Instruction for use: Next

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)

G43 Migraine

The pain of migraine, Migraine, hemiplegic migraine, Migraine headache, A migraine attack, Continuous headache, hemicranias

J10 Influenza caused by an identified influenza virus

Influenza A, Influenza B, Influenza A type, Influenza A of type B

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

M13.9 Arthritis, unspecified

Arthritis,Purulent arthritis (non-infectious), acute Arthritis,Pain in acute inflammatory diseases of the musculoskeletal system,Pain in chronic inflammatory diseases of the musculoskeletal system,The pain in osteoarthritis, Inflammation in osteoarthritis, Inflammatory arthropathy, Inflammatory and degenerative joint diseases, Inflammatory disease of the musculoskeletal system, Inflammatory joint disease, Inflammatory diseases of the musculoskeletal system, destructive arthritis, The disease of the musculoskeletal system, Diseases of the musculoskeletal system, Diseases of the musculoskeletal system and connective tissue, Infections musculoskeletal system, monoartrit, Non-infectious arthritis, rheumatic arthritis, Osteoarthritis, Acute inflammation of the musculoskeletal tissue, Acute inflammatory diseases of the musculoskeletal system, Acute inflammatory condition of the musculoskeletal system, Acute arthritis, Acute osteoarthritis, Post-traumatic osteoarthritis, Reactive arthritis, Chronic inflammatory diseases of the joints, Chronic arthritis, Chronic inflammatory arthritis, Chronic inflammation of the inner layer of the joint capsule, Chronic inflammation of the joint capsule,Chronic inflammatory disease of the joints, Exudative arthritis

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

M46.9 Inflammatory spondylopathies, unspecified

Spondylitis, Inflammatory disease of the spine, Inflammatory diseases of the spine

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

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

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

R52.9 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

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

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 200 mg

Excipients

core: calcium hydrophosphate (Fujikalin) - 80 mg; MCC - 64.5 mg; croscarmellose sodium - 24.3 mg; giprolase (hydroxypropyl cellulose (Klucel EF) 19.3 mg, talc 12.1 mg, magnesium stearate 7.3 mg, silicon colloidal dioxide (aerosil) 2.5 mg

film membrane: Opadry 20A250004 red (red) (hypromellose (hydroxypropylmethylcellulose) - 13.1 mg, giprolose (hydroxypropylcellulose) - 8.1 mg, talc 6.4 mg, titanium dioxide 2.5 mg, dye crimson (Ponso 4R ) (E124) - 0.9 mg, dye "Sunset Sun" yellow (E110) - 0.5 mg) - 31.5 mg; Opadry II 85F19250 clear (clear) (macrogol (polyethylene glycol) 0.3 mg (polyvinyl alcohol 1 mg, polysorbate 80 0.1 mg, talc 0.6 mg) 2 mg

Description of dosage form

Oval biconvex tablets, covered with a film shell of red color, with a risk.

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

pharmachologic effect

Pharmacological action - anti-inflammatory, antipyretic, analgesic.

Pharmacodynamics

The combined preparation, has analgesic, anti-inflammatory and antipyretic effect.

Paracetamol - a non-narcotic analgesic, has an antipyretic and analgesic effect due to blockade of COX in the central nervous system and exposure to pain centers and thermoregulation.

Ibuprofen - NSAIDs, has an analgesic, anti-inflammatory and antipyretic effect associated with a non-selective inhibition of COX activity that regulates the synthesis of PG.

The components of the drug affect both the central and peripheral mechanisms of the formation of the pain syndrome. Directed, complementary action of the two components has a rapid therapeutic effect and a pronounced analgesic effect.

Pharmacokinetics

Paracetamol

Absorption is high, Cmax is 5-20 μg / ml, Tmax is 0.5-2 h; communication with plasma proteins - 15%. Penetrates through the BBB. Metabolised in the liver with the formation of both active and inactive metabolites.

T1 / 2 - 1-4 hours. Primarily excreted by the kidneys in the form of metabolites - glucuronides and sulfates, 3% - unchanged.

Ibuprofen

It is well absorbed from the digestive tract. Tmax at reception on an empty stomach - 45 minutes, at reception after meal - 1,5-2,5 ÷. Communication with fibers of plasma - 90%. The concentration of the drug in the synovial fluid exceeds the content in the plasma.

It is subjected to pre- and post-systemic metabolism in the liver.

It has a two-phase kinetics of excretion, T1 / 2 is 2-2.5 hours. It is excreted by the kidneys (in unchanged form - no more than 1%), to a lesser extent - with bile.

Indications

headache (including migraine);

toothache;

algodismenorea (painful menstruation);

neuralgia;

myalgia;

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;

feverish conditions (including influenza and colds).

Contraindications

hypersensitivity to the components of the drug;

erosive and ulcerative diseases of the digestive tract (in the phase of exacerbation), gastrointestinal bleeding;

severe hepatic and / or renal insufficiency;

disorders of blood clotting (hemophilia, prolonged bleeding time, a tendency to bleeding, hemorrhagic diathesis);

complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and near the nasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs, incl. in the anamnesis;

condition after aortocoronary bypass surgery;

confirmed hyperkalemia;

deficiency of glucose-6-phosphate dehydrogenase;

pregnancy (III trimester);

children under 12 years.

