Package Faspik granules for oral solution 400mg apricot sachet, 12pcs

Certificate of conformity (COC) Faspik granules for oral solution 400mg apricot sachet, 12pcs

Faspik granules for oral solution 400mg apricot sachet, 12pcs

$9.00

Active ingredient:	Ibuprofen
Dosage form:	Solution for oral use
Indications for use:	Arthritis, Arthrosis, Colds, Flu, Migraine, Periarthritis, Rheumatoid arthritis

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Categories: Medication, Other medications, Pain, inflammation

Indications

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).

Contraindications

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

History of hypersensitivity to acetylsalicylic acid or other NSAIDs.

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).

“Aspirin” asthma.

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

Bleeding of any etiology.

Pregnancy.

Lactation period.

Children under 12 years of age.

Diseases of the optic nerve.

Caution is required in the following cases::

advanced age;

heart failure;

arterial hypertension;

cirrhosis of the liver with portal hypertension;

hepatic and / or renal failure, nephrotic syndrome, hyperbilirubinemia;

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

blood diseases of unknown etiology (leukopenia and anemia).

Composition

Active ingredient

ibuprofen 400 mg;

Excipients:

L-arginine,

sodium bicarbonate,

sodium saccharinate,

aspartame,

apricot flavor,

sucrose.

Composition

Active ingredient

ibuprofen 400 mg;

Auxiliary substances:

L-arginine,

sodium bicarbonate,

sodium saccharinate,

aspartame,

apricot flavor,

sucrose.

Pharmacological action

Nonsteroidal anti-inflammatory drug (NSAID).

Clinical pharmacology

Pharmacodynamic Abuprofen – the Active ingredient of Faspik-is a propionic acid derivative and has analgesic, antipyretic and anti-inflammatory effects due to the indiscriminate blockade of cyclooxygenase 1 and 2 and has an inhibitory effect on prostaglandin synthesis. The analgesic effect is most pronounced in inflammatory pain. The analgesic activity of the drug does not belong to the narcotic type. Like all NSAIDs, Faspik exhibits antiplatelet activity. The analgesic effect when using Faspik (ibuprofen in the form of L-arginine salt) develops 10-45 minutes after ingestion. Pharmacokineticsabsorption: well absorbed from the stomach. When using Faspik, the maximum concentration (Cmax) of ibuprofen in plasma of 26 µg/ml and 56 µg/ml is reached within 15-25 minutes after taking the drug on an empty stomach at a dose of 200 mg and 400 mg, respectively. Distribution: ibuprofen is approximately 99% bound to plasma proteins. It is slowly distributed in the synovial fluid and is removed 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 metabolites are pharmacologically inactive. Elimination: has two-phase elimination kinetics. The plasma half-life (T-i/g) is 1-2 hours. Up to 90% of the dose can be detected in the urine as metabolites and their conjugates. Less than 1% is excreted unchanged in the urine and, to a lesser extent, in the bile.

Indications

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).

Use during pregnancy and lactation

Faspik is contraindicated in pregnant and breast-feeding women.

Contraindications

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

History of hypersensitivity to acetylsalicylic acid or other NSAIDs.

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).

“Aspirin” asthma.

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

Bleeding of any etiology.

Pregnancy.

Lactation period.

Children under 12 years of age.

Diseases of the optic nerve.

Caution is required in the following cases: :

advanced age;

heart failure;

arterial hypertension;

cirrhosis of the liver with portal hypertension;

hepatic and / or renal failure, nephrotic syndrome, hyperbilirubinemia;

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

blood diseases of unknown etiology (leukopenia and anemia).

