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Ibufen D forte 200 mg/5 ml 40 ml suspension. for oral administration with raspberry flavor bottle.

Instructions for medical use of the drug IBUFEN® D Forte Trade name Ibufen® D Forte International nonproprietary name Ibuprofen Dosage form Oral suspension, raspberry 200 mg/5 ml Composition 5 ml of suspension contain the active substance - ibuprofen 200 mg, excipients: hypromellose, xanthan gum, glycerin, sodium benzoate, liquid maltitol, sodium citrate, citric acid monohydrate, sodium saccharinate, sodium chloride, raspberry flavor: aromatic components, triacetin (E1518), water; purified water. Description A homogeneous suspension of white or almost white color with a raspberry odor. Pharmacotherapeutic group Anti-inflammatory and antirheumatic drugs. Non-steroidal anti-inflammatory drugs. Propionic acid derivatives. Ibuprofen ATC code M01AE01 Pharmacological properties Pharmacokinetics After administration, the drug is rapidly absorbed from the gastrointestinal tract (GIT) and distributed in the body. The maximum serum concentration of ibuprofen is achieved 45 minutes after administration on an empty stomach. Food reduces the absorption of ibuprofen, but does not reduce its bioavailability and tmax is 1 - 2 hours. Ibuprofen is approximately 99% bound to plasma proteins. The main proteins that bind the drug are albumin. Ibuprofen and its metabolites are quickly and completely eliminated from the body by the kidneys. The half-life of the drug is approximately 2 hours. According to limited data, ibuprofen is excreted in breast milk in very low concentrations. Pharmacodynamics Ibuprofen is a propionic acid derivative that has antipyretic, analgesic and anti-inflammatory effects. The mechanism of action of ibuprofen is based on inhibition of the synthesis and release of prostaglandins by inhibiting the activity of prostaglandin cyclooxygenase, which catalyzes the conversion of arachidonic acid to prostaglandins, but other mechanisms are not excluded. The antipyretic and analgesic effects of ibuprofen occur within 30 minutes from the moment of taking the drug. Indications for use Increased body temperature of various origins with: colds, acute respiratory viral infections, influenza, sore throat, pharyngitis, childhood infections accompanied by an increase in body temperature Pain syndrome of various origins of weak and moderate intensity with: pain in the ears with an inflammatory process in the middle ear, toothache, painful teething headaches, migraines neuralgia muscle pain pain in bones and joints due to injuries to the musculoskeletal system (damage, sprains) pain due to soft tissue injuries, postoperative pain Dosage method: Used orally. 5 ml of suspension contain 200 mg of ibuprofen. Before use, shake until a homogeneous suspension is obtained. The drug is taken after meals with plenty of liquid. For precise dosage, a syringe dispenser is included in the package. The dose is set depending on the age and body weight of the child. The usually used single dose of Ibufen® D Forte is 7-10 mg/kg body weight up to a maximum daily suspension dose of 30 mg/kg body weight. The drug is prescribed in single doses according to the scheme below: Body weight (patient's age) Single dose Maximum daily dose 10-15 kg (children from 1 to 3 years old) 2.5 ml (corresponds to 100 mg of ibuprofen) 7.5 ml (corresponds to 300 mg ibuprofen) 16-19 kg (children from 4 to 6 years old) 4 ml (corresponding to 160 mg ibuprofen) 12 ml (corresponding to 480 mg ibuprofen) 20-29 kg (children from 7 to 9 years old) 5.0 ml (corresponding to 200 mg ibuprofen) 15 ml (corresponds to 600 mg ibuprofen) 30-39 kg (children from 10 to 12 years old) 5.0-7.5 ml (corresponds to 200-300 mg ibuprofen) 22.5 ml (corresponds to 900 mg ibuprofen) More 40 kg (children and adolescents over 12 years of age and adults) 5.0-10 ml (corresponding to 200-400 mg ibuprofen) 30 ml (corresponding to 1200 mg ibuprofen) The maximum daily dose should not be exceeded. A 6-hour interval should be maintained between subsequent doses. If symptoms persist, worsen, or if new symptoms appear, the patient should consult a doctor. The drug should not be used for more than 3 days without medical supervision. The drug does not contain sugar. Side effects Common ( 1/1000 to  1/100): heartburn, abdominal pain, nausea, vomiting, diarrhea, flatulence, constipation, mild bleeding from the gastrointestinal tract, which in exceptional cases can lead to anemia Not common ( 1/ 1000 to  1/100): allergic reactions with skin rash and itching attacks of suffocation (can occur along with a decrease in blood pressure) headache, dizziness, insomnia, agitation, irritability, feeling tired visual disturbances ulceration of the gastrointestinal tract, possibly with perforation or bleeding ulcerative stomatitis , gastritis, exacerbation of colitis and