Brufika Plus - instructions for use, doses, side effects, contraindications

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

Description:

Viscous suspension of light orange or orange, with a characteristic odor.

Pharmacotherapeutic group:Analgesic combined (NSAID + analgesic non-narcotic)

ATX: & nbsp

M.01.A.E.51 Ibuprofen in combination with other drugs

Pharmacodynamics:

Combined drug.

Has analgesic, anti-inflammatory and antipyretic effect. The mechanism of action of ibuprofen and paracetamol is due to inhibition of the biosynthesis of prostaglandins - mediators of pain and inflammation.

The effectiveness of the combination (ibuprofen + paracetamol) is higher than that of the individual components.

Pharmacokinetics:

Ibuprofen. Absorption is high. The maximum concentration (TC_mOh) in the plasma is achieved 1-2 hours after admission. The connection with plasma proteins is 90%. The half-life (T_1/2) -2 hours Slowly penetrates into the joint cavity, is retained in the synovial tissue, creating in it greater concentrations than in the plasma. After absorption, about 60% of the pharmacologically inactive R-form is slowly transformed into an active S-form. Exposed to metabolism. It is excreted by the kidneys (not more than 1% in unchanged form) and, to a lesser extent, with bile.

Paracetamol. Absorption is high. The maximum concentration (TC_max) in plasma is achieved in 0,5-2 hours after administration. Connection with plasma proteins - 15%. Penetrates through the blood-brain barrier (BBB).

Metabolised in the liver (90-95%): 80% enters the conjugation reaction with glucuronic acid and sulfates with the formation of inactive metabolites; 17% undergoes hydroxylation with the formation of 8 active metabolites, which are conjugated with glutathione with the formation of already inactive metabolites. With a lack of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. In the metabolism of the drug is also involved isoenzyme CYP2E1. T_1/21-4 h. It is excreted by the kidneys in the form of metabolites, mainly conjugates. In the unchanged form, less than 5% is output. T_1/2 is 4-5 hours.

Indications:

Brufika Plus is used in children from 2 years.

As an antipyretic agent for:

- acute respiratory infections;

- influenza;

- children's infectious diseases;

- post-vaccination reactions and other infectious-inflammatory diseases, accompanied by an increase in body temperature.

As an analgesic of a weak or moderate intensity with:

- headache and toothache;

- migraine;

- neuralgia;

- pain in the ears and in the throat;

- pain in the muscles;

- pain in injuries, sprains, burns and other types of pain.

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

Contraindications:

The drug should not be used when:

- hypersensitivity to ibuprofen and / or paracetamol;

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

- bleeding or perforation of the gastrointestinal ulcer in an anamnesis, provoked by the use of NSAIDs;

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

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

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

- cerebrovascular or other bleeding;

- severe disorders of the liver and kidneys;

- severe hepatic insufficiency or active liver disease;

- decompensated cardiovascular insufficiency;

- after coronary artery bypass grafting;

- confirmed hyperkalemia;

- pregnancy III trimester;

- during lactation;

- children under 2 years.

Carefully:

In the presence of the conditions specified in this section, before using Brucic Plus, you should consult your doctor.

- presence in the history of a single episode of peptic ulcer disease or gastric ulcer bleeding, gastritis, enteritis, colitis, ulcerative colitis, the presence of infection Helicobacter pylori;

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

- severe physical illness; systemic lupus erythematosus and other autoimmune diseases of connective tissue (Sharpe's syndrome) - increased risk of aseptic meningitis;

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

- fluid retention and swelling;

- 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;

- diseases of peripheral arteries;

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

- simultaneous administration of oral corticosteroids (including prednisone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline);

- pregnancy I-II trimester;

- elderly age.

Pregnancy and lactation:

The drug is intended for use in children, is contraindicated in the third trimester of pregnancy.

Before using in the I and II trimester or during breastfeeding, you should consult your doctor.

Dosing and Administration:

Brifika Plus is taken inside.

The drug is taken with the appearance of symptoms (fever or pain syndrome).

Shake the bottle thoroughly before use. For accurate measuring the dose syringe attached - dispenser or measuring spoon.

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)	7.5 ml
22-26 kg (7-9 years)	10 ml
27-32 kg (10-11 years)	12.5 ml
33-43 kg (12-14 years)	15 ml

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

A warning: do not exceed the indicated dose.

Duration of treatment:

- not more than 3 days as an antipyretic;

- not more than 5 days as an anesthetic.

If the temperature or pain persists, talk to your doctor.

Using a measuring syringe:

1. Shake the suspension well (vial).

2. Firmly insert the syringe into the neck of the vial.

3. Flip the bottle upside down and gently pull the piston down, dialing the suspension into the syringe to the desired mark.

