Nurofen Express capsules 200mg, 24pcs

Composition

One capsule contains: Active ingredient: ibuprofen 200 mgsupport substances: macrogol-600 218.33 mg, potassium hydroxide 25.6 mg, water 17.07 mg;capsule shell: gelatin 119.8 mg, sorbitol 76% solution 58.19 mg, crimson dye [Ponceau 4R] (E124) 0.485 mg, water 15.02 mg, white ink [Opacode WB NS-78-18011] (water 48%, titanium dioxide (E171) 29%, propylene glycol 10%, isopropanol 8%, hypromellose 5%).

Pharmacological action

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.

Indications

Nurofen® Express is used for headaches, migraines, toothache, painful menstruation, neuralgia, back pain, muscle and rheumatic pains; for feverish conditions with flu and colds.

Contraindications

• Hypersensitivity to ibuprofen or any of the components included in the composition of the drug;
• complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance of acetylsalicylic acid or other NSAIDs (including in the anamnesis);
• erosive and ulcerative diseases of the digestive tract in acute phase (including gastric ulcer and duodenal ulcer, Crohn’s disease, ulcerative colitis) ulcer or bleeding in the active phase or history (two or more episodes of confirmed peptic ulcer or ulcer bleeding);
• bleeding or perforation of the ulcer in the digestive disease, provoked by the use of NSAIDs;
• renal failure severe (creatinine Cl <30 ml/min), confirmed hyperkalemia;
• decompensated heart failure; after the coronary artery bypass surgery;
• cerebrovascular or other bleeding;
• fructose intolerance;
• hemophilia and other blood clotting (including anticoagulation), hemorrhagic diathesis;
• pregnancy (III trimester);
• children up to age 12 years.

Caution: if you have the conditions listed in this section, consult your doctor before using the drug — concomitant use of other NSAIDs, a history of a single episode of gastric ulcer or ulcerative bleeding of the gastrointestinal tract; gastritis, enteritis, colitis, the presence of Helicobacter pylori infection, ulcerative colitis; bronchial asthma or allergic diseases in the acute stage or in the anamnesis — the development of bronchospasm is possible; systemic lupus erythematosus or mixed disease Connective tissue disorders (Sharp’s syndrome) increased risk of aseptic meningitis; 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 arterial diseases; smoking; frequent alcohol consumption; phenylketonuria or intolerance to phenylalanine; concomitant use of drugs that may increase the risk of ulceration or bleeding, in particular, oral corticosteroids (including prednisone), anticoagulants (including warfarin), SSRIs (including citalopram, fluoxetine, paroxetine, sertraline) or antiplatelet agents (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. 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 (6 capsules). 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 <1/10), infrequent (><1/100), rare (>1/10,000 to <1/100), rare (><1/1000), very rare (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.

Immune system disorders

• Infrequent: hypersensitivity reactions – non-specific allergic reactions and anaphylactic reactions, respiratory tract reactions (bronchial asthma, including its exacerbation, bronchospasm, shortness of breath, dyspnea), skin reactions (pruritus, urticaria, purpura, Quincke’s edema, exfoliative and bullous dermatoses, including toxic epidermal necrolysis (Lyell’s syndrome), Stevens-Johnson syndrome, multiforme erythema), 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).

Disorders of the gastrointestinal tract

• 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: liver function disorders (especially with prolonged use), 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

• The frequency is 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.

Other services

• Very rare: edema, including peripheral edema.

Laboratory values

• of 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 per 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, including 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. 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 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 use of NSAIDs and cyclosporine.
• Mifepristone: NSAIDs should be started 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.
• Cefamandol, cefoperazone, cefotetan, valproic acid, plicamycin: increased incidence of hypoprothrombinemia.
• Drugs that block tubular secretion: decreased 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: reducing the risk of hepatotoxic effects.
• Oral hypoglycemic drugs and insulin, sulfonylureas: enhancing the effect.
• Antacids and colestyramine: reduced absorption.
• Caffeine: increases the analgesic effect.

How to take, course of use and dosage

Please read the instructions carefully before taking the drug. For oral use. Only for short-term use. Adults and children over 12 years of age: inside 1 capsule (200 mg), without chewing, up to 3-4 times a day. The capsule should be washed down with water. The interval between doses of the drug should be 6-8 hours. To achieve a faster therapeutic effect in adults, a single dose can be increased to 2 capsules (400 mg) up to 3 times a day. The maximum daily dose is 1200 mg. The maximum daily dose for children aged 12-17 years is 1000 mg. 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, more rarely, 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 remove 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.

Special instructions

It is recommended to take the drug in the shortest possible course and in the minimum effective dose necessary to eliminate symptoms. 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: these drugs inhibit cyclooxygenase and prostaglandin synthesis, affect ovulation, impair 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

At a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf

life is 2 years.

Active ingredient

Ibuprofen

Dosage form

Capsules

Purpose

Children over 12 years of age, Pregnant women in the first and second trimester as prescribed by a doctor, For adults

Indications

Arthritis, Osteoarthritis, Sciatica, Lumbago, Periarthritis, Flu, Cold, Sore Throat, Migraine