Ibuprofen-Hemofarm - instructions for use, dose, side effects, contraindications

Excipients: microcrystalline cellulose PH 101 - 207.290 mg, sodium carboxymethyl starch - 9.795 mg, silicon dioxide colloid, anhydrous - 6,530 mg, stearic acid - 29,385 mg;

film sheath: Methacrylic acid-ethyl acrylate copolymer (1: 1) - 5.6363 mg talc - 4.4455 mg of titanium dioxide, E 171 - 1.9112 Polysorbate 80 - 1.0669 mg.

Description:Round, biconvex tablets, film-coated, white to yellowish white color, with the mark on one side, on the fracture from white to yellow-white color.

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

ATX: & nbsp

M.01.A.E.01 Ibuprofen

Pharmacodynamics:

Has anti-inflammatory, antipyretic, analgesic effect. It selectively blocks cyclooxygenase I and cyclooxygenase II. The mechanism of action of ibuprofen is due to inhibition of the synthesis of prostaglandins - mediators of pain, inflammation and hyperthermia.

Relieves pain syndrome, incl. joint pain at rest and during movement; reduces the morning stiffness and swelling of the joints, contributes to an increase in the volume of movements.

Pharmacokinetics:

Absorption is high, absorption decreases slightly when taking the drug after meals. The maximum concentration in the blood plasma (Cmah) in the fasting state is reached after 45 minutes when administered after a meal -. over 1.5-2.5 hours, and in synovial fluid - 2-3 hours, where large concentrations than in plasma. The connection with plasma proteins is 90%.Slowly penetrates into the joint cavity, lingers in the synovial tissue.

Biological activity is associated with S-enantiomer. After absorption about 60 % pharmacologically inactive Rform is slowly transformed into an active S-form. In the metabolism of the drug takes part isoenzyme CYP2C9. Exposed to the systemic and post-systemic metabolism in the liver. It has a two-phase kinetics of elimination with a half-life (T1 / 2) of 2- 2.5 h.

It is excreted by the kidneys (in an unchanged form not more than 1%) and to a lesser extent with bile.

In elderly people, the pharmacokinetic parameters of ibuprofen do not change.

Indications:

Inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid, juvenile chronic, psoriatic arthritis, osteoarthrosis, gouty arthritis, ankylosing spondylitis (Bekhterev's disease). The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, the progression of the disease is not affected.

Pain syndrome: myalgia, arthralgia, ossalgia, arthritis, sciatica, migraine, headache (including menstrual syndrome) and toothache, neuralgia, tendonitis,tendovaginitis, bursitis, post-traumatic and postoperative pain syndrome, accompanied by inflammation, with oncological diseases,

Algodismenorea, inflammation in the small pelvis, incl. adnexitis. Feverish syndrome with "colds" and infectious diseases.

Contraindications:

Hypersensitivity to any of the components of the drug, hypersensitivity to acetylsalicylic acid (ASA) or other NSAIDs; complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and ASA intolerance or other NSAIDs (including in the anamnesis); erosive and ulcerative diseases of the gastrointestinal tract (GIT) in the stage of exacerbation (including stomach ulcer and duodenal ulcer in the acute stage, ulcerative colitis, peptic ulcer, Crohn's disease - ulcerative colitis), inflammatory bowel disease , gastrointestinal bleeding; disorders of blood clotting (including hemophilia, hypocoagulation, lengthening bleeding time, propensity to bleed, hemorrhagic diathesis); period after aortocoronary shunting; intracranial hemorrhages; severe hepatic impairment or active liver disease; progressive kidney disease,marked renal failure with creatinine clearance less than 30 ml / min, confirmed hyperkalemia; pregnancy (III trimester); children under 12 years of age (for tablets coated with 400 mg film coating).

Carefully:

Elderly age, chronic heart failure, arterial hypertension, coronary heart disease, cerebrovascular disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, frequent alcohol use, liver cirrhosis with portal hypertension, hepatic and / or renal failure with creatinine clearance less 60 ml / min, nephrotic syndrome, hyperbilirubinemia, peptic ulcer of the stomach and duodenum (in the anamnesis), the presence of infection Helicobactor pylori, gastritis, enteritis, colitis, blood diseases of unclear etiology (leukopenia and anemia), prolonged use of NSAIDs, severe somatic diseases, simultaneous administration of oral glucocorticosteroids (GCS) (incl. prednisolone), anticoagulants (incl. warfarin), antiplatelet agents (incl. acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (incl. citalopram, fluoxetine, paroxetine, sertraline), pregnancy (I and II trimesters), lactation period.

Dosing and Administration:

Inside, after eating, and take the tablets effervescent (in the form of a solution) and tablets, covered with a film shell.

The doses of ibuprofen are individually selected so that the desired therapeutic effect is obtained by applying the smallest possible dose.

