Instruction for use: Ibuclin

Active substance Ibuprofen + Paracetamol

ATX code M01AE51 Ibuprofen in combination with other drugs

Pharmacological group

Analgesic combined (NSAIDs + analgesic non-narcotic) [NSAIDs - Propionic acid derivatives in combinations]

Analgesic combined (NSAIDs + analgesic non-narcotic) [Anilides in combinations]

Nosological classification (ICD-10)

J06 Acute upper respiratory infections of multiple and unspecified

Frequent colds viral diseases, Infections of the upper respiratory tract, Acute respiratory disease influenza character, for colds Pain, Acute colds,Cold, respiratory infection,Seasonal colds, Pain in infectious and inflammatory diseases of the upper respiratory tract, Bacterial infections of the upper respiratory tract, Bacterial respiratory infections, Viral disease of the respiratory tract, Viral respiratory tract infections, Inflammatory disease of the upper respiratory tract, Inflammation of the upper respiratory tract disease, Inflammation of the upper respiratory tract illness with difficult sputum, Inflammatory airway disease, Secondary infections with colds, Shortness of sputum in acute and chronic respiratory diseases, Upper respiratory tract infection, Infections of the upper respiratory tract, Respiratory Tract Infections, Infections of the respiratory tract and lungs, Infectious-inflammatory diseases of the upper respiratory tract, Infectious-inflammatory diseases of the upper respiratory tract and ENT-organs, Infectious-inflammatory diseases of the upper respiratory tract in children and adults, Infectious-inflammatory diseases of the upper respiratory tract, Infectious inflammation of the airways,respiratory infection, Qatar upper respiratory tract, Catarrh of the upper respiratory tract, Catarrhal disease of the upper respiratory tract, Catarrhal symptoms of the upper respiratory tract, Coughing with a cold, SARS, ARI, ARI with rhinitis phenomena, Acute respiratory infection, Acute infectious and inflammatory disease of the upper respiratory tract, Acute respiratory disease, Sore throat or nose, Respiratory viral infections, Respiratory diseases, Respiratory infections, Recurrent respiratory infections, Secondary infection with influenza, cold in the chest, Feverish condition with flu usitis, acute sinusitis, genyantritis, purulent sinusitis

J11 Influenza, virus not identified

Flu, Influenza in the early stages of the disease, Flu in children, cold in the chest, Begins flu-like condition, Acute disease parainfluenza, parainfluenza, parainfluenza state, influenza epidemics, The pains of the flu, Influenza

K08.8.0 * Painful toothache

Dentinal pain, Dentinal pains, Pain pulpitis, Anesthesia in dentistry, Pain syndromes in dental practice, Pain after removal of tartar, Pain when extracting a tooth, Toothache, Pain after dental interventions

M06.4 Inflammatory polyarthropathy

Inflammatory-degenerative diseases of the musculoskeletal system

M25.5 Pain in the joint

Arthralgia, Pain syndrome in musculo-articular diseases, Pain syndrome in osteoarthritis, Pain syndrome in osteoarthritis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Pain in the joints, Soreness of the joints, Soreness of joints in severe physical exertion, Painful inflammatory joint damage, Painful conditions of the musculoskeletal system, Painful joint conditions, Painful traumatic affection of joints, Pain in the musculoskeletal system, Pain in Shoulder Joints, Pain in the joints, Joint pain, Joint pain with injuries, Musculoskeletal pain, Pain with osteoarthritis, Pain in the pathology of the joints, Pain in rheumatoid arthritis, Pain in chronic degenerative bone diseases, Pain in chronic degenerative joint diseases, Bone-joint pain, Joint pain, Arthritic pain of rheumatic origin, Articular pain syndrome, Joint pain, Rheumatic pain, Rheumatic pains

M54 Dorsalgia

Pain in the back area, Pain in the spine, Back pain, Pain in different parts of the spine, Backache, Painful pain syndrome in the spine, Pain in the musculoskeletal system

M54.5 Pain below the back

Pain in the lower back, Lumbar pain, Lumbalia, Painful conditions of the spinal column, Back pain, Lower Back Pain Syndrome

