Nurofast Forte pills 400mg, 20pcs

Composition

1 film-coated tablet contains:

Active ingredient: ibuprofen-400 mg;

excipients: sodium croscarmellose, sodium citrate dihydrate, sodium lauryl sulfate, colloidal silicon dioxide (aerosil), magnesium stearate, stearic acid;

excipients for the shell: Opadray II 85F48105 white (polyvinyl alcohol, macrogol, talc, titanium dioxide).

Pharmacological action

Pharmacotherapy group: Nonsteroidal anti-inflammatory drug (NSAID).

ATX code: M 01 AE 01

Pharmacological properties

Pharmacodynamics

The mechanism of action of ibuprofen, a propionic acid derivative from the group of nonsteroidal anti-inflammatory drugs (NSAIDs), is due to inhibition of prostaglandin synthesis – mediators of pain, inflammation and hyperthermic reaction. It selectively blocks cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2), thereby inhibiting prostaglandin synthesis. It has a rapid directed action against pain (analgesic), antipyretic and anti-inflammatory effect. In addition, ibuprofen reversibly inhibits platelet aggregation. The analgesic effect of the drug lasts up to 8 hours.

Pharmacokinetics

Absorption – high, quickly and almost completely absorbed from the gastrointestinal tract (GIT). After taking the drug on an empty stomach, the maximum concentration (cmax) of ibuprofen in blood plasma is reached in 45 minutes. Taking the drug together with food can increase the time to reach the maximum concentration (TC_max) to 1-2 hours. Binding to plasma proteins is 90%. Slowly penetrates the joint cavity, lingers in the synovial fluid, creating higher concentrations in it than in the blood plasma. Lower concentrations of ibuprofen are found in the cerebrospinal fluid compared to blood plasma. After absorption, about 60% of the pharmacologically inactive R-form is slowly transformed into the active S-form. It is metabolized in the liver. The elimination half-life (T_1/2) is 2 hours. It is excreted by the kidneys (no more than 1% unchanged) and, to a lesser extent, with bile.

In limited studies, ibuprofen has been detected in breast milk at very low concentrations.

Indications

Nurofast ® Forte is used for headaches, migraines, toothache, painful menstruation, neuralgia, back pain, muscle pain, rheumatic pain and joint pain; as well as for fever, flu and colds.

Use during pregnancy and lactation

The use of the drug in the third trimester of pregnancy is contraindicated. Avoid using the drug in the first-second trimesters of pregnancy, if necessary, take the drug should consult a doctor.

There is evidence that ibuprofen in small amounts can enter breast milk without any negative consequences for the health of the infant, so usually with short-term use, there is no need to stop breastfeeding. If long-term use of the drug is necessary, you should consult a doctor to decide whether to stop breastfeeding for the period of use of the drug.

Contraindications

* Hypersensitivity to ibuprofen or any of the components that make up the drug.

* Complete or incomplete combination of bronchial asthma, recurrent nasal and paranasal sinus polyposis, and intolerance to acetylsalicylic acid or other NSAIDs (including in the anamnesis).

·  Erosive and ulcerative diseases of the gastrointestinal tract (including peptic ulcer of the stomach and duodenum, Crohn’s disease, ulcerative colitis) active or history of ulcerative bleeding (two or more confirmed episodes of peptic ulcer disease or ulcerative bleeding).

* A history of bleeding or perforation of a gastrointestinal ulcer caused by NSAID use.

·  Severe heart failure (NYHA Class IV-New York Heart Association Classification).

·  Severe liver failure or active liver disease.

·  Severe renal insufficiency (creatinine clearance

* Decompensated heart failure; the period after coronary artery bypass grafting.

* Cerebrovascular or other bleeding.

· Hemophilia and other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis.

* Pregnancy (third trimester).

* Children under 6 years of age.

With caution

If you have the conditions described in this section, you should consult a doctor before using the drug.

Concomitant use of other NSAIDs, a history of a single episode of gastric and duodenal ulcer or ulcerative bleeding of the gastrointestinal tract; gastritis, enteritis, colitis, Helicobacter pylori infection, ulcerative colitis; bronchial asthma or allergic diseases in the acute stage or in the anamnesis – may develop bronchospasm; systemic lupus erythematosus or mixed connective tissue disease (Sharp’s syndrome) – increased risk aseptic meningitis; chickenpox; renal failure, including dehydration (creatinine clearance less than 30-60 ml/min), nephrotic syndrome, liver failure, cirrhosis of the liver with portal hypertension, hyperbilirubinemia, arterial hypertension and/or heart failure, cerebrovascular diseases, blood diseases of unknown etiology (leukopenia and anemia), severe somatic diseases, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral artery disease, smoking, frequent alcohol consumption, concomitant use of medications that may increase the risk of ulceration or bleeding, in particular, oral glucocorticosteroids (including prednisone), anticoagulants (including warfarin), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline) or antiplatelet agents (including including acetylsalicylic acid, clopidogrel), pregnancy I-II trimester, breast-feeding period, elderly 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.