Crohn's disease Rarely ( 1/10000 to  1/1000): tinnitus Very rarely ( 1/10000): hematopoietic disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). necrotizing fasciitis severe hypersensitivity reactions: swelling of the face, tongue and larynx, shortness of breath, tachycardia, arterial hypotension (anaphylaxis, Quincke's edema or severe shock) psychotic reactions, depression palpitations, heart failure, myocardial infarction, stroke exacerbation of bronchial asthma and bronchospasm arterial hypertension esophagitis , pancreatitis, formation of diaphragm-like narrowing of the intestine, peptic ulcer, perforation of the ulcer or bleeding from the gastrointestinal tract, melena, vomiting of blood (sometimes fatal, especially in elderly patients), ulcerative stomatitis, gastritis, exacerbation of ulcerative colitis and acute renal Crohn's disease failure, papillonecrosis (especially with long-term use), associated with an increase in urea in the blood serum and edema, liver dysfunction; the development of severe forms of skin reactions, such as bullous reactions, including erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, symptoms of aseptic meningitis: stiff neck, headache, nausea, vomiting, fever or disorientation, especially in patients with pre-existing autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease) If side effects occur, discontinue use of the drug. Contraindications: hypersensitivity to ibuprofen or other components of the drug, as well as to other non-steroidal anti-inflammatory drugs; bronchial asthma, urticaria, rhinitis, provoked by taking acetylsalicylic acid (salicylates) or other NSAIDs; ulcerative lesions of the gastrointestinal tract (peptic ulcer of the stomach and duodenum); presence history of gastrointestinal bleeding or perforation associated with NSAID therapy cerebrovascular or other acute bleeding in patients with bleeding diathesis, hematopoietic disorders of unspecified etiology in patients with severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake) concomitant use of another NSAID, including specific cyclooxygenase inhibitors -2 severe renal or liver failure severe heart failure III trimester of pregnancy children under 1 year of age, children weighing less than 10 kg Drug interactions Ibufen® D Forte (as well as other drugs from the NSAID group) should not be used simultaneously with the following medications: - acetylsalicylic acid, other NSAIDs and corticosteroids: the risk of side effects from the gastrointestinal tract increases. Caution must be exercised when used simultaneously with the following drugs: - antihypertensive drugs and diuretics: since simultaneous use with NSAIDs reduces their effectiveness - antithrombotic drugs: NSAIDs can enhance the effect of drugs that reduce blood clotting - lithium, methotrexate, digoxin and phenytoin: NSAIDs can increase the concentration of these drugs in plasma (periodic monitoring of them in serum is recommended) - zidovudine: possible increase in bleeding time when used simultaneously with ibuprofen - antiplatelet drugs drugs and selective serotonin reuptake inhibitors (SSRIs): there is an increased risk of gastrointestinal bleeding - mifepristone: NSAIDs should not be used within 8-12 days after taking mifepristone, as NSAIDs may weaken its effect - tacrolimus, cyclosporine: risk of nephrotoxicity increases with simultaneous use of ibuprofen with these drugs - quinolone antibiotics: patients taking a combination of NSAIDs and quinolones may be at risk of seizures - potassium-sparing diuretics: simultaneous use with ibuprofen can lead to the development of hyperkalemia - probenecid, sulfinpyrazone: these drugs can inhibit the elimination of ibuprofen Special instructions The risk of unwanted effects can be reduced if you use the lowest effective dosage, and for the short time necessary to eliminate symptoms. Caution should be exercised when using the drug in patients: - with a history of peptic ulcer disease, especially complicated by bleeding or perforation - concomitantly taking other drugs such as corticosteroids, anticoagulants (warfarin), selective serotonin reuptake inhibitors or antiplatelet agents (acetylsalicylic acid) - with impaired liver and kidney function - with bronchial asthma, hay fever, nasal polyps or chronic obstructive respiratory disorders in history (due to an increased risk of allergic reactions, such as Quincke's edema or urticaria) - with chronic inflammatory bowel diseases (nonspecific ulcerative colitis, Crohn's disease) - with systemic lupus erythematosus and other connective tissue diseases - with uncontrolled arterial hypertension, congestive heart failure, diagnosed coronary heart disease, peripheral arterial disease and/or a history of cardiovascular disease - with cardiovascular risk factors diseases (hyperlipidemia, diabetes mellitus) - with congenital disorders of