Composition, form of production and packaging
? The tablets are effervescent from white to yellowish white, round, flat-cylindrical, with a facet on both sides, with a faint smell of lemon.
ibuprofen D, L-lysinate 342 mg,
which corresponds to the content of ibuprofen 200 mg
Excipients: sodium carbonate, povidone K-25, sodium saccharinate, aspartame, xylitol, lemon flavor, simethicone aqueous emulsion (Silfar SE-4).
10 pieces. - Plastic tubes (1) - packs of cardboard.
10 pieces. - Plastic tubes (2) - packs cardboard.
20 pcs. - Plastic tubes (1) - packs of cardboard.
20 pcs. - Plastic tubes (2) - packs cardboard.
? Tablets covered with a film membrane from white to yellowish white, round, biconvex, with a risk on one side; on a break - from white to yellowish-white color.
ibuprofen 400 mg
Excipients: microcrystalline cellulose PH101, sodium carboxymethyl starch, silicon dioxide colloidal anhydrous, stearic acid.
Composition of the film shell: a copolymer of methacrylic acid and ethacrylate (1: 1), talc, titanium dioxide (E171), polysorbate 80.
10 pieces. - blisters (1) - packs of cardboard.
10 pieces. - blisters (2) - packs of cardboard.
10 pieces. - blisters (3) - packs of cardboard.
10 pieces. - blisters (5) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
Has anti-inflammatory, antipyretic, analgesic action. Non-selective inhibits cyclooxygenase-1 and cyclooxygenase-2. 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.
Absorption is high, absorption decreases slightly when taking the drug after meals. Cmax in blood plasma when taken on an empty stomach is reached after 45 minutes, when taken after meals - after 1.5-2.5 hours, and in synovial fluid - 2-3 hours, where it creates more concentrations than in blood plasma. Relationship with plasma proteins 90%. Slowly penetrates into the joint cavity, lingers in the synovial tissue.
Biological activity is associated with the S-enantiomer. After absorption, about 60% of the pharmacologically inactive R-form is slowly transformed into an active S-form. The isozyme CYP2C9 is involved in the metabolism of the drug. Exposed to the systemic and post-systemic metabolism in the liver. It has a two-phase kinetics of elimination with T 1/2 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.
- inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid, juvenile chronic, psoriatic arthritis, osteoarthritis, gouty arthritis, ankylosing spondylitis (Bechterew'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 cancer diseases;
- algodismenorea, inflammation in the small pelvis, incl. adnexitis;
- febrile syndrome with colds and infectious diseases.
Inside, after eating, and take the tablets effervescent (in the form of a solution), and tablets, coated 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.
The effervescent tablet of the preparation Ibuprofen-Hemofarm is completely dissolved in a glass (200 ml) of water, and the resulting solution is immediately drunk.Effervescent tablets should not be swallowed, chewed and sucked in the mouth.
Effervescent tablets are prescribed for children over 6 years and adults .
Adult - a single dose of ibuprofen is 1-2 effervescent tablets. (200-400 mg); The daily dose is 4-6 tab. effervescent (800-1200 mg), in divided doses with an interval of 4-6 hours.
Children aged 6 to 12 years: a single dose of 1 effervescent tablet. (200 mg); therapeutic dose - 1 effervescent tablet. with an interval of 4-6 hours, 2-4 times / day. The maximum daily dose is 4 effervescent tablets. (800 mg / day).
Children over the age of 12: single dose is 1-2 effervescent tablets. (200-400 mg); therapeutic dose of 1-2 tablets. with an interval of 4-6 hours. The maximum daily dose is 5 effervescent tablets. (1000 mg).
Film-coated tablets are prescribed for adults and children over 12 years , inside after eating, the tablets must be swallowed whole, with a small amount of liquid.
Adults and children over 12 years - inside 1 tab. (400 mg). Re-reception no earlier than 4 hours.
Adults should not take more than 3 tablets. for 24 hours. The maximum daily dose is 1200 mg. The maximum daily dose for children from 12-18 years is 1000 mg.
If symptoms are protected during 2-3 days after taking the drug, stop treatment and consult a doctor.
Co side of the digestive system: NSAIDs-gastropathy (abdominal pain, nausea, vomiting, heartburn, decreased appetite, diarrhea, flatulence, constipation, pain and discomfort in the epigastric region); rarely - ulceration of the mucous membrane of the gastrointestinal tract (in some cases complicated by perforation and bleeding), irritation, dryness of the oral mucosa or pain in the mouth, ulceration of the gingival mucosa, aphthous stomatitis, pancreatitis, hepatitis.
