Ибуфен® Ultra

General characteristics. Structure:

Active agent - an ibuprofen of 200 mg.

Excipients: a macrogoal 600, potassium hydroxide, the water purified.

Cover: sorbitol liquid, not crystallizing, мальтитол liquid, patent blue E131, gelatin.

Pharmacological properties:

Pharmacokinetics. After oral administration more than 80% of an ibuprofen are soaked up from a digestive tract. 90% of drug contact proteins of a blood plasma (generally with albumine).

The period of achievement of the maximum concentration in a blood plasma at reception on an empty stomach – 45 minutes, at reception after food – 1,5-2,5 hours; in synovial fluid – 2-3 hours where big concentration, than in a blood plasma are created. Drug does not kumulirut in an organism.

The ibuprofen, mainly, in a liver is metabolized. Is exposed to presistemny and post-system metabolism. After absorption about 60% pharmacological of inactive R – a form of an ibuprofen are slowly transformed to active S – a form.

60-90% of drug are removed by kidneys in the form of metabolites and products of their connection with glucuronic acid, to a lesser extent, with bile and in an invariable look no more than 1% are allocated. After reception of a single dose drug is completely removed within 24 hours.

Pharmacodynamics. Ибуфен® Ultra is derivative propionic acid. Has anesthetic, febrifugal and antiinflammatory effect. The mechanism of action Ibufena® Ultra is caused, first of all, by suppression of biosynthesis of prostaglandins due to decrease of the activity of cyclooxygenase (TsOG) – the enzyme regulating transformation of arachidonic acid into prostaglandins, prostacyclin and thromboxane. At the same time as a result of irreversible braking of a cyclooxygenase way of metabolism of arachidonic acid formation of prostaglandins decreases. Decrease in concentration of prostaglandins in the place of an inflammation is followed by reduction of formation of bradikinin, endogenous pyrogens, other biologically active agents, radicals of oxygen and NO. All this leads to decrease of the activity of inflammatory process (antiinflammatory effect of an ibuprofen) and is followed by reduction of painful reception (analgeziruyushchy effect). Reduction of concentration of prostaglandins in cerebrospinal liquid leads to normalization of body temperature (antipyretic effect). Soft gelatin capsules of Ibufen® Ultra contain an ibuprofen in the liquid state. The gelatin capsule provides high precision of dosing of the substances placed in them. The cover of the capsule provides protection of active ingredient against light, air and moisture, and also excludes unpleasant taste and a smell of medicinal substance at reception. The capsule breaks up in a GIT quicker, than the dragee and tablets, and its liquid contents is quicker and easier absorbed in a human body, providing high bioavailability of an ibuprofen.

Indications to use:

The increased body temperature of various genesis at:

- catarrhal diseases;

- acute respiratory viral infections (quinsy, pharyngitis);

- flu;

- the children's infections which are followed by fervescence.

Pain syndrome of various origin of weak and moderate intensity at:

- an ear-ache at an inflammation of a middle ear;

- dentagra, painful teething;

- headache, migraine;

- painful periods;

- neuralgia;

- rheumatic pains;

- muscle, joints pains;

- musculoskeletal system injuries.

Route of administration and doses:

It is applied inside. It is necessary to swallow of the capsule entirely, washing down with a small amount of water. On 1-2 capsules each 4-6 hours. Maximum daily dose of 6 capsules (1200 mg of an ibuprofen).

The minimum interval between the next doses makes 4-6 hours.

It is not necessary to use drug more than 4 days as anesthetic and more than 3 days as an antipyretic without observation of the doctor.

Features of use:

Before administration of drug of Ibufen® Ultra it is necessary to consult with the doctor if earlier were confirmed: bronchial asthma, a small tortoiseshell, diseases of a liver and kidneys, a peptic ulcer of a stomach and duodenum in the anamnesis an arterial hypertension.

During prolonged treatment control of a picture of peripheral blood and a functional condition of a liver and kidneys is necessary. At emergence of symptoms of a gastropathy the careful control including carrying out an ezofagogastroduodenoskopiya, the general blood test (hemoglobin definition), the analysis a calla on the occult blood is shown. In need of definition of 17 ketosteroids drug should be cancelled in 48 hours prior to a research.

Patients with the uncontrollable arterial pressure, a circulatory unefficiency and coronary heart disease should appoint Ibufen® Ultra with care.

Patients with rare genetic intolerance of fructose should not accept Ibufen® Ultra because of the maltitol which is available in its structure.

At administration of drug of Ibufen® Ultra it is necessary to refrain from control of motor transport and to service of mechanisms.

Side effects:

Often (> 1/100, <1/10):

- nausea, vomiting, heartburn, diarrhea, abdominal pains, meteorism, locks.