porphyrin metabolism (for example, acute intermittent porphyria) - with blood clotting disorders - immediately after a major surgical operation. Data from epidemiological and clinical studies suggest that the use of ibuprofen (especially at high doses of 2400 mg/day) and for a long time may be associated with a small increase in the risk of arterial thrombosis. You should stop using the drug if symptoms appear: skin rash, damage to the mucous membrane or other symptoms of hypersensitivity. Very rarely, severe skin reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been described in connection with the use of drugs from the NSAID group. The use of the drug for chickenpox should be avoided, since the role of NSAIDs in enhancing the manifestations of this infection cannot be ruled out. Elderly patients should take the drug with caution, as the risk of side effects due to the use of NSAIDs is higher than in younger patients. Elderly patients should take the minimum effective dosage. NSAIDs may mask symptoms of infection and fever. Isolated cases of toxic amblyopia have been reported with the use of ibuprofen. With prolonged use of analgesics, headaches may occur, which should not be treated with increased doses of Ibufen D Forte. Ibufen® D Forte contains liquid maltitol, and therefore the drug should not be used in patients with rare hereditary fructose intolerance. Ibufen® D Forte contains sodium benzoate, and therefore it should be used with great caution in patients with hypersensitivity. Pregnancy and lactation period. There is no comprehensive information regarding the safety of ibuprofen in women during pregnancy. Because the effect of inhibition of prostaglandin synthesis on the human fetus remains unknown, the use of ibuprofen in the first and second trimester of pregnancy is not recommended unless absolutely necessary. The use of ibuprofen in the third trimester of pregnancy is contraindicated, since it promotes premature closure of the ductus arteriosus and can cause pulmonary hypertension in the newborn; the drug also suppresses the contractile activity of the uterus, which delays the onset of labor and prolongs labor, and also increases the risk of bleeding in the mother and child. Ibuprofen and its metabolites pass into breast milk in very low concentrations. Since there have so far been no reports of negative effects on infants, there is no need to stop breastfeeding with short-term use of the drug. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms When taking the drug Ibufen® D Forte, dizziness may occur, which should be taken into account when driving vehicles and servicing moving mechanisms. Overdose In children, a single dose of more than 400 mg may cause overdose symptoms. In adults, the dose that can cause these symptoms has not been clearly established. The half-life during overdose ranges from 1.5 to 3 hours. Symptoms: Most patients taking clinically significant doses of NSAIDs may experience nausea, vomiting, epigastric pain, or diarrhea. You may also experience: tinnitus, headache and bleeding from the gastrointestinal tract. Severe intoxication affects the central nervous system and is manifested by drowsiness, and very rarely also agitation and disorientation or coma. Very rarely, seizures may occur. During severe intoxication, metabolic acidosis may occur and prothrombin time may increase. Possible development of acute renal failure or liver damage. Patients with bronchial asthma may experience an exacerbation of symptoms of the disease. Treatment: symptomatic and supportive treatment is used. It is necessary to monitor cardiac activity and vital signs. Oral activated charcoal should be considered within 1 hour of overdose. There is no specific antidote. Release form and packaging 100 ml or 40 ml of the drug in PET bottles with an adapter, sealed with a child-safe polyethylene screw cap with a tamper evident ring. A label is attached to each bottle. 1 bottle is placed in a cardboard pack. The packs contain approved instructions for medical use in the state and Russian languages and a syringe for oral administration. Storage conditions Store in a place protected from light at a temperature not exceeding 25 °C. Keep out of the reach of children! Shelf life: 2 years Shelf life after opening the original packaging: 6 months. Do not use after expiration date. Conditions for dispensing from pharmacies Without a prescription Name and country of the manufacturing organization Medana Pharma JSC, Poland Name and country of the owner of the registration certificate Khimpharm JSC, Republic of Kazakhstan Name and country of the packaging organization Medana Pharma JSC, Poland Address of the organization accepting claims on the territory of the Republic of Kazakhstan from consumers on the quality of products (products) of Khimpharm JSC, Shymkent, Republic of Kazakhstan, st. Rashidova, 81

