Faspik granules for oral administration, apricot 400mg / 3g, No. 12

• 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 intended for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease.

The drug is administered orally, during or after meals.

Adults with ankylosing spondylitis - 400-600 mg 3-4 times / day; with rheumatoid arthritis - 800 mg 3 times / day; for post-traumatic pain - 1.6-2.4 g / day in several doses; with algodismenorrhea - 400 mg 3-4 times / day; with pain syndrome - up to 1.2 g / day in several doses.

Children over 12 years old with juvenile rheumatoid arthritis - 30-40 mg / kg / day in divided doses 3-4 times / day; to reduce body temperature 39.2 ? — - 10 mg / kg / day, <39.2 ? — - 5 mg / kg / day; when used as a pain reliever, similar doses are prescribed depending on the severity of pain. The maximum daily dose for children is 40 mg / kg body weight.

The recommended daily dose for adults when using the drug is 1.2 g (contents of 6 bags of 200 mg, contents of 3 bags of 400 mg, or contents of 2 bags of 600 mg). For rheumatoid arthritis, the use of higher doses is recommended, but not more than 2.4 mg / day (contents of 12 bags of 200 mg, contents of 6 bags of 400 mg or contents of 4 bags of 600 mg).

The contents of the package are dissolved in water (50-100 ml) and taken orally immediately after preparation of the solution during or after meals.

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, hepatic or cardiac function, the dose should be reduced.

The duration of treatment for febrile syndrome is no more than 3 days, for pain syndrome - no more than 5 days.

Granules for the preparation of a solution for oral administration, white, with a characteristic apricot odor; the prepared solution is colorless, opalescent, with a characteristic apricot odor.

ibuprofen (as arginate) 400 mg

Excipients: arginine - 370 mg, sodium bicarbonate - 200 mg, sodium saccharinate - 20 mg, aspartame - 60 mg, apricot flavor - 180 mg, sucrose - 1770 mg.

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

• complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including a history);

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

• active gastrointestinal bleeding;

• severe renal failure (CC less than 30 ml / min);

• progressive kidney disease; severe liver failure or active liver disease;

• condition after coronary artery bypass grafting;

• confirmed hyperkalemia;

• bleeding of any etiology;

• diseases of the optic nerve;

• phenylketonuria;

• children under 18 years of age (for a dose of 600 mg due to the inability to comply with the dosage regimen);

• deficiency of sucrase / isomaltase, fructose intolerance, glucose-galactose malabsorption;

• pregnancy;

• lactation period;

• children under 12 years of age;

• hypersensitivity to drug components;

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

With carethe drug should be used 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, non-blood diseases etiology (leukopenia and anemia), ischemic heart disease, cerebrovascular diseases, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, chronic renal failure (CC 30-60 ml / min), presence of Helicobacter pylori infection, prolonged use of NSAIDs, alcoholism, severe somatic diseases, concomitant use of oral corticosteroids (including prednisone), anticoagulants (including warfarin), antiplatelet agents (including clopidogrel),selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline), 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 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 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 isoenzyme CYP2C9 is involved in the metabolism of ibuprofen. 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.

Indications of the drug Faspik

• febrile 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 intended for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease.

Side effect

From the digestive system: NSAIDs gastropathy (abdominal pain, nausea, vomiting, heartburn, loss of appetite, diarrhea, flatulence, constipation, ulceration of the gastrointestinal mucosa, which in some cases is complicated by perforation and bleeding), irritation or dryness of the oral mucosa , pain in the mouth, ulceration of the mucous membrane of the gums, aphthous stomatitis, 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, 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).

Contraindications for use

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

• complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including a history);

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

• active gastrointestinal bleeding;

• severe renal failure (CC less than 30 ml / min);

• progressive kidney disease; severe liver failure or active liver disease;

• condition after coronary artery bypass grafting;

• confirmed hyperkalemia;

• bleeding of any etiology;

• diseases of the optic nerve;

• phenylketonuria;

• children under 18 years of age (for a dose of 600 mg due to the inability to comply with the dosage regimen);

• deficiency of sucrase / isomaltase, fructose intolerance, glucose-galactose malabsorption;

• 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 unknown etiology (leukopenia and anemia), ischemic heart disease, cerebrovascular diseases, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, chronic renal failure (CC 30-60 ml / min), the presence of Helicobacter pylori infection, prolonged use of NSAIDs, alcoholism, severe somatic diseases, concomitant use of oral corticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including clopidogrel),selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline), as well as in elderly patients.