In the elderly, there is an increased frequency of adverse reactions associated with NSAID use, especially gastrointestinal bleeding and perforation, in some cases with a fatal outcome.

Side effects are mostly dose-dependent.

The following adverse reactions were observed with short-term use of ibuprofen in doses not exceeding 1200 mg / day (3 tablets). In the treatment of chronic conditions and with prolonged use, other adverse reactions may occur.

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

Disorders of the blood and lymphatic system

·  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 (including heartburn, bloating).

* Rare: diarrhea, flatulence, constipation, vomiting.

·  Very rare: peptic ulcer, perforation or gastrointestinal bleeding, melena, bloody vomiting, in some cases fatal, especially in elderly patients, ulcerative stomatitis, gastritis.

* Frequency unknown: exacerbation of colitis and Crohn’s disease.

Liver and biliary tract disorders

* Very rare: impaired liver function, increased activity of “hepatic” transaminases, hepatitis and jaundice.

Kidney and urinary tract disorders

·  Very rare: acute renal failure (compensated and decompensated), especially with prolonged use, in combination with increased urea concentration in blood plasma and the appearance of edema, hematuria and proteinuria, nephritic syndrome, nephrotic syndrome, papillary necrosis, interstitial nephritis, cystitis.

Nervous system disorders

* Infrequent: headache.

·  Very rare: aseptic meningitis.

Disorders of the cardiovascular system

* Frequency unknown: heart failure, peripheral edema, prolonged use increases the risk of thrombotic complications (for example, myocardial infarction), increased blood pressure.

Respiratory and mediastinal disorders

* Frequency unknown: bronchial asthma, bronchospasm, shortness of breath.

Laboratory parameters

* hematocrit or hemoglobin (may decrease)

* bleeding time (may increase)

· plasma glucose concentration (may decrease)

* creatinine clearance (may decrease)

* plasma creatinine concentration (may increase)

* activity of “hepatic” transaminases (may increase)

If side effects occur, you should stop taking the drug and consult a doctor.

Interaction

Concomitant use of ibuprofen with the following medications should be avoided:

* Acetylsalicylic acid: with the exception of low doses of acetylsalicylic acid (no more than 75 mg / day) prescribed by a doctor, since co-use may increase the risk of side effects. When used concomitantly, ibuprofen reduces the anti-inflammatory and antiplatelet effects of acetylsalicylic acid (it is possible to increase the incidence of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as an antiplatelet agent after starting ibuprofen).

* Other NSAIDs, in particular selective COX-2 inhibitors: concomitant use of two or more NSAID drugs should be avoided due to the possible increased risk of side effects.

Use with caution at the same time as the following medications::

·  Anticoagulants and thrombolytics: NSAIDs may increase the effect of anticoagulants, particularly warfarin and thrombolytics.

·  Antihypertensive agents (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may reduce the effectiveness of drugs in these groups. In some patients with impaired renal function (for example, in patients with dehydration or in elderly patients with impaired renal function), the simultaneous use of ACE inhibitors or angiotensin II antagonists and cyclooxygenase inhibitors may lead to deterioration of renal function, including the development of acute renal failure (usually reversible). These interactions should be considered in patients taking coxibs concomitantly with ACE inhibitors or angiotensin II antagonists. In this regard, the combined use of the above drugs should be prescribed with caution, especially in the elderly. Patients should be prevented from becoming dehydrated, and renal function monitoring should be considered after starting this combination treatment and periodically thereafter.

Diuretics and ACE inhibitors may increase the 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: concomitant use of NSAIDs and cardiac glycosides may worsen heart failure, reduce glomerular filtration rate, and increase the concentration of cardiac glycosides in blood plasma.

* Lithium preparations: there is evidence of the likelihood of an increase in the concentration of lithium in the blood plasma with the use of NSAIDs.

·  Methotrexate: There is evidence for the likelihood of an increase in the concentration of methotrexate in blood plasma against the background of NSAID use.

* Cyclosporine: increased risk of nephrotoxicity with concomitant NSAIDs and cyclosporine.

* Mifepristone: NSAIDs should be taken no earlier than 8-12 days after taking mifepristone, as NSAIDs may reduce the effectiveness of mifepristone.

·  Tacrolimus: concomitant use of NSAIDs and tacrolimus may increase the risk of nephrotoxicity.

