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Ibufen ultra capsules 200 mg N10

IBUFEN ultra International nonproprietary name of the drug Ibuprofen

Composition Each capsule contains: active ingredient: ibuprofen 200 mg excipients: macrogol 600 (E1521), potassium hydroxide (E525), purified water. Gelatin capsule: liquid maltitol (E965), liquid sorbitol, non-crystallizing (E420), gelatin (E441), patent blue dye (E131), purified water.

Description Oval-shaped gelatin capsules with a translucent blue shell containing a viscous liquid.

Dosage form Soft gelatin capsules

Pharmacotherapeutic group Nonsteroidal anti-inflammatory and antirheumatic drugs, propionic acid derivatives. ATS code: M 01 AE 01

Pharmacological properties Ibuprofen is a derivative of propionic acid. It has analgesic, antipyretic and anti-inflammatory effects. The mechanism of action of ibuprofen is primarily due to the suppression of prostaglandin biosynthesis by reducing the activity of cyclooxygenase (COX), an enzyme that regulates the conversion of arachidonic acid into prostaglandins, prostacyclin and thromboxane. At the same time, as a result of irreversible inhibition of the cyclooxygenase pathway of arachidonic acid metabolism, the formation of prostaglandins decreases. A decrease in the concentration of prostaglandins at the site of inflammation is accompanied by a decrease in the formation of bradykinin, endogenous pyrogens, other biologically active substances, oxygen radicals and NO. All this leads to a decrease in the activity of the inflammatory process (anti-inflammatory effect of ibuprofen) and is accompanied by a decrease in pain reception (analgesic effect). A decrease in the concentration of prostaglandins in the cerebrospinal fluid leads to normalization of body temperature (antipyretic effect). Ibufen ultra soft gelatin capsules contain ibuprofen in liquid form. Gelatin capsules ensure high dosing accuracy of the substances placed in them. The capsule shell protects the active substance from light, air and moisture, and also eliminates the unpleasant taste and smell of the medicinal substance when taken. The capsule disintegrates in the gastrointestinal tract faster than dragees and tablets, and its liquid contents are absorbed faster and more easily by the human body, ensuring high bioavailability of ibuprofen. After oral administration, more than 80% of ibuprofen is absorbed from the digestive tract. 90% of the drug binds to blood plasma proteins (mainly albumin). The period to achieve maximum concentration in blood plasma when taken on an empty stomach is 45 minutes, when taken after meals - 1.5-2.5 hours; in synovial fluid - 2-3 hours, where higher concentrations are created than in blood plasma. The drug does not accumulate in the body. Ibuprofen is metabolized mainly in the liver. Subject to presystemic and postsystemic metabolism. After absorption, about 60% of the pharmacologically inactive R form of ibuprofen is slowly transformed into the active S form. 60-90% of the drug is excreted by the kidneys in the form of metabolites and products of their combination with glucuronic acid, to a lesser extent, with bile and no more than 1% is excreted unchanged. After taking a single dose, the drug is completely eliminated within 24 hours.

Indications for use Increased body temperature of various origins with: - colds, - acute respiratory viral infections, - influenza; - sore throat (pharyngitis); - childhood infections accompanied by increased body temperature; - post-vaccination reactions. Pain syndrome of various origins of weak and moderate intensity with: - ear pain due to inflammation of the middle ear; - toothache, painful teething; - headache, migraine; - painful menstruation, - neuralgia, - rheumatic pain, - muscle and joint pain, - musculoskeletal injuries.

Contraindications The drug Ibufen Ultra should not be used in case of individual hypersensitivity to any component of the drug, as well as to other non-steroidal anti-inflammatory drugs; - ever-previous manifestations of allergy symptoms in the form of a runny nose, skin rashes or bronchospastic reactions after using acetylsalicylic acid or other non-steroidal anti-inflammatory drugs; - peptic ulcer of the stomach and duodenum in the acute phase, - severe insufficiency of liver and kidney function; — blood diseases: hemophilia, hypocoagulation, hemorrhagic diathesis; - in the third trimester of pregnancy.