M79.1 Myalgia

Myofascial pain syndromes ,Pain syndrome in musculo-articular diseases, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Pain in the muscles, Tenderness of muscles, Muscular soreness in severe physical exertion, Painful conditions of the musculoskeletal system, Pain in the musculoskeletal system, Pain in the muscles, Pain at rest, Muscle aches, Muscle pain, Musculoskeletal pain, Myalgia, Muscle pain, Muscle pain at rest, Muscle pain, Muscular pain of non-rheumatic origin, Muscle pain of rheumatic origin, Acute muscle pain, Rheumatic pain, Rheumatic pains, Myofascial syndrome, Fibromyalgia

M79.2 Neurology and neuritis, unspecified

Pain syndrome with neuralgia, Brachialgia, Occipital and intercostal neuralgia, Neuralgia, Neuralgic pain, Neuralgia, Neuralgia of intercostal nerves,Neuralgia of the posterior tibial nerve, Neuritis, Neuritis traumatic, Neuritis, Neurological Pain Syndromes, Neurological contractures with spasms, Acute neuritis, Peripheral neuritis,Post-traumatic neuralgia,Severe pain of a neurogenic nature, Chronic neuritis, Essential neuralgia

N94.6 Dysmenorrhea Unspecified

Pain during menstruation, Functional disorders of the menstrual cycle, Menstrual cramps, Emmeniopathy, Pain during menstruation, Painful menstrual irregularities, algomenorrhea, algomenoreya, Pain smooth muscle spasm, Pain spasm of smooth muscles (renal and biliary colic, intestinal spasms, dysmenorrhea), Pain spasm of smooth muscles of internal organs (kidney and biliary colic, intestinal spasms, dysmenorrhea), Disalgomenoreya, dysmenorrhea, Dysmenorrhea (essential) (Exfoliative), menstrual disorder, menstruation painful, metrorrhagia, Violation of the menstrual cycle, Menstrual irregularities, Prolaktinzavisimoe menstrual disorders, Prolaktinzavisimoe menstrual dysfunction, Pain spasm of smooth muscles of internal organs, Spasmodic dysmenorrhea, Primary disalgomenoreya

M89.9 Disease of bone, unspecified

Local osteopathy, Disturbance of bone mineralization processes, Osteopenia, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Pain in the musculoskeletal system, Infection of bones, Ossalgia, Pain in chronic degenerative bone diseases

M95.8 Other specified musculoskeletal deformities

Degenerative and dystrophic disease of the musculoskeletal system ,Degenerative disease of the musculoskeletal system, Obmenno-dystrophic diseases of the musculoskeletal system

N94.6 Dysmenorrhea Unspecified

Pain during menstruation, Functional disorders of the menstrual cycle, Menstrual cramps, Emmeniopathy, Pain during menstruation, Painful menstrual irregularities, algomenorrhea, algomenoreya, Pain smooth muscle spasm, Pain spasm of smooth muscles (renal and biliary colic, intestinal spasms, dysmenorrhea), Pain spasm of smooth muscles of internal organs (kidney and biliary colic, intestinal spasms, dysmenorrhea), Disalgomenoreya, dysmenorrhea, Dysmenorrhea (essential) (Exfoliative), menstrual disorder, menstruation painful, metrorrhagia, Violation of the menstrual cycle, Menstrual irregularities, Prolaktinzavisimoe menstrual disorders, Prolaktinzavisimoe menstrual dysfunction, Pain spasm of smooth muscles of internal organs, Spasmodic dysmenorrhea, Primary disalgomenoreya

R07.0 Sore throat

A sharp pain in the throat, Sore throat

R50.0 Fever with chills

High fever, Heat, Chills, elevated temperature, hyperthermia, Prolonged fever, Feverish syndrome, Fervescence, Increased body temperature in infectious and inflammatory diseases, fever Symptoms, febrile syndrome, Febrile state, Fever, Fever in infectious and inflammatory diseases, Fever with SARS, Fever with cold, Fever for colds, febrility, Feverish condition with flu, Feverish state in infectious and inflammatory diseases , Feverish state of infectious diseases and in the postoperative period, Feverish condition for colds, Febrile of different genesis, Feverish syndrome on the background of infectious diseases, Feverish syndrome in infectious and inflammatory diseases, Feverish syndrome with colds, Feverish syndrome of different genesis, Increased temperature for colds, Increased temperature at catarrhal and infectious and inflammatory diseases, Increased body temperature in cold, etc., Increased body temperature in cold and other infectious and inflammatory diseases, Increased body temperature in cold and other infectious and inflammatory diseases, Fever during pregnancy, Fever with thrombocytopenia, Febrile reaction in blood transfusion