From the side of the central 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 senses: hearing loss, ringing or noise in the ears, reversible toxic optic neuritis, blurred vision or diplopia, dryness and irritation of the eyes, edema of the conjunctiva and eyelids (allergic genesis), scotoma.
On the part of the respiratory system: dyspnea, bronchospasm.
From the cardiovascular system: 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, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome) , eosinophilia, allergic rhinitis.
From the hemopoiesis: anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, and leukopenia.
Other: increased sweating.
The risk of ulceration of the gastrointestinal mucosa, bleeding (gastrointestinal, gum, uterine, hemorrhoidal), visual impairment (color vision, scotoma, amblyopia) increases with prolonged use in large doses.
- complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance of ASA or other NSAIDs (including in the anamnesis);
- erosive and ulcerative diseases of the digestive tract in the acute stage (including gastric ulcer and duodenal ulcer in the acute stage, ulcerative colitis, peptic ulcer, Crohn's disease, NJC), inflammatory bowel diseases, gastrointestinal bleeding;
- Violations of blood clotting (including hemophilia, hypocoagulation, prolongation of bleeding time, propensity to bleed, hemorrhagic diathesis);
- period after aortocoronary shunting;
- intracranial hemorrhage;
- 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 6 years (for effervescent tablets 200 mg),
- Children under 12 years of age (for tablets coated with a film coating of 400 mg);
- hypersensitivity to any of the components of the drug;
- Hypersensitivity to acetylsalicylic acid (ASA) or other NSAIDs.
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, gastric and duodenal ulcer (in the anamnesis), presence of Helicobactor pylori infection, gastritis, enteritis t, colitis, blood diseases of unclear etiology (leukopenia and anemia), long-term use of NSAIDs, severe somatic diseases, simultaneous administration of oral GCS (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (v. Acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline), pregnancy (I and II trimesters), lactation period.
PREGNANCY AND LACTATION
APPLICATION FOR FUNCTIONS OF THE LIVER
- severe hepatic impairment or active liver disease.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
- progressive kidney disease, marked renal failure with creatinine clearance less than 30 ml / min, confirmed hyperkalemia.
APPLICATION FOR CHILDREN
- Children under 6 years (for effervescent tablets 200 mg),
- Children under 12 years of age (for tablets coated with 400 mg film coating).
APPLICATION IN ELDERLY PATIENTS
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 and hematocrit, and analysis of feces for latent blood are 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 digestive tract, a minimum effective dose should be used with the minimum possible short course.
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 charcoal, alkaline drink, forced diuresis, symptomatic therapy (correction of acid-base state, blood pressure).
It is not recommended simultaneous administration of ibuprofen with acetylsalicylic acid (ASA) and other NSAIDs.
With simultaneous administration, ibuprofen reduces the anti-inflammatory and antiaggregant effect of ASA (possibly increasing the incidence of acute coronary insufficiency in patients receiving low doses of ASA as an antiplatelet agent after the onset of ibuprofen administration).
When administered with anticoagulant and thrombolytic drugs (alteplase, streptokinase, urokinase), the risk of bleeding increases at the same time.
Simultaneous reception with serotonin reuptake inhibitors (cytatopram, fluoxetine, paroxetine, sertratin) increases the risk of developing serious gastrointestinal bleeding.
Cefamandol, cefaperazone, cefotetan, valproic acid, plikamycin 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. Drugs that block tubular secretion, reduce excretion and increase the plasma concentration of ibuprofen.
Microsomal oxidation inductors (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of severe hepatotoxic intoxications.
Inhibitors of microsomal oxidation reduce the risk of hepatotoxic action.
Reduces the hypotensive activity of vasodilators (including blockers of slow calcium ropes), ACE inhibitors), natriuretic and diuretic - furosemide and hydrochlorothiazide.
Reduces the effectiveness of uricosuric drugs, increases the effect of indirect anticoagulants, antiplatelet agents, fibrinolytic agents (increased risk of hemorrhagic complications), enhances ulcerogenic effect with bleeding mineralocorticosteroids and glucocorticosteroids, colchicine, estrogens, ethanol.
Strengthens the effect of peroral hypoglycemic drugs (including derivatives of sulfonylureas) and insulin.
Antacids and colestyramine reduce the absorption of ibuprofen.
Increases the concentration in the blood of detoxin, lithium and methotrexate.
Caffeine increases the analgesic effect.
Myelotoxic agents increase the manifestation of hematotoxicity of the drug.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
Tablets, film-coated and effervescent tablets are stored out of reach of children, dry place, at a temperature of 15 В° to 25 В° C. Shelf life - 3 years.