Tablets, film-coated appoint adults and children over 12 years, inside after eating, the pill must be swallowed whole, washed down with a small amount of liquid.

Adults and children over 12 years - inside by 1 tablet (400 mg). Re-reception no earlier than 4 hours later.

Adults should not take more than 3 tablets in 24 hours. The maximum daily dose is 1200 mg. The maximum daily dose for children from 12-18 years is 1000 mg.

If symptoms persist for 2-3 days after taking the drug, stop treatment and consult a doctor.

Side effects:

From the gastrointestinal tract (GIT): NSAIDs-gastropathy (abdominal pain, nausea, vomiting, heartburn, decreased appetite, diarrhea, flatulence, constipation, pain and discomfort in the epigastric region), rarely - ulceration of the gastrointestinal mucosa (in some cases complicated by perforation and bleeding); irritation, dryness of the oral mucosa or pain in the mouth, ulceration of the mucous membrane of the gums,aphthous stomatitis, pancreatitis, hepatitis.

From the central 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 sense organs: hearing loss, ringing or noise in the ears, reversible toxic optic neuritis, blurred vision or diplopia, dry and irritated eyes, conjunctival edema and eyelids (allergic genesis), scotoma.

From the respiratory system: shortness of breath, bronchospasm.

From the cardiovascular system (SSS): heart failure, tachycardia, increased blood pressure.

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

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

From the hematopoiesis: anemia (including haemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia.

Other: increased sweating.

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

Overdose:

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

Treatment: gastric lavage (only for 1 hour after intake), Activated carbon, alkaline drink, forced diuresis, symptomatic therapy (correction of acid-base state, blood pressure).

Interaction:

It is not recommended simultaneous reception of ibuprofen with acetylsalicylic acid and other NSAIDs.

With simultaneous appointment ibuprofen reduces the anti-inflammatory and antiaggregant effect of ASA (it is possible to increase the incidence of acute coronary insufficiency in patients receiving small doses of ASA as an antiplatelet agent after the onset of ibuprofen intake).

When prescribed with anticoagulant and thrombolytic drugs (AL) (alteplase, streptokinase, urokinase), the risk of bleeding increases at the same time.

Simultaneous reception with serotonin reuptake inhibitors (citalopram, fluoxetine, paroxetine, sertraline) increases the risk of developing serious gastrointestinal bleeding. Cefamandol, cefapperazone, cefotetan, valproic acid, plikachicin increase the frequency of hypoprothrombinemia.

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

LS, blocking tubular secretion, reduce excretion and increase the plasma concentration of ibuprofen.

Inductors of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of severe hepatotoxic intoxication.

Inhibitors of microsomal oxidation reduce the risk of hepatotoxic action.

Reduces the hypotensive activity of vasodilators (including blockers of "slow" calcium channels (BCC), angiotensin converting enzyme (ACE) inhibitors), natriuretic and diuretic - furosemide and hydrochlorothiazide.

Reduces the effectiveness of uricosuric drugs, increases the effect of indirect anticoagulants, antiaggregants, fibrinolytics (increased risk of hemorrhagic complications), enhances ulcerogenic effects with bleeding mineralocorticosteroids (ISS) and glucocorticosteroids (GCS), colchicine, estrogens, ethanol.

Strengthens the effect of oral hypoglycemic drugs (including derivatives of sulfonylureas) and insulin.

Antacids and colestramine reduce the absorption of ibuprofen.

Increases the concentration in the blood of digoxin, lithium and methotrexate.

Caffeine increases the analgesic effect.

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

Special instructions:

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 prostaglandins (misoprostol).

If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the test.

Patients should refrain from all activities requiring increased attention, rapid mental and motor reaction.

During the period of treatment, ethanol is not recommended.

To reduce the risk of developing adverse events on the part of the gastrointestinal tract, a minimum effective dose should be used with the minimum possible short course.

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:

Film-coated tablets 400 mg.

Packaging:

10 tablets per blister PVC / AL. 1, 2, 3 or 5 blisters with instructions for use in a pack of cardboard.

Storage conditions:

Tablets, film-coated, are stored in a dry place, at a temperature of 15 to 25 ° C.

Keep out of the reach of children!

Shelf life:

4 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N015343 / 02

Date of registration:26.08.2009 / 24.02.2016

Expiration Date:Unlimited

The owner of the registration certificate:Hemofarm ADHemofarm AD Serbia

Manufacturer: & nbsp

HEMOFARM D.O.O. SABAC Serbia

Representation: & nbspNizhpharm, JSCNizhpharm, JSCRussia

Information update date: & nbsp20.10.2017

Illustrated instructions

Instructions

Ibuprofen-Hemofarm (Ibuprofen-Hemofarm)