4. Return the bottle to its original position and remove the syringe by gently rotating it.

5. Place the syringe in the baby's mouth and slowly press the piston, gently releasing the suspension.

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

Side effects:

The risk of side effects can be minimized if you take the drug with a short course, at the lowest effective dose needed to eliminate the symptoms.

Qualification incidence of adverse reactions performed on the basis of the following criteria: very frequent (≥ 1/10), frequent (from ≥ 1/100 to <1/10), infrequent (from ≥ 1/1000 to <1/100), rare ( from ≥ 1/10 000 to <1/1000), very rare (<1/10 000), the frequency is unknown (there is no data on frequency estimation).

Violations of the blood and lymphatic system

- very rare: disturbances of hematopoiesis (anemia, leukopenia, aplastic anemia, hemolytic anemia, thrombocytopenia, pancytopenia, agranulocytosis).

The first symptoms of such disorders are fever, sore throat, superficial oral ulcers, flu-like symptoms, severe weakness, nosebleeds and bruising, bleeding, and bruising of unknown etiology.

Immune system disorders

- infrequent: hypersensitivity reactions - nonspecific allergic reactions and anaphylactic reaction by the airway reactions (asthma, including its exacerbation, bronchoconstriction, dyspnea, dyspnea), skin reactions (pruritus, urticaria, purpura, angioedema, exfoliative and bullous dermatoses , including toxic epidermal necrolysis, Lyell's syndrome, Stevens-Johnson syndrome, erythema multiforme), allergic rhinitis, eosinophilia;

- very rare: severe hypersensitivity reactions, including swelling of the face, tongue and larynx, dyspnea, tachycardia, hypotension (anaphylaxis, Quincke's edema or severe anaphylactic shock).

Disorders from the gastrointestinal tract

- infrequent: abdominal pain, nausea, indigestion;

- rare: diarrhea, flatulence, constipation, vomiting;

- very rare: peptic ulcer, perforation or gastrointestinal bleeding, melena, bloody vomiting, ulcerative stomatitis, gastritis;

- frequency unknown: exacerbation of ulcerative colitis and Crohn's disease.

Disturbances from the liver and bile ducts

- very rare: violations of the liver.

Disorders from the kidneys and urinary tract

- very rare: acute renal failure (compensated and decompensated), especially with prolonged use, in combination with an increase in the concentration of urea in the blood plasma and the appearance of edema, papillary necrosis.

Disturbances from the nervous system

- infrequent; headache;

- very rare: aseptic meningitis (in patients with autoimmune diseases).

Disorders from the cardiovascular system

- frequency unknown: heart failure, peripheral edema, with prolonged use increased risk of thrombotic complications (eg, myocardial infarction, stroke), increased blood pressure.

Disturbances from the respiratory system and mediastinal organs

- frequency unknown: bronchial asthma, bronchospasm, dyspnea.

Other

- very rare: edema, including peripheral.

Laboratory indicators

- hematocrit or hemoglobin (may decrease);

- bleeding time (may increase);

- the concentration of glucose in the blood plasma (may decrease);

- clearance of creatinine (may decrease);

- plasma concentration of creatinine (may increase);

- activity of "liver" transaminases (may increase).

If side effects occur, stop taking the medication and consult a doctor.

Overdose:

Problems with overdose occur very rarely, but if you accidentally exceed the recommended dose, consult a doctor immediately.

Symptoms: abdominal pain, nausea, vomiting, headache, tinnitus, headache and gastrointestinal bleeding, metabolic acidosis, coma, acute renal failure, lowering of blood pressure, bradycardia, tachycardia.It is possible to develop a hepatotoxic effect with the development of hepatonecrosis associated with paracetamol.

Treatment: gastric lavage (only for an hour after ingestion), Activated carbon, alkaline drink, forced diuresis, the introduction of donors of SH-groups and the precursors of the synthesis of glutathione-methionine and N-acetylcysteine. 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. In addition, symptomatic therapy is indicated.

Interaction:

It should avoid simultaneous use with the following medicines:

- acetylsalicylic acid: with the exception of low doses of acetylsalicylic acid (not more than 75 mg per day), prescribed by a doctor, as joint use may increase the risk of side effects. With simultaneous use, the anti-inflammatory and antiplatelet effect of acetylsalicylic acid decreases (possibly an increase in the incidence of acute coronary insufficiency in patients,receiving as aitiagregantnogo means a small dose of acetylsalicylic acid, after the start of the drug).