Infrequently (> 1/1000, <1/100):

- nausea, heartburn, diarrhea, abdominal pains;

- headache, dizziness, excitement, sleeplessness, irritability, fatigue, depression, confusion of consciousness, hallucination;

- vision disorders;

- skin rash, itch, small tortoiseshell.

Seldom (> 1/10000, <1/1000):

- sonitus;

- abnormal liver function and kidneys.

Very seldom (<1/10000):

- digestive tract erosive cankers, dryness in a mouth, a stomacace, acute colitis, a disease Krone, endogastritis, hepatitis, pancreatitis, an abnormal liver function;

- hypertension;

- tachycardia, heart failure, myocardial infarction, stroke;

- esophagitis, pancreatitis, formation of diafragmopodobny narrowings of intestines;

- acute renal failure, nephrotic syndrome, allergic nephrite, polyuria, cystitis;

- anemia (including, hemolitic, aplastic), thrombocytopenia and Werlhof's disease, agranulocytosis, leukopenia;

- psychotic reactions, depression;

- Quincke's edema, Quincke's disease, anaphylactoid reactions, acute anaphylaxis, bronchospasm, fever, mnogoformny exudative erythema (including, Stephens-Johnson's syndrome), toxic epidermal necrolysis (scalded skin syndrome), eosinophilia, allergic rhinitis;

- reversible toxic neuritis visual, the illegibility of visual perception, a diplopia, konjyuktivit;

- sweating strengthening;

- bleedings (gastrointestinal, gingival, uterine, hemorrhoidal);

- aseptic meningitis.

Interaction with other medicines:

Ибуфен® Ultra (just as other medicines groups of non-steroidal anti-inflammatory drugs) should not be used along with following medicines:

- acetylsalicylic acid or other non-steroidal anti-inflammatory drugs – the risk of emergence of side effects from digestive tract increases;

- anti-hypertensive medicines and diuretics – medicines from group of non-steroidal anti-inflammatory drugs can cause decrease in efficiency of action of these means;

- anticoagulants – not numerous clinical data specify that non-steroidal anti-inflammatory drugs can strengthen effect of the medicines lowering coagulability of blood, digoxin, Phenytoinum, lithium and a methotrexate – is proved that non-steroidal anti-inflammatory drugs can cause increase in concentration in plasma of these medicines. The patients accepting at the same time an ibuprofen and a zidovudine, mineralokortikoida, glucocorticoids have proofs of increase in a bleeding time - side effects, sulphonylurea derivatives amplify - the hypoglycemic effect, antacids amplifies and холестирамин reduce absorption, caffeine strengthens analgeziruyushchy effect.

As a result of reception with cyclosporine amplifies toxic impacts on kidneys. The medicines containing пробенецид or Sulfinpyrazonum can slow down removal of an ibuprofen. The concomitant use of Ibufen® Ultra and potassium saving diuretics can lead to a hyperpotassemia (it is recommended to carry out potassium concentration in blood serum). NPVP can weaken Mefipreston's actions, it is necessary to refrain from use of NPVP within 8-12 days after Mefipreston's use. At simultaneous use of Takrolimus and Ibufen® Ultra the risk of nephrotoxic action increases.

Simultaneous uses of Ibufen® Ultra and alcohol side effects of drug from a GIT and TsNS can amplify.

Contraindications:

- hypersensitivity to an ibuprofen or other components of drug, and also to other nonsteroid antiinflammatory medicines;

- manifestations ever before allergy symptoms in the form of cold, skin rashes or bronkhospastichesky reactions after use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;

- a peptic ulcer of a stomach and duodenum in an aggravation phase;

- gastrointestinal bleedings;

- heavy heart failure;

- the expressed insufficiency of function of a liver and kidneys;

- deficit glucose-6-fosfatdegidrogenazy;

- blood diseases (hemophilia, hypocoagulation, hemorrhagic diathesis);

- pregnancy and period of a lactation;

- children's and teenage age up to 18 years.

Overdose:

Symptoms: abdominal pains, vomiting, block, headache, sonitus, depression, drowsiness, metabolic acidosis, coma, hemorrhagic diathesis, decrease in the ABP, spasm, acute renal failure, abnormal liver functions, tachycardia, bradycardia.

Treatment: absorbent carbon, symptomatic therapy.

Storage conditions:

To store in original packaging at a temperature not over 25 ⁰С.

To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

On 10 capsules place in a blister strip packaging from a film of polyvinyl chloride/polyvinyldichloride (PVDH/PVH) and aluminum foil.

On 1 or 2 planimetric packaging together with the instruction on a medical use in the state and Russian languages place in a cardboard pack.