Brufica plus suspension for children 100mg / 5ml, 100ml

For adults: pain syndrome of moderate intensity; traumatic inflammation of soft tissues and musculoskeletal system (including bruises, sprains, dislocations, fractures); postoperative period; algodismenorrhea; toothache; neuralgia; myalgia; lumbago; fibrositis; tenosynovitis; headache; febrile syndrome; articular syndrome (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gouty arthritis); sinusitis; tonsillitis.

For children (as an auxiliary medicine): tonsillitis; acute infectious and inflammatory diseases of the upper respiratory tract (pharyngitis, tracheitis, laryngitis).

Brufica Plus is taken orally.

The drug is taken when symptoms appear (fever or pain).

Shake the bottle thoroughly before use. For accurate measurement of the dose of the drug, a syringe - dispenser or measuring spoon is attached.

The dose of the drug depends on the age and body weight of the child.

Body weight (age) Single dosage

10-15 kg (2-3 years) 5 ml

16-21 kg (4-6 years old) 7.5 ml

22-26 kg (7-9 years old) 10 ml

27-32 kg (10-11 years old) 12.5 ml

33-43 kg (12-14 years old) 15 ml

The drug is taken 3 times a day with an interval of 8 hours.

Warning: do not exceed the indicated dose.

Duration of treatment:

- no more than 3 days as an antipyretic;

- no more than 5 days as an anesthetic.

If fever or pain persists, consult your doctor.

Using a measuring syringe:

1. Shake the suspension well (bottle).

2. Insert the syringe firmly into the neck of the bottle.

3. Turn the bottle upside down and gently pull the plunger down, drawing the suspension into the syringe to the desired mark.

4. Return the vial to its original position and remove the syringe by gently turning it.

5. Place the syringe in the child's mouth and slowly push the plunger, gradually releasing the suspension.

After use, rinse the syringe in warm water and dry it out of the reach of the child.

Suspension for oral administration is light orange or orange in color, viscous, with a characteristic odor.

5 ml

ibuprofen 100 mg

paracetamol 162.5 mg

Excipients: sucrose - 3000 mg, methyl parahydroxybenzoate - 5 mg, propyl parahydroxybenzoate - 1 mg, sodium benzoate - 5 mg, aspartame - 13 mg, sorbitol - 500 mg, sodium carmellose - 6.25 mg, magnesium aluminosilicate - 37.5 mg, citric acid monohydrate - 1 mg, sodium citrate - 20 mg, glycerol - 100 mg, polysorbate 80 - 5 mg, sunset yellow dye - 0.15 mg, orange flavor - 5 mg, pineapple flavor - 10 mg, purified water - up to 5 ml.

The drug should not be used when:

- hypersensitivity to ibuprofen and / or paracetamol;

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

- bleeding or perforation of gastrointestinal ulcers in history, provoked by the use of NSAIDs;

- complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses, and intolerance to acetylsalicylic acid or other NSAIDs;

- a violation of blood coagulation (including hemophilia, hemorrhagic diathesis);

- severe renal failure (creatinine clearance less than 30 ml / min);

- cerebrovascular or other bleeding;

- severe liver and kidney disorders;

- severe liver failure or active liver disease;

- decompensated cardiovascular insufficiency;

- condition after coronary artery bypass grafting;

- confirmed hyperkalemia;

- pregnancy III trimester;

- during breastfeeding;

- children under 2 years of age.

Carefully:

If you have the conditions mentioned in this section, you should consult your doctor before using Brufica Plus.

- a history of a single episode of gastric ulcer or gastrointestinal ulcer bleeding, gastritis, enteritis, colitis, ulcerative colitis, Helicobacter pylori infection;

- bronchial asthma or allergic reactions in the exacerbation stage or in history - the development of bronchospasm is possible;

- severe somatic diseases; systemic lupus erythematosus and other autoimmune diseases of the connective tissue (Sharp syndrome) - the risk of aseptic meningitis is increased;

- renal failure, including dehydration (creatinine clearance 30-60 ml / min);

- fluid retention and edema;

- impaired liver function (including Gilbert's syndrome);

- impaired renal function;

- genetic absence of the enzyme glucose-6-phosphate dehydrogenase;

- liver failure;

- arterial hypertension and / or heart failure;

- cerebrovascular diseases;

- dyslipidemia / hyperlipidemia;

- diabetes;

- peripheral arterial disease;

- blood diseases of unknown etiology (leukopenia, anemia, thrombocytopenia);

- Simultaneous administration of oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxinetine); paroxetine

- pregnancy I-II trimester;

- elderly age

pharmachologic effect

Combined drug containing ibuprofen (NSAIDs) and paracetamol (analgesic-antipyretic).

Ibuprofen has an analgesic, anti-inflammatory, antipyretic effect. Oppressing COX-1 and COX-2, disrupts the metabolism of arachidonic acid, reduces the amount of prostaglandins (mediators of pain, inflammation and hyperthermic reaction), both in the focus of inflammation and in healthy tissues, suppresses 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 the gastrointestinal mucosa. It has an 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.