R51 Headache

Pain in the head, Cephalgia, Pain with sinusitis, Pain in the back of the head, Painful headache, Headache of vasomotor genesis, Headache of vasomotor origin, Headache with vasomotor disorders, Headache, Neurological headache, Serial headache

R52.0 Acute pain

Acute pain syndrome, Acute pain syndrome with osteoarthritis, Acute pain syndrome of traumatic origin, Severe pain of a neurogenic nature, Severe pain, Pain syndrome at delivery

R52.9 Unspecified Pain

Pain after cholecystectomy, Pain shooting, Non-malignant pain, Obstetric and gynecological pain, Pain syndrome, Pain in the postoperative period, Pain in the postoperative period after orthopedic surgery, Pain of inflammatory genesis, Pain than cancer genesis, Pain syndrome after diagnostic procedures, Pain after surgery Diagnostic, Pain after surgery, Pain after orthopedic surgery, Pain after injuries, Pain after the removal of hemorrhoids, Pain at the non-rheumatic inflammation of nature, Pain in inflammatory lesions of the peripheral nervous system, Pain in diabetic neuropathy, Pain in acute inflammatory diseases of the musculoskeletal system, Pain when the tendon pathology, Pain smooth muscle spasm, Pain spasm of smooth muscles (renal and biliary colic, intestinal spasms, dysmenorrhea), Pain spasm of smooth muscles of internal organs, Pain spasm of smooth muscles of internal organs (kidney and biliary colic, intestinal spasms, dysmenorrhea), Pain in trauma syndrome, Pain with injuries and after surgical interventions, Pain in chronic inflammatory diseases of the musculoskeletal system, Pain with duodenal ulcer, Pain syndrome in gastric ulcer, Pain syndrome in gastric ulcer and duodenal ulcer, pain, Pain during menstruation, pain syndromes, painful condition, Painful foot fatigue, Sore gums when wearing dentures, Soreness of the cranial nerves exit points, Painful menstrual irregularities, Painful dressings, Painful muscle spasm, Painful teeth growth, Melosalgia, Pain in the area of the surgical wound, Pain in the postoperative period, Pain in the body, Pain after diagnostic procedures, Pain after orthopedic surgery, Pain after surgery, The pains of the flu, Pain in diabetic polyneuropathy, Pain for burns, Pain during sexual intercourse, Pain during diagnostic procedures, Pain during therapeutic procedures, for colds Pain, Pain in sinusitis, Pain in trauma, Pain traumatic, The pain in the postoperative period, Pain after diagnostic procedures, The pain after sclerotherapy, Pain after surgery, postoperative Pain, Pain postoperative and posttraumatic, posttraumatic pain, Pain when swallowing, Pain in infectious and inflammatory diseases of the upper respiratory tract, The pain of burns, The pain in traumatic muscle injury, Pain in trauma, The pain of tooth extraction, The pain of traumatic origin, Pain caused by spasm of smooth muscles, Expressed pain syndrome, Expressed pain syndrome, traumatic origin, Postoperative pain, Post-traumatic pain, Post-traumatic pain syndrome, Torpid pain, Traumatic pain, Traumatic pain, Mild pain, Moderately severe pain, Moderate pain, Polyarthralgia with polymyositis