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

Contraindicated in children under 12 years of age.

special instructions

If signs of bleeding from the gastrointestinal tract occur, 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.

The risk of ulceration of the gastrointestinal tract mucosa, bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), visual impairment (color vision disorders, scotoma, optic nerve damage) increases with prolonged use of the drug in large doses.

Side effects can be reduced by using the drug in the lowest effective dose for the shortest duration of treatment. 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 (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 preparation contains sucrose, so it should be borne in mind that 1 package of 200 mg contains 0.24 XE, the maximum daily dose of 1.2 mg (6 packages) contains 1.44 XE; 1 package of 400 mg contains 0.18 XE, the maximum daily dose of 1.2 mg (3 packages) contains 0.54 XE; 1 packet dose of 600 mg contains 0.13 XE, the maximum daily dose of 1.2 mg (2 packets) contains 0.26 XE.

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).

ѕри одновременном назначении с ацетилсалициловой кислотой ибупрофен снижает ее антиагрегантное действие (возможно повышение частоты развити¤ острой коронарной недостаточности у больных, получающих в качестве антиагрегантного средства малые дозы ацетилсалициловой кислоты).

»бупрофен может снижать эффективность антигипертензивных средств (в т.ч. блокаторов медленных кальциевых каналов и ингибиторов јѕ‘).

¬ литературе были описаны единичные случаи увеличени¤ плазменных концентраций дигоксина, фенитоина и лити¤ при одновременном приеме ибупрофена. —редства, блокирующие канальцевую секрецию, снижают выведение и повышают плазменную концентрацию ибупрофена.

‘аспик, как и другие Ќѕ¬—, следует примен¤ть с осторожностью в комбинации с ацетилсалициловой кислотой или другими Ќѕ¬—, т.к. это увеличивает риск развити¤ неблагопри¤тного воздействи¤ препарата на ? “.

»бупрофен может увеличивать концентрацию метотрексата в плазме.

ѕри комбинированной терапии зидовудином и ‘аспиком возможно повышение риска гемартрозов и гематомы у ¬»„-инфицированных пациентов, страдающих гемофилией.

 омбинированное применение ‘аспика и такролимуса может увеличивать риск развити¤ нефротоксического действи¤ из-за нарушени¤ синтеза простагландинов в почках.

»бупрофен усиливает гипогликемическое действие пероральных гипогликемических средств и инсулина; может возникнуть необходимость коррекции дозы.

ќписано ульцерогенное действие с кровотечени¤ми при сочетании ‘аспика с колхицином, эстрогенами, этанолом, v —.

јнтациды и колестирамин снижают абсорбцию ибупрофена.

 офеин усиливает анальгезирующий эффект ‘аспика.

ѕри одновременном применении ‘аспика с антикоагул¤нтами и тромболитическими средствами (альтеплазой, стрептокиназой, урокиназой) повышаетс¤ риск развити¤ кровотечений.

?ефамандол, цефоперазон, цефотетан, вальпроева¤ кислота, пликамицин при одновременном применении с ‘аспиком увеличивают частоту развити¤ гипопротромбинемии.

ћиелотоксические средства при одновременном применении усиливают про¤влени¤ гематотоксичности ‘аспика.

?иклоспорин и препараты золота усиливают вли¤ние ибупрофена на синтез простагландина в почках, что про¤вл¤етс¤ повышением нефротоксичности.

»бупрофен повышает плазменную концентрацию циклоспорина и веро¤тность развити¤ его гепатотоксических эффектов.

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.

Microsomal oxidation inhibitors reduce the risk of hepatotoxic effects of ibuprofen