Nurofen Express, 200 mg capsules 24 pcs

The mechanism of action of ibuprofen, a propionic acid derivative of the group of non-steroidal anti-inflammatory drugs (NSAIDs), is due to the inhibition of the synthesis of prostaglandins – mediators of pain, inflammation and hyperthermia. It indiscriminately blocks cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2) and inhibits the synthesis of prostaglandins.

It has rapid directed action against pain (analgesic), antipyretic and anti-inflammatory effects. In addition, ibuprofen reversibly inhibits platelet aggregation.

Indications

Pain after injuries and operations, Toothache, Fever, Sore throat, Colds, Joint pain (arthralgia), Back pain, Headache, PainNurofen® Express is used for headache, migraine, toothache, painful menstruation, neuralgia, back pain, muscle and rheumatic pain; febrile states at flu and colds.

Active ingredient

Ibuprofen

Composition

One capsule contains:

active ingredient:

ibuprofen 200 mg

excipients:

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 %)..

How to take, the dosage

Read the instructions carefully before taking the drug.

For oral administration. Only for short-term use.

Adults and children over 12 years: Orally, 1 capsule (200 mg), without chewing, up to 3-4 times a day. The capsule should be taken with water. The interval between the doses of the drug should be 6-8 hours.

To achieve a more rapid therapeutic effect in adults the single dose may 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 12-17 years old is 1000 mg.

If the symptoms persist or intensify while taking the drug for 2-3 days it is necessary to stop the treatment and consult a physician.

Interaction

Simultaneous use of ibuprofen with the following drugs should be avoided:

• Acetylsalicylic acid: except for low doses of acetylsalicylic acid (no more than 75 mg per day) prescribed by a physician, because co-administration may increase the risk of side effects. When concomitant use, ibuprofen reduces the anti-inflammatory and antiplatelet effects of acetylsalicylic acid (increased incidence of acute coronary failure is possible in patients receiving low doses of acetylsalicylic acid as antiplatelet agents after starting ibuprofen administration).
• Other NSAIDs, including selective COX-2 inhibitors: avoid simultaneous use of two or more drugs from the group of NSAIDs due to a possible increase in the risk of side effects.

Precaution should be used concomitantly with the following medicines:

• Anticoagulants and thrombolytics: NSAIDs may increase the effect of anticoagulants, particularly warfarin and thrombolytics.
• Antihypertensive drugs (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may decrease the effectiveness of drugs in these groups. Diuretics and ACE inhibitors may increase nephrotoxicity of NSAIDs.
• Glucocorticosteroids: increased risk of GI ulcers and gastrointestinal bleeding.
• Antiaggregants and selective serotonin reuptake inhibitors: increased risk of GI bleeding.
• Methotrexate: there is data on the possibility of increased plasma concentrations of methotrexate with NSAIDs.
• Cyclosporine: increased risk of nephrotoxicity when NSAIDs and cyclosporine are prescribed at the same time.
• Mifepristone: NSAIDs should not be started earlier than 8-12 days after mifepristone administration because NSAIDs may reduce the effectiveness of mifepristone.
• Tacrolimus: Simultaneous use of NSAIDs and tacrolimus may increase the risk of nephrotoxicity. There is evidence of an increased risk of hemarthrosis and hematoma in HIV-positive patients with hemophilia who have received concomitant treatment with zidovudine and ibuprofen.
• Quinolone antibiotics: in patients receiving concomitant treatment with NSAIDs and quinolone antibiotics, an increased risk of seizures may occur.
• Cefamandol, cefoperazone, cefotetan, valproic acid, plicamycin: increased incidence of hypoprothrombinemia.
• Drugs that block tubular secretion: reduced excretion and increased plasma concentration of ibuprofen.
• Microsomal oxidation inducers (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants): increased production of hydroxylated active metabolites, increased risk of severe intoxication.
• Microsomal oxidation inhibitors: decreased risk of hepatotoxic effects.
• Peroral hypoglycemic drugs and insulin, sulfonylurea derivatives: increased effect.
• Antacids and colestyramine: decrease absorption.
• Caffeine: increase analgesic effect.

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Special Instructions

It is recommended to take the drug for the shortest possible course and in the minimum effective dose required for elimination of symptoms.

During long-term treatment it is necessary to control peripheral blood picture and functional state of liver and kidneys. In case of gastropathy symptoms occurrence a thorough control is required, including esophagogastroduodenoscopy, general blood test (hemoglobin determination), fecal occult blood test. If it is necessary to determine 17-ketosteroids, the drug should be cancelled 48 hours before the study.

Patients with renal insufficiency should consult a physician prior to using the drug because there is a risk of worsening of the functional state of the kidneys.

In patients with hypertension, including in the anamnesis and/or chronic heart failure it is necessary to consult with the physician before using the drug, because the drug may cause fluid retention, increased blood pressure and edema.

Patients with uncontrolled arterial hypertension, congestive heart failure II-III class according to NYHA, coronary heart disease, peripheral arterial disease and/or cerebrovascular disease should administer ibuprofen only after careful assessment of the benefit-risk ratio, while avoiding high doses of ibuprofen (>2400 mg/day).

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

Information for women planning pregnancy: these drugs inhibit cyclooxygenase and prostaglandin synthesis, affect ovulation, affecting female reproductive function (reversible after treatment withdrawal).

