or other NSAIDs, because this increases the risk of developing adverse effects of the drug on the gastrointestinal tract. Ibuprofen can increase the plasma concentration of methotrexate. Combination therapy with zidovudine and Faspic may increase the risk of hemarthrosis and hematoma in HIV-infected patients with hemophilia. The combined use of Faspic and tacrolimus may increase the risk of developing nephrotoxic effects due to impaired synthesis of prostaglandins in the kidneys. Ibuprofen enhances the hypoglycemic effect of oral hypoglycemic agents and insulin; dose adjustment may be necessary.An ulcerogenic effect with bleeding is described when Faspik is combined with colchicine, estrogens, ethanol, GCS. Antacids and cholestyramine reduce the absorption of ibuprofen. Caffeine enhances the analgesic effect of Faspik. With the simultaneous use of Faspik with thrombolytic agents (alteplase, streptokinase, urokinase), the risk of bleeding increases. Cefamandol, cefoperazone, cefotetan, valproic acid, plikamycin, when used simultaneously with Faspic, increase the incidence of hypoprothrombinemia. Myelotoxic drugs, with simultaneous use, increase the manifestations of Faspik's hematotoxicity. Cyclosporine and gold preparations increase the effect of ibuprofen on prostaglandin synthesis in the kidneys, which is manifested by an increase in nephrotoxicity.Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of developing its hepatotoxic effects. Microsomal oxidation inducers (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites of ibuprofen, increasing the risk of severe hepatotoxic reactions. Inhibitors of microsomal oxidation reduce the risk of hepatotoxic effects of ibuprofen.