Side effects

shortness of breath, bronchospasm,

gastrointestinal tract (GIT): pain in the mouth, irritation or dryness of the mucous membrane of the mouth, aphthous stomatitis, ulceration of the gingival mucosa, pancreatitis, NSAID-gastropathy (diarrhea, constipation, loss of appetite, heartburn, flatulence, nausea, vomiting, abdominal pain, ulceration of the mucous membrane of the gastrointestinal tract, in some cases complicated by perforation and bleeding);

the Central and peripheral nervous system: hallucinations, nervousness, insomnia, confusion, irritability, dizziness, drowsiness, anxiety, psychomotor agitation, depression, headache, aseptic meningitis (usually in patients with autoimmune diseases);

cardiovascular system: increased blood pressure, tachycardia, heart failure;

the organs of hematopoiesis: agranulocytosis, thrombocytopenic purpura, thrombocytopenia, leukopenia, anemia (including hemolytic and aplastic);

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

hepatic biliary system: hepatitis; the organ of vision: swelling of the conjunctiva and eyelids (allergic Genesis), blurred vision or double vision, toxic damage to the optic nerve, irritation and dry eyes, scotoma;

organ of hearing: a ringing noise in the ears, hearing loss;

allergic reactions: itching, skin rash (usually urticarial and erythematous), allergic rhinitis, eosinophilia, fever, bronchospasm or dyspnea, anaphylactoid reaction, angioedema, anaphylactic shock, toxic epidermal necrolysis (Lyell’s syndrome), exudative erythema multiforme (including Stevens – Johnson syndrome);

laboratory indicators: increased bleeding time, serum concentrations of creatinine and liver enzymes, decrease in creatinine clearance of glucose concentration in the blood, hemoglobin or hematocrit.

Long-term use of Faspik in high doses increases the risk of ulceration of the gastrointestinal mucosa, bleeding (gingival, gastrointestinal, hemorrhoidal or uterine) and visual disturbances (optic nerve damage, color vision disorders and the development of scotoma).

Interaction

acetylsalicylic acid (ASA): its antiplatelet effect decreases (and therefore the incidence of acute coronary insufficiency may increase in patients receiving ASA as an antiplatelet agent);

other NSAIDs (including ASA): increases the likelihood of side effects from the gastrointestinal tract;

methotrexate: increases its concentration in plasma;

furosemide, thiazide diuretics: their effectiveness may decrease due to sodium retention due to inhibition of prostaglandin synthesis in the kidneys;

indirect anticoagulants, antiplatelet agents, fibrinolytics: their effect increases, the risk of hemorrhagic complications increases;

vasodilators (including angiotensin converting enzyme inhibitors and slow calcium channel blockers): their hypotensive effect is reduced;

tacrolimus: increased likelihood of developing nephrotoxicity;

caffeine: increases the analgesic effect of ibuprofen;

zidovudine: increased risk of hematomas and hemarthrosis in HIV-infected patients with concomitant hemophilia;

means of myelotoxicity: the increased expression of gematotoksichnosti ibuprofen;

inhibitors of microsomal liver enzymes: reduced risk of hepatotoxic action;

inducers of microsomal liver enzymes (tricyclic antidepressants, barbiturates, phenylbutazone, phenytoin, rifampin, ethanol) increased the risk of severe hepatotoxic reactions by increasing the active and hydroxylated metabolites);

anticoagulants, thrombolytic preparations (streptokinase, urokinase, alteplase): increases the likelihood of bleeding;

plicamycin, cefotetan, cefoperazone, of cefamandol, valproic acid: increases the frequency of gipoprotrombinemii;

gold drugs, cyclosporine: increased nephrotoxicity of ibuprofen because of strengthening its influence on the synthesis of prostaglandins in the kidneys;

cyclosporine: increased plasma concentrations and, consequently, the risk of hepatotoxic effects;

antacids, cholestyramine: reduces absorption of ibuprofen;

ethanol, estrogens, corticosteroids, colchicine: possible development of ulcerogenic action with bleeding;

insulin, oral hypoglycemic drugs: their effect increases, which may require dose adjustment;

agents that block tubular secretion: the excretion decreases and the plasma concentration of ibuprofen increases;

phenytoin, lithium, digoxin: the probability of an increase in their plasma concentrations is not excluded.

How to take it, course of administration and dosage

The drug is taken orally, during or after a meal. Granules should be dissolved in 50-100 ml of water before use. Dosages for adults according to indications:

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

rheumatoid arthritis: 800 mg 3 times a day;

pain syndrome: in a daily dose of up to 1200 mg in several doses;

post-traumatic pain: in a daily dose of 1600-2400 mg in several doses;

algodismenorrhea: 400 mg 3-4 times a day.