Influence on driving and operating machinery

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

Contraindications

• Hypersensitivity to ibuprofen or any of the ingredients of the drug;
• complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including history).gastrointestinal erosive and ulcerative diseases in aggravation stage (including peptic ulcer disease);
• gastrointestinal erosive and ulcerative diseases in aggravation stage (including gastric and duodenal ulcer, Crohn’s disease, ulcerative colitis) or peptic ulcer bleeding in active phase or in anamnesis (two or more confirmed episodes of peptic ulcer or ulcer bleeding);
• a history of bleeding or gastrointestinal ulcer perforation triggered by the use of NSAIDs;
• severe renal insufficiency (creatinine Clt; 30 ml/min), confirmed hyperkalemia;
• decompensated heart failure; post aortocoronary bypass;
• cerebrovascular or other bleeding;
• fructose intolerance;
• hemophilia and other clotting disorders (including
• pregnancy (III trimester);
• children under 12 years of age.

With caution: In the presence of the conditions mentioned in this section, consult a physician before using the drug – concomitant use of other NSAIDs, a history of a single episode of peptic ulcer disease or peptic ulcer bleeding; gastritis, enteritis, colitis, the presence of Helicobacter pylori infection, ulcerative colitis; bronchial asthma or allergic diseases in the acute stage or in the history – possible development of bronchospasm; systemic lupus erythematosus or mixed connective tissue disease (Sharp syndrome) increased risk of aseptic meningitis; renal failure, includingч. in dehydration (creatinine Cl less than 30-60 ml/min); nephrotic syndrome; liver failure; cirrhosis with portal hypertension; hyperbilirubinemia; arterial hypertension and/or heart failure; cerebrovascular disease; blood diseases of unclear etiology (leukopenia and anemia); Severe somatic diseases; dyslipidemia/hyperlipidemia; diabetes mellitus; peripheral arterial disease; smoking; frequent alcohol consumption; phenylketonuria or phenylalanine intolerance; concomitant use of drugs that may increase the risk of ulceration or bleeding, in particular oral GCS (incl.Prednisolone, anticoagulants (including warfarin), SSRIs (including citalopram, fluoxetine, paroxetine, sertraline) or antiaggregants (including acetylsalicylic acid, clopidogrel), pregnancy, I-II trimesters, breastfeeding, old age.

Side effects

The risk of side effects can be minimized if the drug is taken in a short course, in the minimum effective dose necessary to eliminate the symptoms.

Side effects are mainly dose-dependent.

The following adverse reactions were observed during short-term administration of ibuprofen in doses not exceeding 1200 mg/day (6 capsules). During treatment of chronic conditions and during long-term use other adverse reactions may occur.

Evaluation of the frequency of adverse reactions is made on the basis of 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 (< 1/10 000), Frequency unknown (data to estimate frequency are not sufficient).
Blood and lymphatic system disorders

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

Immune system disorders

• Infrequent: hypersensitivity reactions – non-specific allergic reactions and anaphylactic reactions, reactions from the respiratory system (bronchial asthma, including its exacerbation, bronchospasm, shortness of breath, dyspnea), skin reactions (itching, urticaria, purpura, Quincke’s edema, exfoliative and bullous dermatoses including toxic epidermal necrolysis (Lyell syndrome), Stevens-Johnson syndrome, erythema multiforme), allergic rhinitis, eosinophilia.
• Very rare: severe hypersensitivity reactions, including swelling of the face, tongue and throat, shortness of breath, tachycardia, arterial hypotension (anaphylaxis, Quincke’s edema 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: liver function disorders (especially with long-term use), hepatitis and jaundice.

Renal and urinary tract disorders

• Very rare: Acute renal failure (compensated and decompensated) especially with prolonged use, combined with an increase in plasma urea concentration 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.

Cardiovascular system disorders

• Frequent unknown: heart failure, peripheral edema, increased risk of thrombotic complications (such as myocardial infarction) with long-term use, increased blood pressure.

Respiratory and mediastinal disorders

• Frequency unknown: bronchial asthma, bronchospasm, dyspnea.

Other

• Very rare: edema, including peripheral.

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)
• hepatic transaminase activity (may increase)

If side effects occur, discontinue use and seek medical attention.

Overdose

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

Symptoms: nausea, vomiting, epigastric pain or, less frequently, diarrhea, tinnitus, headache and gastrointestinal bleeding. In more severe cases the following symptoms of the central nervous system may be observed: 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 may develop. Patients with bronchial asthma may have exacerbation of the disease.

Treatment: symptomatic, with mandatory provision of airway patency, ECG monitoring and basic vital signs until the patient’s condition normalizes.

Oral administration of activated charcoal or gastric lavage within 1 hour after taking a potentially toxic dose of ibuprofen is recommended. If ibuprofen has already been absorbed, alkaline drinking may be prescribed to eliminate the acidic ibuprofen derivative by the kidneys, forced diuresis. Frequent or prolonged seizures should be controlled with intravenous diazepam or lorazepam. In worsening bronchial asthma the use of bronchodilators is recommended.

Similarities

Nurofen, Nurofen Express, Brufen, Ibuprofen, Dolgit, Ibuprofen-Chemopharm, Nurofen Forte, MIG 400, Faspik, Nurofen Express Lady, Nurofen Express Forte, Nurofen Children, Next Uno Express, Nurofast