Pharmacokinetics

After oral administration, more than 80% is absorbed from the gastrointestinal tract. Cmax in blood plasma is achieved when taken on an empty stomach - after 45 minutes, when taken after meals after 1.5–2.5 hours. Protein binding - 90%. Slowly penetrates into the joint cavity, but in the synovial fluid it creates higher concentrations than in the blood plasma (Cmax in the synovial fluid is reached after 2–3 hours). Metabolized mainly in the liver. Subject to pre- and post-systemic metabolism. After absorption, about 60% of the pharmacologically inactive R-form is slowly transformed into the active S-form. Excreted by the kidneys (60–90% in the form of metabolites and products of their combination with glucuronic acid, to a lesser extent with bile, unchanged - no more than 1%). It has a two-phase elimination kinetics with T1/2 of 2–2.5 hours, after taking a single dose it is completely eliminated within 24 hours. The antipyretic effect of Ibufen develops after 30 minutes and lasts 6–8 hours.

Side effects

From the side of the central nervous system:

headache, dizziness, sleep disturbance, anxiety, drowsiness, depression, agitation, visual impairment (reversible toxic amblyopia, blurred vision or double vision).

From the hematopoietic organs:

heart failure, tachycardia, increased blood pressure; anemia, thrombocytopenia, agranulocytosis, leukopenia.

From the gastrointestinal tract:

nausea, vomiting, loss of appetite, heartburn, abdominal pain, diarrhea, constipation, flatulence, liver dysfunction, peptic ulcers, gastric bleeding.

From the urinary system:

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

Allergic reactions:

itching, rash, bronchospastic syndrome, allergic rhinitis, Quincke's edema, Steven-Johnson syndrome, Lyell's syndrome.

Directions for use and doses

Inside

, after meal.
The average single dose is 5–10 mg/kg body weight 3–4 times a day. Children aged 6 months - 1 year (7-9 kg)
- 2.5 ml (50 mg) 3 times a day, maximum daily dose - 7.5 ml (150 mg).
1-3 years (10-15 kg)
- 2.5 ml (50 mg) 3-4 times a day, maximum daily dose - 7.5-10 ml (150-200 mg).
3-6 years (16-20 kg)
- 5 ml (100 mg) 3 times a day, maximum daily dose - 15 ml (300 mg).
6-9 years (21-30 kg)
- 5 ml (100 mg) 4 times a day, maximum daily dose - 20 ml (400 mg).
9-12 years (31-41 kg)
- 10 ml (200 mg) 3 times a day, maximum daily dose - 30 ml (600 mg).
Over 12 years (over 41 kg)
- 10 ml (200 mg) 4 times a day, maximum daily dose 40 ml (800 mg). The dose can be repeated every 6–8 hours. Do not exceed the maximum daily dose. For children from 6 months to 1 year, the drug is prescribed on the recommendation of a doctor.

pharmachologic effect

Antipyretic, analgesic, anti-inflammatory.