With caution: chronic heart failure; viral hepatitis, alcoholic liver damage, hepatic and / or renal insufficiency of mild and moderate severity, benign hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson and Rotor syndrome), liver cirrhosis with portal hypertension, nephrotic syndrome; diabetes, peripheral arterial disease, gastric and duodenal ulcer (in history); gastritis, enteritis, colitis; bronchial asthma, bronchospasm; elderly age; Pregnancy (I and II trimesters - use is possible only according to the doctor's prescription in cases where the potential benefit exceeds the possible risk), lactation period (if breastfeeding is necessary, breast-feeding should be stopped).

pregnancy and lactation

If you need to use the drug in the first and second trimesters of pregnancy, you should be careful - the application is only possible on the prescription of the doctor in cases where the potential benefit exceeds the possible risk. The use of the drug in the third trimester of pregnancy is contraindicated.

If breastfeeding is necessary, breast-feeding should be discontinued.

Side effects

From the nervous system: headache, dizziness, sleep disorders, anxiety, depression.

From the CCC (cardiovascular system): tachycardia, increased blood pressure, heart failure.

On the part of the respiratory system: dyspnea, bronchospasm.

From the gastrointestinal tract (GI tract): abdominal pain, nausea, vomiting, heartburn, loss of appetite, diarrhea or constipation, flatulence, ulceration of the mucous membrane of the gums, aphthous stomatitis, pancreatitis.

From the sense organs: hearing impairment, ringing or noise in the ears, visual impairment, blurred vision or diplopia, dryness and irritation of the eyes.

From the urinary system: acute renal failure, nephrotic syndrome, polyuria, cystitis.

Allergic reactions: skin rash, pruritus, allergic rhinitis, angioedema, erythema multiforme (including Stevens-Johnson syndrome), toxic epndermalny necrolysis (Lyell's syndrome).

On the part of the organs of hematopoiesis: anemia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis, leukopenia, eosinophilia.

With long-term use in large doses - hepatotoxic and nephrotoxic (hepatitis, interstitial nephritis and papillary necrosis) effect; hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia.

Interaction

Inductors microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, flumetsinol, rifampischsh, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, which makes the possibility of severe toxicity in overdose.

Inhibitors of microsomal oxidation (including cimetidine) reduce the risk of hepatotoxic effects.

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

The combination of ibuprofen with ethanol, GCS increases the risk of erosive and ulcerative gastrointestinal lesions.

Simultaneous use of paracetamol with ethanol increases the risk of acute pancreatitis.

Paracetamol and ibuprofen increase the effect of anticoagulants of indirect action and reduce the effectiveness of uricosuric drugs.

Long-term use of barbiturates reduces the effectiveness of paracetamol.

Diflunisal increases the plasma concentration of paracetamol by 50%, which increases the risk of hepatotoxicity.

Ibuprofen reduces the hypotensive activity of vasodilators, natriuretic and diuretic - furosemide and hydrochlorothiazide.

Antacids and colestyramine reduce the absorption of ibuprofen.

Ibuprofen enhances the effect of oral hypoglycemic agents and insulin.

Ibuprofen increases the concentration in the blood of digoxin, lithium and methotrexate.

With concomitant administration with acetylsalicylic acid, ibuprofen reduces its anti-inflammatory and antiplatelet effect.

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

Dosing and Administration

Inside, after eating.

Adults - 1 table. 3 times a day. The maximum daily dose is 3 tablets.

Children older than 12 children (body weight over 40 kg) - 1 tab. 2 times a day.

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.

Overdose

Symptoms: abdominal pain, nausea, vomiting, agitation, or lethargy, drowsiness, confusion, tachycardia, arrhythmia, acute renal insufficiency, metabolic acidosis, frequent urination, hyperthermia, headache, tremor or muscle twitching; increased activity of hepatic transaminases, increased PV. If you suspect an overdose, seek medical help immediately.

Treatment: gastric lavage, followed by the appointment of activated charcoal; alkaline drink, forced diuresis, symptomatic therapy.

special instructions

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, it is necessary to monitor the peripheral blood and the functional state of the liver.

Paracetamol distorts the results of laboratory studies of glucose and uric acid in the blood plasma.

When symptoms of NSAID-gastropathy are shown, careful monitoring is performed, including esophagogastroduodenoscopy, a blood test with determination of hemoglobin and hematocrit, analysis of feces for latent blood.

If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the test.

Against the background of taking the drug patients should refrain from all activities that require increased attention, rapid mental and motor reaction.

During the period of treatment, it is not recommended to take alcohol-containing drinks.

Form of issue

Tablets, film-coated, 400 mg + 200 mg. By 2, 6, 10 or 12 of the table. in the outline cell pack.

1 or 2 contour squares are placed 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

2 years.

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