Dosages for adolescents from 12 years of age according to indications:

juvenile rheumatoid arthritis: in a daily dose of 30-40 mg / kg in 3-4 divided doses;

elevated body temperature: from 39.2 °C-in a daily dose of 10 mg/kg, below 39.2 °C-5 mg/kg;

pain syndrome: in a daily dose of 5-10 mg/kg.

The maximum daily dose of Faspik: for children-40 mg / kg, for adults-1200 mg. For rheumatoid arthritis, higher doses are recommended, but not more than 2400 mg per day. To overcome the morning stiffness of arthritis, the first dose should be taken immediately after waking up.Duration of Faspic: as an antipyretic-up to 3 days, analgesic – up to 5 days. In patients with impaired liver, kidney or heart function, the dose of the drug is reduced.

Overdose

An overdose of ibuprofen may cause the following symptoms: drowsiness, lethargy, nausea, vomiting, abdominal pain, acute renal failure, metabolic acidosis, tinnitus, headache, depression, low blood pressure, tachycardia, bradycardia, atrial fibrillation, coma, respiratory arrest. After taking too high a dose of Faspik, if no more than an hour has passed, you should do a gastric lavage and take activated charcoal. Further, alkaline drinking, forced diuresis, and symptomatic therapy, including correction of blood pressure and acid-base status, are recommended.

Special instructions

Patients with an infection should be prescribed the drug with caution and subject to adequate antimicrobial therapy, since ibuprofen can mask the objective and subjective signs of infection.

Patients with allergic reactions and a history of bronchial asthma have an increased risk of developing bronchospasm during ibuprofen therapy.

With prolonged use of NSAIDs, there is a possibility of developing analgesic nephropathy.

In case of symptoms of gastrointestinal bleeding, Faspik is canceled.

Patients who notice visual impairment during therapy should stop taking the drug and consult an ophthalmologist.

The risk of side effects is reduced when Faspik is taken at the lowest effective dose for the shortest possible course.

During treatment, it is necessary to periodically monitor the picture of peripheral blood and the functional state of the kidneys and liver. Faspik should be discontinued within 48 hours in patients who are shown a test for the determination of 17-ketosteroids.

If signs of gastropathy appear, careful monitoring of the patient’s condition is required, including a fecal occult blood test, a blood test to determine hematocrit and hemoglobin, as well as esophagogastroduodenoscopy. To prevent the development of gastropathy associated with NSAID use, it is recommended to combine the drug with prostaglandin E agents (for example, misoprostol).

Ibuprofen can negatively affect female fertility, so it is not recommended for women to take it during pregnancy planning.

During treatment, you should refrain from drinking alcoholic beverages.

1 tablet of Faspik contains 16.7 mg of sucrose. The content of sucrose in granules with a dosage of 400 mg is 0.18 XE in 1 package and 0.54 XE in the maximum daily dose.

Influence on the ability to drive vehicles and complex mechanisms. During therapy, patients are advised to refrain from performing any work that requires rapid reactions and increased attention, including driving a car and operating complex mechanisms.

Faspik is contraindicated in pregnant and breast-feeding women.

Use in children Faspik in a dose of 200 and 400 mg is contraindicated in children under 12 years of age, in a dosage of 600 mg-in children and adolescents under 18 years of age.

With impaired renal function. Advanced renal disease and severe renal insufficiency with creatinine clearance (CC) less than 30 ml/min are contraindications to the use of Faspik. In patients with chronic renal failure (creatinine clearance 30-60 ml / min), the drug should be used with caution.

With impaired liver function. Severe hepatic insufficiency and active liver diseases are considered contraindications to the appointment of Faspik. In case of hepatic insufficiency, the drug should be used with caution.

Form of production

Granules for the preparation of a solution for oral use,400 MGCUS: Apricot packagingedit:12 multi-layer foil bags together with instructions for medical use in a cardboard box.

Storage conditions

Keep out of reach of children at temperatures up to 25 °C.

Shelf

life is 3 years. Do not use after the expiration date indicated on the package.

Active ingredient

Ibuprofen

Dosage form

solution for oral use

Purpose

Children over 12 years old, For adults

Indications

Cold, Periarthritis, Migraine, Osteoarthritis, Flu, Osteoarthritis and Arthritis, Rheumatoid Arthritis

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