Blocks arachidonic acid cyclooxygenase and reduces PG synthesis. The antipyretic effect is due to a decrease in the concentration of PG in the cerebrospinal fluid, a decrease in excitation of the thermoregulation center, which results in the normalization of body temperature. The analgesic effect is associated with a decrease in the production of PG classes E, F, I, biogenic amines, a change in the sensitivity of nociceptors and the prevention of the development of hyperalgesia. The analgesic effect is most pronounced for inflammatory pain. The anti-inflammatory effect is due to a decrease in the secretion of inflammatory mediators and a decrease in the activity of the exudative and proliferative phase of the inflammatory process. The antipyretic and analgesic effect appears earlier and at lower doses than the anti-inflammatory effect, which occurs on days 5–7 of treatment.

Nosological classification (ICD-10)

G43 Migraine
J02.9 Acute pharyngitis, unspecified
J06 Acute upper respiratory tract infections of multiple and unspecified localization
J11 Influenza, virus not identified
K00.7 Teething syndrome
K08.8.0* Toothache
M25.5 Joint pain
M79.1 Myalgia
M79.2 Neuralgia and neuritis, unspecified
R50 Fever of unknown origin
R51 Headache
T14.3 Dislocation, sprain and damage to the capsular-ligamentous apparatus of a joint of an unspecified area of the body
T14.9 Injury, unspecified
T88.1 Other complications associated with immunization, not elsewhere classified

Overdose

Symptoms:

abdominal pain, nausea, vomiting, lethargy, headache, tinnitus, depression, drowsiness, metabolic acidosis, hemorrhagic diathesis, decreased blood pressure, acute renal failure, liver dysfunction, tachycardia, bradycardia, atrial fibrillation; convulsions, apnea and coma (especially typical for children under 5 years of age).

Treatment:

gastric lavage, administration of activated carbon, alkaline drinking, symptomatic therapy (correction of acid-base balance, blood pressure).

Contraindications

Hypersensitivity (including to acetylsalicylic acid or other NSAIDs), peptic ulcer of the stomach and duodenum, severe failure of the liver, kidneys, cardiovascular system, arterial hypertension, hemophilia, hypocoagulation, hemorrhagic diathesis, deficiency of glucose-6-phosphate dehydrogenase , bronchospastic reactions after the use of acetylsalicylic acid or other NSAIDs (“aspirin asthma”), Quincke’s edema, nasal polyps, hearing loss, infancy (up to 6 months, with body weight below 7 kg).

Interaction

It should not be combined with other NSAIDs (acetylsalicylic acid reduces the anti-inflammatory effect and increases side effects). When taken simultaneously with diuretics, the diuretic effect is reduced and the risk of developing renal failure increases. Weakens the effect of antihypertensive drugs, incl. ACE inhibitors (at the same time reduces their excretion by the kidneys), beta-adrenergic agents, thiazides. Enhances the effect of oral hypoglycemic agents (especially sulfonylurea derivatives) and insulin, indirect anticoagulants, antiplatelet agents, fibrinolytics (increases the risk of hemorrhagic complications), the toxic effect of methotrexate and lithium preparations, increases the concentration of digoxin in the blood.

Inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, zixorin, rifampicin, phenylbutazone, tricyclic antidepressants) increase the risk of severe hepatotoxic complications (increase the production of hydroxylated active metabolites), inhibitors of microsomal oxidation reduce it. Caffeine enhances the pain-relieving effect.