Use with caution simultaneously with the following medicines:

- anticoagulants and thrombolytic drugs: NSAIDs can enhance the effect of anticoagulants, in particular, warfarin and thrombolytic drugs;

- antihypertensives (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may decrease the effectiveness of the drugs of these groups. Diuretics and ACE inhibitors can increase nephrotoxicity of NSAIDs;

- glucocorticosteroids: increased risk of gastrointestinal ulcers and gastrointestinal bleeding;

- antiplatelet agents and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding;

- cardiac glycosides: the simultaneous administration of NSAIDs and cardiac glycosides can lead to worsening of heart failure, a decrease in glomerular filtration rate and an increase in the concentration of cardiac glycosides in blood plasma;

- lithium preparations: there are data on the probability of an increase in the concentration of lithium in blood plasma against the background of NSAIDs;

- methotrexate: there are data on the probability of an increase in plasma methotrexate concentration on the background of NSAIDs;

- Cyclosporine: increased risk of nephrotoxicity with simultaneous administration of NSAIDs and cyclosporine;

- mifepristone: NSAIDs should be started no earlier than 8-12 days after taking mifepristone, because NSAIDs may reduce the effectiveness of mifepristone;

- tacrolimus: with simultaneous administration of NSAIDs and tacrolimus, an increased risk of nephrotoxicity may occur;

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

- antibiotics of the quinolone series: in patients who are considering joint treatment with NSAIDs and quinolone antibiotics, an increased risk of seizures is possible;

- barbiturates, carbamazepine, phenytoin, diphenine, primidon and other anticonvulsants, ethanol, rifampicin, zidovudine, flumecinol, phenylbutazone, butadione,preparations of St. John's wort and other induction of microsomal oxidation increase the production of hydroxylated active metabolites, causing the possibility of developing severe liver damage with small overdoses;

- inhibitors of microsomal liver enzymes reduce the risk of hepatotoxic action;

- under the influence of paracetamol, the time of removal of levomycetin (chloramphenicol) is increased by 5 times, which increases the risk of poisoning with levomycetin (chloramphenicol);

- metoclopramide and domperidone increase, and colestramine reduces the rate of absorption of paracetamol. The drug may reduce the effectiveness of uricosuric drugs.

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.

During long-term treatment, control of the peripheral blood picture and the functional state of the liver and kidneys is necessary.

When symptoms of gastropathy appear, careful monitoring including esophagogastroduodenoscopy, a general blood test (determination of hemoglobin), and analysis of feces for latent blood are shown.

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

During the period of treatment, ethanol is not recommended.

Patients with renal insufficiency should consult with a doctor before using the drug, since there is a risk of impairment of the functional state of the kidneys.

Patients with hypertension, including anamnesis and / or chronic heart failure, should consult with a doctor before using the drug, because the drug can cause fluid retention, increased blood pressure and swelling.

When performing tests for the determination of uric acid and blood sugar level, tell your doctor about the use of the drug.

Deficiency of glutathione due to eating disorders, cystic fibrosis, HIV infection, starvation, exhaustion causes the possibility of developing severe liver damage with small overdoses.

The drug should not be used concurrently with other drugs containing ibuprofen and / or paracetamol.

Patients with a rare hereditary intolerance to fructose should not take this drug.

Effect on the ability to drive transp. cf.and fur:

Patients reporting dizziness, drowsiness, blockage, or visual impairment when taking ibuprofen and / or paracetamol should avoid driving vehicles or controlling mechanisms.

Form release / dosage:

Suspension for oral administration, 100 mg / 5 ml + 162.5 mg / 5 ml.

Packaging:

For 60 or 100 ml of the preparation is placed in a glass or PET bottle of dark color with a screwed aluminum cover with a control of the first opening and a low density polyethylene liner or a high density polyethylene lid with a child protection system and a first opening control equipped with an adapter or lid of Polyethylene of high density with the control of the first opening and a lining of polyethylene of low density.

Each bottle, complete with a syringe dispenser or measuring spoon, is packed in a cardboard box along with instructions for medical use. The lower part of the cardboard bundle can be equipped with adhesive tape if necessary.

Storage conditions:

Store in a dry place at a temperature of no higher than 25 ° C. Do not freeze!

Keep out of the reach of children.

After opening the bottle the drug can be stored for no more than 6 months.

Shelf life:

3 years.

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

Terms of leave from pharmacies:On prescription

Registration number:LP-004020

Date of registration:13.12.2016

Expiration Date:13.12.2021

The owner of the registration certificate:Highgans Laboratories Pvt. Ltd.Highgans Laboratories Pvt. Ltd. India

Manufacturer: & nbsp

HIGLANCE LABORATORIES Pvt. Ltd. India

Representation: & nbspPharma Group, LLCPharma Group, LLCRussia

Information update date: & nbsp11.03.2017

Illustrated instructions

Instructions

Brifika Plus (Brufica Plus)