R68.8.0 * Inflammatory syndrome

Painful syndrome of inflammatory genesis, Pain syndrome with inflammation of non-rheumatic nature, Pain syndrome with inflammatory lesions of the peripheral nervous system, Painful inflammation of the shoulder joint, Painful inflammation after trauma or surgery, Painful inflammation after surgery, Painful hemorrhoids, Inflammation of the tympanic membrane, Inflammation of the larynx, Inflammation of the gums, Inflammation of cellulose, Inflammation of lymph nodes, Tonsillitis, Inflammation of muscles, Inflammation of soft tissues, Inflammation of the mouth, Inflammation after surgery and trauma, Inflammation after orthopedic surgery, Inflammation after trauma, Inflammation in rheumatoid arthritis, Inflammation of the middle ear, Inflammatory gum disease, Inflammatory diseases of the eyelids, Inflammatory eye diseases, Inflammatory swelling of soft tissues, Inflammatory processes, Inflammatory processes after surgical interventions, Inflammatory process, Inflammatory Syndrome, Inflammatory syndrome of non-rheumatic origin, Inflammatory syndrome after surgery, Purulent infections, Infringements of function of a liver of an inflammatory etiology, Acute inflammation of the musculoskeletal tissue, Pre-inflammatory soft tissue inflammation

T03.9 Multiple dislocations, sprains and injuries of capsular-ligamentous apparatus of joints, unspecified

Dislocation, Dislocations, Distortion

T14.0 Surface injury of unspecified body region

Abrasions, Scratch, Skin Wounds, Wounds of soft tissues, Hematoma, Hematoma of traumatic origin, Hematomas, Hematomas of muscles, Hematomas of soft tissues, Healing of the skin, Bruise, Bruising due to sprains and bruises, Microtrauma, External bruises, Small combing, Superficial hematoma, Superficial damage to the skin and mucous membranes, Subcutaneous hematoma, Post-traumatic hematoma, Post-traumatic disturbance of microcirculation, Skinness of the skin, Traumatic plexus lesions, Injury, Contusion of soft tissues, Joint bruise, Traumatic bruises, Traumatic injury, Primary treatment of surface contaminated wounds, Abrasion, Bruise

T14.2 Fracture in unspecified area of body

Internal fixation of bone fracture, Acute period after fractures of bones, Edema after interventions for fractures, Fracture, Fractures of bones, Reposition of bone fragments in fractures, Traumatic bone injuries, Traumatic bone injury,Injuries of the osteoarticular system, Injuries to bone tissue

T14.3 Dislocation, sprain and damage to the capsular-ligamentous apparatus of the joint of the unspecified area of the body

Painful stretching of muscles, Pain and inflammation in tension, Dislocation of dislocation, Degenerative changes in the ligamentous apparatus, Edema due to sprains and bruises, Edema after interventions for sprains, Damage and rupture of ligaments, The musculoskeletal system is damaged, Damage to ligaments, Damage to the joints, Ligament ruptures, Tendon tendons,Ruptures of the tendons of muscles,Stretching, Crick, Stretching of the muscle, Sprain, Tension of the tendons, Extensions,Stretch muscles, Sprains, Tension of the tendons, Injury of the musculoskeletal system, Injuries to the joints, Injuries of capsule-articular tissues, Injuries of the osteoarticular system, Injuries to ligamentsInjuries to the joints, Joint wounds, Stretching of the ligamentous apparatus, Habitual stretching and tearing

T14.9 Injury unspecified

Pain syndrome after trauma, Pain syndrome with injuries, Pain syndrome with trauma and after surgery, Pain in case of injury, Pain of a traumatic nature, Joint pain with injuries, Postoperative and post-traumatic pain, Pain in case of injury, Pain of a traumatic origin, Severe pain syndrome of traumatic origin, Deep tissue damage, Deep scratches on the trunk, Closed injury, Minor Household Injuries, Minor skin damage, Violations of the integrity of soft tissues, Uncomplicated trauma, Extensive traumatic injury, Acute pain syndrome of traumatic origin, Edema with trauma, Postponed sports injuries, Post-traumatic pain, Soft tissue injuries, Joint wounds, Sports injuries, Injury, Traumatic pain, Traumatic pains, Traumatic infiltrate,Injuries to sports

