Faspik - instructions for use, doses, side effects, contraindications

Excipients: arginine 555 mg, sodium hydrogen carbonate 300 mg, sodium saccharinate 20 mg, aspartame 60 mg, apricot flavoring 180 mg, sucrose 1285 mg.

* Ibuprofen arginate is formed by the interaction of ibuprofen and arginine.

Granules for the preparation of solution for ingestion mint-anise: 1 pack contains:

active substance - ibuprofen (in the form of arginate), in terms of ibuprofen 400 mg *;

Excipients: arginine 370 mg, sodium hydrogen carbonate 200 mg, sodium saccharinate 20 mg, aspartame 25 mg, mint flavor 135 mg, anise flavor 15 mg, sucrose 1835 mg. or

active substance: ibuprofen (in the form of arginate), in terms of ibuprofen 600 mg *;

Excipients: arginine 555 mg, sodium hydrogen carbonate 300 mg, sodium saccharinate 25 mg, aspartame 30 mg, mint flavor 135 mg, anise flavor 15 mg, sucrose 1340 mg.

* Ibuprofen arginate is formed by the interaction of ibuprofen and arginine.

Description:Granules of white color with a characteristic mint, apricot or mint-anise odor.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID).

ATX: & nbsp

M.01.A.E.01 Ibuprofen

Pharmacodynamics:

Ibuprofen, the active substance of the preparation Faspik, is a derivative of propionic acid and has analgesic, antipyretic and anti-inflammatory effects due to the indiscriminate blockade of cyclooxygenase-1 and cyclooxygenase-2, which have an inhibitory effect on the synthesis of prostaglandins. Analgesic effect is most pronounced for inflammatory pains. The analgesic activity of the drug does not apply to the narcotic type.

Like all NSAIDs, ibuprofen exhibits antiaggregant activity. Anesthetic effect in the application of Faspik (ibuprofen in the form of arginate) develops 10 minutes after admission.

Pharmacokinetics:

Suction: well absorbed from the stomach. When using Faspeak, the maximum concentration (Cmax) of ibuprofen in plasma is 26 μg / ml and 56 μg / ml is achieved within 15-25 minutes after taking the drug on an empty stomach at a dose of 200 mg and 400 mg respectively.

Distribution: ibuprofen approximately 99% is associated with plasma proteins. It is slowly distributed in the synovial fluid and is withdrawn from it more slowly than from the plasma.

Biotransformation: ibuprofen is metabolized in the liver, mainly by hydroxylation and carboxylation of the isobutyl group. The isozyme CYP2C9 is involved in the metabolism of ibuprofen. Metabolites are pharmacologically inactive.

Excretion: has a two-phase kinetics of elimination. The half-life (T1 / 2) of plasma is 1-2 hours. Up to 90% of the dose can be detected in the urine in the form of metabolites and their conjugates. Less than 1% is excreted unchanged in urine and, to a lesser extent, with bile.

Indications:

- Feverish syndrome of different genesis.

- Pain syndrome of various etiology (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).

- It is intended for symptomatic therapy, reducing pain and inflammation at the time of use, the progression of the disease is not affected.

Contraindications:

- Hypersensitivity to any of the ingredients that make up the drug.

- Hypersensitivity to acetylsalicylic acid or other NSAIDs in anamnesis.

- Erosive and ulcerative diseases of the gastrointestinal tract (including peptic ulcer of the stomach and duodenum in the acute stage, Crohn's disease, ulcerative colitis).

- Complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including in the anamnesis).

- Hemophilia and other disorders of blood clotting (including hypocoagulation), hemorrhagic diathesis.

- Bleeding of any etiology.

- Sucrose / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.

- Phenylketonuria.

- Pregnancy.

- Lactation period.

- Children under 12 years.

- Children under 18 years of age for a dosage of 600 mg due to the inability to perform the dosing regimen.

- Diseases of the optic nerve.

- Active gastrointestinal bleeding; severe renal failure (creatinine clearance less than 30 ml / min), progressive kidney disease, severe hepatic insufficiency or active liver disease, condition after coronary artery bypass grafting; confirmed hyperkalemia.

