Brufica Plus oral suspension 100mg+162.5mg/5ml, 100ml

Composition

Each 5 ml suspension contains:

active ingredients:

ibuprofen-100 mg,

paracetamol-162.5 mg;

excipients:

sucrose – 3000 mg,

methyl parahydroxybenzoate,5 mg,

parahydroxybenzoate – 1 mg,

sodium benzoate 5 mg,

aspartame – 13 mg,

sorbitol – 500 mg,

carmellose sodium – 6.25 mg,

magnesium aluminium silicate – 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,

the flavour of pineapple – 10 mg,

purified water to 5 ml.

Pharmacological properties

Pharmacotherapeutic group: analgesic agent (NSAID+ non-narcotic analgesic agent).

ATX Code: M01AE51

Pharmacological Properties

Combined drug.

It has analgesic, anti-inflammatory and antipyretic effects. The mechanism of action of ibuprofen and paracetamol is due to inhibition of prostaglandin biosynthesis-mediators of pain and inflammation.

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

As a result of the mutually reinforcing effect of the combination (ibuprofen + paracetamol), a more pronounced decrease in pain sensitivity and an increase in antipyretic effect are achieved than separately.

Pharmacokinetics

of Ibuprofen. Absorption is high. The maximum concentration (TC_max) in plasma is reached 1-2 hours after use. Plasma protein binding is 90%. The half-life (T_1/2) is 2 hours. It slowly penetrates 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. It is metabolized. It is excreted by the kidneys (no more than 1% unchanged) and, to a lesser extent, with bile.

Paracetamol. Absorption is high. The maximum concentration (TC_max) in plasma is reached in 0.5-2 hours after use. Binding to plasma proteins is 15%. Penetrates the blood-brain barrier (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 conjugate with glutathione to form already inactive metabolites. When glutathione is deficient, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. The CYP2E1. T isoenzyme is also involved in drug metabolism_1/2 – 1 – 4 It is excreted by the kidneys in the form of metabolites, mainly conjugates. Less than 5% is excreted unchanged. T_1/2 is 4-5 hours.

Indications

Brufika Plus is used in children from 2 years of age.

As an antipyretic agent for:

– acute respiratory diseases;

– flu;

– children’s infectious diseases;

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

As a mild-to-moderate-intensity painkiller when:

– headache and toothache;

– migraines;

– neuralgia;

– ear and throat pain;

– muscle pain;

– pain from injuries, sprains, burns and other types of pain.

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

Use during pregnancy and lactation

The drug is intended for use in children and is contraindicated in the third trimester of pregnancy. Before using in the first and second trimester or during breastfeeding, you should consult your doctor.

Contraindications

The drug should not be used when:

– hypersensitivity to ibuprofen and/or paracetamol;

– erosive and ulcerative diseases of the gastrointestinal tract (including stomach ulcers and 12 duodenal ulcer, Crohn’s disease, ulcerative colitis) or peptic ulcer bleeding in the active phase or in history (two or more episodes of confirmed peptic ulcer or ulcer bleeding);

– bleeding or perforation of an ulcer of the gastrointestinal tract in history, triggered by the use of NSAIDs;

– complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses, and intolerance of 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;

– pronounced violations of the liver and kidneys;

– severe hepatic impairment or active liver disease;

– decompensated heart insufficiency;

– status after conducting coronary artery bypass grafting;

– confirmed hyperkalemia;

– the III trimester of pregnancy;

– the period of breastfeeding;

– children’s age up to 2 years.

With caution

If you have any of the conditions listed in this section, consult your doctor before using Brufica Plus.

– a history of a single episode of peptic ulcer or bleeding of the gastrointestinal tract, gastritis, enteritis, colitis, ulcerative colitis, infection with Helicobacter pylori;

– bronchial asthma or allergic reactions in the acute stage or in history – perhaps the development of bronchospasm;

– severe somatic diseases; systemic lupus erythematosus and other autoimmune connective tissue disease (sharp’s syndrome) – increased risk of aseptic meningitis;

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

– fluid retention and swelling;

– violation of liver function (including Gilbert’s syndrome);

– violation of the kidney;

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

– liver failure;

– arterial hypertension and/or heart failure;

– cerebrovascular disease;

– dyslipidemia / hyperlipidemia;

diabetes mellitus;

diseases of peripheral arteries;

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

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

– pregnancy-I-II trimester, old age.

Side effects

The risk of side effects can be minimized by taking the drug in a short course, at the minimum effective dose necessary to eliminate symptoms.

The frequency of adverse reactions is estimated based on the following criteria: very frequent (>> 1/10), frequent (>> 1/100 to < 1/10), infrequent (>>1/1000 to < 1/100), rare (>>1/10 000 to < 1/1000), very rare (

Blood and lymphatic system disorders

are very rare: hematopoietic disorders (anemia, leukopenia, aplastic anemia, hemolytic anemia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms of such disorders are fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, severe weakness, nosebleeds and subcutaneous hemorrhages, bleeding and bruising of unknown etiology.

Violations of the immune system

– infrequent: hypersensitivity reactions are non – specific allergic reactions and anaphylactic reactions, reactions of the respiratory tract (bronchial asthma, including its exacerbation, bronchospasm, dyspnea, dyspnea), skin reactions (pruritus, urticaria, purpura, angioedema, bullous and exfoliative dermatitis including toxic epidermal necrolysis, Lyell’s syndrome, and Stevens-Johnson syndrome, erythema multiforme), allergic rhinitis, eosinophilia.

– very rare: severe hypersensitivity reactions, including swelling of the face, tongue and larynx, shortness of breath, tachycardia, hypotension (anaphylaxis, angioedema or severe anaphylactic shock).

Gastrointestinal disorders

– infrequent: abdominal pain, nausea, dyspepsia.

– 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.

Liver and biliary tract

disorders are very rare: liver function disorders.

Renal and urinary tract

disorders are 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.

Nervous system disorders

-infrequent; headache.

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

Disorders of the cardiovascular system

-the frequency is unknown: heart failure, peripheral edema, prolonged use increases the risk of thrombotic complicaStore at a temperature not exceeding 25 °C.

Do not freeze!

Keep out of reach of children.

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

Shelf

life is 3 years. Do not use after the expiration date indicated on the package.

Active ingredient

: Ibuprofen, Paracetamol

Conditions of release from pharmacies

By prescription

Dosage form

Oral suspension