T88.9 Complication of surgical and medical care, unspecified

Pain in the postoperative period, Pain in the postoperative period after orthopedic surgery, Pain syndrome after diagnostic procedures, Pain after surgery Diagnostic, Pain after surgery, Pain after orthopedic surgery, Pain after the removal of hemorrhoids, Pain in the application of excimer laser, Pain with injuries and after surgical interventions, Pain syndromes in the dental practice, Painful diagnostic intervention, Painful diagnostic manipulations, Painful instrumental diagnostic procedures, Painful instrumental manipulation, Painful treatments, Painful manipulations, Painful dressings, Painful therapeutic interventions, Pain in the area of the surgical wound, Pain in the postoperative period, Pain after diagnostic procedures, Pain after orthopedic surgery, Pain during diagnostic procedures, Pain during therapeutic procedures, Pain in orthopedics, The pain in the postoperative period, Pain after diagnostic procedures, The pain after sclerotherapy, The pain after dental surgery, postoperative Pain, Pain postoperative and posttraumatic, The pain of tooth extraction, Inflammation after surgery or injury, Inflammation after orthopedic surgery, Inflammation after surgery, The inflammatory syndrome after surgery, Festering postoperative fistula, Operating wound, Complications after tooth extraction

Composition

Tablets covered with a film membrane 1 tab.

active substances:

ibuprofen 400 mg

paracetamol 325 mg

auxiliary substances: MCC - 120 mg; corn starch - 76 mg; glycerol - 3 mg; sodium carboxymethyl starch (type A) - 7 mg; silicon dioxide colloid - 5 mg; talcum - 8 mg; magnesium stearate - 6 mg

membrane film: hypromellose 6 cps - 11.32 mg; dye "Sunset Sun" yellow (E110), aluminum lacquer - 1.78 mg; macrogol 6000 - 2.2 mg; talc - 4.06 mg; titanium dioxide - 0.16 mg; polysorbate 80 - 0.16 mg; sorbic acid 0.16 mg; dimethicone 0.16 mg

Description of dosage form

The capsule-shaped tablets are covered with a film coating of orange color, with a risk on one side.

On the cross-section - the core is white or almost white.

pharmachologic effect

Pharmacological action - anti-inflammatory, antipyretic, analgesic, inhibitory COX.

Pharmacodynamics

Combined drug, the effect of which is due to its constituent components.

Ibuprofen - NSAIDs, has analgesic, anti-inflammatory, antipyretic effect. Inhibiting COX-1 and COX-2, disrupts the metabolism of arachidonic acid, reduces the amount of PG (mediators of pain, inflammation and hyperthermia) both in the inflammation focus and in healthy tissues, suppressing the exudative and proliferative phases of inflammation.

Paracetamol - indiscriminately blocks COX, mainly in the central nervous system, has little effect on water-salt metabolism and gastrointestinal mucosa. Has analgesic and antipyretic effect. In inflamed tissues, peroxidases neutralize the effect of paracetamol on COX-1 and COX-2, which explains the low anti-inflammatory effect.

The effectiveness of the combination is higher than that of the individual components. Relieves arthralgia at rest and during movement, reduces morning stiffness and swelling of joints, promotes an increase in the volume of movements.

Pharmacokinetics

Ibuprofen

Absorption is high, quickly and almost completely absorbed from the digestive tract. Tmax after ingestion - about 1-2 hours. Connection with blood plasma proteins - more than 90%. T1 / 2 - about 2 hours Slowly penetrates into the joint cavity, accumulates in the synovial fluid, creating in it higher concentrations than in the blood plasma. After absorption, about 60% of the pharmacologically inactive R-form is slowly transformed into an active S-form. Exposed to metabolism. More than 90% is excreted by the kidneys (unchanged not more than 1%) and to a lesser extent with bile in the form of metabolites and their conjugates.

Paracetamol

Absorption is high, the association with plasma proteins is less than 10% and slightly increases with an overdose. Sulfate and glucuronide metabolites do not bind to plasma proteins even at relatively high concentrations. The value of Cmax is 5-20 μg / ml, Tmax is 0.5-2 hours. It is fairly evenly distributed in the liquid media of the body. Penetrates through the BBB.

About 90-95% of paracetamol is metabolized in the liver with the formation of inactive conjugates with glucuronic acid (60%), taurine (35%) and cysteine (3%), as well as a small amount of hydroxylated and deacetylated metabolites. A small part of the preparation is hydroxylated by microsomal enzymes with the formation of highly active N-acetyl-n-benzoquinonimine, which binds to the sulfhydryl groups of glutathione. When depletion of glutathione stores in the liver (with an overdose) enzyme systems of hepatocytes can be blocked, leading to the development of their necrosis.