* Zidovudine: concomitant use of NSAIDs and zidovudine may lead to increased hematotoxicity. There is evidence of an increased risk of hemarthrosis and hematomas in HIV-positive patients with hemophilia treated with zidovudine and ibuprofen.

·  Quinolone-type antibiotics: patients receiving concomitant treatment with NSAIDs and quinolone antibiotics may have an increased risk of seizures.

* Myelotoxic drugs: increased hematotoxicity.

* Cefamandol, cefoperazone, cefotetan, valproic acid, plicamycin: increased incidence of hypoprothrombinemia.

* Drugs that block tubular secretion: reduced excretion and increased plasma concentrations of ibuprofen.

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

* Microsomal oxidation inhibitors: reduce the risk of hepatotoxic effects.

* Oral hypoglycemic drugs and insulin, sulfonylureas: enhancing the effect of drugs.

* Antacids and colestyramine: reduced absorption.

* Uricosuric drugs: reducing the effectiveness of drugs.

·  Estrogens, ethanol: increased risk of side effects.

* Caffeine: increases the analgesic effect.

How to take, course of use and dosage

For oral use. Patients with hypersensitivity of the stomach are recommended to take the drug with meals.

Only for short-term use. Please read the instructions carefully before taking the drug.

Adults and children over 12 years of age inside 1 tablet (400 mg) up to 3 times a day.

Children from 6 to 12 years of age: 1/2 tablet (200 mg) up to 3-4 times a day; the drug can only be taken if the child’s body weight is more than 20 kg. Tablets should be washed down with water.

The interval between taking tablets should be at least 4 hours.

The maximum daily dose for adults is 1200 mg (3 tablets).

The maximum daily dose for children from 6 to 18 years is 800 mg (2 tablets).

If symptoms persist or worsen after taking the drug for 2-3 days, you should stop treatment and consult a doctor.

Overdose

In children, overdose symptoms may occur after taking a dose exceeding 400 mg / kg of body weight. In adults, the dose-dependent effect of overdose is less pronounced. The half-life of the drug in case of overdose is 1.5-3 hours.

Symptoms: nausea, vomiting, epigastric pain or, less commonly, diarrhea, tinnitus, headache, and gastrointestinal bleeding. In more severe cases, there are manifestations of the central nervous system: drowsiness, rarely-agitation, convulsions, disorientation, coma. In cases of severe poisoning, metabolic acidosis and increased prothrombin time, renal failure, liver tissue damage, decreased blood pressure, respiratory depression and cyanosis can develop. Patients with bronchial asthma may have an exacerbation of this disease.

Treatment: symptomatic, with mandatory provision of airway patency, monitoring of ECG and basic vital signs until the patient’s condition normalizes. Oral use of activated charcoal or gastric lavage within 1 hour of taking a potentially toxic dose of ibuprofen is recommended. If ibuprofen has already been absorbed, an alkaline drink may be prescribed to eliminate the acidic ibuprofen derivative by the kidneys, forced diuresis. Frequent or prolonged seizures should be stopped by intravenous use of diazepam or lorazepam.In case of worsening of bronchial asthma, the use of bronchodilators is recommended.

Description

Biconvex tablets of oblong shape with rounded ends, covered with a film-coated white or almost white color, with a risk. On a cross-section, the core is white or almost white in color.

Special instructions

It is recommended to take the drug in the shortest possible course and in the minimum effective dose necessary to eliminate symptoms. If you need to take the drug for more than 10 days, you should consult a doctor.

In patients with acute bronchial asthma or allergic disease, as well as in patients with a history of bronchial asthma/allergic disease, the drug may provoke bronchospasm. The use of the drug in patients with systemic lupus erythematosus or mixed connective tissue disease is associated with an increased risk of aseptic meningitis.

During long-term treatment, it is necessary to monitor the picture of peripheral blood and the functional state of the liver and kidneys. When symptoms of gastropathy appear, careful monitoring is indicated, including esophagogastroduodenoscopy, a general blood test (determination of hemoglobin), and a fecal occult blood test. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. During the treatment period, it is not recommended to take ethanol.

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

Patients with hypertension, including a history of hypertension and/or chronic heart failure, should consult a doctor before using the drug, as the drug can cause fluid retention, increased blood pressure and edema.

Patients with uncontrolled hypertension, NYHA class II-III congestive heart failure, coronary artery disease, peripheral artery disease, and/or cerebrovascular disease should only be prescribed ibuprofen after careful benefit-risk assessment, and high doses of ibuprofen (≥2400 mg/day) should be avoided.

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

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

Influence on the ability to drive vehicles and mechanisms

Patients who experience dizziness, drowsiness, lethargy, or visual disturbances while taking ibuprofen should avoid driving vehicles or operating machinery.

Storage conditions

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf

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

Active ingredient

Ibuprofen

Dosage form

Tablets