Interaction with other drugs Ibuprofen (as well as other drugs from the group of non-steroidal anti-inflammatory drugs) should not be used simultaneously with the following drugs: - acetylsalicylic acid or other non-steroidal anti-inflammatory drugs - the risk of side effects from the gastrointestinal tract increases, - antihypertensive drugs drugs and diuretics - drugs from the group of non-steroidal anti-inflammatory drugs can cause a decrease in the effectiveness of these drugs, - anticoagulants - limited clinical data indicate that non-steroidal anti-inflammatory drugs can enhance the effect of drugs that reduce blood clotting, - lithium and methotrexate - it has been proven that non-steroidal anti-inflammatory drugs anti-inflammatory drugs can cause an increase in plasma concentrations of both lithium and methotrexate, - zidovudine - there is evidence of an increase in bleeding time in patients taking ibuprofen and zidovudine at the same time, - mineralocorticoids, glucocorticoids - increased side effects, - sulfonylurea derivatives - increased hypoglycemic effect, - antacids and cholestyramine reduce absorption, - caffeine enhances the analgesic effect.

Special instructions Before taking Ibufen ultra, you should consult a doctor if the following have been previously confirmed: - bronchial asthma, urticaria, - liver and kidney diseases, - a history of gastric and duodenal ulcers - arterial hypertension. During long-term treatment, monitoring of the peripheral blood picture and the functional state of the liver and kidneys is necessary. When symptoms of gastropathy appear, careful monitoring is indicated, including esophagogastroduodenoscopy, a complete blood count (hemoglobin determination), and a stool test for occult blood. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study.

Pregnancy and lactation The use of ibuprofen in the first 6 months of pregnancy requires caution and is permitted only as prescribed by a doctor, after assessing the expected benefits and possible risks. Ibuprofen should not be used in the last trimester of pregnancy. Ibuprofen may be excreted in breast milk in small quantities. There are no known cases of side effects in infants, however, it is recommended to stop breastfeeding during treatment with ibuprofen.

Impact on the ability to drive vehicles and maintain mechanical equipment There is no information on contraindications to driving and servicing machinery while taking Ibufen ultra.

Method of administration and dosage For oral use. 1 capsule contains 200 mg of ibuprofen. Adults and children over 12 years of age (over 40 kg): single dose 200-400 mg (1-2 capsules). Then, if necessary, 1-2 capsules every 4-6 hours. The maximum daily dose is 6 capsules (1200 mg ibuprofen). The minimum interval between subsequent doses is 4-6 hours. The capsule must be swallowed whole with a small amount of water. Capsules should not be cracked, sucked or chewed. When using the drug in children, the child’s weight should be taken into account for accurate dosing. The drug should not be used for more than 5 days as an analgesic and for more than 3 days as an antipyretic without medical supervision.

Overdose If you take a higher dose of the drug than recommended, you should immediately contact your doctor or pharmacist. Symptoms of overdose: abdominal pain, vomiting, lethargy, headache, tinnitus, depression, drowsiness, metabolic acidosis, coma, hemorrhagic diathesis, decreased blood pressure, convulsions, acute renal failure, liver dysfunction, tachycardia, bradycardia. High doses of ibuprofen are usually well tolerated, provided that no other drugs are used at the same time. Measures in case of overdose: gastric lavage (only within an hour after taking the drug), activated carbon, alkaline drinking, symptomatic therapy (correction of the acid-base state, blood pressure).

Side effects Side effects are classified by frequency using the following definitions: - very common: > 1/10 - common: > 1/100 to < 1/10 - uncommon: > 1/1000 to < 1/100 - rare: > 1 /10,000 to <1/1000 - very rare: <1/10,000 When using Ibufen ultra for 2-3 days, practically no side effects are observed. In case of long-term use, the following side effects may occur: From the gastrointestinal tract Uncommon: nausea, heartburn, diarrhea, abdominal pain. Rarely: vomiting, flatulence, constipation, inflammation of the gastrointestinal tract. Very rare: ulceration of the gastrointestinal mucosa, bleeding, Crohn's disease, impaired liver function. From the nervous system: Uncommon: headache; Rare: dizziness, agitation, insomnia, drowsiness. In isolated cases, hearing loss, tinnitus, and depression have been described. From the urinary system Rarely: edematous syndrome, Very rarely: acute renal failure, allergic nephritis, polyuria, cystitis. From the hematopoietic organs Very rare: anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia. Allergic reactions Uncommon: skin rash, itching, urticaria, Very rare: Quincke's edema, 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 cardiovascular system: Heart failure, increased blood pressure, tachycardia. Any side (unusual) effects, including those not listed in the package insert, should be reported to your doctor.

Shelf life: 2 years Do not use after the expiration date indicated on the package. The medicine should be stored out of the reach of children.

Storage conditions Store in original packaging at a temperature not exceeding 25C.

Packaging Ibufen ultra, soft gelatin capsules 200 mg: 10 capsules each in a blister made of PVC/PVDC and aluminum foil. 10 (1 blister) or 20 (2 blisters) capsules together with an insert in a cardboard box.