T1 / 2 - 2-3 hours. In patients with liver cirrhosis T1 / 2 slightly increases. In elderly patients the clearance of the drug decreases and T1 / 2 increases. It is excreted by the kidneys, mainly in the form of glucuronide and sulfate conjugates (less than 5% in unchanged form). Breast milk penetrates less than 1% of the accepted dose of paracetamol. In children, the ability to form conjugates with glucuronic acid is lower than in adults.

Indications

Symptomatic therapy of infectious and inflammatory diseases (cold, flu) accompanied by fever, chills, headache, pain in muscles and joints, sore throat;

myalgia;

neuralgia;

back pain;

joint pain, pain syndrome with inflammatory and degenerative diseases of the musculoskeletal system;

pain with bruises, sprains, dislocations, fractures;

post-traumatic and postoperative pain syndrome;

toothache;

algodismenorea (painful menstruation).

The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use; on the progression of the disease is not affected.

Contraindications

increased individual sensitivity to the components of the drug and other NSAIDs;

erosive and ulcerative diseases of the digestive tract (including gastric ulcer and duodenal ulcer, Crohn's disease, ulcerative colitis) or ulcerative bleeding in the active phase or in the anamnesis (2 or more confirmed episodes of peptic ulcer or ulcer bleeding);

cerebrovascular or other bleeding;

hemophilia or other disorders of blood clotting (hypocoagulation), hemorrhagic diathesis, intracranial hemorrhage;

severe renal failure (Cl creatinine less than 30 mL / min);

complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including in anamnesis);

severe heart failure (NYHA class IV);

Decompensated heart failure;

lesions of the optic nerve;

genetic absence of glucose-6-phosphate dehydrogenase;

diseases of the blood system;

period after aortocoronary shunting;

progressive kidney disease;

severe hepatic impairment or active liver disease;

confirmed hyperkalemia;

pregnancy (III trimester);

children's age till 18 years.

With caution: ischemic heart disease; chronic heart failure; diseases of peripheral arteries; arterial hypertension; blood diseases of unclear etiology (leukopenia and anemia); cerebrovascular diseases; dyslipidemia / hyperlipidemia; presence in the anamnesis of a single episode of peptic ulcer of stomach and duodenal ulcer or ulcerative bleeding in the gastrointestinal tract; the presence of Helicobacter pylori infection, gastritis, enteritis, colitis, ulcerative colitis in history; viral hepatitis; hepatic insufficiency of moderate and mild severity; benign hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson and Rotor syndrome); cirrhosis of the liver with portal hypertension; renal failure, incl. when dehydrated (Cl creatinine less than 30-60 ml / min); nephrotic syndrome; A bronchial asthma or allergic diseases in a stage of an exacerbation or in the anamnesis - development of a bronchospasm is possible; systemic lupus erythematosus or mixed connective tissue disease (Sharpe's syndrome) - increased risk of aseptic meningitis; chickenpox; severe physical illness; diabetes; simultaneous intake of other NSAIDs; oral GCS (including prednisone), anticoagulants (including warfarin), antiaggregants (including acetylsalicylic acid, clopidogrel), SSRIs (including citalopram, fluoxetine, paroxetine, sertraline); elderly age; smoking; alcoholism; pregnancy (I-II trimester); the period of breastfeeding.

pregnancy and lactation

In the I and II trimesters of pregnancy, the use of the drug Ibuclin® is only possible on the prescription of the doctor in cases where the potential benefit to the mother exceeds the potential risk to the fetus. The use of the drug in the third trimester of pregnancy is contraindicated.

If it is necessary to use the drug during breastfeeding, breast-feeding should be stopped.

In experimental studies, embryotoxic, teratogenic and mutagenic effects of the components of the drug Ibuclin® have not been established.

Before using Ibuclin®, if a woman is pregnant or suggests that she might be pregnant, or planning a pregnancy, it is necessary to consult a doctor.