Carefully:

- Elderly age;

- Heart failure;

- Arterial hypertension;

- Cirrhosis of the liver with portal hypertension;

- Hepatic and / or renal failure, nephrotic syndrome, hyperbilirubinemia;

- Peptic ulcer of stomach and duodenum (in the anamnesis), gastritis, enteritis, colitis;

- Diseases of unclear etiology (leukopenia and anemia).

- Ischemic heart disease, cerebrovascular disease.

- Dyslipidemia / hyperlipidemia, diabetes mellitus.

- Diseases of peripheral arteries, smoking.

- Chronic renal failure (KK 30 - 60 ml / min), the presence of H. pylori infection.

- Prolonged use of NSAIDs, alcoholism, severe physical illnesses, simultaneous admission oral glucocorticosteroids (incl.prednisolone), anticoagulants (including warfarin), antiaggregants (including clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline)

Pregnancy and lactation:Contraindicated.

Dosing and Administration:

Inside. During or after a meal.

Adults:

- with ankylosing spondylitis - 400-600 mg 3 - 4 times a day;

- with rheumatoid arthritis - 800 mg 3 times a day;

- at posttraumatic pains - 1,6 - 2,4 g per day in several receptions;

- at algodismenorea - on 400 mg 3 - 4 times a day;

- with pain syndrome up to 1.2 grams per day in several receptions.

Children over 12 years of age:

- with juvenile rheumatoid arthritis - 30-40 mg / kg / day in divided doses 3-4 times a day;

- to reduce the body temperature 39.2 ° C and above - 10 mg / kg / day, below 39.2 ° C

- 5 mg / kg / day;

- when used as an analgesic, depending on the strength of the pain, prescribe similar doses.

The maximum daily dose for children is 40 mg / kg of body weight.

The recommended daily intake for adults with the drug

is 1200 mg (the contents of 6 packets of 200 mg or the contents of 3 packages of 400 mg, or the contents of 2 packets of 600 mg). In rheumatoid arthritis, the use of higher doses is recommended,but not more than 2400 mg per day (the contents of 12 packages of 200 mg, the contents of 6 packages of 400 mg or the contents of 4 packets of 600 mg). The contents of the package are dissolved in water (50 - 100 ml) and taken inside immediately after the preparation of the solution during or after a meal. To overcome the morning stiffness in patients with arthritis, it is recommended to take the first dose of the drug immediately after awakening. In patients with impaired renal, hepatic or cardiac function, the dose should be reduced.

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

Side effects:

Gastrointestinal tract (GIT): NSAIDs-gastropathy (abdominal pain, nausea, vomiting, heartburn, decreased 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 gingival mucosa, aphthous stomatitis, pancreatitis.

Hepatobiliary system: hepatitis.

Respiratory system: shortness of breath, bronchospasm. The organ of hearing: hearing loss, ringing or noise in the ears.

Central 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).

The cardiovascular system: heart failure, tachycardia, increased blood pressure.

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

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

Hematopoiesis: anemia (including haemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia.

Body of vision: toxic optic nerve damage, blurred vision or dying, scotoma, dry and irritated eyes, conjunctival edema and eyelids (allergic genesis).

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

Laboratory indicators:

- bleeding time (may increase);

- serum glucose concentration (may decrease);

- clearance of creatinine (may decrease);

- hematocrit or hemoglobin (may decrease);

- serum creatinine concentration (may increase);

- activity of "liver" transaminases (may increase).

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

Treatment: gastric lavage (only for an hour after ingestion), Activated carbon, alkaline drink, forced diuresis, symptomatic therapy (correction of acid-base state, blood pressure).

Interaction:

- The efficacy of furosemide and thiazide diuretics can be reduced due to a delay in sodium associated with inhibition of prostaglandin synthesis in the kidneys.

- Strengthens the effect of indirect anticoagulants, antiaggregants, fibrinolytic drugs (increased risk of hemorrhagic complications).

- With simultaneous use 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 antiplatelet agents).

- Reduces the hypotensive activity of vasodilators (including blockers of "slow" calcium channels and ACE inhibitors).

In the literature, single cases of an increase in plasma concentrations of digoxin, phenytoin and lithium with simultaneous administration of ibuprofen have been described. The agents blocking the tubular secretion, reduce the excretion and increase the plasma concentration of ibuprofen.