Pharmacokinetics

Ibuprofen. Absorption is high. Cmax in plasma is achieved within 1-2 hours after administration. Plasma protein binding - 90%. T1 / 2 - 2 hours. Slowly penetrates into the joint cavity, lingers in the synovial tissue, creating higher concentrations in it than in plasma. After absorption, about 60% of the pharmacologically inactive R-form is slowly transformed into the active S-form. Metabolized. It is excreted by the kidneys (not more than 1% unchanged) and, to a lesser extent, with bile.

Paracetamol. Absorption is high. Cmax in plasma is achieved within 0.5-2 hours after administration. Plasma protein binding - 15%. Penetrates the BBB. It is metabolized in the liver (90-95%): 80% enters into conjugation reactions with glucuronic acid and sulfates to form inactive metabolites; 17% undergoes hydroxylation to form 8 active metabolites, which are conjugated with glutathione to form already inactive metabolites. With a lack of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. The isoenzyme CYP2E1 is also involved in the metabolism of the drug. T1 / 2 - 1-4 hours. It is excreted by the kidneys in the form of metabolites, mainly conjugates. Less than 5% is excreted unchanged. T1 / 2 is 4-5 hours.

Side effect

From the digestive system: NSAIDs-gastropathy - nausea, vomiting, heartburn, anorexia, epigastric discomfort or pain, diarrhea, flatulence; rarely - erosive and ulcerative lesions, bleeding; liver dysfunction, hepatitis, pancreatitis; irritation or dryness in the mouth, pain in the mouth, ulceration of the gum mucosa, aphthous stomatitis; constipation.

From the nervous system: headache, dizziness, insomnia, anxiety, nervousness, irritability, agitation, drowsiness, depression, confusion, hallucinations; rarely - aseptic meningitis (more often in patients with autoimmune diseases).

From the senses: hearing loss, tinnitus, visual impairment, toxic damage to the optic nerve, blurred vision or double vision, scotoma, amblyopia.

From the side of the cardiovascular system: heart failure, increased blood pressure, tachycardia.

From the side of hematopoiesis: anemia (including hemolytic and aplastic), thrombocytopenia, thrombocytopenic purpura, agranulocytosis, leukopenia.

From the respiratory system: shortness of breath, bronchospasm.

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

Allergic reactions: skin rash, pruritus, urticaria, Quincke's edema, bronchospasm, dyspnoea, allergic rhinitis, dryness and irritation of the eyes, edema of the conjunctiva and eyelids, eosinophilia, fever, anaphylactic shock, erythema multiforme (non-Stevens Johns syndrome) (Lyell's syndrome).

Laboratory indicators: a decrease in serum glucose concentration, a decrease in hematocrit and hemoglobin, an increase in bleeding time, an increase in serum creatinine concentration, an increase in the activity of hepatic transaminases.

Others: increased sweating.

With long-term use in high doses: ulceration of the gastrointestinal tract mucosa, bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), visual impairment (impaired color vision, scotoma, amblyopia).

Application during pregnancy and lactation

In the I and II trimesters of pregnancy, use is possible only as directed by a doctor in cases where the potential benefit outweighs the possible risk to the mother and the potential risk to the fetus. The use of this combination in the third trimester of pregnancy is contraindicated.

If necessary, use during lactation should stop breastfeeding.

Application for violations of liver function

Contraindicated in liver failure.

Application for impaired renal function

Contraindicated in renal failure.

Application in children

The use is contraindicated in children under the age of 2 years.

special instructions

With care: coronary artery disease, chronic heart failure, cerebrovascular disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, CC less than 60 ml / min, history of gastrointestinal ulcers, Helicobacter pylori infection, advanced age, prolonged use of NSAIDs, alcoholism, severe somatic diseases, concomitant use of oral corticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including including citalopram, fluoxetine, paroxetine, sertraline), viral hepatitis, hepatic and / or renal failure of mild or moderate severity, benign hyperbilirubinemia (Gilbert's syndrome, Dubin-Johnson syndrome, Rotor syndrome),cirrhosis of the liver with portal hypertension, nephrotic syndrome.

Simultaneous use with other medicinal products containing paracetamol and / or NSAIDs should be avoided. When using the drug for more than 5-7 days as directed by a doctor, the peripheral blood parameters and the functional state of the liver should be monitored.

With the simultaneous use of indirect anticoagulants, it is necessary to monitor the indicators of the blood coagulation system.

You should avoid taking this combination together with other NSAIDs.

To avoid possible damaging effects on the liver, you should not drink alcohol while taking the drug.

The drug can distort the results of laboratory tests in the quantitative determination of glucose, uric acid in the blood serum, 17-ketosteroids (the drug must be discontinued 48 hours before the study).

Influence on the ability to drive vehicles and mechanisms

During the period of treatment, the patient should refrain from engaging in potentially hazardous activities that require increased attention and speed of psychomotor reactions.

Drug interactions

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

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

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

This combination enhances the hypoglycemic effect of insulin and oral hypoglycemic drugs.

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

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

Caffeine enhances the analgesic effect of ibuprofen.

With the simultaneous use of this combination with cyclosporine, gold preparations, nephrotoxicity increases.

With the simultaneous use of this combination with cefamandol, cefoperazone, cefotetan, valproic acid, plikamycin, the incidence of hypoprothrombinemia increases.

Antacids and cholestyramine reduce the absorption of the ibuprofen + paracetamol combination.

Myelotoxic drugs contribute to the manifestation of hematotoxicity of the ibuprofen + paracetamol combination.