Side effects

From the digestive tract: NSAID-gastropathy (nausea, vomiting, heartburn, anorexia, discomfort or pain in epigastrium, diarrhea, flatulence); rarely - erosive and ulcerative lesions, bleeding, liver dysfunction, hepatitis, pancreatitis, irritation or dryness in the oral cavity, mouth pain, ulceration of the gingival mucosa, aphthous stomatitis, constipation, peptic ulcer, melena, bloody vomiting, in some cases with lethal outcome, especially in elderly patients, gastritis, exacerbation of colitis and Crohn's disease, increased activity of hepatic transaminases, jaundice.

From the nervous system and sensory organs: headache, dizziness, insomnia, anxiety, nervousness, irritability, agitation, drowsiness, depression, confusion, hallucinations; rarely aseptic meningitis (more often in patients with autoimmune diseases), hearing loss, tinnitus, visual impairment, toxic optic nerve damage, unclear vision or double vision, scotoma, amblyopia.

From the CCC: heart failure, peripheral edema, with prolonged use increased risk of thrombotic complications (including myocardial infarction), increased blood pressure, tachycardia.

On the part of the blood and lymphatic system: anemia (including hemolytic and aplastic), thrombocytopenia, thrombocytopenic purpura, agranulocytosis, leukopenia, pancytopenia.

From the respiratory system and mediastinal organs: dyspnea, bronchospasm, bronchial asthma.

From the kidneys and urinary tract: allergic nephritis, acute renal failure, nephrotic syndrome, edema, polyuria, cystitis, hematuria, proteinuria, nephritic syndrome, papillary necrosis, interstitial nephritis.

Allergic reactions: skin rash, itching, urticaria, Quincke's edema, bronchospasm, dyspnoea, allergic rhinitis, dry and irritated eyes, conjunctival edema and eyelids, eosinophilia, fever, anaphylactic shock, erythema multiforme exudative (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).

Laboratory indicators: decrease in serum glucose concentration, decrease in hematocrit and Hb, increase in bleeding time, increase in serum creatinine concentration.

Other: increased sweating.

With prolonged use in high doses: ulceration of the mucous membrane of the gastrointestinal tract, bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), visual impairment (violation of color vision, scotoma, amblyopia).

If the patient has side effects indicated in the description, or they are aggravated, or any other side effects not indicated in the description have been noted, the physician should be informed.

Interaction

With the simultaneous use of the drug Ibuclin® with drugs (drug), it is possible to develop various interaction effects.

With simultaneous administration with acetylsalicylic acid, ibuprofen reduces its anti-inflammatory and anti-aggregation effect (it is possible to increase the incidence of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as anti-aggregation agent after the onset of admission).

The combination with ethanol, GCS (glucocorticosteroids), corticotropin increases the risk of erosive and ulcerative lesions of the digestive tract (gastrointestinal tract).

Ibuprofen enhances the action of direct (heparin) and indirect (coumarin and indanedione derivatives) anticoagulants, thrombolytic agents (alteplase, anestreplase, streptokinase, urokinase), antiplatelet agents, colchicine - increases the risk of hemorrhagic complications.

Strengthens hypoglycemic action of insulin and oral hypoglycemic drugs.

Weakens the effects of antihypertensive drugs and diuretics (by inhibiting the synthesis of renal PG).

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

Caffeine increases the analgesic effect of ibuprofen.

Cyclosporine and gold preparations increase nephrotoxicity.

Cefamandol, cefoperazone, cefotetan, valproic acid, plikamycin increase the frequency of hypoprothrombinemia.

In patients who have been co-treated with NSAIDs (non-steroidal anti-inflammatory drugs) and with quinolone antibiotics, an increased risk of seizures is possible.

Antacids and colestyramine reduce the absorption of the drug.

Myelotoxic drugs contribute to the manifestation of hematotoxicity of the drug.

Mifepristone. Admission of NSAIDs should begin no earlier than 8-12 days after taking mifepristone, since NSAIDs may reduce the effectiveness of mifepristone.

Tacrolimus. With the simultaneous use of NSAIDs and tacrolimus may increase the risk of nephrotoxicity.

Zidovudine. The simultaneous use of NSAIDs and zidovudine may lead to an increase in hematotoxicity. There is evidence of an increased risk of hemarthrosis and hematoma in HIV-positive patients with hemophilia who received co-treatment with zidovudine and ibuprofen.

Drugs that block tubular secretion. Decreased excretion and increased plasma concentrations of ibuprofen.