Ibuprofen (like other NSAIDs) should be used with caution in combination with acetylsalicylic acid or other NSAIDs (this increases the risk of adverse drug effects on the gastrointestinal tract). Ibuprofen can increase the concentration of methotrexate in plasma. Combined treatment with zidovudine and ibuprofen may increase the risk of hemarthrosis and hematoma in HIV-infected patients with hemophilia.

The combined use of ibuprofen and tacrolimus may increase the risk of developing nephrotoxic effects due to a reduction in the synthesis of prostaglandins in the kidneys.

Ibuprofen enhances the hypoglycemic effect of oral hypoglycemic agents and insulin. With their joint application, it may be necessary to correct the dose of oral hypoglycemic agents and insulin. Ulcerogenic action with bleeding is described when combined with colchicine, estrogens, ethanol, glucocorticosteroids. Antacids and colestramine reduce the absorption of ibuprofen. Caffeine strengthens the analgesic effect.

When used simultaneously with anticoagulants and thrombolytic agents (alteplase, streptokinase, urokinase), the risk of bleeding increases at the same time. Cefamandol, cefapperazone, cefotetan, valproic acid, plikamycin increase the frequency of hypoprothrombinemia.

- Myelotoxic agents increase the manifestation of hematotoxicity of the drug.

- Cyclosporine and gold preparations increase the effect of ibuprofen on the synthesis of prostaglandin in the kidneys, which is manifested by increased nephrotoxicity. Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of its hepatotoxic effects.

- Inductors of microsomal liver enzymes (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated and active metabolites, increasing the risk of developing severe hepatotoxic reactions.

- Inhibitors of microsomal liver enzymes reduce the risk of hepatotoxic effects.

Special instructions:

If there are signs of bleeding from the gastrointestinal tract, the Faspic should be canceled (see the section "Contraindications"). Faspik can mask objective and subjective signs of infection, therefore, ibuprofen therapy in patients with infection should be administered with caution in the presence of adequate antimicrobial therapy.

The occurrence of bronchospasm is possible in patients with bronchial asthma or allergic reactions in the anamnesis or in the present.Side effects can be reduced by applying the minimum effective dose with the shortest duration of treatment. With prolonged use of H11VP, the risk of developing analgesic nephropathy is possible.

The use of Faspik can adversely affect female fertility and is not recommended for women planning a pregnancy.

Patients who report a visual impairment with Faspic therapy should stop treatment and undergo an ophthalmologic examination. NSAIDs can increase the activity of "liver" enzymes. During treatment, it is necessary to monitor the picture of peripheral blood and the functional state of the liver and kidneys.

When symptoms of gastropathy appear, careful monitoring including esophagogastroduodenoscopy, a blood test with determination of hemoglobin, hematocrit, analysis of feces for latent blood is shown. To prevent the development of NSAIDs, gastropathy is recommended to be combined with preparations of prostaglandin E (misoprostol). If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the test. During the period of treatment, ethanol is not recommended.

The composition of the drug includes sucrose, so you need to consider that:

- 1 package with a dosage of 200 mg contains 0.24 bread units (XE), the maximum daily dose of 1200 mg (6 packs) contains 1.44 XE;

- 1 package with a dosage of 400 mg contains 0.18 XE, the maximum daily dose of 1200 mg (3 packs) contains 0.54 XE;

- 1 package with 600 mg dosage contains 0.13 XE, the maximum daily dose of 1200 mg (2 packs) contains 0.26 XE.

Effect on the ability to drive transp. cf. and fur:Patients should refrain from all activities requiring increased attention, rapid mental and motor reaction.

Form release / dosage:Granules for solution for oral administration.

Packaging:

Granules for solution for oral administration [mint] 200 mg, granules for oral solution [apricot, mint-anise] 400 mg, 600 mg.

By 3.0 grams in bags of multi-layer (paper-aluminum-polyethylene) foil. For 12 or 30 packets, paired two, along with the instruction for medical use put in a pack of cardboard.

Storage conditions:At a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-001803

Date of registration:21.06.2011

The owner of the registration certificate:Zambon Switzerland Co., Ltd.Zambon Switzerland Co., Ltd. Switzerland

Manufacturer: & nbsp

ZAMBON SWITZERLAND, Ltd. Switzerland

Representation: & nbspZAMBON SpA ZAMBON SpA Italy

Information update date: & nbsp21.06.2011

Illustrated instructions

Instructions

Faspik (Faspic)