Inductors of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants). Increased production of hydroxylated active metabolites, increased risk of severe intoxication.

Inhibitors of microsomal oxidation. Reducing the risk of hepatotoxic action.

Urikozuric drugs. Decrease in the effectiveness of drugs.

If the patient uses the above or other drugs (including over-the-counter drugs), before using the drug Ibuclin®, consult a physician.

Dosing and Administration

Inside, before or 2-3 hours after eating, without chewing, squeezed with enough water.

According to 1 table. 3 times a day. The maximum daily dose is 3 tablets.

Duration of treatment no more than 3 days as an antipyretic agent and no more than 5 days - as an anesthetic. Continuation of treatment with the drug is possible only after consulting a doctor.

If there is no improvement after treatment, or the symptoms worsen, or new symptoms appear, it is necessary to consult a doctor.

Use the drug only according to the indications, the method of administration and the doses specified in the description.

Overdose

Symptoms: gastrointestinal disorders (diarrhea, nausea, vomiting, anorexia, pain in the epigastric region), increased PV, bleeding after 12-48 h, retardation, drowsiness, depression, headache, tinnitus, impaired consciousness, cardiac arrhythmias , a decrease in blood pressure, manifestations of hepato- and nephrotoxicity, convulsions, possibly the development of hepatonecrosis.

Treatment: gastric lavage for the first 4 hours, alkaline drink, forced diuresis, activated charcoal inside, administration of SH-group donors and glutathione-methionine synthesis precursor - 8-9 hours after an overdose and N-acetylcysteine by mouth or IV after 12 h, antacids, hemodialysis, symptomatic therapy. The need for additional therapeutic measures (further introduction of methionine, intravenous injection of N-acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration.

If you suspect an overdose, seek medical help immediately.

special instructions

It is recommended to take the drug as short a course as possible and at the minimum effective dose necessary to eliminate symptoms.

In patients with bronchial asthma or allergic diseases at the stage of exacerbation, as well as in patients with an anamnesis of bronchial asthma / allergic disease, the drug can provoke bronchospasm.

The use of the drug in patients with systemic lupus erythematosus or a mixed disease of connective tissue is associated with an increased risk of developing aseptic meningitis.

Patients with hypertension, incl. in the history, and / or CHF it is necessary to consult a doctor before using the drug, since the drug can cause fluid retention, increased blood pressure and swelling. Patients with uncontrolled hypertension, congestive heart failure of NYHA class II-III, coronary artery disease, peripheral arterial disease and / or cerebrovascular disease should be prescribed ibuprofen only after a thorough evaluation of the benefit-risk ratio, while high doses of ibuprofen should be avoided (≥ 2,400 mg / day).

The use of NSAIDs in patients with chickenpox may be associated with an increased risk of developing severe purulent complications of infectious inflammatory diseases of the skin and subcutaneous fat (eg, necrotizing fasciitis). In this regard, it is recommended to avoid the use of the drug in case of chicken pox.

Information for women planning pregnancy: the drug suppresses COX and the synthesis of PG, affects ovulation, disrupting female reproductive function (reversible after drug discontinuation).

It should avoid simultaneous application of the drug to other drugs containing paracetamol and / or NSAIDs. When using the drug for more than 5-7 days according to the doctor's prescription, the parameters of peripheral blood and the functional state of the liver should be monitored.

At simultaneous application of anticoagulants of indirect action it is necessary to supervise parameters of a coagulating system of blood.

To avoid possible damaging effects on the liver during the intake of the drug should not drink alcohol.

The drug can distort the results of laboratory tests in quantitative determination of glucose, uric acid in the blood serum, 17-ketosteroids (it is necessary to cancel the drug 48 hours prior to the study).

Influence on the ability to drive vehicles, mechanisms. During treatment, the patient should refrain from engaging in potentially dangerous activities requiring increased attention and speed of psychomotor reactions.

Form of issue

Tablets, film-coated, 400 mg + 325 mg. For 10 tab. in PVC / aluminum blister. By 1, 2 or 20 bl. in a pack of cardboard.

Conditions of leave from pharmacies

Without recipe.

storage Conditions

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life

5 years.

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